restraining sleeve

Abstract

An endoprosthesis delivery system includes an endoprosthesis and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis. The endoprosthesis constraining sleeve includes a sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge; and a deployment line coupled to the sheet of material along at least a portion of the first edge and along at least a portion of the second edge, wherein the sheet of material defines an internal cavity for receiving the endoprosthesis, and wherein the first surface of the sheet of material faces the internal cavity at the first edge and the second edge, and the second surface of the sheet of material faces away from the internal cavity at the first edge and the second edge.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of Provisional Application No. 63 / 564,044, filed on March 12, 2024, the full text of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to apparatus, systems, and methods for restraining and delivering built-in 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 provide simplified manufacturing and deployment of the delivery system. Background Technology

[0004] Intravascular prostheses used to treat treatment areas of 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 a graft or scaffold component, with or without graft covering. They can be designed to expand when restraints such as sleeves are removed, or to expand from a delivery diameter balloon to a predetermined functional diameter. During delivery, the intravascular prosthesis generally needs to be restrained to a small diameter to deliver it from the distal insertion site to the target site. To allow the intravascular prosthesis to advance through lumens (e.g., vascular systems), it is typically restrained to limit resistance to advancement, damage to surrounding tissues, etc. Therefore, there is a need for systems and methods for delivering intravascular prostheses.

[0005] Intravascular prostheses used to treat treatment areas of 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 graft covering in the stent space. They can be designed to expand when restraints such as sleeves are removed, or to expand from a delivery diameter balloon to a predetermined functional diameter. During delivery, the intravascular prosthesis needs to be restrained to a small diameter to allow delivery from the distal insertion site to the target site. For the intravascular prosthesis to advance through a lumen (e.g., the vascular system), it must be restrained to limit resistance to advancement, damage to surrounding tissues, etc. Therefore, there is a need for systems and methods for delivering intravascular prostheses with reduced diameters. Summary of the Invention

[0006] This disclosure relates to a constraint sleeve and deployment system configured to deliver and release a built-in prosthesis at a target location. The constraint sleeve and deployment system provides a reduced delivery profile.

[0007] 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 includes a material sheet including a first surface, a second surface opposite to the first surface, a first edge, and a second edge opposite to the first edge; and a development line connected to the material sheet along at least a portion of the first edge and at least a portion of the second edge. The material sheet defines an inner cavity for receiving the embedded prosthesis, and wherein the first surface of the material sheet faces the inner cavity at the first and second edges, and the second surface of the material sheet faces away from the inner cavity at the first and second edges.

[0008] According to a further example of Example 1 (“Example 2”), the first edge and the second edge do not overlap.

[0009] According to any of the foregoing examples, in a further example (“Example 3”), the unfolded line includes a sutured portion and an unsutured portion.

[0010] According to a further example of Example 3 (“Example 4”), at least a portion of the non-sutured portion is located within the lumen.

[0011] According to a further example of Example 3 (“Example 5”), the stitched portion is warp-knitted.

[0012] According to a further example (“Example 6”) of any of the foregoing examples, the first edge and the second edge overlap.

[0013] According to a further example of Example 6 (“Example 7”), the unfolded lines are chain stitched.

[0014] According to a further example of Example 7 (“Example 8”), the unfolded line includes a chain stitch at the sutured portion.

[0015] According to a further example of Example 8 (“Example 9”), the chain stitch defines a loop portion on one of the inner and outer sides of the constraint sleeve.

[0016] According to a further example of Example 9 (“Example 10”), the looped portion of the chain stitch is positioned on the outside of the constraint sleeve, and the unstitched portion of the unfolded line is positioned to extend through at least a portion of the inner cavity of the constraint sleeve.

[0017] According to one 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 material sheet including a first surface, a second surface opposite to the first surface, a first edge, and a second edge opposite to the first edge; and a development line connected to the material sheet along at least a portion of the first edge and at least a portion of the second edge, the development line including a warp-knitted loop defined along at least a portion of the length of the first edge and the second edge.

[0018] According to a further example of Example 11 (“Example 12”), the first edge and the second edge do not overlap.

