Granted Patent B2

US 12,409,055 · App. 17/200,213 · Granted Sep 9, 2025

Inventor: Bryan Vancheri (Sunrise, FL)

Assignee: Bolton Medical, Inc.

A61F2/966A61F2/9517A61F2002/9505

Abstract

Claims (62)

1. A delivery device ( 10 ), comprising:

a) a handle body ( 20 ), having a longitudinal axis ( 22 ), a proximal end ( 24 ), and a distal end ( 26 );

b) a gear rack ( 106 ) extending within the handle body ( 20 );

c) a proximal handle ( 36 ) extending about the gear rack ( 106 ) and defining teeth ( 156 ), the proximal handle ( 36 ) being rotatable about the handle body ( 20 ) and the gear rack ( 106 );

d) a distal handle ( 40 ) that extends around the handle body ( 20 ) at the distal end ( 26 ) of the handle body ( 20 );

e) a guidewire catheter ( 12 ) having a proximal end ( 14 ) and a distal end ( 16 ), the guidewire catheter ( 12 ) extending through the handle body ( 20 ), the proximal handle ( 36 ), and the distal handle ( 40 ), and along the longitudinal axis ( 22 );

f) a delivery catheter ( 28 ) axially fixed to the proximal handle ( 36 ), and having a distal end ( 30 ) extending from within the distal end ( 26 ) of the handle body ( 20 ) and about the guidewire catheter ( 12 );

g) an outer catheter ( 48 ) extending distally from the distal handle ( 40 ), and about the delivery catheter ( 28 ) when the delivery catheter ( 28 ) is in a first, retracted position;

h) a gear assembly linking the teeth ( 156 ) of the proximal handle ( 36 ) to the gear rack ( 106 ), whereby rotation of the proximal handle ( 36 ) about the longitudinal axis ( 22 ) moves the proximal handle ( 36 ) and the delivery catheter ( 28 ) along the longitudinal axis ( 22 ) relative to the gear rack ( 106 );

i.) the gear assembly further including:

1) A pinion gear assembly ( 164 ) engaging the gear rack ( 106 ); and

2) a linking gear assembly ( 158 ) including an upper linking gear ( 160 ) engaging the teeth ( 156 ) of the proximal handle ( 36 ) and a lower linking gear ( 162 ) fixed to the upper linking gear ( 160 ) and between the upper linking gear ( 160 ) and the longitudinal axis ( 22 ) of the handle body ( 20 ), and having teeth engaging the pinion gear assembly ( 164 ), the upper linking gear ( 166 ) and the lower linking gear ( 162 ) having a common axis of rotation that is normal to the longitudinal axis ( 22 ) of the handle body ( 20 ), wherein the upper linking gear ( 160 ) and the lower linking gear ( 162 ) each define a central opening along the common axis of rotation;

i) a clutch at the gear assembly, whereby the clutch engages the gear assembly with the proximal handle and thereby biases longitudinal movement of the gear assembly and associated rotation of the proximal handle ( 36 ) about the longitudinal axis;

wherein rotation of the proximal handle ( 36 ) about the longitudinal axis ( 22 ) when the clutch is engaged is resisted by friction between the clutch and at least one of the gear assembly and a portion of the remainder of the delivery device ( 10 ), and

wherein the clutch engages when the gear assembly is directed in a proximal direction along the longitudinal axis;

j) a push rod ( 32 ) extending about the guidewire catheter ( 12 ) and within the delivery catheter ( 28 ), the push rod ( 32 ) being fixed to the guidewire catheter ( 12 ) at the proximal end of the guidewire catheter ( 12 ) proximal to the handle body ( 20 ), and selectively fixed to the proximal handle ( 36 ); and

k) a locking mechanism assembly extending about the push rod, the locking mechanism including

i.) a first locking mechanism ( 38 ) that locks the delivery catheter to the push rod when the locking mechanism is in a first locking position, and

ii.) a second locking mechanism ( 132 ) fixed to the distal end ( 26 ) of the handle body ( 20 ) that locks the push rod ( 32 ) to the handle body ( 20 ) when the locking mechanism assembly is in a second locking position, wherein the first locking position and the second locking position are mutually exclusive

