US-12622797-B2 - Vascular and aortic connectors with robotic delivery and deployment methods thereof

US12622797B2US 12622797 B2US12622797 B2US 12622797B2US-12622797-B2

Abstract

A deployment tool and associated method are disclosed for implanting a vascular connector in a patient. The vascular connector deployment tool has a housing, an inner sheath extending distally from the housing, a floating mandrel, a vascular connector disposed coaxially about the mandrel, and an outer sheath telescopically deployed over an inner sheath. The outer sheath constrains the vascular connector around the mandrel in an insertion profile when the outer sheath is disposed over the vascular connector. The inner sheath may be rotated to cause the outer sheath to retract relative to the floating mandrel and expose sequential portions of the vascular connector. A drive disposed within the housing and coupled to a proximal end of the outer sheath translates rotational motion of the inner sheath into longitudinal motion of the outer sheath.

Inventors

Thomas J. Palermo

Assignees

Aquedeon Medical, Inc.

Dates

Publication Date: 20260512
Application Date: 20220719

Claims (19)

1 . A vascular connector deployment tool, comprising: a housing; an inner sheath extending distally from the housing, wherein the inner sheath is rotatable with respect to the housing; a floating mandrel; a connector coupling the floating mandrel to a distal end of the inner sheath such that the inner sheath is capable of rotation with respect to the floating mandrel; a vascular connector disposed coaxially about the floating mandrel; an outer sheath telescopically deployed over the inner sheath, wherein the outer sheath is configured to constrain the vascular connector around the floating mandrel in an insertion profile when the outer sheath is disposed over the vascular connector; and a drive disposed within the housing that is coupled to a proximal end of the outer sheath and is configured to translate a rotational motion of the inner sheath into a longitudinal motion of the outer sheath.
2 . The vascular connector deployment tool of claim 1 , wherein the drive is coaxially disposed over a proximal portion of the inner sheath and engages external threads on the proximal portion of the inner sheath.
3 . The vascular connector deployment tool of claim 2 , wherein the drive travels along guides in the housing that permit longitudinal motion and resist rotational motion.
4 . The vascular connector deployment tool of claim 2 , wherein the drive is configured to translate a first predetermined amount of rotation of the inner sheath into a first known amount of longitudinal motion of the outer sheath.
5 . The vascular connector deployment tool of claim 4 , wherein the first known amount of longitudinal motion exposes a distal portion of the vascular connector.
6 . The vascular connector deployment tool of claim 5 , wherein the drive is configured to translate a second predetermined amount of rotation of the inner sheath into a second known amount of longitudinal motion of the outer sheath and wherein the second known amount of longitudinal motion exposes a proximal portion of the vascular connector.
7 . The vascular connector deployment tool of claim 4 , wherein the inner sheath has an interface that extends from a proximal end of the housing and is configured to rotate the inner sheath.
8 . The vascular connector deployment tool of claim 1 , wherein the floating mandrel comprises a shoulder configured to engage and resist proximal longitudinal motion of the vascular connector when the outer sheath is retracted.
9 . The vascular connector deployment tool of claim 1 , wherein the vascular connector is visible through the outer sheath.
10 . The vascular connector deployment tool of claim 1 , wherein the outer sheath comprises a marker configured to indicate a position of the vascular connector prior to retraction of the outer sheath.
11 . The vascular connector deployment tool of claim 1 , wherein the vascular connector is a self-expanding connector and is able to maintain radial force at a temperature in a range of 19° C. to 37° C.
12 . The vascular connector deployment tool of claim 1 , wherein the floating mandrel and the inner sheath comprise a guidewire lumen.
13 . A method for implanting a vascular connector in a patient, comprising: providing a vascular connector deployment tool including a housing, an inner sheath extending distally from the housing, wherein the inner sheath is rotatable with respect to the housing, a floating mandrel, a connector coupling the floating mandrel to a distal end of the inner sheath such that the inner sheath is capable of rotation with respect to the floating mandrel, a vascular connector disposed coaxially about the floating mandrel, an outer sheath telescopically deployed over the inner sheath, wherein the outer sheath is configured to constrain the vascular connector around the floating mandrel in an insertion profile when the outer sheath is disposed over the vascular connector, and a drive disposed within the housing that is coupled to a proximal end of the outer sheath and is configured to translate a rotational motion of the inner sheath into a longitudinal motion of the outer sheath; positioning at least a distal portion of the vascular connector within a first lumen for conducting blood of the patient, the vascular connector being constrained around the floating mandrel in an insertion profile; rotating the inner sheath to cause the drive to translate the rotational movement of the inner sheath to longitudinal movement of the outer sheath to cause the outer sheath to retract longitudinally relative to the floating mandrel and expose a distal portion of the vascular connector; and securing the distal portion of the vascular connector within the first lumen by expansion of the portion of the vascular connector from the insertion profile.
14 . The method of claim 13 , wherein rotating the inner sheath comprises imparting a first predetermined amount of rotation to cause a first known amount of longitudinal motion of the outer sheath, such that the first known amount of longitudinal motion exposes the distal portion of the vascular connector.
15 . The method of claim 14 , further comprising: advancing a second lumen for conducting blood of the patient coaxially over the deployment tool until an end of the second lumen is adjacent the opening of the first lumen; further rotating the inner sheath to cause the outer sheath to retract relative to the floating mandrel and expose a remaining portion of the vascular connector; and securing the remaining portion of the vascular connector within the second lumen by expansion of the remaining portion of the vascular connector from the insertion profile.
16 . The method of claim 15 , wherein further rotating the inner sheath comprises imparting a second predetermined amount of rotation of the inner sheath to cause a second known amount of longitudinal motion of the outer sheath, such that the second known amount of longitudinal motion exposes the remaining portion of the vascular connector, wherein the remaining portion of the vascular connector comprises a proximal portion of the vascular connector.
17 . The method of claim 15 , wherein the first lumen is a blood vessel and the second lumen is a graft.
18 . The method of claim 13 , wherein positioning at least the distal portion of the vascular connector within the first lumen comprises visualizing the vascular connector through the outer sheath.
19 . The method of claim 13 , wherein positioning at least the distal portion of the vascular connector within the first lumen comprises using a marker that indicates a position of the vascular connector prior to retraction of the outer sheath.

