Vascular prosthetic delivery device and method of use
Methods for delivering a vascular prosthesis to a treatment site of a subject include advancing the vascular prosthesis, rotating a proximal handle in a first direction about a handle body, shifting the position of a first locking component securing the proximal handle to the push rod from a first position to a second position, rotating the proximal handle in a second direction, releasing the proximal end of the prosthesis from the apex delivery device, shifting the second locking component to disengage the push rod from the handle body; and withdrawing the push rod and the guidewire catheter from within the prosthesis, thereby delivering the vascular prosthesis to the treatment site.
1. A delivery device, comprising,
a) a gear rack ( 106 );
b) a proximal handle ( 36 ) extending about the gear rack ( 106 ) and defining teeth ( 156 ) at an end of the proximal handle ( 36 ), the proximal handle ( 36 ) being rotatable about the gear rack ( 106 );
c) a pinion gear assembly ( 164 ) rotatable about an axis that intersects with the axis of rotation of the proximal handle ( 36 ) and engages the gear rack ( 106 );
d) a linking gear assembly ( 158 ) that is engaged with the teeth ( 156 ) of the proximal handle ( 36 ) and selectively rotates with rotation of the pinion gear assembly ( 164 );
e) an actuator ( 80 ) that selectively engages the pinion gear assembly ( 164 ) with the linking gear assembly ( 158 );
f) a delivery catheter ( 28 ) fixed to the proximal handle ( 36 ), whereby rotation of the proximal handle ( 36 ) selectively moves the delivery catheter ( 28 ) relative to the gear rack ( 106 ) upon engagement of the pinion gear assembly ( 164 ) with the linking gear assembly ( 158 ) by the actuator ( 80 );
g) a handle body ( 20 ) having a major longitudinal axis ( 22 ), a proximal end ( 24 ) and a distal end ( 26 ), wherein the gear rack ( 106 ) extends longitudinally within the handle body ( 20 ) and wherein the proximal handle ( 36 ) extends about the handle body ( 20 ); and
h) a distal handle ( 40 ) that extends around the handle body ( 20 ) at the distal end ( 26 ) of the handle body ( 20 ).
2. The delivery device of claim 1 , further including an outer catheter ( 48 ) extending distally from the distal handle ( 40 ), and about the delivery catheter ( 28 ) in a first, retracted position.
3. The delivery device of claim 2 , further including a push rod ( 32 ) having a proximal end ( 34 ), the push rod ( 32 ) being selectively fixed to the proximal handle ( 36 ) and extending within the delivery catheter ( 28 ).
4. The delivery device of claim 3 , wherein the actuator ( 80 ) disengages the proximal handle ( 36 ) of the handle body ( 20 ), whereby rotation of the proximal handle ( 36 ) is independent of longitudinal movement of the delivery catheter ( 28 ) relative to the handle body ( 20 ) along the major longitudinal axis ( 22 ).
5. The delivery device of claim 4 , further including a first locking mechanism ( 38 ) that selectively engages the push rod ( 32 ).
6. The delivery device of claim 5 , wherein the first locking mechanism ( 38 ) is fixed relative to the proximal handle ( 36 ).
7. The delivery device of claim 6 , further including
a) a shifting knob ( 42 ) at the distal handle ( 40 ) that is rotatable about the handle body ( 20 ); and
b) a drive shaft ( 88 ) that links the shifting knob ( 42 ) with the first locking mechanism ( 38 ), whereby rotation of the shifting knob ( 42 ) actuates the first locking mechanism ( 38 ) to thereby engage or disengage the proximal handle ( 36 ) with the push rod ( 32 ), and wherein engagement of the proximal handle ( 36 ) with the push rod ( 32 ) causes distal advancement of the proximal handle ( 36 ) to move the push rod ( 32 ) and the delivery catheter ( 28 ) from the first, retracted position to a second, extended position distal to the outer catheter ( 48 ).
8. The delivery device of claim 7 , further including a second locking mechanism ( 132 ) proximal to the first locking mechanism ( 38 ), whereby rotation of the shifting knob ( 42 ) in a direction that disengages the proximal handle ( 36 ) from the push rod ( 32 ) will cause engagement of the second locking mechanism ( 132 ) with the push rod ( 32 ).
9. The delivery device of claim 8 , wherein the second locking mechanism ( 132 ) is fixed to the handle body ( 20 ), whereby locking the second locking mechanism ( 132 ) with the push rod ( 32 ) also locks the push rod ( 32 ) to the handle body ( 20 ), and whereby subsequent proximal movement of the proximal handle ( 36 ) will cause retraction of the delivery catheter ( 28 ) from the push rod ( 32 ) to a third position.
10. The delivery device of claim 9 , wherein rotation of the shifting knob ( 42 ) to a position intermediate to locking the first locking mechanism ( 38 ) to the push rod ( 32 ) and locking the second locking mechanism ( 132 ) to the push rod ( 32 ) causes the push rod ( 32 ) to be locked to neither the first locking mechanism ( 38 ) nor the second locking mechanism ( 132 ), whereby the push rod ( 32 ) can be retracted independently of movement of the proximal handle ( 36 ).
11. The device of claim 10 , further including,
a) a guidewire catheter ( 12 ) having a distal end ( 16 ), the guidewire catheter ( 12 ) extending within the push rod ( 32 );
b) an apex release catheter ( 154 ) having a distal end ( 210 , the apex release catheter extending about the guidewire catheter ( 12 ) and within the push rod ( 32 ); and
c) an apex clasp assembly ( 52 ) that includes,
i) a distal capture component ( 56 ) proximal to the distal end ( 16 ) of the guidewire catheter ( 12 ); and
ii) a proximal capture component ( 54 ) that is fixed to the distal end ( 210 ) of the apex release catheter ( 154 ) and is mateable to the distal capture component ( 56 ).
12. The device of claim 11 , further including a proximal clasp assembly ( 184 ) at the proximal end ( 34 ) of the push rod ( 32 ), proximal to the handle body ( 20 ), wherein the proximal clasp assembly ( 184 ) includes
a) a fixed component ( 188 ) that is fixed to the distal end ( 16 ) of the guidewire catheter ( 12 ), and
b) an outer coupling ( 186 ) distal to the fixed component ( 188 ), the outer coupling ( 186 ) being fixed to the apex release catheter ( 154 ) and in interfering relation with the fixed component ( 188 ) in a first position that locks the proximal capture component ( 54 ) in mated relation with the distal capture component ( 56 ) in a first position, and is moveable from the first position to a second position relative to the fixed component ( 188 ) that moves the proximal capture component ( 54 ) away from distal capture component ( 56 ) and out of mated relation with the distal capture component ( 56 ).
13. The delivery device of claim 12 , wherein the proximal capture component ( 54 ) includes distally-extending tines and the distal capture component ( 56 ) defines recesses that receive the tines in mating relation, whereby apices ( 68 ) of an exposed stent ( 66 ) of a vascular prosthetic component ( 58 ) loaded within the delivery device are captured by the apex clasp assembly ( 52 ) prior to implantation, and whereby the movement of the outer coupling ( 186 ) of the proximal clasp assembly ( 184 ) from the first position to the second position releases the exposed stent ( 66 ) during implantation of the vascular prosthetic component ( 58 ) at a surgical site.
14. The delivery device of claim 13 , further including a nose cone ( 50 ) at the distal end ( 16 ) of the guidewire catheter ( 12 ) and distal to the distal capture component ( 56 ).