[0019] According to a further example of Example 11 or Example 12 (“Example 13”), the unfolded line includes a sutured portion and an unsutured portion.

[0020] According to a further example of Example 13 (“Example 14”), at least a portion of the unstitched portion is positioned within an inner cavity defined by a sheet of material.

[0021] According to a further example (“Example 15”) of any of Examples 11-15, the first edge and the second edge overlap.

[0022] According to a further example (“Example 16”) of any of Examples 11-16, the first edge and the second edge are adjacent to each other.

[0023] According to one example (“Example 17”), a method of manufacturing a constraint sleeve includes: providing a material sheet including a first surface, a second surface opposite to the first surface, a first edge, and a second edge opposite to the first edge; positioning the material sheet such that the first edge and the second edge face each other, and the material sheet defines an inner cavity, wherein the first surface of the material sheet faces the inner cavity at the first edge and the second edge, and the second surface of the material sheet faces away from the inner cavity at the first edge and the second edge; and attaching a development line to the material sheet along at least a portion of the longitudinal length of the first edge and the second edge, wherein the material sheet and the development line define the constraint sleeve.

[0024] According to a further example of Example 17 (“Example 18”), the connecting unfolding line includes forming a knit along the longitudinal length of the material sheet.

[0025] According to a further example of Example 17 (“Example 19”), the connecting unfolding line includes forming a chain stitch along the longitudinal length of the material sheet.

[0026] According to a further example (“Example 20”) of any of Examples 17-19, a flip constraint sleeve is also included.

[0027] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by this disclosure. While several examples have been disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples. Therefore, the accompanying drawings and detailed description should be considered illustrative in nature and not restrictive in nature. Attached Figure Description

[0028] The accompanying drawings are included to provide a further understanding of this disclosure, and the drawings, which are incorporated in and form a part of this specification, illustrate embodiments and, together with the specification, serve to explain the principles of this disclosure: Figure 1 This is a schematic diagram of an embodiment of a delivery system according to an embodiment, the delivery system including a constraint sleeve that constrains a built-in prosthesis; Figure 2 This is a schematic diagram of an embodiment of a constraint sleeve defined by a material sheet and a development line according to an embodiment; Figures 3A-3D It is a cross-sectional view of a constraint sleeve in various configurations according to various embodiments; Figure 4A and Figure 4B This is a top view of a constraint sleeve implemented according to various embodiments to releasably connect the edges of a material sheet using warp knitting; Figure 5A and Figure 5B This is a top view of a constraint sleeve, according to various embodiments, implementing chain stitching to releasably connect the edges of material sheets, wherein... Figure 5B The flipped constraint sleeve is shown; and Figure 6 A cross-sectional view is shown of a constraint sleeve, according to an embodiment, which implements chain stitching to releasably connect the edges of a material sheet. Detailed Implementation

[0029] Definitions and Terms

[0030] This disclosure is not intended to be interpreted in a restrictive manner. For example, the terms used in this application should be interpreted broadly in the context of their meanings as would be attributed to those skilled in the art.

[0031] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to a measurement that includes the measured value and also includes any measurement that is reasonably close to the measured value. A measurement that is reasonably close to the measured value is a reasonably small deviation from the measured value that is understood and readily determined by a person skilled in the art. Such deviation may be attributed to, for example, measurement errors, differences in the calibration of measuring and / or manufacturing equipment, human errors in reading and / or setting the measured value, fine-tuning made to optimize performance and / or structural parameters in view of differences in measured values ​​associated with other components, specific implementation scenarios, imprecise adjustments and / or operations performed on the object by a person or machine, and / or the like. If the value of such a reasonably small difference is determined to be not readily determined by a person skilled in the art, the terms "about" and "approximately" may be understood to mean plus or minus 10% of the value.

[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 apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings mentioned herein are not necessarily drawn to scale but may be exaggerated to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting.

