Vascular grafts and aortic grafts and deployment tools

Abstract

A vascular graft deployment tool can include a handle, an elongate mandrel positioned distal to the handle, a vascular graft at least partially disposed coaxially about the mandrel, a sheath assembly including a distal sheath portion and a proximal sheath portion, wherein the distal and proximal sheath portions are configured to constrain the vascular graft against the mandrel at an insertion diameter, and an actuator movable relative to the handle and engaging the sheath assembly, wherein operation of the actuator causes at least one of the distal and proximal sheath portions to longitudinally separate to free at least a portion of the vascular graft. Further, the vascular graft is expandable from an insertion state to a deployed state, and at least two suture envelopes are positioned between opposite end portions of the vascular graft.

Description

[0001] Cross-reference to related applications

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 906041, filed September 25, 2019, which is incorporated herein by reference in its entirety and for all purposes. Technical Field

[0003] The present invention generally relates to vascular grafts and aortic grafts, as well as deployment tools for such grafts. Background Technology

[0004] The circulatory system includes the aorta and other large-diameter blood vessels, as well as smaller-diameter vessels and capillaries. Although diseases and conditions affecting other blood vessels can be serious, diseases and conditions affecting the aorta can be more severe and more likely to cause death due to the volume and pressure of blood pumped through it.

[0005] Complex thoracic aortic diseases include acute type A aortic dissection (AAD) and chronic type A aortic dissection (CAD), as well as aortic arch aneurysm (TAA), with or without involvement of the ascending and descending aorta.

[0006] Aortic dissection is caused by a tear in the inner lining of the aortic wall, allowing blood to enter and causing separation of the wall layers. Acute aortic dissection is defined as a dissection identified within the first two weeks after the initial tear, while chronic dissection is defined as a dissection identified after more than two weeks. Aortic dissections are classified according to their location and the extent of involvement of the thoracic aorta. Stanford type A dissection affects the ascending aorta and can extend to the aortic arch and descending thoracic aorta. Stanford type B dissection does not affect the ascending aorta and typically involves the descending thoracic aorta distal to the origin of the left subclavian artery. Approximately two-thirds of aortic dissections are Stanford type A.

[0007] Acute aortic dissection typically presents with pain and is classified as an emergency because the dissection ruptures the aortic wall, affecting the integrity of the aortic valve and impacting myocardial perfusion by affecting the origin of the coronary arteries.

[0008] An aortic aneurysm is a serious condition that can affect any segment of the aorta. An aortic aneurysm in the abdomen is called an abdominal aortic aneurysm or AAA; an aortic aneurysm in the chest cavity is called a thoracic aortic aneurysm, and an aortic aneurysm in the chest cavity above the aortic arch can be called an aortic arch aneurysm. Aortic aneurysms can be caused by various factors, such as untreated or severe hypertension, smoking, hereditary diseases such as Marfan syndrome, and degenerative dilatation of the aortic wall. Thoracic aortic aneurysms are caused by weakening of the aortic wall, leading to localized dilatation, and are a life-threatening condition. Patients with thoracic aortic aneurysms are often asymptomatic until the aneurysm dilates. The most common symptoms are pain and aortic rupture. A ruptured aneurysm can cause severe internal bleeding, which can rapidly lead to shock or death.

[0009] Treatment of complex thoracic aortic diseases typically requires lengthy and complex open surgery. During such procedures, the patient is typically placed on a cardiopulmonary bypass (or cardiopulmonary bypass) pump, and the heart is stopped to allow the aorta to be clamped and operated on. While on cardiopulmonary bypass, the patient is usually also cooled to a hypothermic condition. The risk of the patient not surviving the procedure is directly related to the duration of time the patient experiences on the pump and under hypothermia. Summary of the Invention

[0010] This disclosure includes a vascular graft deployment tool, which may characteristically have: a handle; an elongated mandrel positioned distal to the handle; a vascular graft at least partially coaxially disposed around the mandrel; a sheath assembly including a distal sheath portion and a proximal sheath portion, wherein the distal and proximal sheath portions are configured to restrain the vascular graft against the mandrel with an insertion diameter; and an actuator movable relative to the handle and engaging the sheath assembly, wherein operation of the actuator longitudinally separates at least one of the distal and proximal sheath portions to free at least a portion of the vascular graft.

[0011] In one aspect, the sheath assembly may further include a central segment connecting the distal sheath portion and the proximal sheath portion, wherein the central segment has at least two strips, and wherein an actuator engages the strips. The actuator may have a plurality of rollers, wherein each roller is configured to engage one of the strips. The rollers may be oriented substantially perpendicular to a longitudinal axis of the mandrel. Alternatively, the actuator may have a plurality of pins, wherein each pin is configured to engage one of the strips.

[0012] In one aspect, proximal movement of the actuator relative to the handle can be configured to longitudinally separate the distal sheath portion and detach the distal portion of the vascular graft. Further proximal movement of the actuator can be configured to longitudinally separate the proximal sheath portion and detach the proximal portion of the vascular graft.

[0013] In one aspect, the vascular graft deployment tool may have an expander tip at the distal end of a skeletal axis. The skeletal axis may have a lumen extending substantially longitudinally through the skeletal axis, and the deployment tool may also have a needle defining the lumen therein, wherein the needle is disposed within the lumen of the skeletal axis and is slidable relative to the lumen of the skeletal axis. A guidewire may extend through the needle such that the distal end of the guidewire can slidably extend through the needle lumen. The needle may have a lumen and a needle return port configured to create a fluid flow path through the needle lumen, through the needle return port, and through the return port in the expander tip when the needle is in a distally extended position protruding beyond the expander tip.

[0014] In one aspect, the vascular graft deployment tool may also have a needle retraction assembly within a handle. The needle retraction assembly may be configured to hold the needle in a distally extended position protruding beyond the end of the dilator, such that releasing the needle retraction assembly moves the needle proximally to a retracted position that does not protrude beyond the end of the dilator. A guidewire may extend through the needle retraction assembly, wherein the distal end of the guidewire is configured to slidably extend through a lumen in the needle. The guidewire may also have a guidewire handle at its proximal end, wherein the needle retraction assembly is configured to be released upon distal movement engagement via the guidewire handle.

[0015] This disclosure also includes a method for implanting a vascular graft into a patient's blood vessel. The method may involve providing a vascular graft deployment tool comprising: a handle; an elongated mandrel positioned distal to the handle; a vascular graft at least partially coaxially disposed around the mandrel; a sheath assembly including a distal sheath portion and a proximal sheath portion, wherein the distal and proximal sheath portions restrain the vascular graft against the mandrel at an insertion diameter; and an actuator movable relative to the handle and engaging the sheath assembly. At least a distal portion of the vascular graft may be positioned within the lumen of a patient's blood vessel. The actuator may be operated to longitudinally separate at least one of the distal and proximal sheath portions to free at least a portion of the vascular graft and to secure at least a portion of the vascular graft within the lumen of the blood vessel by expansion of that portion of the vascular graft at the insertion diameter.

[0016] In one respect, expansion is self-expanding expansion.

[0017] In one aspect, securing a vascular graft within a blood vessel may include suturing with suture material. The suture may be attached to a suture cap of the vascular graft.

[0018] In one aspect, the sheath assembly may have a central segment connecting a distal sheath portion and a proximal sheath portion, wherein the central segment includes at least two bands, and wherein an actuator engages the bands such that the method includes operating the actuator by moving it proximally relative to a handle to longitudinally separate the distal sheath portion and free the distal portion of the vascular graft. Operating the actuator may further include moving the actuator proximally relative to a handle to longitudinally separate and free the proximal portion of the vascular graft.

[0019] In one aspect, the vascular graft deployment tool may also have an expander end at the distal end of a skeletal axis and a needle defining a lumen therein, the skeletal axis having a lumen extending substantially longitudinally through the skeletal axis, wherein the needle is disposed within the lumen of the skeletal axis and slidable relative to the lumen of the skeletal axis, such that the method also involves positioning the needle in a distally extended position protruding beyond the expander end, inserting the needle through the wall of the blood vessel, and positioning the needle in a retracted position not protruding beyond the expander end. The needle may have a lumen and a needle return port, such that inserting the needle through the wall of the blood vessel may involve creating a fluid flow path through the needle lumen, through the needle return port, and through the return port in the expander end.

[0020] In one aspect, the handle may also have a needle retraction assembly, such that the method further relates to actuating the needle retraction assembly to position the needle in a retracted position. Releasing the needle retraction assembly may involve advancing a guidewire distally through the needle retraction assembly, such that the distal end of the guidewire slidably extends through a lumen in the needle, and a guidewire handle at the proximal end of the guidewire engages the needle retraction assembly.

[0021] This disclosure also includes a vascular graft configured to transition from an insertion state to a deployment state, and characteristically having a proximal end with an expandable mesh, a distal end with an expandable mesh, and at least one suture closure positioned between the proximal and distal ends, wherein the suture closure includes additional material relative to the proximal and distal ends, the additional material being configured to form during the transition of the vascular graft from the insertion state to the deployment state. The transition from the insertion state to the deployment state may be a self-expanding expansion.

[0022] In one aspect, at least two suture closures may be positioned closer to each other relative to the proximal and distal ends of the vascular graft. At least one of the suture closures may be formed at least partially by compressing the vascular graft substantially in the longitudinal direction. For example, at least one of the suture closures may have at least two longitudinal slits defined therethrough, and wherein the expansion of the vascular graft is configured such that the portion of the vascular graft circumferentially located between the circumferentially adjacent longitudinal slits forms a flap extending radially outward from the vascular graft.

[0023] Correspondingly, this disclosure also includes a method for implanting a vascular graft in a patient by providing a vascular graft, the vascular graft having a proximal end with an expandable mesh, a distal end with an expandable mesh, and at least one suture closure positioned between the proximal and distal ends. At least one end of the vascular graft may be positioned within a lumen for conducting blood from the patient. The vascular graft may expand from an inserted state to a deployed state. At least one of the suture closures may be formed as a result of the expansion, wherein each suture closure may have additional material relative to the proximal and distal ends. The first suture closure of the vascular graft may be secured to the wall of the lumen for conducting blood from the patient by suturing with suture material.

[0024] In one aspect, the method may also involve positioning the opposite end of the vascular graft within another lumen for conducting the patient's blood, and securing a second suture cap of the vascular graft to the wall of the other lumen for conducting the patient's blood by suturing with suture material.

[0025] Furthermore, this disclosure also includes a method for implanting a vascular graft into a patient's blood vessel, the method involving: providing a vascular graft deployment tool comprising: a handle; an elongated mandrel positioned distal to the handle; a vascular graft at least partially coaxially disposed around the mandrel; a sheath configured to retract proximally, restraining the vascular graft against the mandrel with an insertion diameter; and an actuator movable relative to the mandrel and engaging the sheath assembly; positioning at least a distal portion of the vascular graft within the lumen of the patient's blood vessel; operating the actuator to cause retraction of the sheath to free the at least distal portion of the vascular graft; securing at least a portion of the vascular graft within the lumen of the blood vessel by expansion of that portion of the vascular graft from the insertion diameter; and operating the actuator to cause further retraction of the sheath to free the proximal portion of the vascular graft, thereby securing the vascular graft to a branch graft.

[0026] In one aspect, the vascular graft deployment tool may also have an expansion balloon positioned below the vascular graft around the heart axis, such that the method includes delivering inflation fluid into the interior of the balloon and, after inflation, evacuating to deflate the balloon. The evacuation may occur automatically after the balloon is inflated.

[0027] In one aspect, the vascular graft deployment tool may also have an expander end at the distal end of a skeletal axis and a needle defining a lumen therein, the skeletal axis having a lumen extending substantially longitudinally through the skeletal axis, wherein the needle is disposed within the lumen of the skeletal axis and slidable relative to the lumen of the skeletal axis, such that the method also involves positioning the needle in a distally extended position protruding beyond the expander end, inserting the needle through the wall of the blood vessel, and positioning the needle in a retracted position not protruding beyond the expander end. The needle may have a lumen and a needle return port, such that inserting the needle through the wall of the blood vessel may involve creating a fluid flow path through the needle lumen, through the needle return port, and through the return port in the expander end.

[0028] In one aspect, the handle may also have a needle retraction assembly, such that the method further relates to actuating the needle retraction assembly to position the needle in a retracted position. Releasing the needle retraction assembly may involve advancing a guidewire distally through the needle retraction assembly, such that the distal end of the guidewire slidably extends through a lumen in the needle, and a guidewire handle at the proximal end of the guidewire engages the needle retraction assembly.

[0029] This disclosure also includes a vascular graft deployment tool, which may characteristically include: a handle; an elongated mandrel positioned distal to the handle; a vascular graft at least partially coaxially disposed around the mandrel; a sheath assembly configured to restrain the vascular graft against the mandrel with an insertion diameter; and an actuator movable relative to the handle and engaging the sheath assembly, wherein a first operation of the actuator causes retraction of the sheath to free at least a distal portion of the vascular graft, and repeated operation of the actuator causes further retraction of the sheath to free a proximal portion of the vascular graft.

[0030] In one aspect, the vascular graft deployment tool may have an expander tip at the distal end of a skeletal axis. The skeletal axis may have a lumen extending substantially longitudinally through the skeletal axis, and the deployment tool may also have a needle defining the lumen therein, wherein the needle is disposed within the lumen of the skeletal axis and is slidable relative to the lumen of the skeletal axis. A guidewire may extend through the needle such that the distal end of the guidewire can slidably extend through the needle lumen. The needle may have a lumen and a needle return port configured to create a fluid flow path through the needle lumen, through the needle return port, and through the return port in the expander tip when the needle is in a distally extended position protruding beyond the expander tip.

[0031] In one aspect, the vascular graft deployment tool may also have a needle retraction assembly within a handle. The needle retraction assembly may be configured to hold the needle in a distally extended position protruding beyond the end of the dilator, such that releasing the needle retraction assembly moves the needle proximally to a retracted position that does not protrude beyond the end of the dilator. A guidewire may extend through the needle retraction assembly, wherein the distal end of the guidewire is configured to slidably extend through a lumen in the needle. The guidewire may also have a guidewire handle at its proximal end, wherein the needle retraction assembly is configured to be released upon distal movement engagement via the guidewire handle. Attached Figure Description

[0032] Figure 1 This is a side view of an exemplary vascular graft.

[0033] Figure 2 It is in the insertion construction Figure 1 A side view of an exemplary vascular graft.

[0034] Figure 3 It is after the first deployment step Figure 1 A side view of an exemplary vascular graft.

[0035] Figure 4 It is after the second deployment step Figure 1 A side view of an exemplary vascular graft.

[0036] Figure 5 It is after the third deployment step Figure 1 A side view of an exemplary vascular graft.

[0037] Figure 6 This is a perspective view of an exemplary central segment of an aortic graft.

[0038] Figure 6A This is a perspective view of a second exemplary central segment of an aortic graft.

[0039] Figure 7 yes Figure 6 A detailed view of the bridging graft shown.

[0040] Figure 8 This is a perspective view of the third exemplary central segment of an aortic graft.

[0041] Figure 9 This is a perspective view of the fourth exemplary central segment of an aortic graft.

[0042] Figure 9A This is a perspective view of the fifth exemplary central segment of an aortic graft.

[0043] Figure 10 This is a side view of several first exemplary jumpers.

[0044] Figure 11 This is a side view of several second exemplary jumpers.

[0045] Figure 12 This is a side view of a first exemplary implantation of an embodiment of an exemplary central segment of an aortic graft.

[0046] Figure 12A yes Figure 12 An exemplary implanted side view, which has exemplary differences.

[0047] Figure 12B yes Figure 12A An exemplary implanted side view, which has exemplary differences.

[0048] Figure 13 This is a side view of an exemplary dual automatic infusion device.

[0049] Figure 14 This is a side view of a second exemplary implantation of an embodiment of an exemplary central segment of an aortic graft.

[0050] Figure 15 This is a side view of a floating suture ring in its first normal state.

[0051] Figure 16 It is in the second expansion state. Figure 15 Side view of the floating suture ring.

[0052] Figure 17 It is in the third regulatory state. Figure 16 Side view of the floating suture ring.

[0053] Figure 18 yes Figure 17 Front view of the floating suture ring.

[0054] Figure 19 yes Figure 15 A perspective view of the floating suture ring.

[0055] Figure 20 This is a perspective view of an exemplary system for implanting aortic grafts.

[0056] Figure 21 This is a perspective view of a flexible endoscope system.

[0057] Figure 22 This is a perspective view of a single infusion catheter.

[0058] Figure 23 It is inserted into Figure 22 In a single infusion catheter Figure 21 A perspective view of a flexible endoscope system.

[0059] Figure 24 yes Figure 20 A perspective view of the steps involved in the operation of the system.

[0060] Figure 25 yes Figure 20 A perspective view of another step in the operation of the system.

[0061] Figure 26 yes Figure 20 A perspective view of another step in the operation of the system.

[0062] Figure 27 This is a partial cross-sectional perspective view of the deployment tool in its first state.

[0063] Figure 28 It is in the second state. Figure 27 A partial cross-sectional perspective view of the deployment tools.

[0064] Figure 29 It is in the third state. Figure 27 A partial cross-sectional perspective view of the deployment tools.

[0065] Figure 30 It is in the fourth state. Figure 27 A partial cross-sectional perspective view of the deployment tools.

[0066] Figure 31 This is a side view of a vascular graft with a sutured cover in its first position.

[0067] Figure 32 It has a sewn-on envelope in its first state. Figure 31 A side view of a vascular graft, with the sutured cap close to the vessel wall.

[0068] Figure 33 It has a suture closure in a second state relative to the blood vessel wall. Figure 32 A side view of a vascular graft.

[0069] Figure 34 This is a side view of the housing sheath in a flat construction.

[0070] Figure 35 It is placed around a vascular graft that is in a compressed state. Figure 34 A cross-sectional side view of the housing sheath.

[0071] Figure 36 It involves compressing the vascular graft into a compressed state. Figure 35 A cross-sectional side view of the housing sheath.

[0072] Figure 37 It involves compressing the vascular graft into a compressed state. Figure 36A cross-sectional perspective view of the housing sheath, showing the drawing process that keeps the housing sheath in a compressed state.

[0073] Figure 38 yes Figure 37 A cross-sectional side view of the containment sheath, which allows the vascular graft to self-expand upon filament withdrawal.

[0074] Figure 39 This is a side view of an embodiment of a graft connected to a scaffold to form a hybrid graft.

[0075] Figure 40 This is a side view of the sleeve.

[0076] Figure 41 Is with Figure 40 sleeve assembly Figure 39 A side view of the hybrid graft.

[0077] Figure 42 This is a side view of the steps in the fabrication of an embodiment of the hybrid graft.

[0078] Figure 43 yes Figure 42 A side view of another step in the fabrication of an embodiment of the hybrid graft.

[0079] Figure 44 It is Figures 42 to 43 A side view of the steps involved in placing a hybrid graft into a blood vessel.

