Vascular and aortic grafts with expandable sheaths and methods for deployment thereof

Abstract

The vascular connector deployment tool may include a handle, an elongated mandrel extending distally from the handle, a vascular connector coaxially disposed around the mandrel, a retractable sheath assembly including an outer sheath telescopically deployed over the inner sheath, and an actuator on the handle configured to selectively retract the outer sheath and the inner sheath relative to the mandrel. The sheath assembly is configured to restrain the vascular connector relative to the mandrel in an insertion profile. A distal transition between the outer sheath and the inner sheath visually indicates the position of the vascular connector.

Description

Disclosure Contents

[0001] [Related Applications] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 984,898, filed March 4, 2020, which is incorporated herein by reference in its entirety for all purposes.

[0002] Field of the Disclosure The present invention relates generally to vascular and aortic connectors, and more particularly to deployment tools and methods for deploying such connectors.

[0003] 〔background〕 The circulatory system includes the aorta and other large blood vessels, as well as small blood vessels and capillaries. Therapeutic interventions to replace or support diseased or otherwise damaged blood vessels may involve the use of synthetic grafts to maintain or restore patency of the diseased vessel and perfuse downstream anatomical structures. While diseases and other ailments are known to affect all types of blood vessels, those affecting the aorta may be more serious and more likely to lead to patient death due to the volume and pressure of blood pumped through the aorta. Thus, while the examples discussed below are conceived in the context of aortic grafts, it should be recognized that the techniques of the present disclosure are applicable to other portions of a patient's vasculature.

[0004] Aortic aneurysms are serious conditions that can affect any portion of the aorta. An aortic aneurysm within the abdomen is called an abdominal aortic aneurysm or AAA; an aortic aneurysm within the thoracic cavity is called a thoracic aortic aneurysm or TAA; and an aneurysm located on the aortic arch within the thoracic cavity may be called an aortic arch aneurysm. Aortic aneurysms can result from a variety of causes, including untreated or severe hypertension, smoking, common conditions such as Marfan syndrome, and degenerative dilation of the aortic wall. Thoracic aortic aneurysms result from weakening of the aortic wall, leading to localized dilation and are life-threatening. Patients with thoracic aneurysms are often asymptomatic until the aneurysm expands. The most common symptoms are pain and aortic rupture. Rupture of an aneurysm can cause severe internal bleeding, which can rapidly lead to shock and death.

[0005] Patients with acute dissections typically present with pain and are classified as emergency situations because the dissection ruptures the aortic wall, impacting the integrity of the aortic valve and risking myocardial perfusion by involving the origins of the coronary arteries. Dissections of the ascending aorta, which typically extend into the aortic arch or involve any of the arteries of the aortic arch, require the surgical insertion of a graft to replace the diseased portion of the ascending aorta and additional grafts to restore blood flow to each artery arising from any dissected or diseased aortic branch. These grafts may be connected to the vasculature by expanding connectors from an insertion profile to a deployment profile to secure the graft to the vessel. The procedure may also include the insertion of an additional stent specifically designed to provide blood flow from the ascending aorta to the vasculature distal to the descending aorta. Conditions affecting other parts of the patient's vasculature may also be treated similarly.

[0006] Complex thoracic aortic disease includes acute (AAD) and chronic type A dissections (CAD), as well as aortic arch aneurysms with or without involvement of the ascending and descending aorta. Aortic dissection occurs when the inner layer of the aortic wall tears, allowing blood to enter the wall and separate these layers. Acute aortic dissections are defined as those identified within the first two weeks after the initial rupture, while chronic dissections are defined as those identified more than two weeks later. Aortic dissections are classified by their location and the extent of thoracic aortic involvement. Stanford type A dissections affect the ascending aorta and may extend into the aortic arch and descending thoracic aorta. Stanford type B dissections do not affect the ascending aorta and typically involve the descending thoracic aorta distal to the origin of the left subclavian artery. Nearly two-thirds of aortic dissections are Stanford type A.

