Constraint arrangements for stent grafts loaded onto delivery systems

Abstract

A constraining arrangement for a stent graft loaded onto a delivery device. The stent graft has a graft body defining an elongate lumen and a positionable region. At least one juxtaposed release wire releasably secures the graft body to the guidewire cannula along the length of the guidewire cannula. The suture is sewn circumferentially through and around the graft body such that a plurality of internal suture portions are formed. The restraint loop is formed by a first one of the inner suture portions. The plurality of narrowing rings are formed from other ones of the inner suture portions. At least one juxtaposition release wire passes through each of the plurality of reduction rings and the restraint ring, and releases each of the reduction rings and the restraint ring when the juxtaposition release wire is retracted, thereby allowing the stent graft to expand and release from the guidewire cannula.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 581,548, filed September 8, 2023, which is hereby incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to medical devices, and more specifically to stent grafts that can be mounted onto deployment devices for intravascular introduction. Background Technology

[0004] This disclosure will specifically discuss stent grafts used for placement in the aorta to treat aneurysms. However, this disclosure is not limited to this and can be applied to stent grafts used for placement in any lumen of a human or animal body.

[0005] Precise placement of stent grafts is crucial for several reasons, including the need to avoid branch artery occlusion in many cases. However, placement is complex because the diameter of the stent graft is typically intentionally made larger than the diameter at placement to allow for an accurate seal against the vessel wall. Once released from the delivery device, the stent graft, with its self-expanding structure, will occupy the position against the vessel wall.

[0006] Many aneurysm repair cases require precise placement of the stent graft relative to certain anatomical features, such as fenestrations or fan-shaped notches. Accurate rotational positioning is also important in many cases. When the stent graft is to be deployed in a curved portion of the vessel (such as the aortic arch), it is also important that the stent graft conforms to, for example, the internal portion of the curved section of the aorta. The purpose of this disclosure is to provide a stent graft system that allows for accurate placement, repositioning, and conformation.

[0007] Throughout this specification, the term "distal" refers to the end of the aorta, deployment device, or prosthesis that is away from the heart in the direction of blood flow, while the term "proximal" refers to the portion of the aorta, deployment device, or prosthesis that is closer to the heart. Similar terms, such as caudal and cephalic, should be understood when applied to other blood vessels. Summary of the Invention

[0008] A constraint arrangement for a scaffold graft, in combination with a scaffold graft, for loading onto a delivery device. The scaffold graft has a graft body defining an elongated lumen and a positionable region. At least one juxtaposed release wire releasably secures the graft body to a guidewire cannula along its length. A first suture passes circumferentially through and sutures around the graft body, forming a plurality of outer suture portions and a plurality of inner suture portions. A constraint loop is formed by a first inner suture portion among the inner suture portions and surrounds the guidewire cannula to constrain the positionable region, making the positionable region closely juxtaposed with the guidewire cannula. A plurality of shrinking loops are formed by other inner suture portions among the inner suture portions, extending radially inward from the graft body. At least one juxtaposed release wire passes through each of the plurality of shrinking loops and the constraint loop, and releases each of the shrinking loops and the constraint loop upon retraction of the juxtaposed release wire, thereby allowing the scaffold graft to expand and be released from the guidewire cannula. The juxtaposed release wire may be helical, wavy, or vortex-shaped. The juxtaposed release threads can be woven into and out of the graft. The first suture can be attached at the distal apex of the nearest internal scaffold.

[0009] This invention can be practiced according to the claims, without needing some or all of these specific details. For clarity, known technical materials in the art related to this invention have not been described in detail, so as not to unnecessarily obscure the invention. Attached Figure Description

[0010] The invention has been generally described above, but for the purpose of understanding, reference will now be made to the accompanying drawings which illustrate preferred embodiments of the invention.

[0011] Figure 1A This is a side view of the scaffold graft;

[0012] Figure 1B This is a side view of a portion of the scaffold graft and delivery device assembly;

[0013] Figure 2A yes Figure 1B A stylized end view of the proximal interior of the scaffold graft shown;

[0014] Figure 2B yes Figure 2A A close-up illustrative view of the proximal interior of the scaffold graft shown;

[0015] Figure 3 Is with Figure 2B The view is similar to the previous one, but shows an alternative suture arrangement;

[0016] Figure 4 yes Figure 1B , Figure 2A and Figure 2BA close-up view of the proximal portion of the scaffold graft and delivery device assembly;

[0017] Figure 5 and Figure 6 It shows Figure 1B , Figure 2A and Figure 2B A schematic view of the deployment of the stent graft and delivery device components under the patient's aortic arch;

[0018] Figure 7A This is a side view of the alternative scaffold graft;

[0019] Figure 7B This is a side view of the alternative scaffold graft and delivery device assembly;

[0020] Figure 8 yes Figure 7B A close-up view of the proximal portion of the scaffold graft and delivery device assembly;

[0021] Figure 9 yes Figure 8 A side view of the handle end of the delivery device;

[0022] Figure 10A It is an isometric view of the scaffold graft and delivery device assembly;

[0023] Figure 10B Is with Figure 10A The view is similar to the view shown, but it shows the released scaffold graft;

[0024] Figure 11A This is a front view of the constraint arrangement for the stent graft to be loaded onto the delivery system;

[0025] Figure 11B This is a front view of another constrained arrangement for a stent graft to be loaded onto a delivery system;

[0026] Figure 12A yes Figure 11A A close-up view of the lumen of the stent graft, showing the sutures surrounding the cannula tether.

[0027] Figure 12B Is with Figure 12A The view is similar to the view shown, but the stitching is taut;

[0028] Figure 13 yes Figure 11A The scaffold graft shown is another view taken from inside the lumen before it is fixed;

[0029] Figure 14 yes Figure 11A , Figure 12A , Figure 12B and Figure 13 A close-up view of a portion of the constraint arrangement;

[0030] Figure 15A and Figure 15B They are shown separately Figure 11A A schematic view of the wiring of the suture line in both constrained and unconstrained states;

[0031] Figure 16A , Figure 16B and Figure 16C The illustration is a step-by-step diagram showing the constraint arrangement of the previous figures deployed within the patient's lumen and then released.

[0032] Figure 17 This is a front view of an alternative constraint arrangement for a stent graft loaded onto a delivery system, according to the second aspect of this disclosure.