[0080] Figure 45 It is Figures 42 to 43 A side view of another step in the placement of a hybrid graft into a blood vessel.

[0081] Figure 46 This is a perspective view of an embodiment of an exemplary deployment tool including a sheath that can be used with hybrid grafts.

[0082] Figure 47 yes Figure 46 A side view of an exemplary sheath.

[0083] Figure 48 yes Figure 47 A bottom view of the sheath.

[0084] Figure 49 yes Figures 46 to 47 Front view of the sheath.

[0085] Figure 50 During the deployment of hybrid grafts Figure 46 A perspective view of the deployment tools.

[0086] Figure 51This is a perspective view of an exemplary deployment tool that includes a sheath deployment slider actuator in its initial configuration for use with hybrid grafts.

[0087] Figure 52 It is in the second structure Figure 51 A perspective view of the deployment tools.

[0088] Figure 53 yes Figure 52 A perspective view of the deployment tool, with the hybrid graft removed to show the structure of the deployment tool.

[0089] Figure 54 This is a perspective view of an embodiment of a hybrid graft utilizing suture flaps.

[0090] Figure 55 This is a perspective view of another exemplary embodiment of the deployment tool in the first configuration.

[0091] Figure 56 It is in the second structure Figure 55 A perspective view of the deployment tools.

[0092] Figure 57 It is in the third structure Figure 55 A perspective view of the deployment tools.

[0093] Figure 58 This is a perspective view of another embodiment of an exemplary deployment tool.

[0094] Figure 59 This is a perspective view of another embodiment of an exemplary deployment tool.

[0095] Figure 60 yes Figure 58 Another perspective of an exemplary deployment tool.

[0096] Figure 61 This is a perspective view of an exemplary sheath component that can be utilized in various embodiments of the deployment tool.

[0097] Figure 62 Such as Figure 58 and Figure 59 An exemplary deployment tool's remote perspective, including a hidden view of the remote interior.

[0098] Figure 63 This is a side sectional view of a needle retraction assembly within a handle, used in various embodiments of the deployment tool, wherein the needle retraction assembly is in a latched state.

[0099] Figure 64 Is Figure 63 A perspective view of the latch used in the needle retraction assembly.

[0100] Figure 65 yes Figure 63 A side sectional view of the needle retraction component, wherein the needle retraction component is in the unlocked state.

[0101] Figure 66 This is a side view of an exemplary deployment tool after it has been inserted through the wall of a blood vessel.

[0102] Figure 67 This is a perspective view of an exemplary deployment tool being withdrawn after a vascular graft has been inserted into the end of a blood vessel.

[0103] Figure 68 This is a perspective view of an exemplary deployment tool during actuation to separate the distal sheath.

[0104] Figure 69 yes Figure 68 A detailed view of an exemplary deployment tool.

[0105] Figure 70 This is a perspective view of the vascular graft being inserted into the end of the second blood vessel.

[0106] Figure 71 This is a perspective view of an exemplary deployment tool being removed from the deployment segment of a vascular graft.

[0107] Figure 72 This is a perspective view of a vascular graft including two exemplary suture covers.

[0108] Figure 73 yes Figure 58 An exploded diagram of an exemplary deployment tool.

[0109] Figure 74 yes Figure 58 A perspective view of an exemplary deployment tool, in which the needle is in the advancing configuration.

[0110] Figure 75 yes Figure 58 A perspective view of an exemplary deployment tool, in which the needle is in a retracted configuration.

[0111] Figure 76 This is a perspective view of an exemplary deployment tool after actuation to separate the distal sheath.

[0112] Figure 77 This is a perspective view of an exemplary deployment tool having a distal portion and a proximal sheath of an expanded vascular graft prior to separation.

[0113] Figure 78 yes Figure 59 An exploded diagram of an exemplary deployment tool.

[0114] Figure 79 This is a side view of an exemplary deployment tool after the needle has been inserted through the wall of the blood vessel.

[0115] Figure 80 yes Figure 79 A detailed view of an exemplary deployment tool, schematically depicting visual regeneration indicators.

[0116] Figure 81 This is a perspective view of an exemplary deployment tool that is actuated to separate the distal sheath to deploy a vascular graft into the end of a blood vessel.

[0117] Figure 82 After the separation of the distal sheath Figure 81 A perspective of an exemplary deployment tool.

[0118] Figure 83 This is a perspective view of an exemplary vascular graft with two suture covers.

[0119] Figure 84 yes Figure 83 A detailed view of the vascular graft, schematically depicting the formation of the flap of the sutured cap.

[0120] Figure 85 This is a perspective view of another exemplary embodiment of the deployment tool.

[0121] Figure 86 This is a detailed view showing the openings created in the branch graft to allow for the introduction of deployment tools.

[0122] Figure 87 This is a perspective view of an exemplary deployment tool introduced via a branch graft of an aortic graft.

[0123] Figure 88 This is a perspective view of an embodiment of an exemplary graft clamp.

[0124] Figure 89 This is a side view of an exemplary graft clamp fixed around a branch graft.

[0125] Figure 90 This is a remote perspective of an exemplary deployment tool.

[0126] Figure 91 yes Figure 90 The hidden view inside the far end.

[0127] Figure 92 yes Figure 90 A detailed view of an exemplary deployment tool, schematically depicting visual regeneration indicators.

[0128] Figure 93This is a side view of an exemplary deployment tool after the needle has automatically retracted.

[0129] Figure 94 This is a side view of an exemplary deployment tool during the deployment of the distal portion of a vascular graft.

[0130] Figure 95 This is a side view of an exemplary deployment tool after deployment of the proximal portion of the vascular graft.

[0131] Figure 96 This is a schematic diagram of a sequence of operations involving an exemplary deployment tool during the deployment of a vascular graft.

[0132] Figure 97 This is a side view of an exemplary deployment tool after the inflation of the inflation balloon.

[0133] Figure 98 This is a side view of an exemplary deployment tool after the inflatable balloon has deflated.

[0134] Figure 99 This is a perspective view of an exemplary deployment tool introduced through the ventilation port of an aortic graft.

[0135] Figure 100 This is a side view of an exemplary deployment tool within a blood vessel.

[0136] Figure 101 This is a side view of the distal portion of the vascular graft deployed within the blood vessel.

[0137] Figure 102 This is a side view of the positioning of the branch graft relative to the vascular graft after the distal portion of the vascular graft has been deployed within the blood vessel.

[0138] Figure 103 This is a side view of the deployment of the proximal portion of the vascular graft within the branch graft.

[0139] Use the same reference symbol in different diagrams to indicate similar or identical items. Detailed Implementation

[0140] Vascular grafts

[0141] refer to Figure 1The diagram illustrates a vascular graft 2. The vascular graft 2 includes a first graft anchor 4 at one end and a second graft anchor 6 at the other end. The first graft anchor 4 and the second graft anchor 6 are longitudinally spaced apart. A cover 10 extends along substantially the entire length of the vascular graft 2, thereby covering substantially all outer surfaces of the first graft anchor 4 and the second graft anchor 6. Alternatively, at least a portion of the first graft anchor 4 and / or the second graft anchor 6 (such as the ends of graft anchors 4, 6) may not be covered by the cover 10. Alternatively, more than one cover 10 may be used, such that the cover 10 may have multiple layers, or may include two or more overlapping segments along the length of the vascular graft 2. The cover 10 may be made of any suitable one or more materials (such as, but not limited to, polytetrafluoroethylene (PTFE)).

[0142] Between the two graft anchors 4, 6, the central section 12 may include a cover 10 not supported by internal structures. In this way, the distance between the graft anchors 4, 6 can vary during insertion and while still in use to accommodate different vascular anatomy. The distance between the graft anchors 4, 6 is adjustable, not fixed. In other embodiments, the central section 12 may be supported by structures that do not interfere with the ability to adjust the distance between the graft anchors 4, 6 during insertion and deployment.

[0143] The first graft anchor 4 and the second graft anchor 6 can expand from a first insertion diameter to a second deployment diameter. The length of each graft anchor 4, 6 remains substantially unchanged during its expansion to the deployment configuration. Alternatively, at least one graft anchor 4, 6 can change its length during its expansion to the deployment configuration. The graft anchors 4, 6 can have any structure that allows expansion from the first insertion diameter to the second deployment diameter and securely holds the graft anchors 4, 6 within the blood vessel in the deployed state. As an example, each graft anchor 4, 6 may include a plurality of hoops 8 extending circumferentially around the vascular graft. The hoops 8 may be longitudinally spaced; if so, adjacent hoops 8 can be connected by one or more tie rods 14. Alternatively, the spaced-out hoops 8 are not interconnected except by a covering 10. Alternatively, at least two adjacent hoops 8 are not spaced apart, but are adjacent to or overlap each other. In such a configuration, such adjacent hoops 8 can be fixed to each other, for example, by laser welding. The hoops 8 can be made of metal or other materials. Each hoop 8 may have a complex shape, wherein the hoop 8 is made of wire or laser-cut from a tube, or otherwise manufactured such that the hoop 8 has a complex shape, such as a zigzag, a repeating Z-shape, a zigzag curve, or other shape. Such a shape allows the hoop 8 to expand from the insertion diameter to the deployment diameter. The zigzag pattern of at least one hoop 8 may be continuously curved, or may include straight segments connected by curved sections. In one embodiment, the zigzag pattern of the hoop 8 may be as set forth in overdue U.S. Patent No. 4,580,568, which is incorporated herein by reference in its entirety. However, at least one hoop 8 may be constructed differently.

[0144] In one embodiment, the different clamps 8 may be made of different materials. For example, at least one clamp 8 may be made of a superelastic material such as a nickel-titanium alloy, and at least one other clamp 8 may be made of a malleable material such as 316L stainless steel. Adjacent clamps 8 may alternate between different materials such that no clamp 8 is adjacent to a clamp made of the same material. In other embodiments, several clamps 8 made of the same material may be grouped together, and at least one clamp 8 made of a different material may be adjacent to the group. For example, the clamp 8 at the outer end of the graft anchors 4, 6 may be made of stainless steel, and the remaining clamps 8 may be made of a superelastic material such as a nickel-titanium alloy. By using clamps 8 made of different materials, the vascular graft 2 utilizes the different properties of those different materials. For example, one or more clamps 8 made of a superelastic material may be used to expand the graft anchors 4, 6; the outward force applied by a standard interventional balloon catheter inside such a superelastic clamp 8 pushes such clamps between the martensitic and austenitic phases, thereby causing those clamps 8 to self-expand to a larger diameter configuration. One or more additional hoops 8, made of a malleable material such as 316L stainless steel, may be used to maintain the lumen opening of each anchor 4, 6, because such a material has greater resistance to hoop stress and is less likely to revert to a different crystalline phase after expansion. Although the term "hoop" is used in this document, the hoop 8 does not need to be perfectly circular when viewed from one end and may have different shapes and curvatures as suited to a particular application. In some embodiments, the hoop 8 is substantially circular when viewed from one end.

[0145] In one embodiment, graft anchors 4 and 6 each expand to the same or similar diameter in the deployed state. In other embodiments, the first graft anchor 4 expands to a different diameter than the second graft anchor 6 in the deployed state. Similarly, in some embodiments, the first graft anchor 4 has a different diameter than the second graft anchor 6 in the inserted state. In this way, deployment of the vascular graft 2 can be facilitated, and / or better fit of the vascular graft 2 in the patient's specific vascular tissue can be facilitated. The diameter difference between the first graft anchor 4 and the second graft anchor 6 can be controlled by making the diameter of the clamp 8 in the first graft anchor 4 different from the diameter of the clamp 8 in the second graft anchor 6, by providing different mixtures of clamps 8 made of different materials in the different graft anchors 4 and 6, or by any other suitable means.

[0146] Procedure - Vascular graft

[0147] refer to Figure 2 The vascular graft 2 is positioned in an insertion configuration for introduction into the patient's vascular system. The second graft anchor 6 moves toward the first graft anchor 4, and the central segment 12 is everted over the second graft anchor 6. The graft anchors 4 and 6 may optionally be close to each other in the insertion configuration and are separated by the thickness of the covering 10.

[0148] The vascular graft 2, in its insertion configuration, is inserted into the vascular system in any suitable manner, such as via a standard femoral artery incision. During insertion, the vascular graft 2 may remain within the lumen of the catheter, and a guidewire may extend through the lumen of the vascular graft. The vascular graft 2 is advanced through the vascular system to the treatment site using the guidewire and catheter in a standard manner, or through the vascular system in any other suitable manner.

[0149] refer to Figure 3 When the vascular graft 2 reaches the treatment site, a standard interventional balloon inflates within the first graft anchor 4. The inflation of the balloon causes the clamps 8 of the first graft anchor 4 to expand to a larger diameter. In the case where at least one of the clamps 8 is made of a hyperelastic material, the inflation of the balloon pushes between the martensitic and austenitic phases of such at least one clamp 8, thereby causing such at least one clamp 8 to expand to a larger diameter.

[0150] refer to Figure 4 After the first graft anchor 4 expands to its deployment diameter, the second graft anchor 6 is pulled proximally from the first graft anchor 4 to its desired deployment position. The flexibility of the central section 12 allows for this adjustment of the distance between graft anchors 4 and 6. Figure 4 As seen, the diameter of the central section 12 may be smaller than the diameter of the first graft anchor 4. Finally, refer to Figure 5 The standard interventional balloon inflates within the second graft anchor 6 in the same manner described above with respect to the first graft anchor 4. As explained above, the inflation diameter of the first graft anchor 4 may be substantially the same as or different from the inflation diameter of the second graft anchor 6. The interventional balloon, guidewire, catheter, and / or other interventional devices are withdrawn from the treatment site, and the vascular graft 2 remains in its deployed state and deployment position.

[0151] aortic graft

[0152] refer to Figures 6 to 7 This shows the central segment 22 of the aortic graft 20. Also see... Figure 12 and Figure 14The entire aortic graft 20 is shown, and is described in more detail below. The central segment 22 of the aortic graft 20 reinforces or replaces the aortic arch during surgery. The aortic graft 20 (including the central segment 22) is typically made of polyester such as polyethylene terephthalate (PET), sometimes referred to as DACRON® brand polyester, which is available from DuPont, Wilmington, Delaware. Advantageously, the aortic graft 20 (including the central segment 22) is impregnated with collagen, which promotes the growth of the patient's own tissue into the aortic graft 20. Alternatively, if desired, the aortic graft 20 may be made of any other robust, flexible, and leak-proof biocompatible material.

[0153] The central segment 22 of the aortic graft 20 may include three bridging grafts 24a, 24b, and 24c. The three bridging grafts 24a, 24b, and 24c correspond to the three arteries originating from the aortic arch: the brachiocephalic trunk, the left common carotid artery, and the left subclavian artery. Each of the three bridging grafts 24a, 24b, and 24c includes an inner lumen that allows blood to flow through it from the central segment 22 of the aortic graft 20. The base 26 of each bridging graft 24a, 24b, and 24c is advantageously secured to the central segment 22 of the aortic graft 20. In some embodiments, at least one bridging graft 24a, 24b, or 24c is made of PTFE and attached to the central segment 22 of the aortic graft 20. In other embodiments, at least one bridging graft 24a, 24b, or 24c is integral with the aortic graft 20 and is also made of the same material as the central segment 22 of the aortic graft 20. The distal end 28 of each bridging graft 24a, 24b, 24c may include an expandable mesh 34, which is generally tubular and has a lumen defined therethrough. In some embodiments, the expandable mesh 34 has a substantially uniform diameter along its entire length. In other embodiments, the proximal end of the expandable mesh 34 (closer to the end of the central segment 22 of the aortic graft 20) may flare outward. In some embodiments, the proximal end of at least one expandable mesh 34 may be sewn or otherwise secured to the distal end of the corresponding bridging graft 24a, 24b, 24c. In some embodiments, at least one expandable mesh 34 may be made in the same or similar manner as at least one graft anchor 4, 6, and scaled down to a smaller length and diameter. The expandable mesh 34 is advantageously self-expanding; for example, the expandable mesh 34 may be made of a superelastic material such as nitinol; as another example, the expandable mesh 34 may be made of a malleable material such as stainless steel, which is compressed to a amount below its elastic limit, and then such compression is removed to allow the expandable mesh 34 to self-expand into place.

[0154] The central segment 22 of the aortic graft 20 advantageously also includes a proximity port 30. The proximity port 30 includes an inner lumen that allows instruments and / or guidewires to be inserted into and withdrawn from the central segment 22 of the aortic graft 20. In some embodiments, the proximity port 30 is made of PTFE and attached to the central segment 22 of the aortic graft 20. In this way, the proximity port 30 can be easily sealed and / or removed after implantation of the aortic graft 20 is completed. In other embodiments, the proximity port 30 is integral with the aortic graft 20 and is also made of the same material as the central segment 22 of the aortic graft 20. One end of the proximity port 30 is connected to the central segment 22 of the aortic graft 20; the other end of the proximity port 30 includes a hemostatic valve 32 that allows instruments and / or guidewires to enter and exit the proximity port 30 as blood flows through the central segment 22 of the aortic graft 20.

[0155] Also refer to Figure 6A This illustrates another exemplary embodiment of the central segment 22 of the aortic graft 20. Figure 6A In an exemplary embodiment, suture bands or loops 23 are provided at or near one or both ends of the central segment 22. Each suture band 23 may be a thicker section of the wall of the central segment 22, or may be a separate article, such as a metallic or non-metallic mesh, attached to the central segment 22. As described in more detail below, each suture band 23 provides an area on the central segment 22 that can be sutured to the aorta or other tissue, having even greater fit to engage sutures and hold the central segment 22 in place during implantation. In other embodiments, additional suture loops 23 may be provided, or a larger suture area 23 may be provided on the central segment 22. Optionally, in addition to one or more suture loops 23, one or more central segment anchors 25 may be attached to the central segment 22. Each central segment anchor 25 may be self-expanding; for example, at least one central segment anchor 25 may be made of a superelastic material such as nitinol; as another example, at least one central segment anchor 25 may be made of a malleable material such as stainless steel, which is compressed to an amount below its elastic limit, and then this compression is removed to allow the central segment anchor 25 to self-expand into place. Each central segment anchor 25 may be attached to the central segment 22 in any suitable manner, such as by molding, adhesive, or thread. Optionally, at least one central segment anchor 25 may be secured to a corresponding suture band 23, and the attachment between the suture band 23 and the central segment 22 subsequently attaches the central segment anchor 25 to the central segment 22. Alternatively, the central segment anchor 25 may be attached to the central segment 22, and one or more suture bands 23 may be omitted.

[0156] Also refer to Figure 8 This illustrates another exemplary embodiment of the central segment 22 of the aortic graft 20. Figure 8 In an exemplary embodiment, the grafts 24a, 24b, and 24c are made of PTFE or similar materials, and are more than Figure 7 The exemplary embodiments are longer. Because these bridging grafts 24a, 24b, 24c are longer than... Figure 7 Those embodiments are longer, giving surgeons greater flexibility to cut or place those bridging grafts in the body as needed. The distal end 28 of each bridging graft 24a, 24b, 24c does not include the features described above. Figure 7 The expandable mesh 34 is described; instead, the end of each bridging graft 24a, 24b, 24c is simply the end of a tube.