[0007] Treatment of complex thoracic aortic disease typically requires a long and complicated open-heart surgery. During such surgery, the patient is typically placed on a cardiopulmonary bypass pump and the heart is stopped so that the aorta can be clamped and the surgery can be performed. While the patient is on cardiopulmonary bypass, the patient is generally cooled to a state of hypothermia. The risk that the patient will not survive the surgery is directly related to the amount of time the patient is on the pump and under hypothermia.

[0008] Correspondingly, it would be desirable to provide tools and methods for deploying aortic connectors that facilitate and expedite placement of the aortic connector for aneurysm repair. Similarly, it would be desirable to provide tools and methods that can be used to deploy connectors into other portions of a patient's vasculature. As detailed in the data below, the present disclosure achieves these and other goals.

[0009] 〔overview〕 The present disclosure is directed to a vascular connector deployment tool including a handle, an elongated mandrel extending distally from the handle, a vascular connector coaxially disposed around the mandrel, a retractable sheath assembly including an outer sheath telescopically deployed over an inner sheath, the sheath assembly configured to restrain the vascular connector relative to the mandrel in an insertion profile, a distal transition between the outer sheath and the inner sheath visually indicating the position of the vascular connector, and an actuator on the handle configured to selectively retract the outer sheath and the inner sheath relative to the mandrel.

[0010] In one aspect, the inner sheath is visible through the outer sheath.

[0011] In one aspect, the outer sheath can be transparent.

[0012] In one aspect, the outer sheath can cover all of the vascular connector before retraction, and the inner sheath can cover a predetermined amount of the proximal portion of the vascular connector before retraction. For example, the inner sheath can cover the proximal half of the vascular connector before retraction.

[0013] In one aspect, the distal end of the vascular connector may be visible through the outer sheath.

[0014] In one aspect, the actuator can be configured to initially retract only the outer sheath relative to the mandrel to expose a distal portion of the vascular connector, and then retract both the outer and inner sheaths relative to the mandrel to expose all of the vascular connector. The actuator can be a slider. The slider can be configured to initially engage only the outer sheath and, upon reset, engage both the inner and outer sheaths. Alternatively, the slider can have a range of motion and be configured to engage only the outer sheath over a first portion of the range of motion and engage both the inner and outer sheaths over the remainder of the range of motion.

[0015] In one aspect, the inner sheath may be transparent, and a marker on the distal end of the inner sheath may be visible through the outer sheath. A stationary shoulder tube, coaxially disposed over the mandrel and internal to the outer and inner sheaths, may abut the proximal end of the vascular connector. The shoulder tube may be visible through the outer and inner sheaths.

[0016] In one embodiment, the vascular connector may be a self-expanding connector capable of maintaining a radial force at temperatures ranging from 22°C to 37°C.

[0017] The present disclosure also includes a method of implanting a vascular connector in a patient. The method may include providing a vascular connector deployment tool, the vascular connector deployment tool including a handle, an elongated mandrel extending distally from the handle, a vascular connector coaxially disposed around the mandrel, and a retractable sheath assembly including an outer sheath telescopically deployed over an inner sheath, the sheath assembly restraining the vascular connector against the mandrel in an insertion profile, and an actuator on the handle configured to selectively retract the outer sheath and the inner sheath relative to the mandrel; positioning at least a distal portion of the vascular connector within a first lumen for conducting blood of a patient by visualizing a distal transition between the outer sheath and the inner sheath; operating the actuator to retract the outer sheath relative to the mandrel to expose a distal portion of the vascular connector; and securing the distal portion of the vascular connector within the first lumen by expanding that portion of the vascular connector from the insertion profile.

[0018] In one aspect, positioning at least a distal portion of the vascular connector within the first lumen of the patient may include advancing the deployment tool until the distal end of the inner sheath is adjacent an opening to the first lumen of the patient.

[0019] In one aspect, positioning at least a distal portion of the vascular connector within a first lumen of the patient can include positioning one half of the vascular connector within the first lumen.

[0020] In one aspect, the method may also include verifying the stationarity of the deployment tool during retraction of the outer sheath by visualizing the inner sheath through the outer sheath.