[0033] Figure 18 yes Figure 17 Another view of the scaffold graft shown, taken from inside the lumen before fixation;

[0034] Figure 19A and Figure 19B They are shown separately Figure 17 A schematic view of the wiring of the suture line in both constrained and unconstrained states;

[0035] Figure 20 This is a front view of the constraint arrangement for the alternative scaffold graft to be loaded onto the delivery system;

[0036] Figure 21 This is a stylized end view of the proximal end of the stent graft, showing two sutures with two release wires.

[0037] Figure 22 and Figure 23 This is an illustration of a stylized end view within the proximal end of a stent graft, showing two sutures with a single release wire; and

[0038] Figure 24 This is an illustration of a stylized end view within the proximal end of a stent graft, showing a suture with two release wires. Detailed Implementation

[0039] The terms “approximately,” “substantially,” “roughly,” and other degree terms, when used to refer to any volume, size, proportion, or other quantitative or qualitative value, are intended to convey a definite and identifiable value within a standard parameter that would be understood by a person skilled in the art (e.g., equivalent to an experienced mechanical engineer in the art), and should be interpreted to include at least any legal equivalents, minor but functionally insignificant variations, standard manufacturing tolerances, and at least mathematically meaningful numbers (though not required to be as extensive as their maximum range), including deviations up to, for example, 5%, 2%, 1%, or smaller or larger as a person skilled in the art would deem appropriate.

[0040] refer to Figure 1A The diagram shows a side view of a stent graft 10 that can be used in conjunction with or form part of the embodiments disclosed herein. The stent graft 10 extends between a proximal portion 11 and a distal portion 19 and has a graft body 13 defining an elongated lumen 15, as well as a plurality of stents 17, 20, 22, 31, 32, 33, 34, 35, 36, 40, 50. In the particular embodiment shown, stents 20, 22 at one end of the stent graft 10 are internal stents, and similarly, stents 40, 50 at the opposite end of the stent graft 10 are internal stents, while external stents 31, 32, 33, 34, 35, 36 are between the internal stents. The internal stents 20, 22, 40, 50 help to provide a sealing area at the respective ends of the stent graft 10. It should be understood that other suitable stent arrangements may be used based on various considerations, including the use of external stents, for example, at the distal and / or proximal ends.

[0041] Figure 1A The stent graft 10 also has an exposed distal stent 17 with barbs to prevent displacement along the interior of the blood vessel after deployment. Other stent grafts that do not have an exposed distal stent, such as Figure 1B The scaffold graft 10 shown can also be used in conjunction with the embodiments disclosed herein.

[0042] Figure 1B This is a side view of a portion of the scaffold graft and delivery device assembly. The scaffold graft 10 of this assembly is similar to... Figure 1A The scaffold graft shown, but without... Figure 1A The exposed distal stent 17 of the stent graft in the middle. Figure 1A In other embodiments of the scaffold graft and delivery device assembly shown, an exposed end scaffold 17 with or without barbs may be provided.

[0043] from Figure 1BIt can be seen that the delivery device component of the scaffold graft and delivery device assembly may include a guidewire cannula 115 positioned therein. Figure 10A and Figure 10B The sleeve 110 (shown in the diagram) is made of urethane nontransparent tubing (UAT). Other suitable materials and constructions may be used. The sleeve 110, and therefore the guidewire cannula 115, passes through the lumen 15.

[0044] Figure 1B The diagram also shows a graft-mounted release wire 120 that releasably secures the graft body 13 relative to the guidewire cannula 115 along the length of the guidewire cannula 115. The release wire 120 can repeatedly penetrate the graft body 13 from the inside to the outside and then back to the inside of the graft body 13 around the guidewire cannula 115, so as to repeatedly wrap around the guidewire cannula 115 along the longitudinal length of the scaffold graft 10, thereby securing the scaffold graft 10 against the inner wall of the guidewire cannula 115. Figure 1B Elements 124 to 127 in the diagram show juxtaposed release filaments woven into and out of the graft in the manner described above.

[0045] Now go to Figure 1B , Figure 2A , Figure 2B , Figure 4 , Figure 5 , Figure 6 , Figure 10A and Figure 10B The following will describe in further detail the constraint arrangement of a stent graft 10 combined with a delivery device according to embodiments of this disclosure. The stent graft 10 has a graft body 13 defining an elongated lumen 15 and a positionable region 16. Figure 3 and Figure 4 The image shows a positionable region 16. In the illustrated embodiment, the positionable region 16 is located at the distal end 18 of the inner scaffold 20 on the nearest side. The positionable region is also positioned to define a 12 o'clock position 23 on the scaffold graft.

[0046] The restraint arrangement includes a graft body juxtaposition release wire 120 that releasably secures the graft body 13 relative to the guidewire cannula 115 along the length of the guidewire cannula 115. In the illustrated embodiment, a sleeve 110 is present on the guidewire cannula 115, so the graft body 13 is also secured around the sleeve 110. The stent graft can be any type of stent graft. Specific stent grafts suitable for use with the present invention are described and disclosed, for example, in U.S. Patent No. 9,649,188, entitled “Thoracic Aorta Stent Graft,” filed February 9, 2011; U.S. Publication No. 2018 / 0303641, filed April 23, 2018; and U.S. Publication No. 2024 / 0122695, filed October 16, 2023, the contents of which are incorporated herein by reference in their entirety. This discloses a stent graft with one or more shaped depressions having fenestrations and internal branches extending from the fenestrations. This type of stent graft is particularly suitable for the thoracic aorta or aortic arch.

[0047] See Figure 1B as well as Figure 2A and Figure 2B It can be clearly seen that the suture 81 passes circumferentially through and sutures around the graft body 13, thus forming multiple external suture portions 80 and multiple internal suture portions 70. For example... Figure 2B As shown, a constraint ring 72 is provided, formed by a first internal suture portion 70, having legs 72a and 72b and an annular end 73. The constraint ring 72 surrounds the sleeve 110 and constrains the positionable region 16, placing it tightly juxtaposed with the sleeve 110 (and thus with the guide wire cannula 115 within the sleeve 110). A plurality of narrowing rings 74, 76, 78, formed by other internal suture portions 70, extend radially inward from the graft body 13. A juxtaposed release wire 120 passes through each of the multiple narrowing rings 74, 76, 78 and the constraint ring 72, which reduces the diameter of the scaffold graft at the location of at least the distal end 18 of the nearest side scaffold 20, such as at least Figure 1B As shown. In some embodiments, when the stent graft 10 also includes a lateral branch located within the nearest-side stent, the nearest-side ring (e.g., a nitinol ring) on ​​the lateral branch is in an open position and is at least proximal to the position where the restraint ring 72 engages and the release wire 120 is positioned. The lateral branch can then be compressed (e.g., downwards by about one-third), but this has no effect on the lateral branch because its support structure is made of a flexible material (e.g., nitinol), so the lateral branch springs back into place once the stent graft is released.