l.) An actuator ( 80 ) that includes the gear assembly and which further includes

i.) a housing ( 81 ) extending about the handle body ( 20 ) and having a proximal end defining a proximal opening and a distal end defining a distal opening, the housing ( 81 ) further defining an aperture between the proximal opening and the distal opening; and

ii.) a center pin extending through the central openings of the upper linking gear ( 160 ) and the lower linking gear ( 162 ), the pin including the center pin including opposite ends that are at the locking mechanism assembly and the housing ( 81 ), wherein the clutch selectively engages the pin with the linking gear assembly whereby engagement depends upon the direction of rotation of the proximal handle ( 36 ) about the handle body ( 20 );

m) wherein the linking gear assembly ( 158 ) further includes a second clutch that engages the linking gear assembly ( 158 ) with the pin when the pinion gear assembly 164 ) is directed distally along the gear rack ( 106 ) during the engagement of the linking gear assembly ( 158 ) with the pinion gear assembly ( 164 );

n) wherein the second clutch is a second one-way needle roller clutch bearing that is press-fit into a first socket or a second socket into which the pin extends, whereby the second one-way needle roller clutch bearing engages the linking gear assembly ( 158 ) with the pin when the pinion gear assembly ( 163 ) is directed proximally along the gear rack ( 106 ) during engagement of the linking gear assembly ( 158 ) with the pinion gear assembly ( 164 ), and wherein resistance to proximal movement of the pinion gear assembly while the second one-way needle roller clutch is engaged is caused by at least one of resistance to rotation of the second roller needle clutch bearing within the socket within which the one-way needle roller bearing is press-fit or the interface between the pin and the second one-way needle roller clutch, and wherein the resistance is less than that between the first roller needle clutch and the pin.

2. The delivery device of claim 1 , wherein the gear assembly includes a pinion gear assembly ( 164 ) that includes

a) an upper pinion gear ( 166 ) engaged with the proximal handle ( 36 ), the upper pinion gear ( 166 ) defining a non-circular pinion gear orifice ( 182 ) and rotatable about a pinion gear axis ( 269 ); and

b) a lower pinion gear ( 168 ) axially aligned with the upper pinion gear ( 166 ) and defining a lower pinion gear orifice ( 263 ), the lower pinion gear ( 168 ) engaged with the gear rack ( 106 ) and selectively engaged with the upper pinion gear ( 166 ), wherein the clutch ( 260 ) engages the lower pinion gear ( 168 ) when the gear assembly is directed in a proximal direction.

3. The delivery device of claim 2 , wherein the lower pinion gear ( 168 ) includes

a. a lower portion extending toward the longitudinal axis ( 22 ) of the handle body ( 20 );

b. a gear portion engaged with the gear rack ( 106 );

c. a pinion gear extension ( 265 ) that extends within the upper pinion gear orifice ( 182 ), wherein the pinion gear extension ( 265 ) defines a side opening ( 180 ), the side opening ( 180 ) and the upper pinion gear orifice ( 182 ) of the upper pinion gear ( 166 ) together defining an interference opening ( 183 ) that, when occupied, prevents rotation of the upper pinion gear ( 166 ) and the lower pinion gear ( 168 ) relative to each other;

d. a ball bearing ( 178 ) in at least one of each side opening ( 180 ), the ball bearing ( 178 ) having a diameter greater than a thickness of a wall defining the side opening ( 180 );

e. a center pin ( 170 ) moveable along the pinion gear axis and within the upper pinion gear orifice, the lower pinion gear orifice, and the pinion gear extension orifice, the center pin ( 170 ) including a frustoconical portion ( 176 ) between a base portion having a first diameter within the lower pinion gear orifice and a second diameter that is less than the first diameter, and located in the upper pinion gear orifice, whereby movement of the frustoconical portion ( 176 ) of the center pin ( 170 ) causes radially outward displacement of the ball bearing ( 178 ) into the interference opening ( 183 ), thereby causing an interfering relation between rotation of the upper pinion gear ( 166 ) and the lower pinion gear ( 168 ); and

