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 delivery system, comprising:
a proximal handle comprising a handle housing and a first actuator;
a catheter body coupled to the handle, the catheter body comprising a distal section, a proximal section and a middle section therebetween;
a rotatable drive shaft coupled to the first actuator and located in the catheter body;
a first stator housing attached to the catheter body, the first stator housing comprising an internal opening and an external opening;
a first rotor attached to the rotatable drive shaft and located in the first stator housing, the first rotor comprising at least one tension line attachment site; a self-expanding implant, the implant comprising a contracted configuration and an expanded configuration; and a first tensioning member releasably coupled to the self-expanding implant and fixedly coupled to the attachment site of the first rotor and
a movable sheath located over the catheter body.
2 . The delivery system of claim 1 , wherein the first tensioning member is further wound around the first rotor.
3 . The delivery system of claim 2 , wherein the first tensioning member is wound around the first rotor at least three times.
4 . The delivery system of claim 1 , wherein the self-expanding implant further comprises:
a stent frame, the stent frame comprising:
a non-foreshortening tubular valve support;
a fixation support comprising a fixation ring and a fixation brim.
5 . The delivery system of claim 1 , wherein the self-expanding implant comprises a first opening, and a first attachment ring located in the first opening, and wherein the first tensioning member is looped through the first attachment ring.
6 . The delivery system of claim 5 , wherein the first attachment ring is movable in the first opening.
7 . The delivery system of claim 5 , wherein the first attachment ring is a metal ring.
8 . The delivery system of claim 5 , wherein the first opening is aligned with a first longitudinal strut of the self-expanding implant.
9 . The delivery system of claim 1 , further comprising:
a second stator housing attached to the catheter body and spaced apart from the first stator housing, the second stator housing comprising an internal opening and an external opening;
a second rotor attached to the rotatable drive shaft and located in the second stator housing, the second rotor comprising at least one tension line attachment site.
10 . The delivery system of claim 9 , further comprising:
a third stator housing attached to the catheter body and spaced apart from the first and second stator housings, the third stator housing comprising an internal opening and an external opening;
a third rotor attached to the rotatable drive shaft and located in the third stator housing, the third rotor comprising at least one tension line attachment site.
11 . The delivery system of claim 10 , wherein the first stator housing is larger than the second stator housing and the first rotor is larger than the second rotor.
12 . The delivery system of claim 10 , wherein the first stator housing is larger than both the second and third stator housings and the first rotor is larger than the second and third rotors.
13 . The delivery system of claim 1 , wherein the proximal handle further comprise a first actuator lock, wherein the first actuator lock comprises locked and unlocked configurations and is biased to the lock configuration.
14 . The delivery system of claim 1 , further comprising a catheter extension assembly configured to reversibly adjust a longitudinal spacing between the distal section and the middle section of the catheter body.
15 . The delivery system of claim 14 , wherein the catheter extension assembly comprises a proximal housing with a proximal threaded lumen, a distal housing and a threaded extension shaft located in the proximal threaded lumen and coupled to the distal housing.
16 . The delivery system of claim 15 , wherein the proximal housing and distal housing comprise a slotted interface therebetween to resist rotational displacement therebetween.
17 . The delivery system of claim 15 , wherein the proximal handle further comprises a second actuator coupled to the threaded extension shaft.
18 . The delivery system of claim 14 , further comprising a first steering assembly comprising a first segmented tubular body and a first plurality of elongate steering wires.
19 . The delivery system of claim 18 , wherein the first steering assembly is located proximal to the catheter extension assembly.
20 . The delivery system of claim 18 , wherein the first segmented tubular body comprises a laser-cut tubular body.
21 . The delivery system of claim 18 , further comprising a second steering assembly comprising a second segmented tubular body and a second plurality of steering wires.
22 . The delivery system of claim 21 , wherein the first steering assembly and second steering assembly comprise different bending configurations.
23 . The delivery system of claim 21 , wherein the first steering assembly comprises a two-way steering assembly and the second steering assembly comprises a four-way steering assembly.
24 . The delivery system of claim 21 , wherein the first segmented tubular body comprises segments attached by living hinges.
25 . The delivery system of claim 24 , wherein the second segmented tubular body comprises a plurality of discrete segments.
26 . The delivery system of claim 25 , wherein each of the plurality of discrete segments comprises one or two non-planar end openings.
27 . The delivery system of claim 26 , wherein the non-planar end openings comprise a hyperbolic paraboloid shape.
28 . The delivery system of claim 27 , wherein the each of the plurality of discrete segments comprises a perimeter bumper.
29 . The delivery system of claim 18 , wherein the second steering assembly is located distal to the catheter extension assembly.
30 . The delivery system of claim 1 , wherein the first stator housing comprises at least one routing ring attached to an outer surface of the first stator housing.
31 . The delivery system of claim 30 , wherein the at least one routing ring is attached along a perimeter of the first stator housing.
32 . The delivery system of claim 30 , wherein the at least one routing ring comprises at least three routing rings attached to an end wall of the first a stator housing.
33 . The delivery system of claim 1 , further comprising a first guide structure located on the first stator housing.
34 . The delivery system of claim 33 , wherein the first guide structure is a first guide ring.
35 . The delivery system of claim 1 , further comprising a second guide structure located on the catheter body.
36 . The delivery system of claim 35 , wherein the second guide structure comprises a second guide ring and a ring support.
37 . The delivery system of claim 36 , wherein the first guide ring and the second guide ring have the same inner diameter.
38 . A delivery system, comprising:
a proximal handle comprising a handle housing and a first actuator;
a catheter body coupled to the handle, comprising;
a first rotatable drive shaft coupled to the first actuator and located in the catheter body, the first rotatable drive shaft comprising a first mechanical interfit interface at a distal end of the first rotatable drive shaft; and
a first locking structure coupled to the catheter body;
an implant delivery body, comprising:
a first stator housing attached to the implant delivery body, the first stator housing comprising an internal opening and an external opening; and
a second rotatable drive shaft located in the implant delivery body, the second rotatable drive shaft comprising a second mechanical interfit interface at a proximal end of the second rotatable drive shaft and configured to form a mechanical interfit with the first mechanical interfit interface of the first rotatable drive shaft;
a first rotor attached to the second rotatable drive shaft and located in the first stator housing, the first rotor comprising at least one tension line attachment site; and
a second locking structure coupled to the implant delivery body, the second locking structure configured to attach to the first locking structure; and
a movable sheath located over the catheter body.
39 . The delivery system of claim 38 , wherein the first and second locking structures are configured to attach via a threaded interface.
40 . The delivery system of claim 39 , wherein the first locking structure comprises a threaded lumen, and the second locking structure comprises a complementary threaded tubular body.
41 . The delivery system of claim 38 , wherein the first and second locking structure configured to attach via a bayonet mount interface.
42 . The delivery system of claim 41 , wherein the first locking structure comprises an L-shape slot, and the second locking structure comprises a radial pin configured to movably reside in the L-shape slot.
43 . The delivery system of claim 38 , wherein the first rotor is a rotor plate.
44 . The delivery system of claim 43 , wherein the rotor plate comprises at least one elongate projection.
45 . The delivery system of claim 43 , wherein the rotor plate comprises a plurality of identical groups of attachment structures comprising at least one projection and at least one aperture.