[0048] The restraint ring and shrinkage ring can be placed anywhere along the length of the scaffold graft, as in US Publication No. 2022 / 0280280. Figure 1B As shown, the disclosure of this U.S. public domain is incorporated herein by reference in its entirety. U.S. Patent No. 9,855,128, filed October 9, 2009, entitled “Introducer for Deploying a Stent Graft in a Curved Lumen and Stent Graft Thererfor,” describes and illustrates a shrinking ring that engages one or more trigger wires within the lumen of a stent graft; the disclosure of that U.S. patent is incorporated herein by reference in its entirety.

[0049] Once the stent graft is introduced and properly positioned, the retraction of the release wire 120 releases each of the shrinking rings 74, 76, 78 and the restraint ring 72, thereby allowing the stent graft 10 to expand and be released from the guidewire cannula 115 and the sleeve 110.

[0050] Refer again Figure 1B and Figure 2B As can be seen, the juxtaposed release wire 120 penetrates from the outside of the graft body 13 into the interior of the graft body 13, and then returns from the interior of the graft body 13 to the outside, thereby providing a substantially linear attachment region 14 within the graft body 13, wherein the restraint ring 72 restrains the positionable region 16 of the stent graft to the sleeve 110 and the guide wire cannula 115 within the sleeve 110. The juxtaposed release wire 120 includes a proximal end 128. The proximal end 128 and the tip (e.g., nasal cone) 160 are located within the sleeve 110 in the loading position and outside the sleeve 110 in the deployment position.

[0051] exist Figure 2B In this case, the constraint ring 72 engages and releases the release wire 120 at a position near the position where the shrinking rings (e.g., 74, 76, and 78) engage and release the wire 120.

[0052] exist Figure 3 An alternative arrangement is shown, wherein the restraint ring 72 engages and releases the release wire 120 at a position distal to the position where the shrinking rings (e.g., 74, 76, and 78) engage and release the wire 120.

[0053] Figure 4 yes Figure 1B , Figure 2A and Figure 2BA close-up view of the proximal portion of the scaffold graft and delivery device assembly. The figure shows a proximal release wire 131 that releasably secures a portion of the proximal end of the scaffold graft to the sleeve 110 and thus to the guidewire cannula 115.

[0054] Refer again Figure 4 As can be seen, the restraint arrangement includes a proximal support 20 attached to the graft body. A proximal release wire 131 passes through the proximal end of the proximal support 20. (As shown...) Figure 10A and Figure 10B As shown, two additional proximal release wires 132 and 133 also pass through the proximal end of the proximal stent and hold the proximal stent in a defined position. All three proximal release wires 131, 132, and 133 are... Figure 10A and Figure 10B The image shows, and is operatively connected to, a drawing mechanism (e.g., a first release knob) 176. U.S. Patent No. 9,855,128, entitled “Introducer for Deploying a Stent Graft in a Curved Lumen and Stent Graft Therefor,” discloses and describes a suitable configuration for the proximal end of a stent graft, the contents of which are incorporated herein by reference in their entirety. Alternatively, a distal release filament (not shown) can be used to hold the distal end of the stent graft. The distal release filament can be directly attached to the distal end of the stent graft by piercing the fabric of the graft at the distal end. Alternatively, the distal release filament can be engaged with a suture (not shown) at the distal end of the stent graft.

[0055] Return to Figure 10A and Figure 10B These figures illustrate isometric views of a stent graft and delivery device assembly according to embodiments of this disclosure. As can be seen, the delivery device includes: a guidewire cannula 115 described above for sliding on a guidewire; a sleeve 110 disposed around the guidewire cannula 115; an end 160 (e.g., a nasal cone) located at the proximal end 116 of the guidewire cannula 115; a handle 170 located at the distal end 117 of the guidewire cannula 115; and a pusher 150 disposed around the guidewire cannula 115 and extending proximally from the handle 170. The delivery device also has a stent graft receiving area 119 located between the end and the pusher, such as... Figure 10A As shown.

[0056] Refer again Figure 10A and Figure 10BA multi-functional wire-drawing mechanism 176 is provided on the handle 170. A release wire 120 is operatively connected to the multi-functional wire-drawing mechanism 176, such that the multi-functional wire-drawing mechanism 176 is actuated to release each of the shrinking rings 74, 76, 78 and the restraint ring 72. This release allows the stent graft 10 to expand and be released from the guidewire cannula 115.

[0057] The multi-functional wire-drawing mechanism 176 on the handle 170 is actuated by pulling in a distal direction by an operator (such as a surgeon). In other embodiments of this disclosure, a rotatable multi-functional wire-drawing mechanism 176 of the type described in U.S. Patent No. 8,968,380, filed October 9, 2009, entitled “Deployment Handle For An Introducer,” and U.S. Patent No. 10,335,301, filed August 23, 2016, entitled “Modular Handle Comprising a Trigger Wire Actuation Mechanism for a Prosthesis Delivery Device,” both of which are incorporated herein by reference in their entirety.

[0058] Figure 7A It can be used in the embodiments of this disclosure (e.g.) Figure 7B A side view of the alternative scaffold graft 10 used in conjunction with an embodiment shown in the middle section. (Compared to, for example...) Figure 1A Compared to the conventional stent graft 10, this simpler stent graft 10 can be used in the ascending aorta of some patients. Figure 7A The scaffold graft 10 has only one external scaffold 35 and two internal scaffolds 20, 50. An exemplary device is shown in U.S. Patent No. 9,757,263 entitled “Stent Graft and Introducer Assembly,” the contents of which are incorporated herein by reference in their entirety.

[0059] Figure 7B This is a side view of the alternative scaffold graft and delivery device assembly, showing... Figure 7A The scaffold graft 10 is loaded onto the scaffold graft receiving area of ​​a delivery device having a tip 160 (e.g., a nasal cone). A release wire 120 is placed to releasably secure the graft body 13 relative to the guide wire cannula 115 within the sleeve 110 along the length of the guide wire cannula 115.

[0060] Figure 8 yes Figure 7A and Figure 7B A close-up view of the proximal portion of the stent graft 10. This figure illustrates how the proximal release wire 131 releasably attaches the proximal end of the stent graft to the sleeve 110 and the guidewire cannula 115 within it. The same or similar arrangements, including distal release wire arrangements, can be provided at the distal end.