[0021] In one aspect, a second lumen for conducting the patient's blood can be coaxially advanced over the deployment tool until the end of the second lumen is adjacent the opening of the first lumen, and the actuator can be operated to retract the outer and inner sheaths relative to the mandrel and expose the remaining portion of the vascular connector, which can be secured within the second lumen by expanding that portion of the vascular connector from the insertion profile. The first lumen can be a blood vessel and the second lumen can be a graft.

[0022] In one aspect, the deployment tool can have a shoulder tube that abuts the vascular connector, so that the method also includes visualizing the shoulder tube through the outer sheath and the inner sheath to confirm placement of the vascular connector within the second lumen.

[0023] In one embodiment, the vascular connector may be a self-expanding connector capable of maintaining a radial force at temperatures ranging from 22°C to 37°C.

[0024] Further features and advantages will be apparent from the following more particular description of preferred embodiments of the present disclosure, as illustrated in the accompanying drawings, in which like reference characters generally refer to the same parts or elements throughout the drawings. [Brief explanation of the drawings]

[0025] [Figure 1] 1A and 1B illustrate schematic diagrams of a vascular connector used to connect a blood vessel and a graft, according to an embodiment of the present disclosure. [Figure 2] 1A and 1B illustrate schematic diagrams of a deployment tool for positioning and deploying a vascular connector according to an embodiment of the present disclosure. [Figure 3] 10A and 10B schematically illustrate a vascular connector positioned within a blood vessel, according to an embodiment of the present disclosure. [Figure 4] 10A-10C schematically illustrate the outer sheath of the deployment tool being retracted to expand and anchor a distal portion of the vascular connector within the vessel, according to an embodiment of the present disclosure. [Figure 5] 10A-10C schematically illustrate a graft advanced over a deployment tool and into proximity with a vessel, according to an embodiment of the present disclosure. [Figure 6] 10A-10C schematically illustrate the outer and inner sheaths of the deployment tool being retracted to expand and secure the remaining portion of the vascular connector within the graft, according to an embodiment of the present disclosure. [Figure 7] 10A-10C schematically illustrate another deployment tool for positioning and deploying a vascular connector, according to an embodiment of the present disclosure.

[0026] Detailed Description At the outset, it is to be understood that this disclosure is not limited to the specifically exemplified materials, architectures, routines, methods, or structures, as these may vary. Thus, although several such options similar or equivalent to those described herein may be used in the practice or embodiments of this disclosure, the preferred materials and methods are described herein.

[0027] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the disclosure only, and is not intended to be limiting.

[0028] The detailed description set forth below in connection with the accompanying drawings is intended as a description of exemplary embodiments of the present disclosure and is not intended to represent the only exemplary embodiments in which the present disclosure may be practiced. The term "exemplary" as used throughout this description means "serving as an example, instance, or illustration," and should not necessarily be construed as preferred or advantageous over other exemplary embodiments. The detailed description includes specific details for the purpose of providing a thorough understanding of the exemplary embodiments herein. It will be apparent to those skilled in the art that the exemplary embodiments herein may be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form in order to avoid obscuring the novelty of the exemplary embodiments presented herein.

[0029] For convenience and clarity only, directional terms such as top, bottom, left, right, up, down, over, above, below, below, rear, back, and front may be used with respect to the accompanying drawings. These and similar directional terms should not be construed as limiting the scope of the disclosure in any way.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. As used herein and customary in the art, the word "substantially" and similar approximating terms refer to normal variations in dimensions and other characteristics of the finished product resulting from manufacturing tolerances and other manufacturing inaccuracies. Finally, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise.