[0157] Also refer to Figure 9 This illustrates another exemplary embodiment of the central segment 22 of the aortic graft 20. Figure 9 In an exemplary embodiment, the branch graft 27 includes a manifold 24d extending from the central segment 22 of the aortic graft 20. The manifold 24d may be secured to the central segment 22 or connected to a bridging graft 24 secured to the central segment 22 in a manner similar to that described above. Bridging grafts 24a, 24b, and 24c extend from the manifold 24d and are in fluid communication with the lumen of both the manifold 24d and the central segment 22. This configuration provides additional versatility for certain anatomical structures. Figure 9 In an exemplary embodiment, the bridging grafts 24a, 24b, and 24c may further be as described regarding Figure 7 or Figure 8 The described construction may include or exclude an expandable mesh 34 at the distal end 28 of at least one bridging graft 24a, 24b, 24c. It will be apparent that the features described in the different embodiments of the central segment 22 may be incorporated into the aortic graft 20 as desired. It should also be noted that bridging graft 24 and vascular graft 2 may be used interchangeably at the clinician's discretion, and the phrases "bridging graft" and "vascular graft" may be used interchangeably in this document.

[0158] Also refer to Figure 9A This illustrates another exemplary embodiment of the central segment 22 of the aortic graft 20. The central segment 22 is generally as described above regarding... Figure 6AAs described above. The central segment 22 may be corrugated and made of a generally kink-resistant material. During implantation of the central segment 22, the corrugation optionally allows the central segment 22 to be lengthened or shortened as desired by the clinician. The central segment includes a single bridging graft 24 extending therefrom, which may also be corrugated and made of a generally kink-resistant material. The corrugation optionally allows the bridging graft 24 to be lengthened or shortened as desired by the clinician. As described above regarding... Figure 6A The described suture band 23 may be located proximal to the mesh structure 34, between the mesh structure 34 and the remainder of the graft 24.

[0159] Branch graft 27 includes manifold 24d and bridging grafts 24a, 24b, and 24c extending from manifold 24d, as per [reference needed]. Figure 9 As described above. At least one of the manifold 24d and bridging grafts 24a, 24b, 24c may be corrugated and made of a generally kink-resistant material. During implantation of the manifold 24d and bridging grafts 24a, 24b, 24c, the corrugation optionally allows the manifold 24d and / or at least one bridging graft 24a, 24b, 24c to be lengthened or shortened according to the clinician's wishes. As described above regarding... Figure 6A The described suture band 23 may be located at the free end of the manifold 24d, corresponding to the suture band 23 of the bridging graft 24. When the manifold 24d is attached to the bridging graft 24, the suture bands 23 of the bridging graft 24 and the manifold 24d may be sutured together to connect them or to reinforce the connection formed by the expansion of the expansion mesh 34. Similarly, the suture band 23 may be located near the end 28 of at least one of the bridging grafts 24a, 24b, 24c. Each suture band 23 may be as described above regarding... Figure 6A As described, and can be located proximal to the mesh structure 34, between the mesh structure 34 and the remaining portions of the bridging grafts 24a, 24b, 24c. The suture band 23 facilitates suturing the ends of the bridging grafts 24a, 24b, 24c to the vessel 29, thus providing a strong and accessible location for suturing. This suturing can be used to reinforce the connection with the bridging grafts 24a, 24b, 24c formed by the expansion of the expandable mesh 34 within the vessel 29. Furthermore, if additional bridging pieces 40, 50, as described below, are attached to the ends 28 of the bridging grafts 24a, 24b, 24c to obtain additional length, the proximal ends of these bridging pieces 40, 50 can be sutured to the suture band 23 at the ends of the bridging grafts 24a, 24b, 24c to reinforce the connection with the bridging grafts 24a, 24b, 24c formed by the expansion of the expandable mesh 34 within the additional bridging pieces 40, 50.

[0160] Also refer to Figures 31 to 33According to some embodiments, the end of at least one bridging graft 24a, 24b, 24c may include a suture cap 160. The suture cap 160 is a piece of material in a configuration initially rolled up like the top of a sock. The suture cap 160 may be integral with the outer covering of the bridging graft 24 and may be longer than the bridging graft 24 in a fully unfolded configuration, and may initially be connected in length to the bridging grafts 24a, 24b, 24c. Alternatively, the suture cap 160 may be a single piece of material sewn to or otherwise attached to the end of the bridging graft 24. As described in more detail below, the suture cap 160 may unfold symmetrically or asymmetrically from the end of the bridging graft 24 to engage with the wall of the blood vessel to which the bridging graft 24 is attached, and also provides a material loop that the surgeon can use to suture the bridging graft 24 to the blood vessel wall to provide a more secure connection to the blood vessel wall. The graft 24 may include an outer cover 161 surrounding a cylindrical support frame 163. The outer cover 161 may be made of any suitable biocompatible material, such as, but not limited to, polytetrafluoroethylene (PTFE) or polyesters such as polyethylene terephthalate (PET), sometimes referred to as DACRON® brand polyester, which is available from DuPont, Wilmington, Delaware. The support frame 163 may be made of nickel-titanium alloy, spring steel, or any other suitable biocompatible material. The support frame 163 may be shorter longitudinally than the outer cover 161, and the longitudinally outwardly extending portion of the outer cover 161 from the end of the support frame 163 may form a suture cap 160. That is, the excess length of the outer cover 161 relative to the support frame 163 may initially be rolled into a loop around the longitudinal centerline of the support frame 163 at one end of the support frame 163. Although the suture envelope 160 is described here in the context of its use with the bridging graft 24, the suture envelope 160 may be used with any other bridging graft, graft or anchor described in this document (where appropriate).

[0161] Also refer to Figures 34 to 38 A containment sheath 180 can be used to retain at least one bridging graft 24 in a confined initial configuration prior to deployment. The containment sheath 180 can be made of any suitable biocompatible material, such as, but not limited to, polytetrafluoroethylene (PTFE) or polyesters such as polyethylene terephthalate (PET), sometimes referred to as DACRON® brand polyester, which is available from DuPont, Wilmington, Delaware. Advantageously, as described in more detail below, the containment sheath 180 does not remain in the body. Reference Figure 34The receiving sleeve 180 is shown in a flat configuration prior to assembly. The lateral edges 182 of the receiving sleeve 180 are curved in a sinusoidal or generally sinusoidal pattern and offset from each other such that when the receiving sleeve 180 is rolled up around the crossgraft 24, a peak 184 on one lateral edge 182a of the receiving sleeve 180 mates with a valley 186 on another lateral edge 182b of the receiving sleeve 180. A hole 188 is laterally adjacent to each peak 184. Alternatively, the hole 188 is located near some peak pairs 184, wherein the peak pair 184 is defined as two peaks 184 that are closest to each other in the longitudinal direction but spaced apart in the lateral direction.

[0162] Also refer to Figure 35 The receiving sheath 180 is rolled up around the bridging graft 24 in an initial compression configuration and compresses the bridging graft 24 to the insertion diameter. See also... Figures 36 to 37 The wire 190 passes through longitudinally adjacent holes 188 in the rolled-up receiving sleeve 180. In this way, the wire 190 holds adjacent edges 182a, 182b of the receiving sleeve 180 together. The proximal end 192 of the wire 190 may extend proximally along the deployment tool 200. As described in more detail below, the wire 190 may retract proximally from the holes 188 to open the receiving sleeve 180 and allow the bridging graft 24 to expand. The wire 190 may be made of any suitable material, such as stainless steel wire. Alternatively, the wire 190 may be made of a biocompatible nonmetallic material such as nylon or biocompatible fabric. Although the receiving sleeve 180 is described herein in the context of its use with the bridging graft 24, the receiving sleeve 180 may be used with any other bridging, graft, or anchor described in this document (where appropriate).

[0163] Also refer to Figure 27 An exemplary deployment tool 200 is shown. At the distal end of the deployment tool 200 is a blunt dilator tip 202. The dilator tip 202 is sized and shaped to dilate an incision or opening formed in a blood vessel, as described in more detail below. A channel 204 is defined through the dilator tip 202. Advantageously, the channel 204 is straight and substantially coaxial with the longitudinal centerline of the deployment tool 200. Alternatively, the channel 204 may be differently shaped and / or differently oriented relative to the deployment tool 200. A guidewire 206 may be able to extend through the channel 204 and / or retract into the channel 204. Figure 27 and Figures 29 to 30 As seen, advantageously, guidewire 206 is configured to bend as it exits channel 204. That is, upon exiting channel 204, the distal end of guidewire 206 bends away from the longitudinal centerline of deployment tool 200, whether bending to one side or as... Figure 27 and Figures 29 to 30The distal end of the guidewire 206 is seen to be oriented proximally and posteriorly. Alternatively, after the distal end of the guidewire 206 has been advanced distally to space it from the distal end of the expander tip 202, the distal end of the guidewire 206 begins to bend away from the longitudinal centerline of the deployment tool 200. See also... Figure 28 The needle 210 can be positioned in a neutral position within the channel 204 passing through the end of the dilator 202. The needle 210 can be advanced relative to the end of the dilator 202 to puncture a blood vessel in the patient. Advantageously, the needle 210 is hollow, allowing the guidewire 206 to pass through it.

[0164] Also refer to Figure 27 Proximal to the distal end 202 of the expander, the deployment tool 200 includes a mandrel 208. The bridging graft 24 is wrapped around the mandrel 208 and compressed at least partially against the mandrel 208 by a receiving sheath 180. Also referenced is... Figure 36 A filament 190 extends through longitudinally adjacent holes 188, thereby holding the lateral edges 182 of the receiving sheath 180 together. In this manner, the bridging graft 24 is compressed against the mandrel 208 by the receiving sheath 180. The bridging graft 24 is located proximal to the expander end 202. Alternatively, the distal end of the bridging graft 24 may be positioned near the distal end of the expander end 202. The bridging graft 24 may include a suture cap 160 as described above. The suture cap 160 may be positioned proximal to the bridging graft 24 relative to the deployment tool 200. Alternatively, the suture cap 160 may be positioned distal to the bridging graft 24 relative to the deployment tool 200.

[0165] Also refer to Figure 27 The handle 212 is connected to the proximal end of the spindle 208. The spindle 208 may be manufactured separately from and attached to the handle 212, or the spindle 208 and handle 212 may be manufactured integrally. The handle 212 may be made of any suitable material. (As in...) Figure 27As seen in a partial cross-sectional view, lumen 214 extends substantially longitudinally through handle 212 and spindle 208. Lumen 214 may have a generally circular cross-section, or any other suitable cross-sectional shape. Side port 216 extends laterally through handle 212 into lumen 214. Wire 190 extends proximally into lumen 214 and then extends outward through side port 216. The proximal portion of lumen 214 may be wider than the distal portion of lumen 214. This wider portion of lumen 214 may be referred to as spring receiver 218. Spring receiver 218 may have a generally circular cross-section, or any other suitable cross-section. Flange 220 may be located at the proximal end of spring receiver 218, where the width of lumen 214 widens. Compression spring 222 may be located within spring receiver 218. The distal end of the compression spring 222 may be positioned on the flange 220, preventing the distal end of the compression spring 222 from moving distally toward the flange 220. A needle advance button 224 is positioned proximal to the compression spring 222. The proximal end of the needle advance button 224 is directly or indirectly connected to the compression spring 222, such that movement of the distal end of the needle advance button 224 compresses the compression spring 222. The needle advance button 224 is attached to or otherwise coupled to a needle deployment controller 228. The needle deployment controller 228 extends through the lumen 214 and is attached to or otherwise coupled to the needle 210. The needle deployment controller 228 may be a generally rigid wire or any other structure capable of withstanding compressive force and transmitting that force distally. Alternatively, the needle deployment controller 228 may be selectively engageable and disengageable from the needle 210, such as via at least one intermediate mechanism. The compression spring 222 pushes the button 224 proximally towards the bias needle, and thereby biases the needle 210 proximally into the channel 204 in the expander end 202 via the needle deployment controller 228. When the needle 210 is biased into the channel 204 in the expander end 202, the needle 210 and the needle deployment controller 228 are in a neutral state. Depression of the needle deployment controller 228 in the distal direction propels the needle 210 distally out of the expander end 202, as described in more detail below.

[0166] The needle advance button 224 includes a lumen 226 that extends generally longitudinally through it. In this way, the guidewire 206 can extend through the lumen 214 of the handle 212 and the mandrel 208, and also through the lumen 226 of the needle advance button 224, and then extend from the proximal end of the needle advance button 224.

[0167] Although the deployment tool 200 is described here in the context of its use with the bridging graft 24, the deployment tool 200 may be used with any other bridging graft, graft or anchor described in this document (where appropriate).

[0168] Also refer to Figure 10The diagram shows crossover members 40 with different inner diameters. Crossover member 40a may have an inner diameter of substantially 9 mm, crossover member 40b may have an inner diameter of substantially 11 mm, and crossover member 40c may have an inner diameter of substantially 13 mm. Crossover members 40 with other inner diameters may be provided. Crossover members 40 may be of any length. The expanded end 42 of the crossover member 40 may be constructed in substantially the same manner as the graft anchors 4, 6 as described above, such that the expanded end 42, in the inserted state ( Figure 10 The bridging graft 40 (shown in the diagram) has a small diameter and a larger diameter in the expanded state. Similar to the vascular graft 2 described above, the expanded end 42 of the bridging graft 40 may be connected to and / or covered by a covering 44, which may be made of PTFE or any other suitable material. The anchoring end 46 of the bridging graft 40 may be the end of the covering 44 that is not connected to the expanded end 42 of the bridging graft 40. Advantageously, no anchor or other hardware is attached to the anchoring end 46 of the bridging graft 40 because the bridging graft 40 can be cut between the anchoring end 46 and the expanded end 42 to allow surgeons, nurses, or other operating room professionals to cut the bridging graft 40 to a length appropriate to the patient's anatomy in the operating room before implantation. The covering 44 may accommodate a guidewire 47 or a cannula (not shown) through its lateral side, allowing the guidewire to access the lumen of the bridging graft 40 rather than through an opening in the anchoring end 46 of the bridging graft 40. Guidewire 47 can be easily punctured through covering 44, such that after removal of guidewire 47, the puncture in covering 44 can be sutured closed or otherwise closed. Alternatively, a hemostatic port (not shown) or other port may be provided in the lateral side of covering 44, thereby allowing guidewire 47 to be withdrawn from the inner lumen of bridging member 40 without performing additional actions to close the entry point of guidewire 47 into bridging member 40. When the expanded end 42 is in the inserted state, a nasal cone (not shown) may be placed on the expanded end 42 of bridging member 40 to facilitate insertion of the expanded end of bridging member 40 into its intended position, as described in more detail below.

[0169] Also refer to Figure 11The diagram illustrates fixed-length jumper 50s with different inner diameters. Jumper 50a may have an inner diameter of substantially 9 mm, jumper 50b may have an inner diameter of substantially 11 mm, and jumper 50c may have an inner diameter of substantially 13 mm. Jumpers 50 with other inner diameters may be provided. Each jumper 50 is provided in a fixed length, which may be in the range of 10-20 cm. According to other embodiments, jumper 50 may be provided in the range of 5-10 cm. According to other embodiments, jumper 50 may be provided in the range of 20-30 cm. According to other embodiments, jumper 50 may be provided in the range of 5-20 cm. According to other embodiments, jumper 50 may be provided in the range of 10-30 cm. A particular jumper 50 may be provided in any suitable length. The jumper 50 may be constructed in substantially the same manner as the vascular anchor 2 described above. The expansion end 52 of the jumper 50 can be constructed in substantially the same manner as the graft anchors 4, 6 described above, such that the expansion end 52 is in the inserted state ( Figure 11 (As shown) has a small diameter and a larger diameter in the expanded state. Similar to the vascular graft 2 described above, the expanded end 52 of the bridging member 50 may be connected to and / or covered by a cover 44, which may be made of PTFE or any other suitable material. The anchoring end 56 of the bridging member 50 may be the end of the cover 54 that is not connected to the expanded end 52 of the bridging member 50. Figure 11 As shown, in the expanded state, the outer diameter of the anchoring end 56 of the jumper 50 can be substantially 16 mm. In one embodiment, the anchoring end 56 is capable of expanding from the inserted state to the expanded state. Figure 11 As shown in the diagram, as described above with respect to vascular graft 2. In other embodiments, the anchoring end 56 is substantially non-expandable and has a substantially fixed outer diameter. The cover 54 can accommodate the guidewire 47 through its lateral side, thereby allowing the guidewire to access the lumen of the bridging member 50, rather than through an opening in the anchoring end 56 of the bridging member 50. The guidewire and / or cannula accessing the lumen of the bridging member 50 are substantially as described above with respect to vascular graft 2. Figure 10 As described in the jumper 40.

[0170] Also refer to Figures 39 to 41 According to some embodiments, at least one bridging graft 24a, 24b, 24c may be a hybrid graft 231. (See reference...) Figure 39The hybrid graft 231 may include a first segment 230 and a second segment 232 attached together. The first segment 230 may be a graft made of expanded polytetrafluoroethylene (ePTFE). The second segment 232 may be a scaffold 234 encapsulated with a cover 236, which may be made of polytetrafluoroethylene (PTFE) or other suitable materials. The scaffold 234 is advantageously self-expanding; for example, the scaffold 234 may be made of a hyperelastic material such as nitinol; as another example, the scaffold 234 may be made of a malleable deformable material such as stainless steel, which is compressed to an amount below its elastic limit, and then this compression is removed to allow the expandable mesh 34 to self-expand into place. The first segment 230 may be sintered to the second segment 232 using a sintering process such as that known in the art. Alternatively, the first segment 230 may be attached to or joined to the second segment 232 in any other suitable manner.

[0171] Also refer to Figures 40 to 41 Such bridging grafts 241, 24b, 24c may also include a sleeve 238. The sleeve 238 may receive at least a portion of the first segment 230 therein, such that the first segment 230 partially slides into the lumen of the sleeve 238. According to other embodiments, the sleeve 238 may receive the entire first segment 230 therein, and also receive at least a portion of the second segment 232 therein. The sleeve 238 may be made of polyester and / or any other suitable material. At least a portion of the sleeve 238 may be rolled back toward the first segment 230 to form a sheath 240. (As in...) Figure 41 As seen, at least the end of the second segment 232 extends beyond the sleeve 240, and at least the end of the first segment 230 extends beyond the end of the sleeve 238 opposite to the sleeve 240. Alternatively, at least one of the first segment 230 and the second segment 232 may reside entirely within the lumen of the sleeve 238. The hybrid graft 231 and the sleeve 238 may be combined with a delivery device, as described in more detail below.