[0061] Figure 9 China and Israel Figure 7B and Figure 8 A side view of the handle end of the delivery device shows the handle 170 for actuating the wire.

[0062] Compared to existing art arrangements, the embodiments described above in this disclosure reduce the risk of entanglement. These embodiments also allow for the release of the shrinking ring and restraint ring with a single actuation. These embodiments can further release the proximal release wires 131 (132, 133) simultaneously. Single actuation saves time in aortic interventional procedures, and for example, reduces the risks faced by patients who may be under cardiac control.

[0063] The embodiments described above are easier to manufacture than existing stent graft and delivery device assemblies, thus saving time and reducing the risk of deployment failure. Furthermore, the combined shrinking and restraining rings allow them to be pulled together and released via a single release wire. This saves time for physicians when rapid release under cardiac control is required. The process of attaching the graft to the delivery device in this manner is both quick and simple. This helps reduce aneurysm growth, lowers the likelihood of retrograde tearing, and reduces the rate of re-intervention, among other benefits.

[0064] In the first alternative embodiment, such as Figure 21 As shown, the shrinking rings 74, 76, and 78 can be the first suture 83, and the restraining ring 72 can be a separate / second suture 85, each suture having its own release threads 121 and 123. Figure 21 As shown, a single internal suture portion of the second suture 85 includes a restraint ring 72 and engages with a release wire 123. As further shown, multiple (e.g., three shown here) internal suture portions of the first suture 83 include constriction rings 74, 76, and 78 and engage with a release wire 121. The release wire 121 may be located outside the guidewire cannula 115, such as... Figure 23 As shown, it can also extend through the guidewire cannula 115, exit through the orifice 129, engage multiple internal suture portions of the shrinking rings 74, 76, and 78, and re-enter the guidewire cannula 115 at the orifice 139, as... Figure 21 As shown.

[0065] In a second alternative embodiment, such as Figure 22 and Figure 23As shown, the constricting rings 74, 76, and 78 can be the first suture 83, and the restraint ring 72 can be a separate / second suture 85, employing a single release wire 130, which serves as both the constricting ring release wire and the juxtaposition release wire. The single release wire 130 can be located outside the guidewire cannula 115, such as... Figure 23 As shown, it may extend through the guidewire cannula 115, exit through the orifice 129, engage multiple internal suture portions of the shrinking rings 74, 76 and 78 and the restraint ring 72, and re-enter the guidewire cannula 115 at the orifice 139.

[0066] In a third alternative embodiment, such as Figure 24 As shown, there is a single suture line, and... Figure 2A and Figure 2B Similar to the one shown, but employing two release wires, including a shrinking ring release wire 121 and a juxtaposed release wire 123. (See diagram below.) Figure 24 As shown, the shrinking ring release wire 121 engages multiple internal suture portions of the shrinking rings 74, 76, and 78, and the juxtaposed release wire 123 engages the restraint ring 72. The shrinking ring release wire 121 and the juxtaposed release wire 123 may both be located inside the guidewire cannula 115, or both may be located outside the guidewire cannula 115, or one of them may be located inside the guidewire cannula 115 while the other of them may be located outside the guidewire cannula 115.

[0067] In the embodiments using the first and second sutures discussed above, the first and second sutures may be longitudinally spaced apart from each other. For example, the first suture may be proximal to the second suture, or the second suture may be proximal to the first suture. Alternatively, the first and second sutures may be in the same plane. In embodiments with both first and second sutures, the sutures including the restraint loop may not extend completely circumferentially around the scaffold graft, but only partially, such as... Figure 11A , Figure 11B and Figure 13 As shown and described. Similarly, the sutures including the narrowing ring may not extend circumferentially around the scaffold graft completely, but only partially.

[0068] The embodiments described above do not require a special sleeve 110, as only an additional hole is needed in the sleeve 110 for juxtaposing the proximal end 128 of the release wire. This hole 112 is... Figure 7B As shown in the figure, and can be achieved by placing the proximal end 128 of the release wire in a juxtaposed manner. Figure 7B It is easily made by inserting it into the sleeve 110 at the position shown.

[0069] Typically, the more filaments actuated by a single filament drawing mechanism (e.g., a single release knob) on a delivery device, the greater the frictional force that the operator of the delivery device needs to overcome. However, with the above arrangement, it has been unexpectedly found that the filament drawing mechanism (e.g., the first release knob) 176 can simultaneously actuate three proximal release filaments 131, 132, 133 and the juxtaposed release filament 120 with controllable frictional force.

[0070] Figure 5 and Figure 6 It shows Figure 1B , Figure 2A and Figure 2B A schematic view of the deployment of the stent graft and delivery device assembly within the patient's aortic arch 7. As shown, the aortic arch branches into three arterial branches—the brachiocephalic artery 4, the left common carotid artery 5, and the left subclavian artery 6. Figure 5 A stent graft 10 prepared for deployment in the aortic arch 7 is shown on a delivery device. Figure 6 The deployed stent graft 10 is shown, with no "bird's beak" phenomenon or gap between the aortic wall 8 and the graft body 13.

[0071] A method for fabricating a scaffold graft includes inserting and exiting circumferential sutures into and out of the graft to form an internal loop. The sutures cross the struts of the scaffold, preferably at the apex outside the graft and preferably between the struts inside the graft. The ends of the sutures meet and are knotted at the 12 o'clock position. A lateral release wire (which may be a spiral wire) preferably extends internally before reaching the distal apex of the internally sealed scaffold, exits the graft below the distal apex, and then re-enters the graft, preferably below the distal apex. A 12 o'clock suture loop is used as a suture loop cannula constraint; the loop (located below the wire) slides around the cannula, and the wire extends through the loop. In this way, the loop surrounds the cannula and engages the lateral release wire, such that the lateral release wire and the cannula are side-by-side and abut against the inner wall of the scaffold graft. At least one of the internal suture portions is then pulled toward the lateral release wire, and the lateral release wire is inserted into at least one of the internal suture portions. Figure 2A , Figure 2B and Figure 3 In the illustrated embodiment, the internal suture portions at the 3 o'clock, 6 o'clock, and 9 o'clock positions are pulled toward the juxtaposed release wire, and the juxtaposed release wire is inserted into each of the internal suture portions at the 3 o'clock, 6 o'clock, and 9 o'clock positions. The end of the juxtaposed release wire is then woven from the inside of the graft to the outside and pulled, thereby pulling the loop toward the 12 o'clock position. The juxtaposed release wire and the cannula are flush with the wall of the graft and are in a side-by-side position.