[0031] Referring to FIG. 1 , a vascular connector 10 is shown that may be adapted for use in the aorta or other suitable location within a patient's vasculature to help establish or restore fluid communication by joining a blood vessel 12, such as one that may have dissected, to a graft 14, such as a branch graft. The graft 14 may be made from any suitable material or materials, such as, but not limited to, polytetrafluoroethylene (PTFE) or polyester, e.g., polyethylene terephthalate (PET), sometimes known as DACRON® brand polyester available from EI DuPont De Nemours and Company, Wilmington, Delaware. The vascular connector 10 may be expandable from a first insertion diameter to a second deployment diameter and may have any structure that allows expansion from the first insertion diameter to the second deployment diameter and holds the vascular connector securely in the deployed state inside the blood vessel 12 and graft 14. As one example, the vascular connector 10 may include a plurality of circumferentially extending hoops 16 that are similar in design to stents. The hoops 16 may be longitudinally spaced apart; in that case, adjacent hoops 16 may be connected by one or more tie bars 18. Alternatively, adjacent hoops 16 are not spaced apart but instead abut or overlap one another. In such a configuration, such adjacent hoops 16 may be secured to one another by laser welding or the like. The hoops 16 may be made of metal or other materials. Each hoop 16 may have a complex shape, such as being made from wire, laser cut from a tube, or otherwise manufactured, such that the hoop 16 has a complex shape, such as a zigzag, a repeating Z shape, a serpentine curve, or other shape. Such a shape allows the hoop 16 to expand from an insertion diameter to a deployed diameter. The zigzag pattern of at least one hoop 16 may be continuously curved or may include straight segments connected by curved segments.In one embodiment, the zigzag pattern of the hoops 16 may be as described in expired U.S. Patent No. 4,580,568, which is incorporated herein by reference in its entirety, however, at least one hoop 16 may be configured differently.

[0032] In one embodiment, different hoops 16 may be made from different materials. For example, at least one hoop 16 may be made from a superelastic material such as a nickel-titanium alloy, and at least one other hoop 16 may be made from a plastically deformable material such as 316L stainless steel. Adjacent hoops 16 may alternate between different materials, with no hoops 16 adjacent to a hoop 16 made from the same material. In other embodiments, several hoops 16 made from the same material may be grouped together, with at least one hoop 16 made from a different material adjacent to the group. For example, the hoops 16 at the outer end of the vascular connector 10 may be made from stainless steel, and the remaining hoops 16 may be made from a superelastic material such as a nickel-titanium alloy. By using hoops 16 made from different materials, the vascular connector 10 takes advantage of the different properties of the different materials. For example, one or more hoops 16 made from a superelastic material may be useful for self-expanding the vascular connector 10. One or more additional hoops 16 made from a plastically deformable material, such as 316L stainless steel, are useful for maintaining the lumen of the vascular connector 10 open because such materials have greater resistance to hoop stress and are less likely to revert to a different crystalline phase after expansion. Furthermore, such hoops 16 are fabricated into a structure configured to maintain their radial force at temperatures ranging from 22°C to 37°C. While the term "hoop" is used herein, the hoop 16 need not be perfectly circular when viewed from the end, but may have different shapes and curvatures appropriate for a particular application. In some embodiments, the hoop 16 is substantially circular when viewed from the end.

[0033] In one embodiment, each opposing end of the vascular connector 10 expands to the same or similar diameter in the deployed state. In other embodiments, one end expands to a different diameter than the opposite end in the deployed state to join vessels 12 and grafts 14 having different diameters. The diameter difference can be controlled by controlling the diameter of the hoops 16 at each end, by providing different combinations of hoops 16 made of different materials, or in any other suitable manner.

[0034] As previously mentioned, the vascular connector 10 may be used to join the blood vessel 12 to the graft 14, and correspondingly, it is desirable to first deploy half of the length of the connector 10 within the blood vessel 12 and then deploy the remaining half of the connector 10 within the graft 14 to effectively connect the blood vessel 12 to the graft 14. It should be recognized that accurately deploying the appropriate amount of connector 10 within both the blood vessel 12 and the graft 14 is advantageous because deploying too much connector 10 within the blood vessel 12 jeopardizes the connection within the graft 14, while deploying too little connector 10 within the blood vessel 12 jeopardizes the connection within the blood vessel 12, either of these scenarios being potentially disastrous for the patient. Proper visualization greatly facilitates any open surgical procedure, and thus, the techniques of the present disclosure improve the ability to accurately assess the appropriate amount of connector 10 within the blood vessel 12 or branch graft 14 during surgery, as discussed in detail below.

