# US 12,108,967 B2 · Operating handle for selective deflection or rotation of a catheter

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- Number: US 12,108,967 B2
- Document ID: US12108967B2
- Status: Granted
- Kind: B2
- Application number: 17/813,689
- Filed: 2022-07-20
- Published: 2022-11-10
- Granted: 2024-10-08
- Earliest claimed: 2018-12-28
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Jeremiah Blue
- Web page: https://patentgrep.com/patent/US12108967B2

## CPC

- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61N 1/37205: {Microstimulators, e.g. implantable through a cannula}
- A61B 2017/00323: {Cables or rods}
- A61M 25/0136: {Handles therefor}
- A61M 2025/015: {Details of the distal fixation of the movable mechanical means}
- A61N 1/362: Heart stimulators (heart defibrillators A61N1/39)
- A61N 1/39: Heart defibrillators
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A delivery device 100 includes a catheter assembly 120 and an operating handle 130. The operating handle 130 may include a nose 131 affixed to the catheter assembly 120, an axial shaft 180, a base 132 translationally fixed to a proximal end of the axial shaft, a screw 160 having external threads and a non-circular lumen 161, the axial shaft extending through the non-circular lumen, a proximal end 171 of a pull wire 170 being affixed to the screw, a knob 150 having internal threads engaged with the external threads of the screw, and a collar 140 extending at least partially around the axial shaft. When the collar 140 is in a proximal position, rotation of the knob 150 may deflect the distal end 121 of the catheter assembly 120. When the collar is in a distal position, rotation of the knob 150 may rotate the catheter assembly 120.

## Claims

### Claim 1

A delivery device for an implantable medical device, the delivery device comprising:
a catheter assembly having a proximal end, a distal end, and a compartment at the distal end for retaining the implantable medical device, the catheter assembly extending along a first longitudinal axis, the catheter assembly having a pull wire extending therethrough, a distal end of the pull wire being affixed to the distal end of the catheter assembly; and
an operating handle extending along a second longitudinal axis, the operating handle including:
a nose affixed to a proximal end of the catheter assembly;
an axial shaft having a distal end affixed to the nose and a proximal end, the axial shaft extending along the second longitudinal axis;
a base translationally fixed to the axial shaft;
a screw having external threads and a non-circular lumen, the axial shaft extending through the non-circular lumen so that the screw is translatable along the axial shaft and nonrotatable relative to the axial shaft, a proximal end of the pull wire being operably connected to the screw;
a knob having internal threads engaged with the external threads of the screw, the knob being translationally fixed to the nose; and
a collar extending at least partially around the axial shaft in a circumferential direction, the collar being rotationally fixed to the nose, the axial shaft, and the screw, the collar being translatable between a proximal position and a distal position;
with the collar in the proximal position, the knob being rotatable relative to the collar and the collar being nonrotatable relative to the base, so that rotation of the knob about the second longitudinal axis results in deflection of the distal end of the catheter assembly away from the first longitudinal axis; and
with the collar in the distal position, the base being rotatable relative to the collar and the collar being nonrotatable relative to the knob, so that rotation of the knob about the second longitudinal axis results in rotation of the catheter assembly about the second longitudinal axis.

### Claim 2 (depends on 1)

The delivery device of claim 1, wherein the second longitudinal axis is laterally offset from the first longitudinal axis in a direction transverse to the first longitudinal axis.

### Claim 3 (depends on 1)

The delivery device of claim 1, wherein the collar and the knob each have complementary serrations therein, and when the collar is in the distal position, the serrations of the collar are engaged with the serrations of the knob.

### Claim 4 (depends on 1)

The delivery device of claim 1, wherein the collar and the base each have complementary serrations therein, and when the collar is in the proximal position, the serrations of the collar are engaged with the serrations of the base.

### Claim 5 (depends on 1)

The delivery device of claim 1, wherein the collar and the axial shaft each have complementary serrations therein, and the serrations of the collar are engaged with the serrations of the axial shaft when the collar is in the proximal position and when the collar is in the distal position.

### Claim 6 (depends on 1)

The delivery device of claim 1, wherein a range of motion of the collar along the second longitudinal axis is distally limited by interference between the collar and the knob, and is proximally limited by interference between the collar and the base.

### Claim 7 (depends on 1)

The delivery device of claim 1, wherein the nose, the screw, the knob, the collar, and the base each extend completely circumferentially around a respective longitudinal portion of the axial shaft.

### Claim 8 (depends on 1)

The delivery device of claim 1, wherein a lumen extends at least partially through the axial shaft along the second longitudinal axis, the catheter assembly and the lumen of the axial shaft together being configured to receive a mapping wire therethrough.

### Claim 9 (depends on 1)

The delivery device of claim 1, wherein the proximal end of the pull wire is affixed to the screw.

### Claim 10 (depends on 9)

The delivery device of claim 9, wherein the proximal end of the pull wire is affixed to an insert, the insert being removably engaged with a recess extending into a proximal end of the screw.

### Claim 11 (depends on 10)

The delivery device of claim 10, wherein the screw includes a bore extending axially through the screw to the recess, the bore sized and shaped to receive the pull wire therethrough.

### Claim 12 (depends on 1)

The delivery device of claim 1, wherein the catheter assembly includes a base segment, and the distal end of the catheter assembly includes a first segment positioned distal to the base segment, and a second segment positioned distal to the first segment, the base segment and the first segment being separated by a first weakened portion, and the first segment and the second segment being separated by a second weakened portion.

### Claim 13 (depends on 12)

The delivery device of claim 12, wherein the first and second weakened portions are each less resistant to bending than the base segment, the first segment, and the second segment.

### Claim 14 (depends on 12)

The delivery device of claim 12, wherein the first and second weakened portions are each biased towards a straight position in collinear alignment with the base segment, such that when tension on the pull wire is released, the first and second segments tend to return to the straight position in collinear alignment with the base segment.

### Claim 15 (depends on 14)

The delivery device of claim 14, wherein the first and second weakened portions each comprise a shape memory metal.

### Claim 16 (depends on 12)

The delivery device of claim 12, wherein when the catheter assembly is at a minimum amount of deflection, the base segment, first segment, and second segment are all collinear.

### Claim 17 (depends on 16)

The delivery device of claim 16, wherein when the catheter assembly is at a maximum amount of deflection, the first segment is substantially perpendicular to the base segment, and the second segment is substantially perpendicular to the base segment and substantially parallel to the base segment, such that the base segment, first segment, and second segment form a “C”-shape.

### Claim 18 (depends on 1)

The delivery device of claim 1, wherein in an operative condition of the delivery device, the implantable medical device is retained within the compartment at the distal end of the catheter assembly, the implantable medical device being a lead of an energy delivery device.

### Claim 19 (depends on 18)

The delivery device of claim 18, wherein the lead includes a helical screw-in anchor at a distal end thereof.

### Claim 20 (depends on 18)

The delivery device of claim 18, wherein, when the collar in the distal position, rotation of the knob about the second longitudinal axis results in rotation of the helical screw-in anchor of the lead.