Description

RELATED APPLICATIONS This patent application claims priority to U.S. Provisional Patent Application No. 63/224,561, filed Jul. 22, 2021, which is hereby incorporated by reference in its entirety and for all purposes. Further, this application is a continuation-in-part of U.S. patent application Ser. No. 17/191,945, filed Mar. 4, 2021, which is commonly-assigned and is also incorporated by reference in its entirety and for all purposes. FIELD OF THE PRESENT DISCLOSURE The invention generally relates to vascular and aortic connectors, with particular regard to deployment tools and methods for such deploying such connectors. BACKGROUND The circulatory system includes the aorta and other large-diameter blood vessels, as well as smaller-diameter blood vessels and capillaries. Therapeutic interventions to replace or support diseased or otherwise compromised vessels may involve the use of synthetic grafts to maintain or restore patency of the affected vessel to perfuse downstream anatomy. Although disease and other conditions are known to affect all types of blood vessels, those affecting the aorta may be more serious and more likely to result in patient death, due to the volume and pressure of blood that is pumped through the aorta. Accordingly, the example discussed below is framed in the context of aortic grafts, but it should be appreciated that the techniques of this disclosure are applicable to other portions of a patient's vasculature. Aortic aneurysm is a serious condition that can affect any segment of the aorta. An aortic aneurysm in the abdomen is referred to as an abdominal aortic aneurysm or AAA; an aortic aneurysm in the chest cavity is referred to as a thoracic aortic aneurysm or TAA, and an aneurysm in the chest cavity on the aortic arch may be referred to as an aortic arch aneurysm. Aortic aneurysms may result from different causes, such as untreated or severe hypertension, smoking, generic disease such as Marfan's syndrome, and degenerative dilation of the aortic wall. A thoracic aortic aneurysm results from weakening of the aortic wall, leading to localized dilatation, and is a life-threatening condition. Patients with thoracic aneurysms are often asymptomatic until the aneurysm expands. The most common presenting symptoms are pain and aortic rupture. A ruptured aneurysm can cause severe internal bleeding, which can rapidly lead to shock or death. Patients with acute dissection typically present with pain and are classed as emergencies due to the risk of the dissection rupturing the wall of the aorta, affecting the integrity of the aortic valve and, through involvement of the origins of the coronary arteries, affecting perfusion of the myocardium. Typically, a dissection of the ascending aorta that extends into the aortic arch or that involves any of the arteries of the aortic arch requires surgical insertion of a graft to replace the diseased portion of the ascending aorta and additional grafts to reestablish blood flow to each artery stemming from the aortic branch where any dissection or disease is present. The grafts may be connected to the vasculature by expanding a connector from an insertion profile to a deployed profile to secure the graft to a vessel. The procedure may also involve inserting an additional stent that is dedicated to provide blood flow from the ascending aorta to vasculature distal of the descending aorta. Conditions affecting other portions of the patient's vasculature may also be treated in a similar manner. Complex thoracic aortic disease encompasses acute (AAD) and chronic type A dissections (CAD), as well as aortic arch aneurysm with or without involvement of the ascending and descending aorta. Aortic dissection results from a tear in the inner layer of the wall of the aorta leading to blood entering and separating the layers of the wall. Acute aortic dissections are defined as those identified within the first 2 weeks after the initial tear, and chronic dissections are defined as those identified at times greater than 2 weeks. Aortic dissection is classified by its location and the extent of involvement of the thoracic aorta. Stanford Type A dissection affects the ascending aorta and may extend to the 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. Treatment of complex thoracic aortic disease typically requires long and complicated open surgery. During such surgery, the patient is typically placed on a cardiopulmonary bypass pump, and the heart is stopped to allow the aorta to be clamped and operated upon. While the patient is on cardiopulmonary bypass, the patient generally is also chilled to a condition of hypothermia. The risk that the patient will not be able to survive the surgery is directly related to the duration of time that the patient