# US 11,027,105 B2 · Adjustable instrument for dilation of anatomical passageway

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- Number: US 11,027,105 B2
- Document ID: US11027105B2
- Status: Granted
- Kind: B2
- Application number: 16/032,489
- Filed: 2018-07-11
- Published: 2019-01-17
- Granted: 2021-06-08
- Earliest claimed: 2017-07-13
- Assignees: Biosense Webster (Israel) Ltd.; Acclarent, Inc.
- Applicants: Acclarent, Inc.; Biosense Webster (Israel) Ltd.
- Inventors: George L. Matlock; Yehuda Algawi; Ilya Sitnitsky; Andres C. Altmann; Ygal Zucker; Don Q. Ngo-Chu; Vadim Gliner; Christopher T. Beeckler; John H. Thinnes, Jr.; Assaf Govari
- Web page: https://patentgrep.com/patent/US11027105B2

## CPC

- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 1/07: using light-conductive means, e.g. optical fibres
- A61B 1/233: for the nose, i.e. nasoscopes {, e.g. testing of patency of Eustachian tubes}
- A61B 17/24: for use in the oral cavity, larynx, bronchial passages or nose (for medical inspection of cavities or tubes in the body A61B1/00); Tongue scrapers
- A61B 17/3421: {Cannulas}
- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- A61M 25/0136: {Handles therefor}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/09: Guide wires
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61B 1/00183: {for variable viewing angles}
- A61B 1/0052: {Constructional details of control elements, e.g. handles}
- A61B 2017/00309: {Cut-outs or slits}
- A61B 2017/00323: {Cables or rods}
- A61B 2217/005: with suction drainage system
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0138: {having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/10188: {Inflation or deflation data displays}
- A61M 2025/09125: {Device for locking a guide wire in a fixed position with respect to the catheter or the human body}
- A61M 2025/1093: {having particular tip characteristics}
- A61M 2029/025: {characterised by the guiding element}
- A61M 2210/0618: Nose
- A61M 2210/0681: Sinus (maxillaris)
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An apparatus includes an instrument body, a shaft assembly, a dilation catheter, a guidewire, and a proximal deflection actuation assembly. The dilation catheter includes an expandable dilator and is slidable relative to the shaft assembly to thereby position the dilator distally relative to the distal end of the shaft assembly. The proximal deflection actuation assembly is positioned at the proximal end of the shaft assembly and is operable to selectively deflect the length of the shaft assembly relative to the longitudinal axis of the instrument body to thereby deflect the longitudinal axis of the shaft assembly away from the longitudinal axis of the instrument body.

## Claims

### Claim 1

An apparatus comprising:
(a) an instrument body, wherein the instrument body defines a longitudinal axis;
(b) a shaft assembly extending distally from the instrument body, wherein the shaft assembly has a proximal end and a distal end, with a length defined between the proximal and distal ends, wherein the shaft assembly further defines a longitudinal axis along the length;
(c) a dilation catheter, wherein the dilation catheter comprises an expandable dilator, wherein the dilation catheter is slidable relative to the shaft assembly to thereby position the dilator distally relative to the distal end of the shaft assembly; and
(d) a guidewire, wherein the guidewire is slidable relative to the dilation catheter,
wherein at least a portion of the length of the shaft assembly is operable to be selectively deflected relative to the longitudinal axis of the instrument body to thereby deflect the longitudinal axis of the shaft assembly away from the longitudinal axis of the instrument body.

### Claim 2 (depends on 1)

The apparatus of claim 1, further comprising a lock collar, wherein the lock collar is configured to translate to thereby transition between a locking position and an unlocking position, wherein the lock collar in the locking position is configured to maintain an angle defined between the longitudinal axis of the shaft assembly and the longitudinal axis of the instrument body, wherein the lock collar in the unlocking position is configured to enable adjustment of the angle defined between the longitudinal axis of the shaft assembly away from the longitudinal axis of the instrument body.

### Claim 3 (depends on 1)

The apparatus of claim 1, further comprising a deflection slider, wherein the deflection slider is operable to translate laterally relative to the longitudinal axis of the instrument body to thereby deflect the length of the shaft assembly relative to the longitudinal axis of the instrument body.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the shaft assembly is operable to pivot relative to the instrument body about a pivot axis that is perpendicular to the longitudinal axis of the instrument body.

