Vascular and aortic grafts with telescoping sheath and deployment methods thereof
A vascular connector deployment tool may include a handle, an elongated mandrel extending distally from the handle, a vascular connector disposed coaxially about the mandrel, a retractable sheath assembly including an outer sheath telescopically deployed over an inner sheath and an actuator on the handle that is configured to selectively retract the outer sheath and the inner sheath relative to the mandrel. The sheath assembly is 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 indicates position of the vascular connector.
1. A vascular connector deployment tool, comprising:
a handle;
an elongated mandrel extending distally from the handle, the mandrel having a proximal end coupled to the handle, a distal end and an outer surface;
a vascular connector having a proximal circumferential portion and a distal circumferential portion disposed over a portion of the mandrel distal end, the vascular connector being expandable from a first insertion diameter to a second deployed diameter and has a structure that allows for expansion from the first insertion diameter to the second deployed diameter, the structure being configured to hold the vascular connector securely inside a blood vessel and a graft in the deployed state;
a retractable sheath assembly including a translucent retractable outer sheath telescopically deployed over a retractable inner sheath that is visible through the outer sheath, wherein the inner and outer sheaths of the retractable sheath assembly are configured to constrain the vascular connector against the outer surface of the mandrel in an insertion profile and wherein a distal transition between the outer sheath and the inner sheath visually indicates position of the vascular connector; and
a single actuator on the handle, the single actuator being configured as a slider having a longitudinal range of motion in a slot on the handle, the slider being mechanically coupled to both the outer sheath and the inner sheath to initially retract only the outer sheath relative to the mandrel to expose the distal circumferential portion of the vascular connector and cause the distal circumferential portion to expand from the first insertion diameter to the second deployed diameter, and to subsequently retract the outer sheath and the inner sheath relative to the mandrel to expose the proximal circumferential portion of the vascular connector and cause the proximal circumferential portion to expand from the first insertion diameter to the second deployed diameter.
2. The vascular connector deployment tool of claim 1 , wherein the outer sheath covers all of the vascular connector before retraction, and wherein the inner sheath covers a predetermined amount of the proximal circumferential 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 before retraction.
4. The vascular connector deployment tool of claim 3 , wherein a distal end of the vascular connector is visible through the outer sheath.
5. The vascular connector deployment tool of claim 1 , wherein, upon a first actuation of the slider, the slider is configured to initially engage only the outer sheath and when the slider is reset after the first actuation, the slider then engages the inner sheath such that subsequent actuation retracts both the outer sheath and inner sheath simultaneously.
6. The vascular connector deployment tool of claim 1 , wherein the slider has a range of motion and is configured to engage only the outer sheath over a first portion of the range of motion and to engage both the inner sheath and the outer sheath over a remaining portion of the range of motion.
7. The vascular connector deployment tool of claim 1 , wherein the inner sheath is transparent and a marker on a distal end of the inner sheath is visible through the outer sheath.
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 that abuts a proximal end of the vascular connector.
9. The vascular connector deployment tool of claim 8 , wherein the 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 self-expanding connector and is able to maintain radial force at the temperature in a range of 22° C. to 37° C.
11. A method for implanting a vascular connector in a patient, comprising:
providing a vascular connector deployment tool including a handle, an elongated mandrel extending distally from the handle, the mandrel having a proximal end coupled to the handle, a distal end and an outer surface having a circumference, a vascular connector having a proximal circumferential portion and a distal circumferential portion disposed coaxially around the circumference of the mandrel outer surface at the distal end, the vascular connector being expandable from a first insertion diameter to a second deployed diameter and has a structure that allows for expansion from the first insertion diameter to the second deployed diameter, the structure being configured to hold the vascular connector securely inside a first lumen and a second lumen in the deployed state, a retractable sheath assembly including a translucent retractable outer sheath telescopically deployed over a retractable inner sheath that is visible through the outer sheath, wherein the retractable sheath assembly constrains the vascular connector against the outer surface of the mandrel in an insertion profile, and a single actuator on the handle, the single actuator being configured as a slider having a longitudinal range of motion in a slot on the handle, the slider being mechanically coupled to both the outer sheath and the inner sheath to initially retract only the outer sheath relative to the mandrel to expose the distal circumferential portion of the vascular connector and cause the distal circumferential portion to expand from the first insertion diameter to the second deployed diameter, and to subsequently retract the outer sheath and the inner sheath relative to the mandrel to expose the proximal circumferential portion of the vascular connector and cause the proximal circumferential portion to expand from the first insertion diameter to the second deployed diameter;
positioning at least the distal circumferential portion of the vascular connector within the first lumen for conducting blood of the patient by visualizing a distal transition between the outer sheath and the inner sheath;
manipulating the actuator to cause the outer sheath to retract relative to the mandrel and expose the circumferential distal portion of the vascular connector; and
securing the distal portion of the vascular connector within the first lumen by expansion of the circumferential distal portion of the vascular connector from the insertion profile.
12. The method of claim 11 , wherein positioning at least the 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.
13. The method of claim 11 , wherein positioning at least the 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.
14. The method of claim 11 , further comprising confirming the deployment tool remains stationary during retraction of the outer sheath by visualizing the inner sheath through the outer sheath.
15. The method of claim 11 , further comprising:
advancing the 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;
manipulating the actuator to cause the outer sheath and the inner sheath to retract relative to the mandrel and expose the proximal circumferential portion of the vascular connector; and
securing the proximal circumferential portion of the vascular connector within the second lumen by expansion of the proximal circumferential portion of the vascular connector from the insertion profile.
16. The method of claim 15 , wherein the first lumen is a blood vessel and the second lumen is a graft.
17. The method of claim 15 , wherein the deployment tool has a shoulder tube that abuts the vascular connector and 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.
18. The method of claim 11 , wherein the vascular connector is self-expanding connector and is able to maintain radial force at the temperature in a range of 22° C. to 37° C.