[0172] Also refer to Figures 42 to 43At least one hybrid graft 231 may be configured such that the first segment 230 is a graft with a smaller diameter than the support 34 of the second segment 232. To accommodate the attachment of the larger-diameter second segment 232 to the smaller-diameter first segment 230, the end of the first segment 230 is rolled back (outwardly) to form a sheath 242. The end of the second segment 232 is then sewn to or otherwise attached to the sheath 242. If desired, and if the first segment 230 is made of a suitable stretchable material, at least a portion of the sheath 242 may be stretched at the end of the second segment 232 prior to sewing. According to some embodiments, the end of the second segment 232 may taper to a smaller diameter than the remainder of the second segment 232, facilitating the sewing or other attachment of this end of the second segment 232 to the sheath 242. Also refer to Figure 43 Then, the cover 242 can be partially or fully unfolded on the outer surface of the second segment 232.

[0173] Also refer to Figure 44 Even when the clasp 242 is not fully extended onto the surface of the second segment 232, the free end of the stent 34 of the second segment 232 can be inserted into the lumen 248 of the blood vessel 244. (Reference) Figure 45 Then, the sleeve 242 may be partially or completely unfolded on the outer surface of the wall 246 of the blood vessel 244 and sewn onto the wall 246 of the blood vessel 244. According to some embodiments, the sleeve 242 may be sewn onto the wall 246 of the blood vessel 244 before being unfolded onto the blood vessel 244; according to other embodiments, the sleeve 242 may be sewn onto the wall 246 of the blood vessel 244 after being unfolded onto the blood vessel 244.

[0174] Also refer to Figure 54 According to some embodiments, two or more stitched flaps 280 are used instead of the cover 242. Advantageously, two to five stitched flaps 280 are provided. Alternatively, six or more stitched flaps 280 are provided. Figure 54 As seen, the suture flaps 280 are circumferentially separated from each other at their free ends; however, in use, the ends of at least two adjacent suture flaps 280 may be sutured together or adjacent to each other. Instead of everting the ends of the occluder 242, each suture flap 280 is folded back toward the graft 230. As described above, the suture flaps 280 can be utilized in a similar manner to the occluder 242. The free end of the stent 34 can be inserted into the lumen 248 of the blood vessel 244. The suture flaps 280 can then be partially or fully unfolded on the outer surface of the wall 246 of the blood vessel 244 and sutured to the wall 246 of the blood vessel 244.

[0175] Also refer to Figure 46An exemplary deployment tool 250 is shown. Deployment tool 250 is particularly suitable for use with the hybrid graft 231 described above. According to other embodiments, deployment tool 250 can be used with other embodiments of the bridging grafts 24a, 24b, 24c described herein. Deployment tool 250 includes a sheath 252. Sheath 252 can be made of any suitable material, such as PTFE, ePTFE, or PET mesh, such as DACRON® brand polyester. Also referenced... Figures 47 to 49 The protrusion 254 may be attached to the sheath 252 at or near the proximal end of the sheath 252. Alternatively, the protrusion 254 may be attached to the sheath 252 at or near the distal end of the sheath 252 or at any other suitable location along the sheath 252. The protrusion 254 may be generally bifurcated such that a portion of the protrusion 254 extends laterally to the sheath 252 on both sides of the sheath 252, and the protrusion 254 may be attached to the sheath 252 on the top and on both sides of the sheath 252. The protrusion 254 may be attached to the sheath 252 in any suitable manner, such as by adhesive, by welding, or by sintering. Alternatively, the protrusion 254 may be integrally manufactured with the sheath 252. The protrusion 254 may include a pull member 256 configured to be pulled by a user. The pull member 256 may be shaped and / or textured to facilitate a user's gripping and pulling of the pull member 256. The pull member 256 can be angled upwards from the longitudinal centerline of the sheath 252 in the proximal direction, such as in Figure 47 The clearest view. Also refer to Figure 48 The sheath 252 may include a separation line 258 along which the sheath 252 preferentially separates when the puller 256 is gripped and pulled. The separation line 258 may be generally linear and generally parallel to the longitudinal centerline of the sheath 252. Alternatively, the separation line 258 may describe any other suitable path along the sheath 252. According to one embodiment, the separation line 258 includes a set of perforations along the sheath 252. According to another embodiment, the separation line 258 includes a set of slits along the sheath 252. According to yet another embodiment, the separation line 258 is a line along the sheath 252 with a thickness less than the thickness of the remaining portion of the sheath 252, such that separation of the sheath 252 preferentially occurs along the separation line 258. According to other embodiments, the separation line 258 may be constructed in any other suitable manner. At the proximal end of the separation line 258, the sheath 252 may include a V-shaped or otherwise shaped cut 259 that facilitates separation of the sheath 252 from the proximal to the distal direction. The cut 259 is advantageously wider at its proximal end than at its distal end, and the proximal end may be connected to the proximal end of the sheath 252.

[0176] Also refer to Figure 46 and Figure 50The deployment tool 250 includes a spindle 208 with a dilator tip 202 at its distal end. The dilator tip 202 is sized and shaped to dilate an incision or opening formed in a blood vessel. A channel 204 is defined through the dilator tip 202. Advantageously, the channel 204 is straight and substantially coaxial with the longitudinal centerline of the deployment tool 250. Alternatively, the channel 204 may be differently shaped and / or differently oriented relative to the deployment tool 250. A guidewire 206 may be able to extend through the channel 204 and / or be able to retract into the channel 204. The tip of the guidewire 206 may be configured to bend as the guidewire 206 exits the channel 204. That is, upon exiting the channel 204, the distal end of the guidewire 206 bends away from the longitudinal centerline of the deployment tool 250, either bending to one side or bending posteriorly in a proximal direction.

[0177] The hybrid graft 231 may be wrapped around the mandrel 208. Alternatively, another embodiment of the bridging graft 24 may be wrapped around the mandrel 208. The hybrid graft 231 may be oriented on the mandrel 208 such that a second segment 232 including a support 34 is located at or near the distal end of the mandrel 208, such that the distal end of the support 34 may be adjacent to or abut the proximal end of the expander end 202. The distal end of the first segment 230 of the hybrid graft 231 may be located substantially at the junction between the protrusion 254 and the sheath 252. Alternatively, the distal end of the first segment 230 of the hybrid graft 231 may be located at a different position relative to the protrusion 254. The sheath 252 wraps around all or part of the second segment 232 of the hybrid graft 231, which in turn wraps around the mandrel 208. The sheath 252 compresses at least a portion of the second segment 232 of the hybrid graft 231 against or toward the mandrel 208. The separation line 258 is weak enough to allow the user to tear the sheath 252 along the separation line 258, but strong enough to withstand the outward force exerted by the second segment 232 when the hybrid graft 231 is compressed against or toward the mandrel 208.

[0178] Also refer to Figure 50 The user inserts the guidewire 206 into a blood vessel (such as...) Figure 44The dilator tip 202 is then slid along the guidewire 206 with the sheath 252 until the distal end of the dilator tip 202 and then at least the distal end of the sheath 252 enters the blood vessel. The sheath 252 (and the second segment 232 of the hybrid graft 231 together with it) slides into the blood vessel a suitable distance selected by the user. Once the hybrid graft 231 is in place, the user grasps the puller 256 and applies a force away from the axis 208 and in the proximal direction. The sheath 252 separates along the separation line 258 and peels off from the hybrid graft 231 from the proximal end toward the distal end. The incision 259 first directs the force of movement from the puller 256 (and therefore the protrusion 254) toward the proximal end of the separation line 258. Thus, as the user continues to pull the puller 256 proximally and away from the axis 208, the separation line 258 continues to separate in the distal direction. When the sheath 252 separates, it no longer presses against or compresses the second segment 232 of the hybrid graft 231 against or toward the axis 208, and the stent 34 of the second segment 232 expands outward. Once the separation line 258 separates at its distal end, the stent 234 completes its outward expansion, and the sheath 252 is pulled away from the hybrid graft 231. Any portion of the sheath 252 remaining inside the blood vessel is pulled out of the vessel, and the hybrid graft 231 is in place.

[0179] Also refer to Figure 51 An exemplary deployment tool 260 is shown. Deployment tool 260 is particularly suitable for use with the hybrid graft 231 described above. According to other embodiments, deployment tool 260 can be used with other embodiments of the bridging grafts 24a, 24b, 24c described herein. According to other embodiments, deployment tool 250 can be used with other embodiments of the bridging grafts 24a, 24b, 24c described herein. Deployment tool 260 includes a sheath 252, which can be substantially as described above with respect to deployment tool 250 and as... Figures 47 to 49 As shown in the diagram. Furthermore, deployment tool 260 includes a mandrel 208 and an expander end 202 configured to receive a guide wire 206, which can be substantially as described above with respect to deployment tool 250 and as... Figure 46 and Figure 50 As shown in the diagram. The needle 210 can extend retractably through the expander end 202 and can be coupled to a needle controller 277 located more proximally on the deployment tool 260. The needle 210 can be coupled to the needle controller 277 via a linkage or any other suitable structure or mechanism. The needle 210 can retract into the expander end 202 by proximal movement of the needle controller 277 and extend out of the expander end 202 by distal movement of the needle controller 277. The needle 210 may include an orifice through which a guidewire 206 can pass. Optionally, as in Figure 53 As seen, the mandrel 208 may be ribbed. The hybrid graft 231 may be mounted on the mandrel 208 of the deployment tool 260 and held in place by the sheath 252, essentially as described above with respect to the deployment tool 250.

[0180] Deployment tool 260 also includes a protrusion 254, which may be substantially as described above regarding deployment tool 250 and as... Figures 47 to 49 As shown in the diagram, the protrusion 254 applies a compressive force to the sheath 252 at or near its proximal end. See also... Figures 51 to 53 The protrusion 254 may be generally U-shaped. One or more wings 262 may extend from the protrusion 254. The wings 262 may be attached to the protrusion 254 or integrally formed with the protrusion 254. Each wing 262 is angled outward from the protrusion 254. The protrusion 254 itself may include a movable hinge defined therein between the protrusion 254 and the engagement of each wing 262. The wings 262 are configured such that movement of the wings 262 toward each other (such as the pinching movement of a user's hand and the application of a pinching force) displaces the free ends 264 of the protrusion 254 from each other, as described in more detail below.

[0181] Arm 266 may extend proximally from protrusion 254. Arm 266 may be attached to protrusion 254, integrally formed with protrusion 254, or connected to protrusion 254 in any suitable manner. Arm 266 may be substantially cylindrical, or may have any other suitable shape and / or cross-section. Advantageously, arm 266 may be rigid. Alternatively, arm 266 may be configured to be flexible. The distal end of arm 266 may be connected to protrusion 254, while the proximal end of arm 266 may be connected to hinge 268. The connection between arm 266 and hinge 268 allows arm 266 to rotate about hinge 268, such that rotation of arm 266 causes protrusion 254 to move along an arc from the longitudinal centerline of sheath 252 upward and also proximally, as described in more detail below. Hinge 268 may be attached to support member 272 or be part of support member 272. Reference Figure 53The distal end of the support member 272 may be connected to the proximal end of the spindle 208. The spindle 208 may be attached to or be a portion of the support member 272. The support member 272 may be substantially rigid. Optionally, the handle 270 may be attached to the arm 266 in any suitable manner. For example, the handle 270 may include an orifice 274 defined therethrough to receive the arm 266, and the arm 266 may be slidable relative to the arm 266. Alternatively, the arm 266 may be press-fitted to the orifice 274, adhered to the orifice 274, welded to the orifice 274, or otherwise secured to the orifice 274. The handle wing 276 may extend laterally from the orifice 274 or in any other suitable direction. The handle wing 276 may be generally planar and rectangular, or may have any other suitable shape. The user may use the handle 270 to lift the protrusion 254 away from the spindle 208, as described in more detail below. The handle 270 can be attached to the sheath 252 such that proximal movement of the handle 270 relative to the arm 266 can cause the sheath 252 to split.

[0182] Also refer to Figure 51 The user inserts the guidewire 206 into a blood vessel (such as...) Figure 44 The needle 210 is inserted into the distal end of the vessel 244 (as seen in the image) or into the side of a vessel (such as the aorta). The needle 210 extends distally and is used to puncture the side of the vessel. The dilator tip 202 is then pushed into the puncture hole to inflate it, and the needle 210 is retracted proximally into the dilator tip 202 by proximal movement of the needle controller 277. The guidewire 206 is then slid into the vessel through the dilator tip 202 and optionally through the orifice in the needle 210 (now residing in the dilator tip 202 and no longer exposed). The dilator tip 202 is then slid along the guidewire 206 with the sheath 252 until the dilator tip 202 and then at least the distal end of the sheath 252 enter the vessel. The sheath 252 (and the second segment 232 of the hybrid graft 231 therewith) slides into the vessel a suitable distance selected by the user. Once the hybrid graft 231 is in place, the user grasps the wings 262 and compresses them together. The movement of the wings 262 toward each other causes the free ends 264 of the protrusions 254 to move apart. In the case where the protrusions 254 include a hinge, this hinge facilitates the movement of the free ends 264 of the protrusions 254 apart. Therefore, the protrusions 254 no longer abut against the spindle 208 to compress the sheath 252.

[0183] The user then grasps handle 270 and pulls it proximally along arm 266, initiating the splitting of sheath 252 at its proximal end, similar to the manner described above with respect to deployment tool 250. Sheath 252 may include a separation line along which sheath 252 separates. The splitting of sheath 252 continues as handle 270 moves proximally. As sheath 252 separates, it no longer presses against or toward the mandrel 208 against the second segment 232 of the hybrid graft 231, and the support 34 of the second segment 232 expands outward. Once sheath 252 has separated at its distal end, the support 234 completes its outward expansion, and sheath 252 is pulled away from the hybrid graft 231. Arm 266 then rotates about hinge 268 to remove handle 270, and handle 270 is movable to a position proximal to the proximal end of deployment tool 260. Figure 52 As seen, any portion of the sheath 252 retained inside the blood vessel is pulled out of the blood vessel, and the graft 231 is in place.

[0184] Also refer to Figure 55Another exemplary deployment tool 290 is shown. Deployment tool 290 can be used with a dual-scaffold graft 292. The dual-scaffold graft 292 can be made in a substantially similar manner to the hybrid graft 231 described above, with the differences described below. The dual-scaffold graft utilizes two scaffolds 234 that are substantially aligned with each other along their longitudinal centerlines and can be attached to or attached to each other. Alternatively, the two scaffolds 234 can be a single scaffold 234 extending substantially along the length of the dual-scaffold graft 292. Alternatively, the two scaffolds 234 can be longitudinally separated from each other to allow for greater flexibility in the dual-scaffold graft 292. Sheaths 252 may include two separate sheaths 252a, 252b, with sheath 252a located distal to sheath 252b. As described above, each sheath 252a, 252b may be configured to split along a separation line. Two protrusions 294 may be attached to the end of each sheath 252a, 252b. Alternatively, one protrusion 294 or three or more protrusions 294 may be attached to the end of each sheath 252a, 252b. The protrusions 294 may be generally circular or may be shaped in any other suitable manner, such as oval or polygonal. Alternatively, the protrusions 294 may be substantially linear or may be curved. The protrusions 294 may be oriented to be circumferentially spaced from each other at approximately 90 degrees. Alternatively, the protrusions 294 may be oriented and spaced relative to each other in any other suitable manner. All protrusions 294 may be located in substantially the same longitudinal position relative to the deployment tool 290. Alternatively, the protrusion 294 associated with the first sheath 252a may be longitudinally spaced from the protrusion 294 associated with the second sheath 252b. As described below, the sheaths 252a and 252b are configured to split longitudinally in opposite directions. Each sheath 252a and 252b may be split in a direction toward its free end.

[0185] Deployment tool 290 can be used with the hybrid graft 231 described above. According to other embodiments, deployment tool 290 can be used with other embodiments of the bridging grafts 24a, 24b, 24c described herein. According to other embodiments, deployment tool 290 can be used with other embodiments of the bridging grafts 24a, 24b, 24c described herein. Deployment tool 290 includes a sheath 252, which can be substantially as described above with respect to deployment tool 250 and as... Figures 47 to 49 As shown in the diagram. Furthermore, deployment tool 290 includes a mandrel 208 and an expander end 202 configured to receive a guide wire 206, which can be substantially as described above with respect to deployment tools 250 and 260 and as... Figure 46 and Figure 50As shown in the diagram. Optionally, as in Figure 53 As seen, the mandrel 208 may be ribbed. The dual-scaffold graft 292 may be mounted on the mandrel 208 of the deployment tool 290 and held in place by the sheath 252, essentially as described above with respect to deployment tools 250 and 260.

[0186] Also refer to Figure 55 The user inserts guidewire 206 into the side or end of the blood vessel. Then, the dilator tip 202, along with sheath 252, slides along guidewire 206 until the dilator tip 202 and then at least the distal end of sheath 252 enter the blood vessel. Sheath 252 (and the distal end of the dual-stent graft 292 therewith) slides into blood vessel 244 a suitable distance selected by the user. See also... Figure 56 Once the dual-stent graft 292 is in place, the user grasps the protrusion 294 attached to the first sheath 252a and pulls them apart, causing the first sheath 252a to split. As the first sheath 252a separates, it no longer presses against or compresses the distal end of the dual-stent graft 292 against or towards the mandrel 208, and the stent 234, or the distal portion of the stent 234 at the distal end of the dual-stent graft 292, expands outward. Once the first sheath 252a has separated at its distal end, the stent 234, or the distal portion of the stent 234, completes its outward expansion, and the first sheath 252a is pulled away from the dual-stent graft 292. (As in...) Figure 52 As seen, any portion of the first sheath 252a remaining inside the blood vessel is pulled out of the vessel, and the distal end of the dual-stent graft 292 is in place. The guidewire 206 can then be withdrawn from the blood vessel 244 through the lumen of the dual-stent graft 292.

[0187] Next, also refer to Figure 57 The user can pull the vascular graft 296 onto the proximal end of the double-stent graft 292. The end of the vascular graft 296 can be pulled close to the remaining protrusion 294. Once the vascular graft 296 is in place on the double-stent graft 292, the user grasps the protrusion 294 attached to the second sheath 252b and pulls them apart, causing the second sheath 252b to split. As the sheath 252b separates, it no longer presses against or compresses the proximal end of the double-stent graft 292 against or towards the axis 208, and the stent 234, or a portion of the stent 234 at the proximal end of the double-stent graft 292, expands outward. Once the second sheath 252b has separated at its proximal end, the stent 234, or the proximal portion of the stent 234, completes its outward expansion, and the second sheath 252b is pulled away from the double-stent graft 292, emerging from the end of the vascular graft 296. The proximal end of the double-stent graft 292 is thus secured in place.

[0188] Procedure - Aortic Graft

[0189] refer to Figure 12 An exemplary method for implanting an aortic graft 20 having a central segment 22 is shown. The patient is placed on a cardiopulmonary bypass pump to stop the heartbeat, and a clamp is placed on the aorta 60, spaced apart from the ascending aorta. An incision 62 is formed in the aorta 60 to separate the ascending aorta, and the ascending aorta is removed. The central segment 22 of the aortic graft 20 is then sutured to the proximal end of the aortic stump 70 at or near the incision 62. In this manner, the lumen of the central segment 22 of the aortic graft 20 is easily accessible.