[0035] Thus, vascular connector 10, or a connector having similar features, may be deployed using a deployment tool 20, as depicted schematically in FIG. 2 . Deployment tool 20 includes a handle 22 having an actuator configured as a slider 24 coupled to an outer sheath 26 and an inner sheath 28. The distal end of deployment tool 20 has a blunt, atraumatic tip 30. As shown, vascular connector 10 is wrapped around an inner mandrel 32 and is at least partially compressed against mandrel 32 by sheaths 26 and 28. Outer sheath 26 is telescopically disposed over inner sheath 28, both of which are selectively retractable via actuation of slider 24. In one embodiment, a first actuation of slider 24 retracts only outer sheath 26, and then a second actuation of slider 24 retracts both outer sheath 26 and inner sheath 28 simultaneously, as described in further detail below. Prior to retraction, the outer sheath 26 covers the entire length of the vascular connector 10, while the inner sheath 28 covers a predetermined amount of the proximal portion of the connector 10, determined based on the characteristics of the vascular connector 10 and the purpose of the procedure. As an example, one-half of the connector's entire length is covered by the inner sheath 28 in the illustrated embodiment. For illustrative purposes, the inner sheath 28 may extend 3.5 cm over the 7 cm proximal end of the connector. Thus, the transition between the inner sheath 28 and the outer sheath 26 can be used to indicate the location of the vascular connector 10 deployed within the vessel 12 or graft 14. These distances can be varied as needed depending on the length of the connector 10 and the desired percentage of coverage. The sheaths 26 and 28 can be formed from suitable polymeric materials, such as nylon (polyamide), urethane, polypropylene, and polyamide copolymers, such as polyether block amide (PEBAX®), or others. In particular, the outer sheath 26 is sufficiently translucent to allow at least the distal end of the inner sheath 28 to be visualized through the outer sheath (as shown by the dashed line), for example by using a substantially clear or transparent polymer.It should be appreciated that transparency is relative, and for purposes of this disclosure, any difference in optical properties that allows the inner sheath 28 to be visualized through the outer sheath 26 may be used. As desired, the inner sheath 28 may also use any suitable optical properties to facilitate visualization through the outer sheath 26. For example, the inner sheath 28 may have additional coloring, such as high visibility or high contrast properties. Alternatively, or in addition, the inner sheath 28 may have a relatively higher opacity than the outer sheath 26. Furthermore, the outer sheath 26 may also allow visualization of the connector 10, for example, a distal portion not covered by the inner sheath 28.

[0036] As will be appreciated, these features of the deployment tool 20 facilitate precise placement of the connector 10 within the vessel 12 and graft 14. To the operator, the transition between the optically transparent outer sheath 26 and the visually distinct inner sheath 28 acts as a marker to a known location on the connector 10. For example, in the illustrated embodiment, where the inner sheath 28 covers one-half of the connector 10 before retraction, this provides identification of the midpoint of the connector 10. This therefore helps ensure that one-half of the connector 10 is positioned within the vessel 12, leaving the other half to secure the graft 14. If different relative amounts of the connector 10 are desired for each of the vessel 12 and graft 14, the inner sheath 28 can be configured to cover an appropriate, predetermined amount of the connector 10. Furthermore, when the distal portion of the connector 10 is deployed by retracting only the outer sheath 26, the inner sheath 28 remains visible, thus confirming that it remains stationary and indicates that the delivery system is not moving relative to the target landing area.