[0034] Figure 1 The illustrated deployment system 10 is provided as an example of various features of the systems and apparatus discussed herein, and although combinations of these illustrated features are clearly within the scope of the invention, this example and its schematic diagram are not intended to imply that the inventive concept provided herein is limited to... Figure 1 The features shown include one or more features, fewer features, additional features, or alternative features. For example, in various embodiments, by Figure 1 The constraint sleeve 14 defined by the sheet 100 and the unfolding line 200 of the unfolding system 10 shown may include reference Figures 2-6 The construction of the 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 by Figures 2-6 Used for the components depicted in the text. For example, Figure 1 The elongated member 12, implantable device 14 (e.g., an implantable prosthesis), and other components of the delivery system 10 shown can be coupled with Figures 2-6 The sheet 100 and the unfolding line 200 shown are used together.

[0035] Reference Figure 1The 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 scaffold 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 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, it is important that the components of the delivery system 10 be compact to allow for non-invasive and easier navigation through 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 restraint 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 and releasing the internal prosthesis 14 to a deployment diameter (e.g., releasing the internal prosthesis 14 from radial constraint) when the constraint sleeve 16 is in a release configuration. The constraint sleeve 16 may be provided as a sheet of material 100 (e.g., a film, diaphragm, etc.) having a deployment line 200. The sheet 100 defines an inner cavity 102 when coupled to the deployment line 200, the inner cavity 102 being configured to receive the internal prosthesis 14.

[0038] The constraint sleeve 16 includes a first end 20 and a second end 22, corresponding to a first end 104 and a second end 106 of the sheet 100. An inner cavity 102 is defined between the first end 104 and the second end 106 along the longitudinal length of the constraint sleeve 16. A development line 200 is releasably coupled to the sheet 100 along a first edge 108 and a second edge 110. When the sheet is coupled to the development line 200 to define the inner cavity 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.

[0039] Sheet 100 also includes a first surface 112 and a second surface 114 (see Figures 3A-3DThe first surface 112 is configured to face inward and define the boundary of the cavity 102, and the second surface 114 faces outward when the sheet is attached to the unfolding line 200 to define the constraint sleeve 16. The first surface 112 faces a first direction opposite to a second direction in which the second surface 114 faces. For example, in some embodiments, the material sheet is a flat material sheet, such as a diaphragm or film. In some embodiments, the material sheet is a tubular member flattened to form a flat material sheet, wherein the flattened tubular member defines a first surface 112 and a second surface 114 that are opposite to each other. A first edge 108 is defined at one end of the material sheet, and a second edge 110 is defined at the opposite end of the material sheet. Edges 108, 110 may represent the ends of the material sheet (e.g., the ends of a diaphragm or film), or may represent ends defined by a fold of the tubular member.

[0040] Figure 2 An embodiment of the unfolding line 200 is depicted, wherein the unfolding line connects to the sheet 100 along a first edge 108 and a second edge 110. (Refer to...) Figures 3A-3D In some embodiments, when the unfolding line 200 is attached to the sheet along or near the first edge 108 and the second edge 110, the first surface 112 of the sheet 100 faces the lumen 102 at the first edge 108 and the second edge 110, and the second surface 114 of the sheet 100 faces away from the lumen 102 at the first edge 108 and the second edge 110. This facilitates the ability to reduce the profile of the restraint sleeve 16 by allowing the first surface 112 of the sheet 100 to be flush with or substantially flush with the built-in prosthesis 14 in the restraint configuration. The reduced profile allows the delivery system 10 to include a more compact delivery configuration for navigation and advancement within the patient's biological lumen. A sleeve with the ends of chain-stitched or other material sheets joined together causes the first or second surface to restrain itself, creating a protrusion (e.g., a mohawk) on the outside of the restraint sleeve 16 or within the lumen, both of which can result in an increased diameter of the delivery system. Therefore, the systems and apparatus discussed herein provide a reduced diameter for the delivery system 10. Additionally, the delivery system 10 can reduce snagging of built-in prostheses and / or tissues on the sheet 100 or unfolding line 200 during delivery.