[0072] U.S. Publication No. 2022 / 0280280, entitled “Constraint Arrangement For a Stent-Graft Loaded Onto a Delivery System,” filed on February 28, 2022, and published on September 8, 2022, discloses a release wire. The contents of that '280 publication are incorporated herein by reference in their entirety.

[0073] As described in U.S. Publication No. 2022 / 0280280, refer to this document. Figure 11A The diagram illustrates a constrained arrangement of a scaffold graft 200 loaded onto a delivery system according to a first embodiment of this disclosure. The scaffold graft has a graft 202 defining an elongated lumen 204, a plurality of scaffolds 206, 208, 210, and at least one positionable region 212 of adjacent features (such as a fenestration 214 or a fan-shaped notch 215). The delivery system includes a cannula 216 and a release wire 218.

[0074] Now for reference Figure 11A , Figure 12A , Figure 12B and Figure 13 As can be seen, the constraint arrangement includes: a suture 220 that extends circumferentially around the outer surface 222 of the graft from the first fixed end 224 of the graft to the positioning region 212, and at the first constraint perforation 228 ( Figure 13 The graft passes through the graft 202 into the lumen at the second constraint perforation 230. Figure 13 The tube emerges from the lumen and returns to the outer surface of the graft, reaching the second fixation end 226 fixed to the scaffold graft 200. A suture loop 232 is formed within the lumen. This loop 232... Figure 13 As shown in the image.

[0075] refer to Figure 12A , Figure 12B , Figure 14 and Figure 15A It can be seen that the ring 232 is circumferentially wrapped around the insertion tube 216, so that the pair of legs 234 and 236 of the ring 232 (in) Figure 14 (Most clearly shown) the positioning region 212 held relative to the cannula 216 (in Figure 11A and Figure 11B (As shown in the diagram). The bend 238 of the ring 232 extends through the gap between the legs 234 and 236, and the release wire 218 extends through the bend 238 to capture the bend 238. Thus, the release wire 218 releasably secures the ring 232 around the cannula 216.

[0076] refer to Figure 14and combined Figure 15A The wiring of the suture 220 relative to the cannula 216 and the release wire 218 before tightening is clearly shown. (As in...) Figure 15A As can be seen, the graft 202 is firmly attached to the cannula 216 at a specific location or locatable area 212 (in Figure 11A and Figure 11B (As shown in the diagram). Typically, the locatable area 212 will be adjacent to or located at an important feature of the scaffold graft 200 (such as fenestration 214 or fan-shaped notch 215). The graft 202 is referred to as the "locatable" area because it can be located by a clinician by manipulating a handle attached to the cannula 216.

[0077] The release wire 218 can retract from the bend 238 of the ring 232, thereby releasing the bend 238 so that the positionable area 212 is no longer fixed relative to the cannula 216, such as Figure 15B As shown.

[0078] Using the aforementioned constraint arrangement for stent grafts, a portion of the stent graft 200 can be more precisely controlled for positioning and alignment. This can assist clinicians in several ways. For example, it helps clinicians perform endovascular surgery for aneurysm repair, which requires accurate placement of stent graft features such as fenestrations or fan-shaped notches 215.

[0079] The ability to releasably constrain desired stent graft features (such as fenestrations) by utilizing existing components (such as release wires or trigger wires) is useful and helps keep the entire device compact when introduced into the patient's vascular system.

[0080] consider Figure 15A and Figure 15B As can be seen, the constraint arrangement is configured such that when the release wire is in the retracted state, the expansion of the scaffold graft 200 increases the fixation end 224 of the suture 220 with the first constraint perforation 228 (as shown). Figure 13 The circumferential length between the sutures (shown) creates tension in the suture 220. This tension is used to retract the ring 232 toward the inner surface 240 of the graft. This reduces the length of the suture within the lumen and also reduces the likelihood of interfering with normal blood flow once the procedure of delivering the stent graft into the patient's anatomy is complete.

[0081] The suture 220 passes through the graft 202 at least once between the first fixed end 224 and the first constraint perforation 228, enters the lumen 204, and then exits the lumen, as in combination. Figure 11A and Figure 13 Yes, you can see it. For Figure 11A In the embodiment shown, most of the sutures remain on the outer surface 222 of the scaffold graft 200, thereby advantageously minimizing the length of the sutures within the lumen 204.

[0082] Refer again Figure 11A As can be seen, the release wire 218 repeatedly wraps around the cannula 216 along the longitudinal length of the stent graft 200, thereby securing the stent graft 200 to the cannula 216 at multiple spaced locations. In the illustrated embodiment, the release wire repeatedly penetrates the graft from inside the lumen to outside the lumen, and then penetrates the graft from outside the lumen to inside the lumen. The release wire is arranged in a spiral along the length of the stent graft, as shown in... Figure 11A It can be seen in the image.

[0083] Release wire 218 holds the scaffold graft on the cannula or guidewire catheter and includes a wire of material wound around the cannula and passing through the scaffold graft in a spiral or vortex manner, as described above and as follows. Figure 11A As shown, the pitch of the helically wound release wire 218 can be, for example, between 20 mm and 40 mm. The release wire 218 extends to a handle, such as a handle that can be manipulated by a clinician. A suitable release wire is described and illustrated in U.S. Publication No. 2022 / 0087812, filed December 6, 2021, entitled "Temporary Diameter Reduction Constraint Arrangement for a Stent Graft in Combination With a Stent Graft," the entire disclosure of which is incorporated herein by reference. Another suitable release wire is described and illustrated in U.S. Patent No. 10,188,538, filed December 30, 2015, entitled "Hybrid Trigger Wire," the entire disclosure of which is incorporated herein by reference.

[0084] When the release wire has retracted and the positioning area 212 is no longer held relative to the cannula, the suture 220 extends circumferentially around the outer surface 222 of the graft from the fixed end 224 of the graft 200 to the positioning area 212 with an arc of at least 45 degrees, for example... Figure 15B As shown in [the image]. Figure 11A , Figure 15A and Figure 15B In the illustrated embodiment, when the release wire has retracted and the locatable area is not held relative to the cannula, the suture extends circumferentially around the outer surface 222 of the graft from the fixed end 224 of the scaffold graft with an arc of at least 75 degrees to reach the locatable area.

[0085] In another embodiment of this disclosure, such as Figure 11B As shown, the release wire is not spirally wound. Instead, the release wire is relatively straight, and the scaffold graft 200 is attached to the cannula along its length using multiple sutures, each suture being similar to the suture 220 described above.