f. a spring ( 184 ) at the lower pinion gear ( 168 ) that provides bias to the center pin ( 170 ) radially outward from the longitudinal axis ( 22 ) of the handle body ( 20 ), whereby the ball bearing ( 178 ) is directed radially outward through the side opening ( 180 ), thereby causing the interfering relation between the upper pinion gear ( 166 ) and the lower pinion gear ( 168 ), whereby depressing the center pin ( 170 ) removes outward displacement of the ball bearing ( 178 ) and eliminates the interfering relation between rotation of the upper pinion gear ( 166 ) and the lower pinion gear ( 168 ) to cause rotation of the proximal handle ( 36 ) to be independent of longitudinal movement of the delivery catheter ( 28 ) relative to the handle body ( 20 ) along the longitudinal axis ( 22 ).

4. The delivery devise of claim 1 , wherein the pin is integral to or fused with at least one of the locking mechanism assembly and the housing ( 81 ).

5. The delivery device of claim 1 , wherein the first locking mechanism ( 38 ) defines a first socket ( 174 ) and the housing ( 81 ) defines a second socket, and wherein the opposite ends of the pin are seated in the first socket ( 174 ) and the second socket.

6. The delivery device of claim 5 , wherein the clutch engages the pin when the gear assembly is directed in a proximal direction.

7. The delivery device of claim 6 , wherein rotation of the proximal handle ( 20 ) that directs the gear assembly in a proximal direction is resisted by an interfering relationship between the pin and at least one of the first and the second sockets.

8. The delivery device of claim 6 , wherein rotation of the proximal handle ( 20 ) that directs the gear assembly in a proximal direction is resisted by an interfering relationship between the clutch and at least one of the first and the second sockets.

9. The delivery device of claim 6 , wherein rotation of the proximal handle ( 20 ) that directs the gear assembly in a proximal direction is resisted by an interfering relationship between the clutch and the pin.

10. The delivery device of claim 1 , wherein the second clutch is a coil spring that is fixed at one end to the first locking mechanism ( 38 ) and the pin extends through the coil spring, whereby the coil spring is engaged with the pin when the pinion gear assembly ( 164 ) is directed distally along the gear rack ( 106 ) during engagement of the linking gear assembly ( 158 ) with the pinion gear assembly ( 164 ).

11. The delivery device of claim 1 , wherein the second clutch is a coil spring that is fixed at one end to the housing ( 81 ) and the pin extends through the coil spring, whereby the coil spring is engaged with the pin when the pinion gear assembly ( 164 ) is directed distally along the gear rack ( 106 ) during engagement of the linking gear assembly ( 158 ) with the pinion gear assembly ( 164 ).

12. A delivery device ( 10 ), comprising:

a. a handle body ( 20 ), having a longitudinal axis ( 22 ), a proximal end ( 24 ), and a distal end ( 26 );

b. a gear rack ( 106 ) extending within the handle body ( 20 );

c. a proximal handle ( 36 ) extending about the gear rack ( 106 ) and defining teeth ( 156 ), the proximal handle ( 36 ) being rotatable about the handle body ( 20 ) and the gear rack ( 106 );

d. a distal handle ( 40 ) that extends around the handle body ( 20 ) at the distal end ( 26 ) of the handle body ( 20 );

e. a guidewire catheter ( 12 ) having a proximal end ( 14 ) and a distal end ( 16 ), the guidewire catheter ( 12 ) extending through the handle body ( 20 ), the proximal handle ( 36 ), the distal handle ( 40 ), and along the longitudinal axis ( 22 );

f. a delivery catheter ( 28 ) axially fixed to the proximal handle ( 36 ), and having a distal end ( 30 ) extending from within the distal end ( 26 ) of the handle body ( 20 ) and about the guidewire catheter ( 12 );

g. an outer catheter ( 48 ) extending distally from the distal handle ( 40 ), and about the delivery catheter ( 28 ) in a first, retracted position;

h. a gear assembly linking the teeth ( 156 ) of the proximal handle ( 36 ) to the gear rack ( 106 ), whereby rotation of the proximal handle ( 36 ) about the longitudinal axis ( 22 ) moves the proximal handle ( 36 ) and the delivery catheter ( 28 ) along the longitudinal axis ( 22 ) relative to the gear rack ( 106 ), wherein the gear assembly includes