[0041] Reference Figure 3B and Figure 3C In some embodiments, the first edge 108 and the second edge 110 do not overlap. In these embodiments, the first edge 108 and the second edge 110 may be spaced apart from each other on at least a portion of the first edge 108 and the second edge 110 (see...). Figure 3B The first edge 108 and the second edge 110 may be spaced apart along the entire length of the first edge 108 and the second edge 110, or may be adjacent along a portion or the entire length of the first edge 108 and the second edge 110 (see...). Figure 3CHowever, in order to reduce the profile of the delivery system 10, the first edge 108 and the second edge 110 do not overlap, which means that the first edge 108 and the second edge 110 do not overlap circumferentially along the built-in prosthesis 14. In other words, the non-overlapping of the first edge 108 and the second edge 110 ensures that the sheet 100 does not overlap circumferentially, and that the first surface 112 does not contact the second surface 114 when in the delivery configuration.

[0042] Reference Figure 3D In some embodiments, the first edge 108 and the second edge 110 may overlap at least a portion of their lengths. When the first edge 108 and the second edge 110 overlap, the sheet is configured such that the first surface 112 and the second surface 114 remain oriented as previously described. For example, the first surface 112 may be oriented or facing the lumen 102, and the second surface 114 may be oriented towards the outside of the delivery system (e.g., substantially radially outward). By overlapping the first edge 108 and the second edge 110, the implanted prosthesis 14 can be completely circumferentially surrounded by the sheet 100, such that the implanted prosthesis 14 is not exposed to the biological lumen wall during delivery. Figure 3A One method is depicted in which the unfolded line 200 can be attached to the sheet 100 at the first edge 108 and the second edge 110. While this is one method of attaching the unfolded line 200 to the sheet 100, it should be understood that various other methods can be implemented to achieve the construction depicted and described herein. For example, Figure 3A The unfolded line 200 is depicted as being joined to the sheet 100 at a first orientation at the first edge 108 and the second edge 110, wherein the first edge 108 and the second edge 110 are close together in the first orientation and positioned such that the first surface 112 and the second surface 114 face each other at the first edge 108 and the second edge 110. However, the stitching performed via the unfolded line 200 facilitates rotation and / or movement of the unfolded line 200 relative to the sheet 100, which allows the first edge 108 and the second edge 110 to slide down to a reference. Figures 3B-3C Any position described such that the first surface 112 faces the cavity 102 at the first edge 108 and the second edge 110, and the second surface faces outward (e.g., radially outward) from the first edge 108 and the second edge 110.

[0043] Refer again Figure 2In some embodiments, the unfolding line 200 includes a sutured portion 202 and a non-sutured portion 204. The sutured portion 202 is the portion of the unfolding line 200 connected to (e.g., directly connected, sutured through, etc.) the sheet 100. The sutured portion 202 is releasable, allowing the unfolding line 200 to be released from the sheet 100 and the implanted prosthesis 14 to be freely unfolded (e.g., self-expanding, balloon expansion, etc.). The non-sutured portion 204 is the portion of the unfolding line 200 not directly connected to the sheet 100, extending away from the sheet 100. The extension of the non-sutured portion 204 allows the user to access it to apply force to unfold the implanted prosthesis 14. For example, the non-sutured portion 204, when actuated, facilitates the release of the sutured portion 202 from the sheet 100. The sutured portions 202 released from the sheet 100 remain continuous with the unfolding line 200, thus transitioning from sutured portions 202 to non-sutured portions 204 as they are released from the sheet. The unstitched portion 204 may extend back from the stitched portion 202 across at least a portion of the length of the sheet 100. The unstitched portion 204 may extend through the cavity 102 formed by the sheet or outside the cavity 102. This allows the implanted prosthesis 14 to unfold from the proximal end to the distal end. It should be understood that the suturing direction may be provided in various directions (e.g., such that the implanted prosthesis 14 can unfold from the distal end to the proximal end or other combinations), and is therefore not limited to the specific direction discussed herein. It should also be understood that the sheet 100 may include predefined holes (see...). Figure 1 The sewn part 202 extends through the hole, or the unfolded line 200 can be directly sewn into the sheet 100.