[0086] Now for reference Figure 20 The area adjacent to the fan-shaped notch 215 can be located, allowing clinicians to precisely control the position of the fan-shaped notch 215. In other aspects, the constraint arrangement is... Figure 11A , Figure 11B , Figure 12A , Figure 12B , Figure 13 , Figure 14 , Figure 15A and Figure 15B The constraint arrangements shown are roughly the same, with the locatable area adjacent to the window.

[0087] Figures 17 to 19B A second embodiment of this disclosure is shown in the diagram. Figure 17 The diagram illustrates a constraint arrangement of a scaffold graft 200 loaded onto a delivery system. The scaffold graft has a graft 200 defining an elongated lumen 204, a plurality of scaffolds 206, 208, 210, and at least one positionable region 212 adjacent to feature 214. The delivery system includes a cannula 216 and a release wire 218. The constraint is similar in many respects to the constraint arrangement of the first embodiment of this disclosure, except that each fixation employs two suture loops instead of one. Specifically, the constraint arrangement includes a first suture 220 that extends circumferentially around the outer surface 203 of the graft from a first fixation end 222 fixed to the scaffold graft to the positionable region 212, through the graft and into the lumen, and exits from the lumen back to the outer surface 203 of the graft 202, reaching a second fixation end fixed to the scaffold graft, thereby forming a first loop 232 of the first suture within the lumen. This can... Figure 19A and Figure 19B As can be seen, the first ring 232 is circumferentially (partially) wrapped around the insertion tube 216, so that the first pair of legs 234, 236 of the first ring 232 are fixed in a positionable area relative to the insertion tube 216.

[0088] The second suture 221 also extends circumferentially (partially circumferentially) around the outer surface 203 of the graft from the third fixation end 244 fixed to the scaffold graft to the positioning area 212, enters the lumen 204, and exits from the lumen 204 back to the outer surface 203 of the graft, reaching the fourth fixation end fixed to the scaffold graft, thereby forming a second loop 233 of the second suture within the lumen 204.

[0089] A second ring, formed by a second suture, is circumferentially wrapped around the cannula, such that the second pair of legs 234', 236' of the second ring 233 and the first pair of legs 234, 236 of the first ring 232 are held relative to the positioning region 212 of the cannula. A bend 250 of the second ring 23 extends through the gap between the first pair of legs 234, 236 of the first ring 232. A release wire 218 extends through the bend 250, thereby capturing the bend 250 and releasably securing the first ring 232 and the second ring 220 around the cannula.

[0090] refer to Figure 17 and Figure 18 As can be seen, in this second embodiment, there is also a second positionable region 212' located on the other side of the feature in the form of a window 214. This second positionable region 212' is held to the cannula 216, thereby providing further control for the clinician. However, it should be noted that, if necessary, a double-ring arrangement can be used at only one positionable region 212. Figure 18 As shown, the third and fourth sutures can be placed below the window (or a single suture, such as...). Figure 11A (As shown in the figure). As shown, a third ring 232' and a fourth ring 233' can be formed, similar to the first and second rings.

[0091] For all the above embodiments, when the scaffold graft is fully released and expanded, the suture loop is significantly reduced (retracted), such as Figures 16A to 16C This is shown step by step. For example, this is in Figures 11A to 15B The illustrated embodiment achieves this by first weaving the ring material around the scaffold graft material at approximately 90 degrees circumferentially on either side of the feature, keeping it secure without reducing the scaffold graft diameter, or at least not significantly reducing it. Then, the ring is pulled from the area of ​​the feature requiring constraint. Thus, after the scaffold graft is released, the ring returns to its retracted state along the circumference of the scaffold graft.

[0092] Now refer to it again Figure 11A The illustrated embodiments will be referenced Figures 16A to 16C Describe the deployment order of the constraint arrangement.

[0093] Figure 16AThe diagram illustrates a restraint arrangement within a patient's lumen 2, positioned with a feature (in this case, fenestration 214) aligned with a target branch lumen 300 branching from the main lumen 302. Typically, the restraint arrangement and stent graft 200 will be reached in this position using the Seldinger technique. This technique involves creating a surgical opening in the vascular system with a needle, connecting to the vessel of interest, and inserting a guidewire into the vessel through the needle's orifice. For example, the femoral artery can be used to access the aorta. The needle can be withdrawn, leaving the guidewire in place. A delivery device is then inserted onto the guidewire and into the vessel. The delivery device can be used in a conventional manner to insert a stent graft or other prosthesis or device into the vessel. Figure 16A The image shows a guidewire 303 on which a nasal conus dilator 304 slides. A stent graft 200 is adjacent to the nasal conus dilator 4 and is secured to a cannula 216 by a helically wound release wire 218. (See above reference) Figure 11A , Figure 12A , Figure 12B , Figure 13 , Figure 14 , Figure 15A and Figure 15B The described constraint arrangement is also partially visible in the figure, with the suture 220 and its first fixed end 224 clearly visible.

[0094] When positioned within the main lumen 302 (e.g., the aorta), the clinician can manipulate the position of the fenestration 214 to precisely align it with the opening of the branch lumen 300 (e.g., the renal artery). The clinician can then cannulate the target vessel with a wire and catheter before final positioning and release of the stent graft. Once this is complete, the release wire 218 can be retracted, thereby releasing the locatable area 212 adjacent to the fenestration 214, and the stent graft 200 can be progressively released from the cannula 216 until the target vessel is reached. Figure 16B The location shown.

[0095] In the final step, the stent graft 200 is typically further expanded by deploying an air balloon from within the lumen 204 of the stent graft 200 until the stent graft 200 reaches its maximum expansion. Figure 16C The location shown.

[0096] Throughout this specification, various indications have been given regarding the scope of the invention; however, the invention is not limited to any one of these, but rather two or more of them can be combined. Examples are given for illustrative purposes only and not for limitation.