[0190] like Figure 12 As shown, manifold 24d is fixed to the central segment 22 of aortic graft 20, and three bridging grafts 24a, 24b, and 24c extend from manifold 24d. Alternatively, with the three bridging grafts 24 positioned on the central segment 22, three bridging pieces 40 and 50 are selected. If one of the bridging pieces 40 is selected, it can be used as is, or it can be cut to a shorter length. This length is selected by the clinician based on the distance between the central segment 22 of aortic graft 20 and the arteries 64, 66, and 68 to be connected. If one of the bridging pieces 50 is selected, its length is fixed, and it is not cut to a shorter length. The selected bridging piece 40 or 50 is then inserted through one of the bridging grafts 24 into the lumen of the central segment 22 of aortic graft 20 until most of the bridging piece 40 or 50 has been pulled through the bridging graft 24. When using bridging element 50, advantageously, bridging element 50 is pulled through bridging graft 24 until at least a portion of the anchoring end 56 of bridging element 50 is located within the expandable mesh 34 of bridging graft 24. Bridging elements 40, 50 can be pulled or pushed through the corresponding bridging graft 24 using a guidewire. Advantageously, a standard interventional balloon (not shown) is positioned within the anchoring ends 46, 56 of bridging elements 40, 50 and inflated. This inflation causes the anchoring ends 46, 56 to expand to their inflated state, and also causes the expandable mesh 34 to expand to its inflated state. In this way, the anchoring ends 46, 56 of bridging elements 40, 50 are pressure-fitted into the corresponding expandable mesh 34. The guidewire and interventional balloon are then withdrawn. Alternatively, when the bridging pieces 40 and 50 are integrally formed with the central segment 22 of the aortic graft 20, the selection of the bridging pieces 40 and 50 and their insertion into the central segment 22 of the aortic graft 20 are omitted. Alternatively, the bridging pieces 40 and 50 may be inserted into the corresponding arteries 64, 66, and 68 before at least one of them is connected to the central segment 22 of the aortic graft 20.

[0191] Next, the remaining portion 20a of the aortic graft 20 is inserted into the descending aorta 74. This remaining portion may be secured to the central segment 22 of the aortic graft 20, or it may be a separate component attached to the central segment 22 of the aortic graft 20. In some embodiments, the central segment 22 of the aortic graft 20 is first sutured to the descending aorta 74 at or near incision 62. The remaining portion 20a of the aortic graft 20 may be inserted into the access port 30 via a hemostatic valve 32, and then inserted into the descending aorta 72 through the lumen of the central segment 22, such as via a guidewire (not shown) inserted through the hemostatic valve 32 and through the access port 30. The remaining portion 20a of the aortic graft 20 may be deployed in any suitable manner, such as by inflation of a standard interventional balloon. In other embodiments, the remaining portion 20a of the aortic graft 20 may be self-expanding. If necessary, the remaining portion 20a of the aortic graft 20 may be sutured to the descending aorta 72 to ensure that the remaining portion 20a of the aortic graft 20 remains in place. Alternatively, such suturing is not required. Additionally, the remaining portion 20a of the aortic graft 20 may be sutured or otherwise attached to the central segment 22 of the aortic graft 20. According to other embodiments, the remaining portion 20a of the aortic graft 20 is inserted into the descending aorta 74, and then the central segment 22 is sutured to the descending aorta 74. With the remaining portion 20a of the aortic graft 20 secured, the guidewire, interventional balloon, and / or other mechanisms or devices inserted through the access port 30 are withdrawn via the hemostatic valve 32. The heart then resumes beating, and the patient is removed from cardiopulmonary bypass according to standard practice.

[0192] At least one graft 24 can be implanted using deployment tool 200. (Reference) Figure 27 As described above, the bridging graft 24 is initially wrapped around the mandrel 208 of the deployment tool 200. Also, as described above, see reference to... Figure 35 The sheath 180 is rolled up around the graft 24 in an initial compression configuration. See also... Figures 36 to 37 The wire 190 passes through longitudinally adjacent holes 188 in the rolled-up receiving sheath 180. In this way, the wire 190 holds the adjacent edges 182a, 182b of the receiving sheath 180 together, and thus the receiving sheath 180 abuts against the mandrel 208 to compress the bridging graft 24.

[0193] To begin the deployment process, the user grasps the handle 212 of the deployment tool 200 and actuates the needle advance button 224. The distal force applied by the user to the needle advance button 224 compresses the compression spring 222 connected to the needle advance button 224, and simultaneously, the distal force applied by the user to the needle advance button 224 pushes the needle deployment controller 228 distally. See also... Figure 28Because the needle deployment controller 228 is attached to or otherwise coupled to the needle 210, distal advancement of the needle deployment controller 228 advances the needle 210 distally beyond the channel 204 via the expander end 202. Advantageously, before the advancement of the needle 210, the guidewire 206 extends substantially 1-2 cm beyond the channel 204 via the expander end 202. Alternatively, the guidewire 206 may extend beyond the channel 204 a different distance before the advancement of the needle 210, or may not extend beyond the channel 204 at all. As described above, advantageously, the needle 210 is hollow, and the guidewire 206 passes through the needle. Therefore, as the needle 210 is advanced distally and the guidewire 206 remains substantially longitudinally stationary, the needle 210 temporarily straightens the bent guidewire 206. The needle 210 continues to be advanced distally until its distal end is distal to the distal end of the guidewire 206. In this way, the distal end of the guidewire 206 does not interfere with the ability of the needle 210 to puncture tissue. The needle 210, which was previously protected from contact with the patient's tissue, is now exposed.

[0194] The user then uses needle 210 to pierce the patient's blood vessel at the location where the user wishes to insert the bridging graft 24. After needle 210 pierces the blood vessel, the user releases needle advance button 224. The energy stored in the compression spring 222 then pushes needle advance button 224 proximally, thereby moving needle deployment controller 228, which is attached to or otherwise coupled to needle advance button 224, proximally. Needle deployment controller 228 then moves needle 210 proximally back into channel 204 in dilator tip 202. As needle 210 moves proximally and guidewire 206 remains substantially longitudinally stationary, distal end 206 of guidewire 206 is exposed and held within the lumen of the blood vessel. See also Figure 29 As described above, the distal end of guidewire 206 bends proximally so that guidewire 206 is not damaged relative to the interior of the blood vessel.

[0195] The guidewire 206 is then advanced further into the lumen of the blood vessel by approximately the length of the bridging graft 24. This advancement can be performed manually by pushing the proximal end of the guidewire 206, which extends from the proximal end of the deployment tool 200. Alternatively, such advancement can be performed by a mechanism within the deployment tool 200. The user then advances the deployment tool 200 along the guidewire 206. The dilator tip 202 is blunt, and when pushed against a puncture hole formed in the blood vessel by the needle 210, it dilates the puncture hole and enters the lumen of the blood vessel through the dilated puncture hole. As the deployment tool 200 continues to be advanced through the dilated puncture hole, the compressed bridging graft 24 enters the lumen of the blood vessel. The user continues to advance the deployment tool 200 until the suture cap 160 of the bridging graft 24 approaches the puncture hole in the blood vessel, at which point the user stops advancing the deployment tool 200.

[0196] The bridging graft 24 is then deployed. The pull wire 190 retracts proximally. The user can grasp the proximal portion of the pull wire 190 and pull it proximally. Alternatively, such retraction can be performed by a mechanism in the deployment tool 200. As the pull wire 190 retracts proximally, it is sequentially withdrawn from the holes 188 in the receiving sheath 180, starting from the farthest hole 188. As described above, the receiving sheath 180 is compressed around the bridging graft 24 by the pull wire 190 passing through the holes 188, which holds the receiving sheath 180 in the compressed position. As the pull wire 190 retracts proximally from the holes 188, the edges 182 of the receiving sheath 180 are freed to move apart from each other starting from the proximal end of the receiving sheath 180. The bridging graft 24, already compressed by the receiving sheath 180, is thus able to expand radially as the pull wire 190 retracts proximally from the bridging graft 24. The bridging graft 24 is radially expanded from proximal to distal until the filament 190 has been removed from the distal port 188 in the receiving sheath 180. The bridging graft 24 is then fully radially expanded within the lumen of the vessel. The filament 190 is then completely dissociated from the deployment tool 200 (if it has not already been dissociated). The bridging graft 24 is no longer compressed around the spindle 208 of the deployment tool 200, allowing the spindle 208 of the deployment tool 200 to be easily withdrawn from the lumen of the bridging graft 24. The deployment tool 200 is moved proximally out of the lumen of the bridging graft 24, thereby leaving the bridging graft 24 in place relative to the vessel.

[0197] The suture closure 160 (if used) can then be adjusted to engage with the wall of the vessel 165. The bridging graft 24 extends outward through the dilated puncture hole in the vessel 165 at an angle relative to the longitudinal centerline of the vessel 165. Therefore, the suture closure 160 can be differentially deployed on opposite sides of the bridging graft 24 to engage with the wall 167 of the vessel 165. That is, on the side of the bridging graft 24 forming an obtuse angle with respect to the vessel 165, the suture closure 160 can be deployed to a greater extent than on the side of the bridging graft 24 forming an acute angle with respect to the vessel 165. In practice, the bridging graft 24 can be advanced into the lumen of the vessel 165 such that the suture closure 160 initially contacts the wall of the vessel 165 on the side of the bridging graft 24 forming an acute angle with respect to the vessel 165. The suture closure 160 is differentially deployed until it substantially engages with the tissue surrounding its circumference. The clinician then sutures the suture cap 160 to the wall 167 of the blood vessel 165 to secure the bridging graft 24 to the blood vessel 165. The suture cap 160 provides a thick area for suturing to allow a strong suture connection between the bridging graft 24 and the blood vessel 165. When the suturing is complete, the bridging graft 24 is secured to the blood vessel 165.

[0198] To restart the heartbeat, the bridging grafts 24a, 24b, 24c or manifold 24d are clamped to prevent leakage of aortic blood through them during the next part of the procedure. According to some embodiments, one or more bridging grafts 24 are connected to corresponding arteries 64, 66, 68 using a deployment tool 200 as described above. According to other embodiments, the bridging grafts 24a, 24b, 24c are inserted into corresponding arteries originating from the aortic arch: the brachiocephalic trunk 64, the left common carotid artery 66, and the left subclavian artery 68. An incision is formed in one of those arteries 64, 66, 68, the length of which is shorter than or substantially the same as the diameter of the expanded ends 42, 52 of the selected bridging grafts 40, 50. The expanded ends 42, 52 of the selected bridging grafts 24a, 24b, 24c are inserted through this incision in the inserted state. Such insertion can be performed under direct vision in open surgery or can be performed entirely or partially percutaneously. The nasal cone (not shown) may be tapered and located distal to the expansion ends 42, 52, so that the expansion ends 42, 52 can be accessed through the incision into the lumen of the selected arteries 64, 66, 68. A guidewire may extend into the lumen of the selected bridging grafts 24a, 24b, 24c and pass through the expansion ends 42, 52 to reach the nasal cone; such a guidewire advantageously extends proximally to the selected bridging grafts 24a, 24b, 24c, rather than passing through the coverings 44, 54 of the bridging grafts 24a, 24b, 24c. The expansion ends 42, 52 are placed in the lumen of the corresponding arteries 64, 66, 68. Advantageously, a standard interventional balloon (not shown) is positioned within the expansion ends 42, 52 of the bridging grafts 24a, 24b, 24c and inflated. This inflation causes the expansion terminals 42 and 52 to expand to their inflated state, with a diameter larger than the inner diameter of the corresponding arteries 64, 66, and 68 to which they are inserted. In this way, the expansion terminals 42 and 52 apply pressure to the corresponding arteries 64, 66, and 68. The guidewire and interventional balloon are then withdrawn. Next, bridging grafts 24a, 24b, and 24c are connected to each of the other two arteries 64, 66, and 68.

[0199] refer to Figure 12A Another exemplary method for implanting an aortic graft 20 having a central segment 22. This method is essentially as described above regarding... Figure 12The procedure is performed as described, with the differences described in this section. After removal of the ascending aorta, the tip of the central segment 22 of the aortic graft 20 is inserted into the aortic stump 70. The central segment 22 includes a central segment anchor 25, which self-expands within the aortic stump 70 to help hold the central segment 22 in place. Alternatively, a standard interventional balloon may be used to inflate or assist in inflating the central segment anchor 25. The central segment anchor 25 placed in the aortic stump 70 may be referred to as the proximal central segment anchor 25. The tip of the central segment 22 of the aortic graft 20 is then sutured to the aortic stump 70 at or near incision 62. The central segment 22 includes a suture band 23, and the clinician sutures the aortic stump 70 to the suture band 23 for additional security. The tip of the central segment 22 of the aortic graft 20 is then inserted into the descending aorta 72. The central segment 22 includes a central segment anchor 25, which self-expands within the descending aorta 72 to help hold the central segment 22 in place. Alternatively, a standard interventional balloon can be used to inflate or assist in inflating the central segment anchor 25. The central segment anchor 25 placed in the descending aorta 72 may be referred to as the distal central segment anchor 25. This end of the central segment 22 of the aortic graft 20 is then sutured to the descending aorta 72 at or near incision 62. The central segment 22 includes a suture band 23, and the clinician sutures the descending aorta 72 to the suture band 23 for additional safety. The heart then resumes beating, and the patient is removed from cardiopulmonary bypass according to standard practice.

[0200] Next, a single manifold 24d is connected to the bridging graft 24 on the central segment of the aortic graft 20. Advantageously, a standard interventional balloon (not shown) is positioned within the inflatable mesh 34 of the bridging graft 24 and inflated. This inflation causes the inflatable mesh 34 to expand to its inflated state. In this way, the anchoring end pressure of the single manifold 24d is matched to the corresponding inflatable mesh 34. Figure 9 As shown, individual bridging grafts 24a, 24b, and 24c extend from manifold 24d and are in fluid communication with the lumen of central structure 22 after manifold 24d is connected to bridging graft 24.

[0201] refer to Figure 12B Another exemplary method for implanting an aortic graft 20 having a central segment 22. This method is essentially as described above regarding... Figure 12AThe procedure is performed as described, with the differences described in this section. After the two ends of the central segment 22 are connected to the remainder of the aorta, the patient's heart resumes beating. A manifold 24d is connected to a bridging graft 24, which in turn is connected to the central segment 22, as described above. In this embodiment, the manifold includes two separate bridging grafts 24a and 24c connected to it, and a third bridging graft 24b branches off from the bridging graft 24c. Alternatively, the bridging graft 24b may branch off from the bridging graft 24a. Clinicians determine whether the bridging grafts 24a, 24b, and 24c are long enough to reach the desired location within the patient's body. If they are not long enough, they may be used as described above. Figure 10 The bridging grafts 24a, 24b, and 24c are used as described. The anchoring ends 46 of the bridging grafts 24a, 24b, and 24c can be cut to any suitable length and then placed on the expandable mesh 34 at the distal end of any bridging graft 24c that is too short. Such a bridging graft 40 can be used with any or all of the bridging grafts 24a, 24b, and 24c. Advantageously, a standard interventional balloon (not shown) is positioned within the expandable mesh 34 and inflated. This inflation causes the expandable mesh 34 to expand to an inflated state. In this way, the anchoring ends 46 of the grafts 24a, 24b, and 24c are pressure-fitted into the corresponding expandable mesh 34.

[0202] refer to Figures 13 to 14 This illustrates another exemplary method for implanting an aortic graft 20 with a central segment 22. This method may be referred to as the "warm elephant trunk" method. Figure 13 The warm elephant trunk method utilizes a dual automated perfusion device 80. The dual automated perfusion device 80 includes a flexible cannula 82 and one or more orifices 84. The flexible cannula 82 has a lumen defined therethrough, and the orifices 84 extend through the cannula 82 from the lumen to an outer surface. At least one access port 86 is connected to the cannula 82. The access port 86 includes a lumen that allows instruments and / or guidewires to be inserted into and withdrawn from the lumen of the cannula 82. One end of the access port 86 is connected to the cannula 82; the other end of the access port 86 optionally includes a hemostatic valve 88 that allows instruments and / or guidewires to enter and exit the access port 86 while blood flows through the lumen of the cannula 82. One or more access ports 86 may be provided. Each access port 86 may be off-axis connected to the sleeve 82 such that the longitudinal centerline of the access port 86 is at an angle relative to the longitudinal centerline of the sleeve 82, or coaxially connected to the sleeve 82 such that the longitudinal centerline of the access port 86 is substantially the same as the longitudinal centerline of the sleeve 82.

[0203] The first balloon 90 of the dual automatic infusion device 80 may be substantially hollow to allow blood to flow through it. Alternatively, a tube (not shown) extends between opposite sides of the first balloon 90 and connects to a cannula 82 to allow blood to flow across the tube across the first balloon 90. A bridge tube 94 connects to the first balloon 90 and a second balloon 92 spaced apart from the first balloon. The first balloon 90 and / or the second balloon 92 are slidable relative to the bridge tube 94, which may be press-fitted to the balloons 90, 92. Flanges (not shown) or other suitable structural features at both ends prevent the bridge tube 94 from being pulled out of the balloons 90, 92. The bridge tube 94 may be press-fitted or wire-fitted to the tubes within the balloons 90, 92 to allow the first balloon 90 and / or the second balloon 92 to slide relative to the bridge tube 94 while substantially preventing leakage at each interface between the bridge tube 94 and the balloons 90, 92.

[0204] The second balloon 92 of the dual autoperfusion device 80 may be substantially hollow to allow blood to flow through it. Alternatively, tubing (not shown) extends between opposite sides of the second balloon 92 and connects to a bridge tube 94 to allow blood to flow across the tubing across the second balloon 92. An outlet tube 96 is connected to the second balloon 92 through which blood flows and exits the dual autoperfusion device 80.

[0205] To begin the procedure, the patient is placed on a cardiopulmonary bypass pump to stop the heartbeat, and a clamp is placed on the aorta 60, which is separated from the ascending aorta. An incision 62 is made in the aorta 60 to separate the ascending aorta, and the ascending aorta is removed. The central segment 22 of the aortic graft 20 is then sutured to the proximal end of the aortic stump 70 at or near the incision 62. In this way, the lumen of the central segment 22 of the aortic graft 20 is easily accessible.

[0206] The dual automated perfusion device 80 is inserted through the lumen of the central segment 22 of the aortic graft 20, through the hemostasis valve 32, and then through the access port 30. The dual automated perfusion device 80 is advanced through the access port 30 until the first balloon 90 is located within the central segment 22 of the aortic graft 20, near the opening of the central segment 22; the second balloon 92 is then located outside the lumen of the central segment 22 of the aortic graft 20. The first balloon 90 is then inflated.