i. A pinion gear assembly ( 164 ) engaging the gear rack ( 106 ), and

ii. a linking gear assembly ( 158 ) including an upper linking gear ( 160 ) engaging the teeth ( 156 ) of the proximal handle ( 36 ) and a lower linking gear ( 162 ) fixed to the upper linking gear ( 160 ) and between the upper linking gear ( 160 ) and the longitudinal axis ( 22 ) of the handle body ( 20 ), and having teeth engaging the pinion gear assembly ( 164 ), the upper linking gear ( 166 ) and the lower linking gear ( 162 ) having a common axis of rotation that is normal to the longitudinal axis ( 22 ) of the handle body ( 20 ), wherein the upper linking gear ( 160 ) and the lower linking gear ( 162 ) each define a central opening along the common axis of rotation;

i. a push rod ( 32 ) extending about the guidewire catheter ( 12 ) and within the delivery catheter ( 28 ), the push rod ( 32 ) being fixed to the guidewire catheter ( 12 ) at the proximal end of the guidewire catheter ( 12 ) proximal to the handle body ( 20 ), and selectively fixed to the proximal handle ( 36 );

j. a locking mechanism assembly extending about the push rod, the locking mechanism including

i. a first locking mechanism ( 38 ) that locks the delivery catheter to the push rod when the locking mechanism is in a first locking position, wherein the first locking mechanism ( 38 ) defines a first socket ( 174 ) and the housing ( 81 ) defines a second socket, and wherein the opposite ends of the pin are seated in the first socket ( 174 ) and the second socket, and

ii. a second locking mechanism ( 132 ) fixed to the distal end ( 26 ) of the handle body ( 20 ) that locks the push rod ( 32 ) to the handle body ( 20 ) when the locking mechanism assembly is in a second locking position, wherein the first locking position and the second locking position are mutually exclusive;

k. an actuator ( 80 ) that includes the gear assembly and which further includes

i. a housing ( 81 ) extending about the handle body ( 20 ) and having a proximal end defining a proximal opening and a distal end defining a distal opening, the housing ( 81 ) further defining an aperture between the proximal opening and the distal opening, and

ii. a center pin extending through the central openings of the upper linking gear ( 160 ) and the lower linking gear ( 162 ), the pin including opposite ends that are at the locking mechanism assembly and the housing ( 81 ); and

l. A clutch at the gear assembly, whereby the clutch engages the gear assembly with the proximal handle and thereby biases longitudinal movement of the gear assembly and associated rotation of the proximal handle ( 36 ) about the longitudinal axis, wherein rotation of the proximal handle ( 36 ) about the longitudinal axis ( 22 ) when the clutch is engaged is resisted by friction between the clutch and at least one of the gear assembly and a portion of the remainder of the delivery device ( 10 ), wherein the clutch engages the pin with the linking gear assembly when the gear assembly is directed in a proximal direction, and wherein rotation of the proximal handle ( 20 ) that directs the gear assembly in a proximal direction is resisted by an interfering relationship between the pin and at least one of the first and the second sockets;

m. wherein the linking gear assembly ( 158 ) further includes a second clutch that engages the linking gear assembly ( 158 ) with the pin when the pinion gear assembly ( 164 ) is directed distally along the gear rack ( 106 ) during the engagement of the linking gear assembly ( 158 ) with the pinion gear assembly ( 164 ), wherein the second clutch is a second one-way needle roller clutch bearing that is press-fit into the first socket or the second socket into which the pin extends, whereby the second one-way needle roller clutch bearing engages the linking gear assembly ( 158 ) with the pin when the pinion gear assembly ( 163 ) is directed proximally along the gear rack ( 106 ) during engagement of the linking gear assembly ( 158 ) with the pinion gear assembly ( 164 ), and wherein resistance to proximal movement of the pinion gear assembly while the second one-way needle roller clutch is engaged is caused by at least one of resistance to rotation of the second roller needle clutch bearing within the socket within which the one-way needle roller bearing is press-fit or the interface between the pin and the second one-way needle roller clutch, and wherein the resistance is less than that between the first roller needle clutch and the pin.

Assignments (1)

Continuity (2)

References Cited (400)