[0044] In some embodiments, the stitched portion 202 of the unfolded thread 200 may be attached to the sheet 100 in a warp-knitted pattern. The warp-knitted pattern facilitates the ability of the unfolded thread 200 to be released by pulling the unstitched portion 204. That is, the unfolded thread 200 is provided and attached to the sheet 100 such that the unfolded thread 200 holds the first edge 108 and the second edge 110 together at the location where the unfolded thread 200 is attached to the sheet 100 (e.g., the stitched portion 202), and the portion of the unfolded thread 200 extending away from the sheet (e.g., the unstitched portion 204) can be actuated to release the stitched portion 202 from the sheet 100. In some embodiments, this is achieved using warp knitting, such that the stitched portion 202 of the unfolded thread 200 is stitched through or attached to the sheet 100 in such a way that the stitched portion 202 of the unfolded thread 200 is warp-knitted.

[0045] Reference Figures 5A-6 In some embodiments, the unfolding thread 200 is flush-stitched onto the sheet 100. For example, the stitched portion 202 of the unfolding thread 200 is joined to the sheet 100 with a flush-stitch configuration along the first edge 108 and the second edge 110, the flush-stitch configuration being releasable from the sheet for unfolding the built-in prosthesis 14 from the unfolding system 10. In some embodiments, the stitched portion is a chain stitch. See also Figure 5A and Figure 5B The sheet 100 can be arranged such that the looped portion 210 of the chain stitch is positioned on the outside of the sheet 100 (see Figure 5A ) or the inside of the sheet (see Figure 5B When the looping portion 210 is positioned on the outer side of the sheet 100, the non-sutured portion 204 extends from the inner side of the sheet 100. This can be used to cause the unfolding line to extend through at least a portion of the cavity 102. This allows the non-sutured portion 204 to be protected within the cavity 102 during unfolding, so that the unfolding line is not damaged or causes damage to biological tissue at the target site during unfolding. Alternatively, when the looping portion 210 is positioned on the inner side (e.g., when the restraint sleeve 16 is flipped), the non-sutured portion 204 extends on the outer side of the tubular member defined by the sheet 100. This arrangement may be advantageous in embodiments where the chance of the unfolding line 200 snagging or damaging the built-in prosthesis positioned within the cavity 102 is increased.

[0046] Turning to the discussion of manufacturing methods, in some embodiments, the constraint sleeve 16 may be manufactured using a material sheet 100 as described herein and a development line 200 as described herein. As previously described, the material sheet 100 includes a first surface 112, a second surface 114 opposite to the first surface 112, a first edge 108, and a second edge 110 opposite to the first edge 108. The material sheet 100 is positioned such that the first edge 108 and the second edge 110 face each other and the material sheet 100 defines an inner cavity 102, wherein the first surface 112 of the material sheet faces the inner cavity 102 at the first edge 108 and the second edge 110, and the second surface 114 of the material sheet 100 faces away from the inner cavity 102 at the first edge 108 and the second edge 110. The development line 200 is then coupled to the material sheet 100 along at least a portion of the longitudinal length of the first edge 108 and the second edge 110 of the material sheet 100, wherein the material sheet 100 and the development line 200 define the constraint sleeve 16.

[0047] In some embodiments, the method includes forming a knit or stitch along the longitudinal length of the material sheet 100. The knit or stitch can be those described above herein. For example, in some embodiments, the connecting unfolded line 200 includes forming a chain stitch along the longitudinal length of the material sheet 100. The method may further include flipping the constraint sleeve 16.

[0048] In some embodiments, the material sheet 100 includes 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 includes 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, urethane, 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 the previously described material combinations. The material sheet 100 may include various configurations, including films, laminates, diaphragms, tapes, etc.

[0049] In some embodiments, the unfolded suture 200 may be formed of various materials. For example, the unfolded suture 200 may be formed of any material suitable for suturing, such as ePTFE, nylon, polypropylene, surgical cotton, surgical silk, surgical steel, polyester, etc.