[0207] The heart then resumes beating, and the patient is removed from cardiopulmonary bypass according to standard practice. Simultaneously with or before the heart resumes beating, the remaining portion 20a of the aortic graft 20 is inserted into the descending aorta 74; a second balloon 92 is inserted into the descending aorta 74 within the remaining portion 20a of the aortic graft, and the second balloon 92 is inflated. Automatic perfusion is then initiated via a dual automatic perfusion device 80. For example, the upstream orifice 84 is initially blocked (e.g., through a sliding tube), and then the blockage is released at a selected time, such as by removing the sliding tube from the orifice, to initiate automatic perfusion. Blood flows through a bridging tube 94 between balloons 90 and 92 to allow circulation across the aorta when implantation of the aortic graft 20 is complete. Crossovers 40 and 50 are selected and connected to the brachiocephalic trunk 64, the left common carotid artery 66, and the left subclavian artery 68, and are essentially as described above. Figure 12 It is anchored to the central segment 22 of the aortic graft 20 as described. In this way, the amount of time the patient spends in cardiopulmonary bypass is reduced, and the patient side effects associated with cardiopulmonary bypass are correspondingly reduced.

[0208] If necessary, the remaining portion 20a of the aortic graft 20 may be sutured to the descending aorta 72 to ensure that the remaining portion 20a of the aortic graft 20 remains in place. Alternatively, such suturing is not required. The remaining portion 20a of the aortic graft 20 may be sutured or otherwise attached to the central segment 22 of the aortic graft 20. According to other embodiments, the remaining portion 20a of the aortic graft 20 is inserted into the descending aorta 74, and then the central segment 22 is sutured to the descending aorta 74. With the remaining portion 20a of the aortic graft 20 secured, the balloons 90, 92 deflate, and the dual automatic perfusion device 80 is withdrawn through the hemostatic valve 32.

[0209] refer to Figures 15 to 19 The floating suture loop 100 is shown. The floating suture loop 100 does not need to be perfectly circular and can be bent in any other suitable manner. Reference Figure 15 The floating suture ring 100 is initially in a first state. The floating suture ring 100 includes a spring element 102, which helps the floating suture ring 100 expand from the first state to a second state, such as... Figure 16As shown in the diagram. The spring element 102 may be at least partially covered by a fabric cover 104. In some embodiments, the fabric cover may be a PET mesh, such as DACRON® brand polyester. The spring element 102 may be made of a hyperelastic material such as a nickel-titanium alloy, such that applying a radial force to the spring element 102 causes it to transform between a martensitic and austenitic phase, thereby expanding to a second state. In other embodiments, the spring element 102 may be made of an elastic material such as stainless steel, which is initially compressed in a first state and then self-expands to a second state, or its plastic deformation transforms it from the first state to the second state. The spring element 102 may be generally circular, or may have any other suitable shape. Reference Figures 17 to 18 The floating suture ring 100 may optionally include an adjustable segment 106. The adjustable segment 106 may be a manually adjustable corrugated or accordion-shaped segment of the spring element 102, or other manually adjustable construction. The adjustable segment 106 is optionally made of a different material than the remainder of the spring element 102 and is attached to the spring element 102. The adjustable segment 106 allows for manual adjustment of fit within the patient's body, as described in more detail below. Figure 19 The perspective view shows the first state. Figure 15 100 floating suture rings.

[0210] refer to Figure 20 A system 110 for implanting an aortic graft 20 is shown. The aortic graft 20 implanted using system 110 can be any aortic graft 20 as described above. The aortic graft 20 may include a central segment 22, which includes a proximal port 30, at least one suture band 23, and at least one central segment anchor 25, as described above, such as regarding... Figure 6A As described. One or more bridging grafts may extend from the central segment 22, or a single manifold 24d may extend from the central segment 22, wherein one or more bridging grafts 24a, 24b, 24c extend from the manifold 24d. The system 100 may include one or more floating suture rings 100 associated with the aortic graft 20. Also referenced is... Figure 21The flexible endoscope system 112 may extend through the access port 30 and extend out of the end of the aortic graft 20. The flexible endoscope system 112 may include a visualization head 114 at the end of a flexible endoscope body 118, which includes a lamp and a camera, and such a visualization head 114 may be constructed as is known in the art. A camera 120 may be located proximal to and spaced apart from the visualization head 114, such that the visualization head 114 includes one or more lenses that transmit images along the endoscope body 118 to the camera 120 for resolution. The flexible endoscope system 112 may also be connected to a console 116 that displays the view from the visualization head 114 to a user; such consoles are known in the art. Optionally, the flexible endoscope system 112 may be inserted into the patient through a cannula 118, as is standard practice.

[0211] refer to Figure 20 and Figure 22 A single infusion catheter 130 is shown. The single infusion catheter 130 defines a lumen within a catheter sheath 132. At or near the distal end of the catheter sheath 132 is an occlusion balloon 142, which is capable of inflating to an inflated state and collapsing to a collapsed state. Proximal to the occlusion balloon 12, one or more infusion ports 134 extend through the catheter sheath 132 to the lumen. The balloon infusion port 140 is located proximal to the one or more infusion ports 134 and allows inflation of the occlusion balloon 12. At the proximal end of the catheter sheath 132, a hub 136 and a seal 138 close the end of the single infusion catheter 130 while allowing tools to pass through it, as is standard. Figure 23 A flexible endoscope system 112 is shown inserted through a single irrigation catheter 130 via a hub 136 and a seal 138, wherein the distal end of the flexible endoscope system 112 extends beyond the distal end of the single irrigation catheter 130.

[0212] refer to Figure 20 System 110 is used to place the aortic graft 20 into the patient's body. Such implantation is generally performed as described above, with specific variations described here. System 110 helps clinicians avoid complications arising from the accidental insertion of the aortic graft 20 into the dummy lumen 150 in the descending aorta 74. Dissection occurs when a tear in the intima of the aorta 60 allows blood to leak into the vessel media. This creates two blood channels: the true lumen 152, which is the normal blood flow; and the dummy lumen 150, which is the newly created channel. If the aortic graft 20 is inserted into the dummy lumen 150, it can lead to serious complications.

[0213] Also refer to Figure 24The floating suture ring 100 slides over the end of each remaining portion of the aorta 74. As described above, the proximal end of the aortic graft 20 can be attached to the aortic stump 70. After the proximal central segment anchor 25 is sutured to the aortic stump 70, the proximal floating suture ring 100 slides over the proximal central segment anchor 25 toward the central segment 22. This compresses the aortic wall between the floating suture ring 100 and the proximal central segment anchor 25. The proximal floating suture ring 100 can be inflated to its second state to allow it to slide over the proximal central segment anchor 25. Then, if the floating suture ring 100 is too loose in its inflated state, the adjustable segment 106 of the proximal floating suture ring 100 can be adjusted to tighten the floating suture ring 100. The proximal floating suture ring 100 is then sutured to the proximal central segment anchor 25.

[0214] As in Figure 23 As seen, a portion of the combination of the flexible endoscope system 112 and the single perfusion catheter 130 is inserted through the proximal port 30 of the central segment 22 of the aortic graft 20. The distal end of the flexible endoscope system 112 is then advanced into the descending aorta 74. The clinician uses images from the flexible endoscope system 112 to determine whether the distal end of the flexible endoscope system 112 is located in the true lumen 152 or the false lumen 150 of the descending aorta 74. If the distal end of the flexible endoscope system 112 is located in the false lumen 150, the flexible endoscope system 112 is withdrawn, and the clinician then advances it again and repeats the determination of the location of the distal end of the flexible endoscope system 112. If the distal end of the flexible endoscope system 112 is located in the true lumen 152, the procedure continues. The flexible endoscope system 112 is withdrawn. The heart then resumes beating, and the patient is removed from cardiopulmonary bypass according to standard practice. The bridging grafts 24a, 24b, and 24c were connected to the patient's cerebral arteries and restored blood flow to the brain.

[0215] As described above, the distal end of the aortic graft 20 can be attached to the descending aorta 74. This can be performed instead of connecting the bridging grafts 24a, 24b, and 24c to the cerebral arteries, at the clinician's discretion. See also: Figure 25 After the distal central segment anchor 25 is sutured to the remaining portion of the aorta 74, the distal floating suture ring 100 slides toward the central segment 22 on the distal central segment anchor 25. This compresses the aortic wall between the floating suture ring 100 and the distal central segment anchor 25. The distal floating suture ring 100 can be inflated to its second state to allow it to slide on the distal central segment anchor 25. Then, if the floating suture ring 100 is too loose in its inflated state, the adjustable segment 106 of the distal floating suture ring 100 can be adjusted to tighten the floating suture ring 100. The distal floating suture ring 100 is then sutured to the distal central segment anchor 25, as... Figure 26 As shown in the image.

[0216] Also refer to Figure 58 Another embodiment of an exemplary deployment tool 300 is shown. The deployment tool 300 includes a body 302 distal to and connected to a handle 304. The body 302 may be integrally formed with the handle 304, or it may be separately formed from the handle 304 and subsequently attached to it. Advantageously, the body 302 and the handle 304 are longitudinally fixed relative to each other. One or both of the body 302 and the handle 304 may be generally cylindrical in shape, or may have any other suitable shape. The handle 304 may include one or more ridges extending outward therefrom to facilitate manipulation of the handle 304 by a user. The handle 304 and the body 302 each may include a lumen 214 extending therethrough, wherein the lumen 214 proximally extends to an aperture 308 at a proximal end of the handle 304. The aperture 308 may be generally circular, or may have any other suitable shape. Also referenced is... Figure 60 and Figure 73 The guidewire 310 can be received through the lumen 214, allowing it to extend distally into an orifice 360 ​​at the distal end of the deployment tool 300, thereby extending proximally from the orifice 308 to the guidewire handle 312. The guidewire 310 and the guidewire handle 312 are longitudinally slidable relative to the body 302 and the handle 304, as described in more detail below.

[0217] A slider actuator 320 may be located distal to the handle 304. The slider actuator 320 may include a generally cylindrical slider body 322. The slider body 322 may include a hole 324 defined therein, which receives the distal end of the body 302. The body 302 may include at least one longitudinal groove 326 defined therein, which engages a protrusion (not shown) on the slider body 322 such that the engagement between each longitudinal groove 326 and the corresponding protrusion constrains the body 302 and the hole 324 to substantially longitudinal movement relative to each other and substantially prevents rotational movement between the body 302 and the hole 324. According to other embodiments, one or more longitudinal grooves 326 and corresponding protrusions(s) are omitted, and the body 302 and the hole 324 are free to rotate relative to each other. One or more arms 328 may extend radially outward from the slider body 322. As described in more detail below, one or more arms 328 can be gripped by a user simultaneously with the handle 304, and the one or more arms 328 facilitate user operation of the slider actuator 320 relative to the handle 304. Optionally, at least one ribbed region 330 may be provided on the slider actuator 320. At least one ribbed region 330 may be located at the proximal end of the slider actuator 320. Alternatively, at least one ribbed region 330 may be located at any other suitable location on the slider actuator 320. At least one ribbed region 330 facilitates user gripping of the slider actuator 320.

[0218] According to an exemplary embodiment, two or more rollers 336 may be located at the distal end of the slider actuator 320. Alternatively, one or more rollers 336 may be positioned at different longitudinal locations on the slider actuator 320. The rollers 336 may be oriented substantially perpendicular to the longitudinal axis of the deployment tool 300 and are oriented substantially parallel to each other. A roller frame 338 may extend from the slider actuator 320 such that each roller 336 is held between two roller frames 338 and rotatable relative to those roller frames 338. Each roller 338 may include a pin 340 at its end, and each pin 340 may be received in a corresponding aperture 342 in the roller frame 338. The roller frame 338 receives the roller 336 and positions the roller 336 at a location spaced apart from the slider body 322. As described in more detail below, a portion of a receiving sleeve is held by each roller 336. Also refer to Figure 69 The flange 440 is located on the distal side of the roller 336 and is attached to or integral with the body 302. The flange 440 may be located at the distal end of the body 302. As an example, the flange 440 may be substantially square in shape. As another example, the flange 440 may be substantially I-shaped, wherein each top and bottom horizontal segment of the I is on the distal side of the corresponding roller frame 338 and substantially parallel to the corresponding roller frame 338.

[0219] According to another exemplary embodiment, reference is also made to, such as Figure 59 The deployment tool 301 depicted may omit the roller 336. In this embodiment, each arm 328 of the slider actuator 320 includes a pin 344 extending therefrom. At least one pin 344 may extend substantially at a right angle to the corresponding arm 328. Alternatively, each pin 344 may be oriented at any other suitable angle relative to the corresponding arm 328. Each pin 344 may be attached to the corresponding arm 328. In this way, the manufacture of the deployment tool 301 is simplified by using fixed pins 344 compared to the manufacture of the deployment tool 300 including the rotatable roller 336. As described in more detail below, a portion of the receiving sleeve is held by each pin 344.

[0220] Also refer to Figure 60Deployment tool 300 includes a spindle 350 distal to and connected to body 302, and deployment tool 301 may be similarly constructed. Spindle 350 may be integrally formed with body 302, or may be separately formed from body 302 and subsequently attached to body 302. Advantageously, body 302 and spindle 350 are longitudinally fixed relative to each other. Spindle 350 may extend through and hold vascular graft 24, as described in more detail below. Because spindle 350 is longitudinally fixed relative to body 302, slider actuator 320 is longitudinally slidable relative to spindle 350.

[0221] Also refer to Figure 61 The sheath assembly 380 is shown. The sheath assembly 380 may include a distal sheath 352 and a proximal sheath 382, ​​each configured to surround and compress a different vascular graft 24. The distal sheath 352 and the proximal sheath 382 are each positioned on a central axis 350, and each of the distal sheath 352 and the proximal sheath 382 compresses the vascular graft 24 (not shown in this view for clarity) against the central axis 350. The vascular graft 24 may extend along the sheath assembly 380 from a location near the distal end of the distal sheath 352 to a location near the proximal end of the proximal sheath 382. As with the other embodiments described above, the sheath assembly 380 may be made of any suitable biocompatible material, such as, but not limited to, polytetrafluoroethylene (PTFE) or polyesters such as polyethylene terephthalate (PET), sometimes referred to as DACRON® brand polyester, which is available from DuPont, Wilmington, Delaware. See also... Figure 73An exploded view is shown to illustrate the guidewire 310 extending through the deployment tool 300, needle 362, and sheath assembly 380. The distal sheath 352 may be longitudinally spaced from the proximal sheath 382. The sheath assembly 380 may include a central segment 384 that spaces the distal and proximal sheaths 352. The central segment 384 is pre-split, while each of the distal and proximal sheaths 382 is generally cylindrical and therefore substantially unsplit. The central segment 384 may include two strips, a top strip 386 and a bottom strip 388, each of which is generally flat, starting a short distance away from the corresponding distal or proximal sheath 382. Advantageously, the distal sheath 352 and the proximal sheath 382 may include one or more longitudinal separation lines 389, which are weakening lines in the sheath along which the sheath preferentially tears. The points where the strips 386, 388 are joined also concentrate the tearing force, thereby promoting the splitting or otherwise separation of the distal sheath 352 and the distal sheath 382 at those locations. Each strip 386, 388 loops around a corresponding roller 336, also referencing... Figure 58 And deployment tool 300. Alternatively, according to other embodiments, each strip 386, 388 may wrap around and / or be attached to the corresponding pin 344 on the arm 328 of the slider actuator 320, and also refer to Figure 59 and deployment tool 301. As described in more detail below, during actuation of slider actuator 320, such engagement between strips 386, 388 and rollers 336 or bolts 344 causes distal sheath 352 and / or proximal sheath 382 to split and release the corresponding bridging graft 24.

[0222] Also refer to Figure 60 and Figure 62 The distal end of the spindle 350 may include a dilator tip 202. A lumen 214 extends substantially longitudinally through the dilator tip 202. The dilator tip 202 may include at least one dilator tip reflux port 358 defined through its outer surface, which extends through the lumen 214 defined by the dilator tip 202. The dilator tip 202 may have a maximum diameter not greater than the diameter of the spindle 350 proximal to the dilator tip 202. Alternatively, the dilator tip 202 may have a maximum diameter greater than or less than the diameter of the spindle 350 proximal to the dilator tip 202. The dilator tip 202 may taper at its distal end, and an orifice 360 ​​is located at its distal end, representing the distal end of the lumen defined by the dilator tip 202. The lumen 214 may extend substantially longitudinally through the spindle 350. A needle 362 is capable of extending distally outward from the orifice 360. Figure 60 and Figure 62As seen, needle 362 is in an extended position. Needle 362 extends longitudinally at least partially through the lumen 214 of the deployment tool 300 to the orifice 360. Needle 362 itself includes a lumen 364 defined therein extending longitudinally, which opens at the distal end of needle 362. See also... Figure 62 The needle 362 may also include a needle return port 372 defined through its wall at a location spaced apart from the distal end of the needle 362, thereby allowing fluid to flow from the distal end of the needle 362 through a lumen 364 into the needle 362 and out of the needle 362 through the needle return port 372. The dilator tip 202 may include a hollow filling chamber 374 defined therein. Alternatively, the dilator tip 202 may include a tunnel, channel, or other smaller space through which fluid can flow. When the needle return port 372 is located in or near the filling chamber 374 or other spaces (such as tunnels or channels in the dilator tip 202), blood may flow from the distal end of the needle 362 through a lumen 364 into the needle 362, out of the needle 362 through the needle return port 372, into the filling chamber 374 or other spaces in the dilator tip 202, and then out of the dilator tip return port 358. As described in more detail below, such blood flow from the distal return port 358 of the dilator is useful for confirming the presence of the distal end of the needle 362 in the true lumen of the vessel to be treated.

[0223] The lumen 364 of needle 362 receives guidewire 310 therein. See also... Figure 58 and Figure 73 The guide wire 310 can be supplied to the deployment tool 300 through the guide wire orifice 308 in the handle 304.

[0224] Also refer to Figure 59 The vascular graft 24 may include at least two suture covers 160, substantially as previously described in this document. Optionally, at least one of the suture covers 160 may be secured to the bridging graft 24, meaning that at least one of the suture covers 160 may not be deployable from the bridging graft 24. In this way, one or more such suture covers 160 may be used only to provide the user with a greater thickness and volume of material for suturing the vascular graft 24 to the tissue. Alternatively, at least one of the suture covers 160 may be deployable to engage the tissue, substantially as previously described in this document. The vascular graft 24 including at least two suture covers 160 may be used with any suitable embodiment of the deployment tool, such as, but not limited to, those described above. Figure 58 Deployment tool 300 or Figure 59 Deployment tool 301. The two suture envelopes 160 can be positioned closer to each other than the positioning of either of them relative to the end of the vascular graft 24. See also... Figure 83Two suture closures 160 may be positioned near the longitudinal center of the vascular graft 24, and / or may be positioned at substantially the same distance from the longitudinal center of the vascular graft 24. At least one end of the vascular graft 24 may be formed of an expandable mesh 34, as discussed above. Alternatively, at least one suture closure 160 may be positioned at different locations on the vascular graft 24. Similar to the bridging graft 24 described above, the vascular graft 24, including at least two suture closures 160, is wrapped around the heart axis 350, and at least a portion of the bridging graft 24 is compressed against the heart axis 350 by a distal sheath 352 or other embodiments of the sheath, as previously described in this document. Also refer to... Figure 72 According to other embodiments, at least one suture cap 160 may be self-expanding. The vascular graft 24 may include longitudinal slits 450 defined therein, such that, upon removal of the restraint sheath, the self-expansion of the vascular graft 24 causes material circumferentially located between circumferentially adjacent slits 450 to expand outward to form a flap 452. The flaps 452 collectively form a suture cap 160 to which a user can suture. Alternatively, the vascular graft 24 may be longitudinally compressed to form the flap 452. According to some embodiments, each suture cap 160 in the vascular graft 24 defines at least two slits 450, such that at least two flaps 452 are formed. According to other embodiments, each suture cap 160 in the vascular graft 24 defines four slits 450, such that four flaps 452 are formed. Also referenced... Figure 84 The formation of the flap 452 constituting the suture envelope 160 is schematically shown when the component changes from a compressed structure to an expanded structure.