[0037] By way of example only, and not by way of limitation, FIGS. 3-6 schematically depict the use of a deployment tool 20 to connect a blood vessel 12 to a graft 14 with a connector 10. As shown in FIG. 3 , the deployment tool 20 can be advanced into the blood vessel 12 until the distal end of the inner sheath 28 is adjacent an opening in the blood vessel 12. The distal end of the inner sheath 28 can be visualized through the outer sheath 26, facilitating precise positioning of the vascular connector 10 within the blood vessel 12. Actuation of the slider 24 of the deployment tool 20 retracts only the outer sheath 26, while the inner sheath 28 remains stationary relative to the handle 22. As shown in FIG. 4 , retraction of the outer sheath 26 causes the now-exposed distal portion of the connector 10 to expand from its insertion profile to its deployed profile to engage and secure the blood vessel 12. Next, as shown in FIG. 5 , the graft 14 may be coaxially advanced over the deployment tool 20 until it is adjacent to the vessel 12, such as by abutting or otherwise sufficiently proximate the vessel. Now, the slider 24 may then be actuated to simultaneously retract both the outer sheath 26 and the inner sheath 28, exposing the remaining proximal portion of the connector 10, which can expand from its insertion profile to its deployed profile to engage and secure the graft 14. The deployment tool 20 may now be retracted proximally, leaving the connector 12 in place and connecting the vessel 12 and the graft 14. Any suitable mechanical implementation may be used to cause the slider 24 to selectively retract the outer sheath 26 or to retract both the outer sheath 26 and the inner sheath 28. For example, the slider 24 may engage only the outer sheath 26 in an initial configuration. After the first actuation, slider 24 can be reset so that it then engages inner sheath 28, and subsequent actuations retract both simultaneously. As another example, slider 24 may engage only outer sheath 26 through a first portion of its range of motion, and then engage both outer sheath 26 and inner sheath 28 through the remainder of its range of motion. Those skilled in the art will recognize that other techniques and mechanisms may be used to achieve similar results.Additionally, although the embodiments shown in Figures 3-6 are provided in the context of joining a blood vessel 12 and a graft 14 in an end-to-end configuration, the technique may also be applied to joining any combination of blood vessels, grafts, or other lumens that conduct blood in a patient, and may also be used in an endovascular approach through an opening formed in the sidewall of a blood vessel, graft, or other lumen.

[0038] Another embodiment of the disclosed technology is depicted generally in FIG. 7 in the context of a deployment tool 40. Similar elements with similar functionality are indicated with the same reference numerals. As with the previous embodiment, the deployment tool 40 also includes a handle 22 having an actuator configured as a slider 24 coupled to an outer sheath 26 and an inner sheath 28. The distal end of the deployment tool 20 has a blunt, atraumatic tip 30. As shown, the vascular connector 10 is wrapped around an inner mandrel 32 and is at least partially compressed against the mandrel 32 by the sheaths 26 and 28. The outer sheath 26 is telescopically disposed over the inner sheath 28, both of which are selectively retractable via actuation of the slider 24. Again, a first actuation of the slider 24 retracts only the outer sheath 26, and then a second actuation of the slider 24 retracts both the outer sheath 26 and the inner sheath 28 simultaneously. Similarly, the outer sheath 26 covers the entire length of the vascular connector 10 prior to retraction, and the inner sheath 28 covers a desired, predetermined amount of the proximal portion of the connector 10, as previously described. In this embodiment, both the outer sheath 26 and the inner sheath 28 are clear or otherwise sufficiently transparent, and the transition between the outer sheath 26 and the inner sheath 28 is visually indicated by a circumferential ring 42 or any other suitable marker that can be visualized through the outer sheath 26. The deployment tool 40 also features a stationary shoulder tube 44, which abuts the proximal end of the connector 10 and is colored or otherwise visible through both the outer sheath 26 and the inner sheath 28. The shoulder tube 44 functions to resist proximal movement of the connector 10 during retraction of the outer sheath 26 and the inner sheath 28. Additionally, the visibility of the shoulder tube 44 serves as a convenient visual indicator of the location of the proximal end of the vascular connector 10. During use, this indication can be used to confirm that the proximal portion of connector 10 is, for example, entirely within graft 14 and does not extend out of the opening through which deployment tool 40 is advanced. As will be appreciated, deployment tool 40 can be used to position and deliver connector 10 for connecting a blood-carrying lumen of a patient, as previously described.

[0039] While the present invention has been described in detail, it will be apparent to those skilled in the art that various changes and modifications can be made, and equivalents employed, without departing from the invention. It is understood that the present invention is not limited to the details of construction, the arrangement of components, and / or the method set forth in the above description or illustrated in the drawings. The statements in the Abstract of this document, and any summary statements herein, are merely illustrative and are not intended to limit the scope of the claims, and cannot be construed as such. Moreover, the drawings are merely illustrative and not limiting. Section headings and subheadings are for the convenience of the reader only. They should not be construed as having any essential significance, meaning, or interpretation, and should not be construed as indicating that all information relating to any particular subject matter is to be found under or limited to any particular heading or subheading. Accordingly, the present invention is not limited or restricted except in accordance with the claims and their legal equivalents.