[0097] Throughout this specification and the following claims, unless the context otherwise requires, the words “comprise” and “include” and variations such as “comprising” and “including” should be understood to imply inclusion of the stated integers or groups of integers, but not to exclude any other integers or groups of integers. Claims (as amended under Article 19 of the Treaty) 1. A constraint arrangement for loading a stent graft onto a delivery device in combination with a stent graft, the stent graft having: a graft body defining an elongated lumen; and a positionable region, the delivery device having a sleeve extending through the elongated lumen and the sleeve being disposed around a guidewire cannula, the constraint arrangement comprising: At least one parallel release wire, the at least one parallel release wire releasably securing the graft body relative to the guidewire cannula along the length of the guidewire cannula; At least one suture circumferentially passes through and sutures around the graft body, thereby forming a plurality of external suture portions and a plurality of internal suture portions; A constraint ring, formed by a first internal suture portion of the internal suture portion, surrounds the guidewire cannula and constrains the positionable region, thereby placing the positionable region tightly juxtaposed with the sleeve; and Multiple shrinking rings, formed by other internal suture portions within the internal suture portion, extend radially inward from the graft body. Wherein, the at least one juxtaposed release wire passes through each of the plurality of shrinking rings and the constraint ring, and The retraction of the at least one juxtaposed release wire releases each of the plurality of shrinking rings and the constraint ring, thereby allowing the stent graft to expand and be released from the guidewire cannula. 2. The constraint arrangement of claim 1, wherein the at least one juxtaposed release wire penetrates from the outside of the graft body into the interior of the graft body and then returns from the interior of the graft body to the outside of the graft body, thereby providing a linear attachment area inside the graft body, and wherein the constraint ring constrains the positionable region of the scaffold graft to the sleeve. 3. The constraint arrangement according to claim 2, wherein the at least one juxtaposed release wire includes a proximal end of the juxtaposed release wire, the proximal end of the juxtaposed release wire being located inside the sleeve when in the loading position and outside the sleeve when in the deployment position. 4. The constraint arrangement according to claim 3, wherein the constraint ring engages the at least one juxtaposed release wire at a position proximal to the position where the plurality of shrinking rings engage the juxtaposed release wire. 5. The constraint arrangement according to claim 3, wherein the constraint ring engages the at least one juxtaposed release wire at a position distal to the position where the plurality of shrinking rings engage the juxtaposed release wire. 6. The constraint arrangement of claim 1, further comprising at least one proximal release wire that releasably secures a portion of the locatable region to the guidewire cannula. 7. The constraint arrangement of claim 6, further comprising a proximal support attached to the graft body, The at least one proximal release wire passes through the proximal end of the proximal stent. 8. The constraint arrangement of claim 1, wherein the at least one juxtaposed release wire repeatedly penetrates the graft body from the interior to the exterior of the graft body and then returns from the exterior to the interior of the graft body, thereby repeatedly circling the guidewire cannula along the longitudinal length of the scaffold graft to fix the scaffold graft relative to the guidewire cannula. 9. The constraint arrangement according to claim 1, further comprising a shrink-ring release wire, Wherein, at least one juxtaposed release wire passes through the constraint ring, and the shrinking ring release wire passes through each of the plurality of shrinking rings, and The retraction of the at least one parallel release wire releases the constraint ring, and the retraction of the shrinking ring release wire releases each of the plurality of shrinking rings, thereby allowing the stent graft to expand and be released from the guidewire cannula. 10. The constraint arrangement of claim 1, wherein the at least one suture includes a first suture and a second suture, wherein the constraint loop is formed by the inner suture portion of the second suture, and wherein the plurality of shrinking loops are formed by the inner suture portion of the first suture. 11. The constraint arrangement of claim 10, further comprising a shrink-ring release wire, Wherein, the at least one juxtaposed release wire passes through the constraint loop formed by the inner suture portion of the second suture, and the shrinking loop release wire passes through each of the plurality of shrinking loops formed by the inner suture portion of the first suture, and The retraction of the at least one parallel release wire releases the constraint ring, and the retraction of the shrinking ring release wire releases each of the plurality of shrinking rings, thereby allowing the stent graft to expand and be released from the guidewire cannula. 12. A scaffold graft and delivery device assembly, the assembly comprising: A guidewire cannula for sliding on a guidewire; A sleeve, the sleeve being disposed around the guidewire cannula; The tip is located at the proximal end of the guidewire cannula; A handle, the handle being located at the distal end of the guidewire cannula; A pusher, the pusher being disposed around the guidewire cannula and extending proximally from the handle; A scaffold graft receiving area, wherein the scaffold graft receiving area is located between the end and the pusher; A scaffold graft having: a graft body defining an elongated lumen; and a positioning region where the scaffold graft is positioned at the scaffold graft receiving region; At least one suture circumferentially passes through and sutures around the graft body, thereby forming a plurality of external suture portions and a plurality of internal suture portions; A constraint ring, formed by a first internal suture portion of the plurality of internal suture portions, surrounds and constrains the guidewire cannula, thereby placing the guidewire cannula closely juxtaposed with the positionable region; Multiple shrinking rings, the multiple shrinking rings being formed by other internal suture portions among the multiple internal suture portions, the multiple shrinking rings extending radially inward from the graft body; A juxtaposed release wire is provided, which releasably secures the graft body to the guidewire cannula along its length, the juxtaposed release wire passing through each of the plurality of narrowing rings and the constraint ring; and A multi-functional wire drawing mechanism, located on the handle, The juxtaposed release wire is operatively connected to the multifunctional wire drawing mechanism, such that the multifunctional wire drawing mechanism can be actuated to release each of the plurality of shrinking rings and the constraint ring, thereby allowing the stent graft to expand and be released from the guidewire cannula. 13. The scaffold graft and delivery device assembly of claim 12, further comprising: At least one proximal release wire releasably secures a portion of the locatable region to the guidewire cannula. The multifunctional wire drawing mechanism can be actuated to release the at least one proximal release wire. 14. The scaffold graft and delivery device assembly of claim 13, wherein the juxtaposed release wire penetrates from the outside of the graft body into the interior of the graft body and then returns from the interior of the graft body to the outside of the graft body, thereby providing a linear attachment region inside the graft body, wherein the restraint ring restrains the positionable region of the scaffold graft to the sleeve. 15. The stent graft and delivery device assembly of claim 14, wherein the juxtaposed release wire includes a proximal end of the juxtaposed release wire, the proximal end of which is located within the guidewire cannula in the loading position and outside the guidewire cannula in the deployment position. 16. The scaffold graft and delivery device assembly of claim 15, wherein the restraint ring engages the juxtaposed release wire at a position proximal to the location where the plurality of shrinking rings engage the juxtaposed release wire. 17. The scaffold graft and delivery device assembly of claim 15, wherein the restraint ring engages the juxtaposed release wire at a position distal to the location where the plurality of shrinking rings engage the juxtaposed release wire. 18. The scaffold graft and delivery device assembly of claim 12, further comprising a shrink-loop release wire, Wherein, the juxtaposed release wire passes through the constraint ring, and the shrinking ring release wire passes through each of the plurality of shrinking rings, and The retraction of the juxtaposed release wire releases the constraint ring, and the retraction of the shrinking ring release wire releases each of the plurality of shrinking rings, thereby allowing the stent graft to expand and be released from the guidewire cannula. 19. The scaffold graft and delivery device assembly of claim 12, wherein the at least one suture includes a first suture and a second suture, wherein the constraint loop is formed by an inner suture portion of the second suture, and wherein the plurality of shrinking loops are formed by an inner suture portion of the first suture. 20. The scaffold graft and delivery device assembly of claim 19, further comprising a shrink-loop release wire, The juxtaposed release wire passes through the constraint loop formed by the inner suture portion of the second suture, and the shrinking loop release wire passes through each of the plurality of shrinking loops formed by the inner suture portion of the first suture. The retraction of the juxtaposed release wire releases the constraint ring, and the retraction of the shrinking ring release wire releases each of the plurality of shrinking rings, thereby allowing the stent graft to expand and be released from the guidewire cannula.