[0225] Also refer to Figure 78 The sheath 380, vascular graft 24, and [other components] are shown. Figure 59 An exploded view of the components of the deployment tool 301. As indicated, a needle 362 may extend coaxially through the handle 304 and body 302 of the deployment tool 301, such that the needle 362 may protrude from the expander end 202 and may be configured to be manually extended and retracted. For example, a needle handle 303 may be provided at the proximal end of the needle 362 for ease of manipulation. It is desired that an orifice in the needle handle 303 may receive a guide wire to be advanced through the needle 362 and exit from its distal end, similar to embodiments described elsewhere. A sheath assembly 380 including a proximal sheath 382 and a distal sheath 352 may be provided on the deployment tool 301, wherein strips 386, 388 form loops to engage with the pin 344 of the slider actuator 320. Corresponding to the disclosure of this document, a vascular graft including a suture sheath 160 may be constrained by a sheath 380 against the spindle 350 of a deployment tool 301, such that when the sheath is freed by splitting along the separation line 389, the vascular graft 24 may exhibit its expanded structure.

[0226] Also refer to Figure 63 The handle 304 of the deployment tool 300 may include a needle retraction assembly 390 within a space 392 defined within the handle 304. See also... Figure 64 The needle retraction assembly 390 includes a latch 394 pivotally attached to a handle 304. The latch 394 may include a transversely extending orifice 396 to receive a shaft 398 therein, wherein the shaft 398 is part of or attached to the handle 304. Thus, the latch 394 is rotatable about the shaft 398. Alternatively, the orifice 396 may not extend entirely through the latch, and two orifices may be used, one on each side of the latch 394, with a separate shaft extending into each orifice. The orifice 396 may be located near the distal end of the latch 394. The latch 394 may include a substantially flat first surface 400 located proximal to the orifice 396. A latch 402 may extend upward from and substantially perpendicular to the proximal end of the first surface 400. The latch 402 may also be a substantially flat surface. The latch 394 may include a second surface 404 located proximal to the snap 402, the second surface being substantially flat and substantially perpendicular to the snap 402. The proximal end of the latch 394 may include a protrusion 406 extending upward from and substantially perpendicular to the proximal end of the second surface 404. The upper end of the protrusion 406 may include a rounded corner 408 on its proximal edge. A rounded notch 410 may be defined substantially longitudinally in the upper surface of the protrusion 406 to receive a guidewire 310.

[0227] The needle retraction assembly 390 may include at least one leaf spring 412, wherein the distal end of the leaf spring 412 is fixed relative to the handle 304, and the proximal end of the leaf spring 412 is biased upward against the latch 394. Alternatively, the leaf spring 412 may be otherwise mounted relative to the handle 304 to bias the proximal end of the leaf spring 412 upward against the latch 394. Alternatively, at least one compression spring, other type of spring, or other structure or mechanism may be used to bias the proximal end of the leaf spring 412 upward against the latch 394.

[0228] The needle retraction assembly 390 may include a holdoff spring 413 attached to or adjacent to the front of a space within the handle 304. The holdoff spring 413 may be a compression spring or any other suitable spring or mechanism. A holdoff block 414 may be attached to or adjacent to the proximal end of the holdoff spring 413 and coupled to the needle 362 such that longitudinal movement of the holdoff block 414 results in a corresponding longitudinal movement of the needle 362 (not shown in this view). The holdoff block 414 may include a first surface 416 that is substantially flat, substantially parallel to the first surface 400 of the latch 394, and substantially positioned against the first surface 400 of the latch 394. The holdoff block 414 may include a holdoff block latch 418 extending upward from the proximal end of the first surface 416, substantially parallel to the first surface 400. The release block latch 418 is located distal to the latch 402 of the latch 394 and is positioned substantially parallel to and substantially abutting against the latch 402. The release block 414 may include a second surface 420 that is substantially flat, substantially parallel to the second surface 404 of the latch 394, and substantially abutting against the second surface 404 of the latch 394. The release block 414 includes a channel extending longitudinally through it to receive a guidewire 310, which is capable of sliding freely through the channel relative to the release block 414. A release spring 413 pushes the release block latch 418 against the latch 402 of the latch 394, and a leaf spring 412 pushes the latch 394 into contact with the release block 414. In this way, the needle retraction assembly 390 is in a latched state, and in the latched state, the needle 362 is secured to the release block 414 and held in a fixed position.

[0229] Also refer to Figure 65 To unlock needle 362, guidewire handle 312 is advanced distally by the user. As guidewire handle 312 is advanced, guidewire 310 is also advanced. Guidewire handle 312 may include a cam surface 422 at its distal end. As an example, the cam surface 422 of guidewire handle 312 may be substantially truncated conical, such as... Figure 65As seen, the narrowest diameter of the truncated conical shape is at or near the distal end of the cam surface 422. As another example, the cam surface 422 may be an inclined plane defined on the lower surface of the distal end of the guidewire handle 312, wherein the inclined plane is closer to the guidewire 310 at its distal end than at its proximal end. The guidewire handle 312 may additionally include a narrower region 424 proximal to the cam surface 422, wherein the narrower region 424 has a diameter and / or cross-sectional area sized and shaped to allow access to the orifice 308 in the handle 304. Alternatively, the guidewire handle 312 may not include the narrower region 424, and only the cam surface 422 is sized and / or shaped to allow access to the orifice 308 in the handle 304. The guide wire handle 312 may include a wider region 426, which is sized and / or shaped such that it cannot enter the orifice 308 in the handle 304, and as a result, the wider region 426 acts as a stop that prevents further distal movement of the guide wire handle 312 when the wider region 426 encounters the outer surface of the handle 304 adjacent to the orifice 308.

[0230] As the guidewire handle 312 moves distally toward the handle 304, the cam surface 422 and then the narrower region 424 (if utilized) move through the orifice 308 in the handle 304 and into the space 392 defined within the handle 304. As the guidewire handle 312 moves distally, the cam surface 422 engages the rounded corner 408 at the proximal top edge of the protrusion 406 of the latch 394. Alternatively, without using the rounded corner 408, the cam surface 422 engages the protrusion 406 of the latch 394 in any suitable manner. Because the distance between the cam surface 422 and the longitudinal centerline of the guidewire 310 increases in the proximal direction, the continued distal movement of the guidewire handle 312 after the cam surface 422 initially encounters the protrusion 406 causes the protrusion 406 to move further away from the longitudinal centerline of the guidewire 310. This movement of the protrusion 406 causes the latch 394 to rotate downward about the shaft 398 against the bias applied to the latch 394 by the leaf spring 412. As the latch 394 continues to rotate downward about the shaft 398, the latch 402 rotates increasingly out of contact with the release block latch 418. As the guidewire handle 312 continues to move distally, the latch 402 rotates and completely disengages from the release block latch 418. At this point, the force applied proximally by the release spring 413 to the release block 414 pushes the release block 414 proximally, causing the first surface 416 of the release block 414 to engage the protrusion 406 of the latch 394 and release the latch 394 from its initial latched position. As a result, the needle 362 is no longer held in the latched position. The release block 414 moves freely proximally, and during this proximal movement, the release block 414 engages the distal end of the guidewire handle 312. The release spring 413 applies a sufficient force for the user to feel, but not too much force to pull the guidewire handle 312 sharply from the user's hand. When the user releases pressure on the guidewire handle 312, the proximal force applied to the release block 414 by the release spring 413 is transmitted to the guidewire handle 312, thereby pushing the guidewire handle 312 proximally. Because the release block 414 is connected to the needle 362, the proximal force applied to the guidewire handle 312 is also applied to the needle 362, thereby moving the needle 362 proximally. The dimensions of the release spring 413 and the release block 414 are chosen such that after the latch 394 is released and the guidewire handle 312 is released, the guidewire handle 312 and the needle 362 move proximally a specific distance. This specific distance is sufficient to allow the distal end of the needle 362 to retract proximally to the orifice 360 ​​in the expander end 202, thereby safely moving the sharp end of the needle 362 within the body of the deployment tool 300. Also refer to Figures 74 to 75 The diagram schematically illustrates the automatic retraction of needle 362. Figure 74In the middle, needle 362 is in its distal position of extension, with release block 414 in the corresponding distal position. After latch 394 disengages, due to the force applied by release spring 413, Figure 75 The release block 414 has moved to its proximal position, causing the needle 362 to retract into the orifice 360 ​​at the distal end of the expander end 202.

[0231] The method of operation will now be described in the context of deployment tools 300 and 301. Under initial conditions, the distal end of needle 362 may already be positioned distal to the orifice 360 ​​in the expander end 202. According to other embodiments, under initial conditions, the distal end of needle 362 is positioned proximal to the orifice 360 ​​in the expander end 202. If so, needle 362 initially extends distally. (See reference...) Figure 65 The extension of the guidewire handle 312, along with the deployment tool 300, is performed by pushing the guidewire handle 312 distally. As described above, when the needle 362 is in the retracted position, the first surface 416 of the release block 414 engages the protrusion 406 of the latch 394, releasing the latch 394 from its initial latched position. When the guidewire handle 312 is pushed distally, the distal end of the guidewire handle 312 encounters the proximal end of the release block 414, and then pushes the release block 414 distally against the bias of the release spring 413. The release block latch 418 eventually moves distally to the latch 402 of the latch 394. At this point, the latch 394 is able to rotate upward about the shaft 398 under the pressure of the leaf spring 412. The user then releases the guidewire handle 312. Because latch 394 has rotated upwards and backwards, the release of guidewire handle 312 allows release spring 413 to push release block 414 proximally, causing release block latch 418 to press against latch 402 of latch 394. Needle retraction assembly 390 then enters a position as... Figure 63 The structure seen in the diagram. The needle 362 extends such that its distal end is positioned distal to the orifice 360 ​​in the expander end 202.

[0232] Correspondingly, if necessary, the guidewire 310 can be retracted proximally, and the user then inserts the distal end of the needle 362 into the sidewall of the vessel to be treated. The guidewire 310 is then advanced distally through an orifice 364 at the distal end 362 of the needle 310. The guidewire 310 may have been previously placed in the deployment tool 300 to advance the needle 362 distally and latch the needle retraction assembly 390; otherwise, the guidewire 310 is supplied to the deployment tool 300 through an orifice 308 in the handle 304. The guidewire 310 can be advanced distally through the orifice 364 at the distal end of the needle 362 by grasping the guidewire handle 312 and pushing it distally. See also Figure 62In an insertion configuration of a deployment tool 300, the distal end of the needle is positioned distal to an orifice 360 ​​in the expander end 202, and the needle return port 372 is located in an injection chamber 374 defined in the expander end 202. Similarly, and also referring to... Figure 79 as well as Figure 80 A detailed view shows that when the distal end of the needle 362 of the deployment tool 301 enters the lumen 432 of the blood vessel 430, blood flows from the lumen 432 of the blood vessel 430 into the orifice 364 at the distal end of the needle 362, through the lumen of the needle 362, outward through the needle return port 372, into the filling chamber 374, and then out through the return port 358. The flow of blood from the return port 358 allows the user to confirm that the distal end of the needle 362 is correctly positioned in the true lumen 432 of the blood vessel 430, and that the procedure can continue.

[0233] The user then moves the deployment tool distally along guide wire 310 as desired. See also: Figure 66 With the deployment tool 301, when the dilator tip 202 enters the lumen 432 of the blood vessel 430, the dilator tip 202 dilates the hole in the wall 434 of the blood vessel 430 originally created by the needle 362. Once the dilator tip 202 has entered the lumen 432 of the blood vessel 430, the user may continue to advance the deployment tool 301 distally a clinically appropriate distance. After the dilator tip 202 has reached the appropriate position within the lumen 432 of the blood vessel 430, the user stops moving the deployment tool 301 distally.

[0234] Alternatively, in cases where clinicians wish to connect two blood vessels end-to-end, the needle 362 and guidewire 310 are not required; however, they may be used if the user desires them. See also: Figure 67 The distal end of the dilator tip 202 is inserted into the end 436 of the blood vessel 430. In this case, the blood vessel 430 can be further clamped relative to the deployment tool 301 to prevent blood from flowing outward, or the blood vessel 430 can be dissociated from the circulatory system so that bleeding is not a problem.

[0235] Then, needle 362 retracts after achieving its purpose. The further presence of the distal end of needle 362 within the lumen 432 of blood vessel 430 increases the risk that the distal end of needle 362 will unintentionally damage or penetrate blood vessel 430. Needle 362 is manually or automatically retracted by moving the guidewire handle 312 distally, as described above in more detail with respect to deployment tool 300. Needle 362 is held in place by needle retraction assembly 390, and movement of the guidewire handle 312 distally to at least partially contact the needle retraction assembly 390 causes the needle retraction assembly 390 to release needle 362 and move needle 362 proximally. Relief spring 413 automatically retracts needle 362 proximally, causing the distal end of needle 362 to move proximally relative to the distal end of dilator tip 202. As the needle 362 retracts proximally, the needle return port 372 is no longer located in the filling chamber 374 of the dilator tip 202, and as a result, blood no longer flows from the needle return port 372 into the filling chamber 374. Therefore, blood no longer flows from the return port 358. If in use, the guidewire 310 can be removed by pulling the guidewire 310 proximally until the distal end of the guidewire 310 is proximally removed from the orifice 308 in the handle 304 for deploying the tool 300 or by removing the needle handle 303 for deploying the tool 301.

[0236] With the expander tip 202 positioned in the desired location, the vascular graft 24 is also positioned relative to the vessel 430 in the desired location. See also... Figure 61 The user can then split the distal sheath 352 of the sheath assembly 380. See also... Figure 68 To detach the distal sheath 352, the user moves the slider actuator 320 proximally relative to the handle 304. The user may do this by gripping one or more arms 328 of the slider actuator 320. The user may hold the handle 304 with one hand and the slider actuator 320 with the other. As the user begins to move the slider actuator 320 proximally relative to the handle 304, the distal sheath 352 begins to detach. The distal sheath 352 detaches distally. As noted, the distal sheath 352 may include one or more longitudinal separation lines 389. As the distal sheath 352 is detached, the detachment site no longer abuts against the axial compression vascular graft 24, as described in other embodiments of the deployment tool previously in this document, and the vascular graft 24 begins to swell at the detachment site. See also... Figure 76 The slider actuator 320 has been moved to its nearest side position, and the distal sheath 352 has been completely peeled off, so that the portion of the vascular graft 24 constrained by the distal sheath 352 has been fully expanded, and this portion of the vascular graft 24 has advantageously expanded against the inner wall of the blood vessel 430.

[0237] Alternative locations, regarding Figure 59The deployment tool 301 shown (where the slider actuator 320 includes a bolt 344 instead of a roller 336) also refers to Figure 81 The proximal movement of the slider actuator 320 relative to the handle 304 also causes the distal sheath 352 to split. In this embodiment, the splitting position may be, but does not need to be, at a position substantially 90 degrees rotated relative to the embodiment in which the roller 336 is used. As in the aforementioned embodiments, when the distal sheath 352 is peeled off by the engagement of the slider actuator 320 with the strips 386, 388, the peeled position no longer abuts against the axial compression of the vascular graft 24. When the distal sheath 352 has been completely peeled off, the portion of the vascular graft 24 constrained by the distal sheath 352 has fully expanded, and this portion of the vascular graft 24 has advantageously expanded against the inner wall of the blood vessel 430. Correspondingly and also referring to... Figure 82 When the distal sheath 352 has been completely peeled off, the strips 386 and 388 are freed from the slider actuator 320 and can then be used to split the proximal sheath 382, ​​as discussed below.

[0238] The vascular graft 24 is advantageously placed through a hole formed in the side of the blood vessel 430, such that the distal ends of two suture caps 160 on the vascular graft 24 are adjacent to the hole in the side of the blood vessel 430. The user then sutures the suture caps 160 to the blood vessel 430, thereby providing additional security to hold the vascular graft 24 in place. See also... Figure 70 The vascular graft 24 is placed in the end of the blood vessel 430, one of the two suture caps 160 is advantageously placed at the end 442 of the blood vessel 430, and the suture cap 160 is sutured to the end 442 of the blood vessel 430, thereby providing additional security to hold the vascular graft 24 in place.

[0239] Also refer to Figure 77 With the slider actuator 320 in its proximal position and the distal portion of the vascular graft 24, constrained by the distal sheath 352, fully expanded, the strips 386, 388 can be removed from the roller frame 338, allowing them to be subsequently manipulated to peel off the proximal sheath 382. See also, for example... Figure 71 If the deployment tool 300 has not yet been withdrawn from the blood vessel 430, the deployment tool 300 is withdrawn. The sheath assembly 380 remains in contact with the blood vessel 430, wherein the distal sheath 352 has been peeled off, and the vascular graft 24 is sutured to the blood vessel 430. Alternatively, after the vascular graft 24 has been sutured to the blood vessel 430, the deployment tool 300 is removed from the blood vessel 430. See also... Figure 70The proximal end of the sheath assembly 380, including the proximal sheath 382, ​​is placed into the lumen 431 of the second blood vessel 433 via the end of the second blood vessel 433. The second blood vessel 433 may be a blood vessel in the patient's body or may be a natural or artificial blood vessel to be implanted in the patient's body with a lumen for conducting the patient's blood. The proximal sheath 382 is removed from the proximal end of the vascular graft 24 in the same manner as the distal sheath 352 is removed from the distal end of the vascular graft 24. As an example, the slider actuator 320 may be moved distally to peel the proximal sheath 382 from the vascular graft 24. As another example, the proximal sheath 382 may be removed from the vascular graft 24 in any other suitable manner, such as by manually grasping and pulling the bands 386, 388. When the proximal sheath 382 has been completely removed, the portion of the vascular graft 24 constrained by the proximal sheath 382 has fully expanded, and this portion of the vascular graft 24 has advantageously expanded against the inner wall of the second vessel 433. The proximal sides of the two suture caps 160 on the vascular graft 24 may be adjacent to the end of the second vessel 433, and these suture caps 160 may be sutured to the end 443 of the second vessel 433, thereby providing additional security to hold the vascular graft 24 in place. Both the proximal sheath 382 and the distal sheath 352 are removed from the patient, and the procedure is complete; the vessel 430 and the second vessel 433 are connected, and blood can flow between the vessel 430 and the second vessel 433 through the lumen of the now sutured-in-place vascular graft 24.