[0040] [Embodiment] (1) A vascular connector deployment tool, comprising: The handle and an elongated mandrel extending distally from the handle; a vascular connector disposed coaxially around the mandrel; a retractable sheath assembly including an outer sheath telescopically deployed over an inner sheath, the retractable sheath assembly configured to constrain the vascular connector against the mandrel in an insertion profile, a distal transition between the outer sheath and the inner sheath visually indicating the position of the vascular connector; an actuator on the handle configured to selectively retract the outer sheath and the inner sheath relative to the mandrel; A vascular connector deployment tool comprising: (2) A vascular connector deployment tool as described in embodiment 1, wherein the inner sheath is visible through the outer sheath. (3) A vascular connector deployment tool as described in embodiment 2, wherein the outer sheath is transparent. (4) A vascular connector deployment tool as described in embodiment 2, wherein the outer sheath covers all of the vascular connector before retraction and the inner sheath covers a predetermined amount of the proximal portion of the vascular connector before retraction. (5) A vascular connector deployment tool as described in embodiment 4, wherein the inner sheath covers the proximal half of the vascular connector before retraction.

[0041] (6) A vascular connector deployment tool as described in embodiment 5, wherein the distal end of the vascular connector is visible through the outer sheath. (7) A vascular connector deployment tool as described in embodiment 1, wherein the actuator is configured to first retract only the outer sheath relative to the mandrel to expose a distal portion of the vascular connector, and then retract the outer sheath and the inner sheath relative to the mandrel to expose all of the vascular connector. (8) A vascular connector deployment tool as described in embodiment 7, wherein the actuator includes a slider. (9) A vascular connector deployment tool as described in embodiment 8, wherein the slider is configured to initially engage only the outer sheath and, when reset, to engage both the inner sheath and the outer sheath. (10) The vascular connector deployment tool of embodiment 8, wherein the slider has a range of movement and is configured to engage only the outer sheath over a first portion of the range of movement and to engage both the inner sheath and the outer sheath over a remaining portion of the range of movement.

[0042] (11) A vascular connector deployment tool according to embodiment 2, wherein the inner sheath is transparent and a marker on the distal end of the inner sheath is visible through the outer sheath. (12) The vascular connector deployment tool of claim 11, further comprising a stationary shoulder tube coaxially disposed over the mandrel and within the outer sheath and the inner sheath, the stationary shoulder tube abutting the proximal end of the vascular connector. (13) A vascular connector deployment tool according to claim 12, wherein the shoulder tube is visible through the outer sheath and the inner sheath. (14) A vascular connector deployment tool according to claim 1, wherein the vascular connector is a self-expanding connector and is capable of maintaining a radial force at temperatures ranging from 22°C to 37°C. (15) A method of implanting a vascular connector in a patient, comprising: a retractable sheath assembly including an outer sheath telescopically deployed over an inner sheath, the outer sheath restraining the vascular connector relative to the mandrel in an insertion profile; and an actuator on the handle configured to selectively retract the outer sheath and the inner sheath relative to the mandrel; positioning at least a distal portion of the vascular connector within a first lumen for conducting blood of the patient by visualizing a distal transition between the outer sheath and the inner sheath; operating the actuator to retract the outer sheath relative to the mandrel to expose a distal portion of the vascular connector; securing the distal portion of the vascular connector within the first lumen by expanding the portion of the vascular connector from the insertion profile; A method comprising:

[0043] (16) The method of embodiment 15, wherein positioning at least a distal portion of the vascular connector within the first lumen of the patient comprises advancing the deployment tool until a distal end of the inner sheath is adjacent an opening to the first lumen of the patient. (17) The method of embodiment 15, wherein positioning at least a distal portion of the vascular connector within the first lumen of the patient comprises positioning one-half of the vascular connector within the first lumen. (18) The method of claim 15, further comprising verifying stationary status of the deployment tool during retraction of the outer sheath by visualizing the inner sheath through the outer sheath. (19) coaxially advancing a second lumen for conducting the patient's blood over the deployment tool until an end of the second lumen is adjacent the opening of the first lumen; operating the actuator to retract the outer sheath and the inner sheath relative to the mandrel to expose a remaining portion of the vascular connector; securing the remaining portion of the vascular connector within the second lumen by expanding the portion of the vascular connector from the insertion profile; 16. The method of embodiment 15, further comprising: (20) The method of embodiment 19, wherein the first lumen is a blood vessel and the second lumen is a graft.