Claims

1. A constraint arrangement for loading a scaffold graft onto a delivery device in combination with a scaffold graft, the scaffold graft having: a graft body defining an elongated lumen; And a positionable area, the delivery device having a sleeve extending through the elongated lumen, and the sleeve being arranged around the guidewire cannula, the constraint arrangement including: At least one parallel release wire, the at least one parallel release wire releasably securing the graft body relative to the guidewire cannula along the length of the guidewire cannula; The sutures pass circumferentially through and around the graft body, thereby forming a plurality of external suture portions and a plurality of internal suture portions; A constraint ring, formed by a first internal suture portion of the internal suture portion, surrounds the guidewire cannula and constrains the positionable region, thereby placing the positionable region tightly juxtaposed with the sleeve; and Multiple shrinking rings, formed by other internal suture portions within the internal suture portion, extend radially inward from the graft body. Wherein, the at least one juxtaposed release wire passes through each of the plurality of shrinking rings and the constraint ring, and The retraction of the at least one juxtaposed release wire releases each of the plurality of shrinking rings and the constraint ring, thereby allowing the stent graft to expand and be released from the guidewire cannula.

2. The constraint arrangement as described in claim 1, wherein, The at least one juxtaposed release wire penetrates from the outside of the graft body into the interior of the graft body and then returns from the interior of the graft body to the outside of the graft body, thereby providing a linear attachment area inside the graft body, and wherein the restraint ring restrains the positionable area of ​​the scaffold graft to the sleeve.

3. The constraint arrangement as described in claim 2, wherein, The at least one juxtaposed release wire includes a proximal end of the juxtaposed release wire, which is located inside the sleeve when in the loading position and outside the sleeve when in the deployment position.

4. The constraint arrangement as described in claim 3, wherein, The constraint ring engages the juxtaposed release wire at a position near the location where the plurality of shrinking rings engage the juxtaposed release wire.

5. The constraint arrangement as described in claim 3, wherein, The constraint ring engages the juxtaposed release wire at a position distal to the location where the plurality of shrinking rings engage the juxtaposed release wire.

6. The constraint arrangement of claim 1, further comprising at least one proximal release wire that releasably secures a portion of the locatable region to the guidewire cannula.

7. The constraint arrangement of claim 6, further comprising a proximal support attached to the graft body. in, At least one proximal release wire passes through the proximal end of the proximal stent.

8. The constraint arrangement as described in claim 1, wherein, The juxtaposed release wire repeatedly penetrates the graft body from the inside to the outside of the graft body and then returns to the inside of the graft body from the outside of the graft body, so as to repeatedly wrap around the guide wire cannula along the longitudinal length of the scaffold graft, thereby fixing the scaffold graft relative to the guide wire cannula.

9. A scaffold graft and delivery device assembly, the assembly comprising: A guidewire cannula for sliding on a guidewire; A sleeve, the sleeve being disposed around the guidewire cannula; The tip is located at the proximal end of the guidewire cannula; A handle, the handle being located at the distal end of the guidewire cannula; A pusher, the pusher being disposed around the guidewire cannula and extending proximally from the handle; A scaffold graft receiving area, wherein the scaffold graft receiving area is located between the end and the pusher; A scaffold graft, the scaffold graft having: a graft body defining an elongated lumen; And a positioning area, wherein the scaffold graft is positioned at the scaffold graft receiving area; The sutures pass circumferentially through and around the graft body, thereby forming a plurality of external suture portions and a plurality of internal suture portions; A constraint ring, formed by a first internal suture portion of the plurality of internal suture portions, surrounds and constrains the guidewire cannula, thereby placing the guidewire cannula closely juxtaposed with the positionable region; Multiple shrinking rings, the multiple shrinking rings being formed by other internal suture portions among the multiple internal suture portions, the multiple shrinking rings extending radially inward from the graft body; A juxtaposed release wire is provided to releasably secure the graft body to the guidewire cannula along the length of the guidewire cannula, the juxtaposed release wire passing through each of the plurality of shrinking rings and the constraint ring; as well as A multi-functional wire drawing mechanism, located on the handle, The juxtaposed release wire is operatively connected to the multifunctional wire drawing mechanism, such that the multifunctional wire drawing mechanism can be actuated to release each of the plurality of shrinking rings and the constraint ring, thereby allowing the stent graft to expand and be released from the guidewire cannula.

10. The scaffold graft and delivery device assembly of claim 9, further comprising: At least one proximal release wire releasably secures a portion of the locatable region to the guidewire cannula. The multifunctional wire drawing mechanism can be actuated to release the at least one proximal release wire.

11. The scaffold graft and delivery device assembly of claim 10, wherein, The juxtaposed release wire penetrates from the outside of the graft body into the interior of the graft body, and then returns from the interior of the graft body to the outside of the graft body, thereby providing a linear attachment area inside the graft body, wherein the restraint ring restrains the positionable area of ​​the scaffold graft to the sleeve.

12. The scaffold graft and delivery device assembly of claim 11, wherein, The juxtaposed release wire includes a proximal end that is located inside the guidewire cannula when in the loading position and outside the guidewire cannula when in the deployment position.

13. The scaffold graft and delivery device assembly of claim 12, wherein, The constraint ring engages the juxtaposed release wire at a position near the location where the plurality of shrinking rings engage the juxtaposed release wire.

14. The scaffold graft and delivery device assembly of claim 12, wherein, The constraint ring engages the juxtaposed release wire at a position distal to the location where the plurality of shrinking rings engage the juxtaposed release wire.

Images