[0240] Also refer to Figure 85 Another exemplary deployment tool 500 is shown. At the distal end of the deployment tool 500 is a blunt dilator tip 502. The dilator tip 502 is sized and shaped to dilate an incision or opening formed in a blood vessel, similar to the embodiments described above. A channel 504 is defined through the dilator tip 502, and a guidewire 506 may be able to extend through and / or retract into the channel 504. A needle 508 may be located in a neutral position within the channel 504 through the dilator tip 502 and is capable of being advanced relative to the dilator tip 502 to puncture a blood vessel in a patient. In this embodiment, the needle 508 is hollow, allowing the guidewire 506 to pass through it and enabling blood return indication as discussed below. Proximal to the dilator tip 502, the deployment tool 500 includes a spindle 546, which is not visible in this view but is similar to the embodiments disclosed above, and is, for example, as shown below. Figures 94 to 98As shown schematically, a vascular graft 24a (e.g., having an end formed by an expandable mesh 34 and one or more integral suture caps 160) is wrapped around a mandrel 546 and compressed at least partially against the mandrel by a retractable sheath 510. Although the suture cap 160 is centrally positioned between portions of the expandable mesh 34 in the illustrated embodiment, other configurations as described above are also suitable. A handle 512 is attached to the proximal end of the mandrel by attachment or integral manufacturing. A lumen extending through the handle 512 communicates with a channel 504 exiting the dilator end 502. Thus, manipulating the proximal end of the guidewire 506 (e.g., via a guidewire handle 514) allows the guidewire 506 to be advanced and retracted as desired. A needle 508 is coupled to a needle advance button 516 using any suitable mechanism (such as those described for other embodiments of this disclosure) and is biased proximally toward a retracted position within the dilator end 502. Specifically, the needle advance button 516 can be moved distally to a locked position, which positions the needle 508 in an advance configuration extending beyond the dilator tip 502 for insertion through the vessel wall. Subsequent advance of the guidewire 506 then causes the guidewire handle 514 to release the needle advance button 516, causing the needle 508 to retract automatically. The slider actuator 518 is configured to selectively retract the sheath 510 as a result of proximal movement of the actuator 518. The actuator 518 is, as desired, coupled to the sheath 510 via a ratchet or other suitable mechanism that transmits only a proximal retraction force. For example, a first cycle of the actuator 518 from the distal to the proximal position may induce deployment of the distal end of the vascular graft 24a. The actuator 518 may be configured to move only proximally until the first cycle is completed. Correspondingly, the actuator 518 then returns to the distal position, such that a second cycle from the distal to the proximal position induces deployment of the proximal end of the vascular graft 24a. It should be recognized that other configurations are possible, including providing a complete deployment with a single loop or more than two loops. Deployment tool 500 also characteristically features fittings for delivering the inflating fluid, as discussed below, such as via a three-way stopcock 520. While deployment tool 500 is described herein in the context of its use with vascular graft 24a, deployment tool 500 may be used with any other jumpers, grafts, or anchors described in this document (where appropriate).

[0241] As detailed below, one exemplary use of deployment tool 500 is for placing vascular graft 24a within an aortic branch graft. See also... Figure 86 This image shows a portion of an aortic graft 20 with a branch graft 24. An opening 522 can be formed in the proximal segment of the branch graft 24 using, for example, a scalpel 524 or any other suitable tool. See also... Figure 87Aortic graft 20 is shown as being fixed within the vascular system of a patient between the aortic stump 70 and the descending aorta 72, similar to the embodiment described above. The distal end of a deployment tool 500 with an expander tip 502 is then introduced through an opening 522, supplied through the inner diameter of the branch graft 24, and advanced away from one of the distal ends. A graft clamp 526 is spring-loaded and releasably secured around the branch graft 24, within which the deployment tool 500 is disposed to reduce blood flow / loss during stent graft delivery and deployment. See also... Figure 88 A detailed view of the graft clamp 526 is shown. Opposing jaws 528 are biased to a closed configuration by springs 530, thereby pivoting on hinges 532. When closed, jaws 528 define a generally circular opening 534 sized to compress the graft during surgery to reduce blood leakage. For illustrative purposes only and without limitation, opening 534 may be approximately 12F. See also, for example, [reference needed]. Figure 89 It shows, as Figure 87 The image depicts a side view of a graft clamp 526 positioned around the branch graft 24. Specifically, when the graft clamp 526 is closed, the opening 534 fits snugly to the outer diameter of the deployment tool 500, thereby sealing the branch graft 24 substantially around the outer diameter.

[0242] As with other embodiments of this disclosure, the deployment tool 500 may have a blood return indicator feature to aid in positioning within a patient's blood vessel. Also referenced is... Figure 90 A detailed view of the distal end of the deployment tool 500 is shown. The dilator tip 502 is provided with a return port 536 defined through its outer surface, which is in fluid communication with the lumen 538 of the needle 508. Furthermore, a depth rib 540 on the outer diameter of the distal end of the deployment tool 500 is configured to reduce the risk of inserting the tool beyond the desired amount. In this embodiment, the rib 540 is at an angle of approximately 25-30° relative to the longitudinal axis of the deployment tool 500 to correspond to the desired insertion angle for transvascular artery insertion, and other angles may be used depending on the needs of different applications. An indicator area 542 indicates the intended insertion area, which is approximately 1 cm in this embodiment, but may also be adjusted as needed depending on the intended use. See also... Figure 91 and Figure 92 The diagram schematically illustrates the blood return function. When the needle 508 is in its extended configuration, the needle blood return port 544 in the needle 508 is aligned with the blood return port 536 in the dilator end 502. Therefore, after the needle 508 has penetrated the wall 434 of the blood vessel 430, blood from the lumen 432 of the blood vessel can flow through the needle blood return port 544 into the needle lumen 538 and out of the blood return port 536, thus signaling the presence of the needle within the blood vessel. Therefore, also refer to... Figure 93The guidewire 506 can be advanced distally through the needle 508, causing the full advance of the guidewire 506 to release the needle advance button 516, as noted above, thereby automatically retracting the needle 508, as indicated by the dotted line. The deployment tool 500 can then be further advanced through the vessel wall 434, guided by the rib 540 to the desired insertion depth.

[0243] Also refer to Figure 94 Once the deployment tool 500 is remotely receiving visual feedback (such as that provided by the rib 540), Figure 93 As shown, the actuator 518 is inserted into the desired depth within the blood vessel 430. The actuator 518 then moves proximally (e.g., via a first cycle as discussed above), such that the distal portion of the vascular graft 24a is deployed by withdrawing the sheath 510 proximally, allowing that portion of the vascular graft 24a to expand from its compressed delivery configuration. For example, the first cycle of the actuator 518 may cause a proximal movement of approximately 3 to 3.5 cm in the sheath 510 to expose a corresponding amount of the vascular graft 24a. In this view, the proximal movement of the actuator 518 has not yet completed the first cycle, and the suture sheath 160 remains within the sheath 510. After the actuator 518 has completed its movement to the proximal position, thus completing the first cycle, the actuator 518 can then return to the distal position and may be biased as desired, so that it is automatically in the distal position after the completion of the first cycle. Also refer to... Figure 95 The distal end of the branch graft 24 can be positioned to the location where the vascular graft 24a will be deployed within its lumen. For example, as shown, the distal end of the branch graft 24 can be positioned near the suture cap 160. The actuator 518 moves proximally again (such as through a second cycle as discussed above) such that when the sheath 510 is fully withdrawn, the proximal portion of the vascular graft 24a is deployed, thereby allowing the proximal portion of the vascular graft 24a to expand from its compressed structure. It is desirable that, after the second cycle is completed, the actuator 518 can be locked in its proximal position because the sheath 510 has been fully withdrawn. Furthermore, the vascular graft 24a has been deployed, with the distal portion expanding within the vessel 430 and the proximal portion expanding within the branch graft 24.

[0244] Also refer to Figure 96The diagram schematically illustrates the sequence of operations involving the deployment tool 500. After penetrating the vessel wall 434, the needle 508 automatically retracts as described above when the guidewire 506 is advanced and the guidewire handle 514 engages and releases the needle advance button 516. Next, a first cycle of the actuator 518 from its distal position to its proximal position withdraws the sheath 510 from the distal portion of the vascular graft 24a, thereby deploying that portion within the vessel 430. After the first cycle, the actuator 518 returns to its distal position, and then a second cycle of the actuator 518 from its distal position to its proximal position causes further proximal movement of the sheath 510 to deploy the proximal portion of the vascular graft 24a within the branch graft 24. As shown, the result of these operations is that the vascular graft 24a has been fully deployed within the vessel 430 and the branch graft 24, making the suture occluder 160 available for further fixation of the vascular graft 24a as described above.

[0245] When the vascular graft 24a passes through the opening 522 ( Figure 86 When deploying an endovascular approach (as shown in the diagram), there is a possibility of restriction at the arterial incision site, resulting in a "stenosis" or other effects. Also refer to... Figure 95 The deployment tool 500 may also incorporate an expansion balloon 548 positioned around a central axis 546 to address this situation. Prior to removal of the deployment tool 500, a syringe gun 550, such as by means of a Luer fitting, is attached to a stop valve 520 to provide fluid communication with the interior of the expansion balloon 548. Operation of the trigger 552 causes the plunger 554 to deliver pressurized fluid into the balloon, thereby expanding the stent segment within the arterial incision and releasing the stenosis / constriction. In some embodiments, a single stroke of the trigger 552, used to deliver sufficient inflation fluid to inflate the expansion balloon 548 to a desired diameter at the desired pressure, may end with the release of the plunger 554, which may be driven by a spring 556 or otherwise biased to automatically return to a proximal position selected for vacuuming, which will cause the balloon to collapse. The collapse of the balloon 548 reduces the risk that the deployment tool 500 may remain engaged with the deployed vascular graft 24a during removal and correspondingly dislodge the graft. In other embodiments, the syringe gun 550 may be configured such that individual operation releases the plunger 554, which similarly results in the automatic application of a desired vacuum to induce balloon collapse. For example, the syringe gun 550 may be configured to generate a vacuum of approximately 1 atm after inflating the balloon 548 using these or any other suitable techniques; however, other pressures may be employed depending on the needs of the intended application. Reference is also made to... Figure 97 The operation of trigger 552 has caused plunger 554 to deliver sufficient fluid to inflate balloon 548, thereby widening any possible narrowing. Subsequently, after balloon 548 is fully inflated, and also referring to... Figure 98 The syringe gun 550 is configured to apply a vacuum to deflate the balloon 548 as described above, as shown. For example, the plunger 554 can move proximally to create a vacuum, as shown, either automatically after the full stroke of the trigger 552 or in response to a separate actuation.

[0246] Although the above discussion is conducted in the context of a deployment tool 500 with an endovascular access, delivery of the vascular graft 24a can also be performed by connecting the blood vessel, the graft, or by constructing other lumens end-to-end to conduct the patient's blood. See also Figure 99 A schematic example of this use is depicted. As shown, the dilator tip 502 of the deployment tool 500 can be introduced through the ventilation port 30 of the aortic graft 20. Correspondingly, the dilator tip 502 can then be traced from the aortic graft 20 through the branch graft 24 and into the blood vessel 430. In this embodiment, a graft clamp 526, as described above, can be applied around the ventilation port 30, again to reduce blood flow / leakage to the patient during the procedure. Alternatively or additionally, as described above, the graft clamp 526 can also be used on the branch graft 24. Therefore, reference is also made to... Figure 100 The deployment tool 500 has been positioned such that the distal portion of the dilator tip 502 and the vascular graft 24a, still constrained by the sheath 510, are located within the vessel 430. Then, refer to... Figure 101 Following the first cycle of actuator 518 as discussed above, the distal portion of the vascular graft 24a has been deployed within the vessel 430 by withdrawing the sheath 510 proximally, thereby also exposing the suture closure 160. See also... Figure 102 Once the distal portion of the vascular graft 24a has expanded within the vessel 430 to secure it, the relative position of the branch graft 24 can then be adjusted as desired. For example, but not limited to, in some embodiments, a spacing of approximately 1 cm between the ends of the vessel 430 and the branch graft 24 is suitable, with the suture cap 160 positioned between the ends. See also... Figure 103 The proximal portion of the vascular graft 24a can then be deployed within the branch graft 24 as shown.

[0247] As used in this document, and as is customary in the art, the term “substantially” and similar approximate terms refer to normal variations in the dimensions and other properties of finished products caused by manufacturing tolerances and other manufacturing inaccuracies.

[0248] While the invention has been described in detail, it will be apparent to those skilled in the art that various changes and modifications and equivalents may be made without departing from the invention. It should be understood that the invention is not limited to the details of the construction, the arrangement of components, and / or methods illustrated in the foregoing description or the accompanying drawings. The statements in the abstract of this document and any summary statements herein are merely exemplary; they are not and should not be construed as limiting the scope of the claims. Furthermore, the accompanying drawings are merely exemplary and not restrictive. The main titles and subtitles are for the convenience of the reader only. They should not and must not be construed as having any substantial importance, meaning, or interpretation, and should not and must not be regarded as indicating that all information relating to any particular subject matter will be found under or limited to any particular title or subtitle. Therefore, the invention will not be bound or limited except by the claims and their legal equivalents.

Claims

1. A vascular graft deployment tool, comprising: a handle; an elongate mandrel positioned distal of the handle; a vascular graft at least partially disposed coaxially about the mandrel; a sheath assembly comprising a distal sheath portion and a proximal sheath portion connected by a central section, the central section comprising at least two straps, wherein the distal sheath portion and the proximal sheath portion are configured to constrain the vascular graft against the mandrel at an insertion diameter; and an actuator movable relative to the handle and engaging the at least two straps of the sheath assembly, wherein operation of the actuator causes at least one of the distal sheath portion and the proximal sheath portion to longitudinally separate to free at least a portion of the vascular graft.

2. The vascular graft deployment tool of claim 1, further comprising a plurality of rollers coupled to the actuator, wherein, each roller is configured to engage one of the straps.

3. The vascular graft deployment tool of claim 2, wherein, the rollers are oriented perpendicular to a longitudinal axis of the mandrel.

4. The vascular graft deployment tool of claim 1, wherein, the actuator comprises a plurality of pegs, wherein each peg is configured to engage one of the straps.

5. The vascular graft deployment tool of claim 1, wherein, proximal movement of the actuator relative to the handle is configured to cause the distal sheath portion to longitudinally separate and free a distal portion of the vascular graft.

6. The vascular graft deployment tool of claim 5, wherein, further proximal movement of the actuator is configured to cause the proximal sheath portion to longitudinally separate and free a proximal portion of the vascular graft.

7. The vascular graft deployment tool of claim 1, further comprising a dilator tip at a distal end of the mandrel.

8. The vascular graft deployment tool of claim 7, wherein, the mandrel comprises a lumen extending longitudinally through the mandrel, the vascular graft deployment tool further comprising a needle having a lumen defined therein, wherein the needle is disposed within the lumen of the mandrel and is slidable relative to the lumen of the mandrel.

9. The vascular graft deployment tool of claim 8, wherein, the needle further comprises a needle backbleed port configured to create a fluid flow path through the needle lumen, through the needle backbleed port, and through a backbleed port in the dilator tip when the needle is in a distally extended position protruding beyond the dilator tip.

10. The vascular graft deployment tool of claim 8, further comprising a needle retraction assembly within the handle.

11. The vascular graft deployment tool of claim 10, wherein, the needle retraction assembly is configured to hold the needle in a distally extended position protruding beyond the dilator tip such that release of the needle retraction assembly causes the needle to move proximally to a retracted position not protruding beyond the dilator tip.

12. The vascular graft deployment tool of claim 8, further comprising a guidewire extending through the needle, wherein, a distal end of the guidewire is configured to be slidably extendable through the lumen of the needle.

13. The vascular graft deployment tool of claim 12, further comprising a needle retraction assembly within the handle and configured to transition the needle between a distally extended position and a retracted position, wherein, the guidewire further comprises a guidewire handle at a proximal end of the guidewire, and wherein the needle retraction assembly is configured to transition the needle to the retracted position when engaged by distal movement of the guidewire handle.

14. The vascular graft deployment tool of claim 1, further comprising a dilation balloon disposed about the mandrel beneath the vascular graft.

15. The vascular graft deployment tool of claim 1, wherein, the vascular graft has an end portion formed of an expandable mesh.

16. A vascular graft deployment tool, comprising: a handle; an elongate mandrel positioned distal of the handle; a vascular graft at least partially disposed coaxially about the mandrel; a sheath configured to be proximally withdrawn to constrain the vascular graft against the mandrel at an insertion diameter; and an actuator movable relative to the handle and engaged with the sheath, wherein first operation of the actuator within a range of longitudinal motion along a longitudinal axis of the deployment tool causes withdrawal of the sheath to free at least a distal portion of the vascular graft, and repeated operation of the actuator within the range of longitudinal motion along the longitudinal axis of the deployment tool causes further withdrawal of the sheath to free a proximal portion of the vascular graft.

17. The vascular graft deployment tool of claim 16, further comprising a dilator tip at a distal end of the mandrel.

18. The vascular graft deployment tool of claim 17, wherein, the mandrel includes a lumen extending longitudinally therethrough, the vascular graft deployment tool further comprising a needle having a lumen defined therein, wherein the needle is disposed within the lumen of the mandrel and is slidable relative to the lumen of the mandrel.

19. The vascular graft deployment tool of claim 18, wherein, the needle further comprises a needle flashback port configured to create a fluid flow path through the needle lumen, through the needle flashback port, and through a flashback port in the dilator tip when the needle is in a distally extended position protruding beyond the dilator tip.

20. The vascular graft deployment tool of claim 18, further comprising a needle retraction assembly within the handle.

21. The vascular graft deployment tool of claim 20, wherein, the needle retraction assembly is configured to hold the needle in a distally extended position protruding beyond the dilator tip such that release of the needle retraction assembly causes the needle to move proximally to a retracted position not protruding beyond the dilator tip.

22. The vascular graft deployment tool of claim 18, further comprising a guidewire extending through the needle, wherein, a distal end of the guidewire is configured to be slidably extendable through the lumen of the needle.

23. The vascular graft deployment tool of claim 22, further comprising a needle retraction assembly within the handle and configured to transition the needle between a distally extended position and a retracted position, wherein, the guidewire further comprises a guidewire handle at a proximal end of the guidewire, and wherein the needle retraction assembly is configured to transition the needle to the retracted position when engaged by distal motion of the guidewire handle.

24. The vascular graft deployment tool of claim 16, further comprising a dilation balloon disposed about the mandrel beneath the vascular graft.

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