[0044] (21) The deployment tool has a shoulder tube that abuts against the vascular connector. 20. The method of embodiment 19, further comprising visualizing the shoulder tube through the outer sheath and the inner sheath to confirm placement of the vascular connector within the second lumen. (22) The method of embodiment 15, wherein the vascular connector is a self-expanding connector and can maintain a radial force at a temperature ranging from 22°C to 37°C.

Claims

1. 1. A vascular connector deployment tool comprising: The handle and an elongated mandrel extending distally from the handle; a vascular connector coaxially disposed around the mandrel, the vascular connector being expandable from a first insertion diameter to a second deployed diameter, the vascular connector having structure that allows expansion from the first insertion diameter to the second deployed diameter and that maintains the vascular connector in a deployed state inside a blood vessel and a graft; a retractable sheath assembly including a transparent outer sheath telescopically deployed over an inner sheath, the inner sheath being visible through the outer sheath, the retractable sheath assembly being configured to restrain the vascular connector against the mandrel in an insertion profile, and a distal end of the inner sheath visualized through the outer sheath visually indicating the position of the vascular connector deployed within the blood vessel or the graft; an actuator on the handle configured as a slider coupled to the outer sheath and the inner sheath to initially retract only the outer sheath relative to the mandrel to expose a distal portion of the vascular connector, and thereafter retract the outer sheath and the inner sheath relative to the mandrel to expose all of the vascular connector; and wherein the distal end of the inner sheath, visualized through the outer sheath, acts as a marker indicating a known location on the vascular connector between a portion of the vascular connector that is deployed within the vessel and a portion of the vascular connector that is deployed within the graft.

2. The vascular connector deployment tool of claim 1 , wherein the outer sheath covers all of the vascular connector before retraction and the inner sheath covers a predetermined amount of a proximal portion of the vascular connector before retraction.

3. The vascular connector deployment tool of claim 2 , wherein the inner sheath covers a proximal half of the vascular connector prior to retraction.

4. The vascular connector deployment tool of claim 3 , wherein the distal end of the vascular connector is visible through the outer sheath.

5. 2. The vascular connector deployment tool of claim 1, wherein the slider has a configuration that engages only the outer sheath to retract only the outer sheath relative to the mandrel, and a configuration that engages both the inner sheath and the outer sheath to simultaneously retract the outer sheath and the inner sheath relative to the mandrel.

6. 2. The vascular connector deployment tool of claim 1, wherein the slider has a range of movement and is configured to engage only the outer sheath over a first portion of the range of movement and to engage both the inner sheath and the outer sheath over a remainder of the range of movement.

7. The vascular connector deployment tool of claim 1 , wherein the inner sheath is transparent.

8. 8. The vascular connector deployment tool of claim 7, further comprising a stationary shoulder tube coaxially disposed over the mandrel and within the outer sheath and the inner sheath, the stationary shoulder tube abutting a proximal end of the vascular connector.

9. The vascular connector deployment tool of claim 8 , wherein the stationary shoulder tube is visible through the outer sheath and the inner sheath.

10. The vascular connector deployment tool of claim 1 , wherein the vascular connector is a self-expanding connector and is capable of maintaining a radial force at temperatures ranging from 22°C to 37°C.

11. A vascular connector deployment tool as described in claim 2, wherein the known location is a midpoint between the portion of the vascular connector deployed within the blood vessel and the portion of the vascular connector deployed within the graft.

12. The vascular connector deployment tool of claim 11 , wherein the vascular connector is used to join the blood vessel to the graft.

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