Systems, devices and methods for delivery systems
Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.
1 . A system, comprising:
a delivery catheter comprising:
a proximal handle comprising a handle housing and an actuator;
a catheter body coupled to the proximal handle, the catheter body comprising a distal section, a proximal section and a middle section therebetween, wherein the proximal section of the catheter body is coupled to the proximal handle and wherein the middle section of the catheter body and distal section of the catheter body extend distally from the proximal handle;
a rotatable drive shaft coupled to the actuator and located in the catheter body; and
a rotor disc attached to the rotatable drive shaft at the distal section of the catheter body, the rotor disc comprising a tension member attachment site and a tensioning member fixedly coupled to the tension member attachment site; and
an expandable stent structure approximate the rotor disc,
wherein:
the tensioning member is releasably coupled to the expandable stent structure, and
the tensioning member is at least partially wound about the rotor disc such that actuation of the rotor disc unwinds and extends the tensioning member from the delivery catheter to permit expansion of the expandable stent structure.
2 . The system of claim 1 , wherein the expandable stent structure includes an attachment line located around a circumference of the expandable stent structure and the tensioning member is coupled to the attachment line.
3 . The system of claim 2 , wherein the tensioning member is looped around the attachment line to couple the tensioning member to the expandable stent structure.
4 . The system of claim 3 , wherein the attachment line is wrapped around the circumference of the expandable stent structure more than once.
5 . The system of claim 2 , wherein the attachment line is fixedly attached to the expandable stent structure such that, when the expandable stent structure and the delivery catheter are decoupled from each other, the attachment line remains coupled to the expandable stent structure.
6 . The system of claim 2 , wherein the attachment line is an attachment loop.
7 . The system of claim 2 , wherein:
the delivery catheter further comprises a stator housing attached to the distal section of the catheter body,
the rotor disc is located within the stator housing, and
at least a portion of the attachment line is disposed within the stator housing.
8 . The system of claim 2 , wherein the expandable stent structure is decouplable from the delivery catheter by decoupling the tensioning member from the attachment line and retracting the tensioning member.
9 . The system of claim 1 , wherein the catheter body includes a steerable section and the delivery catheter further comprises a steering assembly to actuate the steerable section.
10 . The system of claim 1 , wherein the distal section of the catheter body is extendible relative to the middle section of the catheter body and the delivery catheter includes a catheter extension assembly to extend the distal section of the catheter body relative to the middle section of the catheter body.
11 . The system of claim 1 , wherein the delivery catheter further comprises a movable sheath located over the catheter body, wherein the movable sheath is configured to retract and expose the distal section of the catheter body.
12 . The system of claim 11 , wherein the expandable stent structure is in a collapsed state and collapsed onto the delivery catheter between the catheter body and the movable sheath.
13 . The system of claim 1 , wherein the tensioning member is one of a plurality of tensioning members.
14 . The system of claim 13 , wherein the expandable stent structure includes an attachment line located around a circumference of the expandable stent structure and each of the plurality of tensioning members is coupled to the attachment line.
15 . The system of claim 14 , wherein actuation of the rotor disc unwinds and extends each of the plurality of tensioning members from the delivery catheter to permit expansion of the expandable stent structure.
16 . The system of claim 1 , wherein the expandable stent structure is a heart valve implant.
17 . The system of claim 1 , wherein the proximal handle further comprises an actuator lock, wherein the actuator lock comprises locked and unlocked configurations and is biased to the lock configuration.
18 . A delivery catheter comprising:
a proximal handle comprising a handle housing and an actuator;
a catheter body coupled to the proximal handle, the catheter body comprising a distal section, a proximal section and a middle section therebetween, wherein the proximal section of the catheter body is coupled to the proximal handle and wherein the middle section of the catheter body and distal section of the catheter body extend distally from the proximal handle;
a rotatable drive shaft coupled to the actuator and located in the catheter body; and
a rotor disc attached to the rotatable drive shaft at the distal section of the catheter body, the rotor disc comprising a tension member attachment site and a tensioning member fixedly coupled to the tension member attachment site,
wherein:
the tensioning member is releasably coupleable to an expandable stent structure, and
when releasably coupled to the expandable stent structure, the tensioning member is at least partially wound about the rotor disc such that actuation of the rotor disc unwinds and extends the tensioning member from the delivery catheter to permit expansion of the expandable stent structure.
19 . The delivery catheter of claim 18 , further comprising a stator housing attached to the distal section of the catheter body, wherein the rotor disc is located within the stator housing.
20 . The delivery catheter of claim 18 , wherein the tensioning member is retractable relative to the distal section of the catheter body.
21 . The delivery catheter of claim 18 , wherein the catheter body includes a steerable section and the delivery catheter further comprises a steering assembly to actuate the steerable section.
22 . The delivery catheter of claim 21 , wherein the steering assembly is one of a two-way steering assembly and a four-way steering assembly.
23 . The delivery catheter of claim 21 , wherein the steering assembly is a two-way steering assembly and the delivery catheter further comprises a four-way steering assembly.
24 . The delivery catheter of claim 18 , wherein the distal section of the catheter body is extendible relative to the middle section of the catheter body and the delivery catheter includes a catheter extension assembly to extend the distal section of the catheter body relative to the middle section of the catheter body.
25 . The delivery catheter of claim 18 , wherein the delivery catheter further comprises a movable sheath located over the catheter body, wherein the sheath is configured to retract and expose the distal section of the catheter body.
26 . The delivery catheter of claim 18 , wherein the tensioning member is one of a plurality of tensioning members.
27 . The delivery catheter of claim 26 , wherein, when releasably coupled to the expandable stent structure, each of the plurality of tensioning members is at least partially wound about the rotor disc such that actuation of the rotor disc unwinds and extends each of the plurality of tensioning members from the delivery catheter to permit expansion of the expandable stent structure.
28 . The delivery catheter of claim 18 , wherein the proximal handle further comprises an actuator lock, wherein the actuator lock comprises locked and unlocked configurations and is biased to the lock configuration.
29 . The delivery catheter of claim 18 , further comprising a movable sheath located over the catheter body, wherein the movable sheath is configured to retract and expose the distal section of the catheter body.
30 . The delivery catheter of claim 29 , wherein:
the actuator is a first actuator,
the proximal handle further comprises a second actuator,
the first actuator is configured to rotate the rotatable drive shaft, and
the second actuator is configured to retract the movable sheath.