[0050] The invention of this application has been described for general purposes and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments without departing from the scope of this disclosure. Therefore, it is intended that the embodiments cover modifications and variations of the invention, provided 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 constrain the internal prosthesis, the internal prosthesis restraint sleeve comprising: A material sheet, the material sheet including a first surface, a second surface opposite to the first surface, a first edge, and a second edge opposite to the first edge; as well as A development line, the development line being connected to the material sheet along at least a portion of the first edge and at least a portion of the second edge. The material sheet defines an internal cavity for receiving the built-in prosthesis, and The first surface of the material sheet faces the inner cavity at the first and second edges, and the second surface of the material sheet faces away from the inner cavity at the first and second edges.

2. The built-in prosthesis delivery system according to claim 1, characterized in that, The first edge and the second edge do not overlap.

3. The built-in prosthesis delivery system according to any of the preceding claims, characterized in that, The unfolded line includes sutured and unsutured portions.

4. The built-in prosthesis delivery system according to claim 3, characterized in that, At least a portion of the unstitched portion is located within the cavity.

5. The built-in prosthesis delivery system according to claim 3, characterized in that, The stitched portion is warp-knitted.

6. The built-in prosthesis delivery system according to any of the preceding claims, characterized in that, The first edge and the second edge overlap.

7. The built-in prosthesis delivery system according to claim 6, characterized in that, The development lines are chain-stitched.

8. The built-in prosthesis delivery system according to claim 7, characterized in that, The unfolded lines include chain stitches at the sutured portions.

9. The built-in prosthesis delivery system according to claim 8, characterized in that, The chain stitch defines a loop portion on one of the inner and outer sides of the constraint sleeve.

10. The built-in prosthesis delivery system according to claim 9, characterized in that, The looped portion of the chain stitch is positioned on the outside of the constraint sleeve, and the unstitched portion of the unfolded line is positioned to extend through at least a portion of the inner cavity of the constraint sleeve.

11. A built-in prosthesis delivery system, comprising: Internal prosthesis; as well as An internal prosthesis restraint sleeve configured to constrain the internal prosthesis, the internal prosthesis restraint sleeve comprising: A material sheet, the material sheet including a first surface, a second surface opposite to the first surface, a first edge, and a second edge opposite to the first edge; as well as A development line, the development line being connected to the material sheet along at least a portion of the first edge and at least a portion of the second edge. The unfolded line includes at least a portion of the length of the first edge and the second edge defining a warp-knitted loop.

12. The built-in prosthesis delivery system according to claim 11, characterized in that, The first edge and the second edge do not overlap.

13. The built-in prosthesis delivery system according to claim 11 or claim 12, characterized in that, The unfolded line includes sutured and unsutured portions.

14. The built-in prosthesis delivery system according to claim 13, characterized in that, At least a portion of the unstitched portion is positioned within an inner cavity defined by the sheet of material.

15. The built-in prosthesis delivery system according to any one of claims 11-15, characterized in that, The first edge and the second edge overlap.

16. The built-in prosthesis delivery system according to any one of claims 11-16, characterized in that, The first edge and the second edge are adjacent to each other.

17. A method for manufacturing a constraint sleeve, comprising: A material sheet is provided, the material sheet including a first surface, a second surface opposite to the first surface, a first edge, and a second edge opposite to the first edge; The material sheet is positioned such that the first edge and the second edge face each other and the material sheet defines an inner cavity, wherein the first surface of the material sheet faces the inner cavity at the first edge and the second edge, and the second surface of the material sheet faces away from the inner cavity at the first edge and the second edge; as well as A development line is connected to the material sheet along at least a portion of the longitudinal length of the first and second edges of the material sheet, wherein the material sheet and the development line define a constraint sleeve.

18. The method according to claim 17, characterized in that, Connecting the unfolded lines includes forming a knit along the longitudinal length of the material sheet.

19. The method according to claim 17, characterized in that, Connecting the unfolded lines includes forming a chain stitch along the longitudinal length of the material sheet.

20. The method according to any one of claims 17-19, further comprising flipping the constraint sleeve.

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