### Claim 5 (depends on 1)

The apparatus of claim 1, further comprising a deflection adjustment knob, wherein the deflection adjustment knob is operable to rotate about the longitudinal axis of the shaft assembly to thereby deflect the length of the shaft assembly relative to the longitudinal axis of the instrument body.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein the instrument body includes a distal portion defining a deflection adjustment knob engagement feature that is oriented obliquely relative to the longitudinal axis of the instrument body, wherein the deflection adjustment knob defines an engagement feature that is oriented obliquely relative to the longitudinal axis of the shaft assembly, wherein the deflection adjustment knob engagement feature and the engagement feature of the deflection adjustment knob are configured to cooperate with each other to transition the length of the shaft assembly between a deflected orientation and a non-deflected orientation.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the shaft assembly includes a flexible distal portion, the apparatus further comprising a distal deflection actuation assembly, the distal deflection actuation assembly comprising:
(i) a rotary actuator,
(ii) a first translatable actuation member at least partially disposed within the rotary actuator, and
(iii) a second translatable actuation member extending through the shaft assembly, wherein the second translatable actuation member couples the first translatable actuation member with the flexible distal portion of the shaft assembly, wherein the rotary actuator is rotatable about a longitudinal axis to thereby drive the first and second translatable actuation members longitudinally, wherein the flexible distal portion is configured to deflect away from the longitudinal axis of the shaft assembly in response to translation of the first and second translatable actuation members longitudinally.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the dilation catheter further comprises:
(i) a shaft having an outer diameter, and
(ii) a bulbous tip feature, wherein the bulbous tip feature is located distal to the dilator, wherein the bulbous tip feature has a width greater than the outer diameter of the shaft, wherein the bulbous tip is deformable to reduce the width of the bulbous tip feature in response to inwardly directed forces exerted on the bulbous tip feature.

### Claim 9 (depends on 1)

The apparatus of claim 1, further comprising an actuator assembly, wherein the actuator assembly comprises:
(i) an actuator body, wherein the actuator body is translatable relative to instrument body to thereby translate the dilation catheter relative to the shaft assembly, and
(ii) a first drive wheel, wherein the first drive wheel is rotatably supported by the actuator body, wherein the first drive wheel is operable to drive the guidewire longitudinally relative to the shaft assembly.

### Claim 10 (depends on 9)

The apparatus of claim 9, wherein the actuator assembly further comprises a second drive wheel, wherein the second drive wheel is coupled with the first drive wheel such that the second drive wheel is configured to rotate in a second direction in response to rotation of the first drive wheel in a first direction, wherein the second drive wheel is operable to drive the guidewire longitudinally relative to the shaft assembly in response to rotation of the first and second drive wheels.

### Claim 11 (depends on 10)

The apparatus of claim 10, wherein the second drive wheel is configured to translate relative to the actuator body between a first position and a second position along a path that is transverse to a longitudinal axis of the guidewire, wherein the second drive wheel is configured to contact the guidewire in the first position, wherein the second drive wheel is configured to be spaced away from the guidewire in the second position.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein the first drive wheel is configured to translate relative to the actuator body along a path that is transverse to a longitudinal axis of the guidewire to thereby drive the second drive wheel from the second position to the first position.

### Claim 13 (depends on 9)

The apparatus of claim 9, further comprising a manifold assembly coupled with the actuator body, wherein the manifold assembly is configured to translate with the actuator body relative to the instrument body, wherein the manifold assembly is configured to couple the dilation catheter with at least two fluid inputs.

### Claim 14

An apparatus comprising:
(a) an instrument body;
(b) a shaft assembly extending distally from the instrument body;
(c) a dilation catheter, wherein the dilation catheter is slidable relative to the shaft assembly, wherein the dilation catheter comprises an expandable dilator;
(d) a guidewire, wherein the guidewire is slidable relative to the shaft assembly;
(e) a guidewire rotation drive assembly, wherein the guidewire rotation drive assembly comprises:
(i) a barrel member,
(ii) a first end cap,
(iii) a second end cap, and
(iv) a plurality of rollers, wherein the guidewire is disposed within the barrel member and the end caps, wherein the rollers are configured to selectively grip the guidewire based on an angular position of the barrel member relative to the first and second end caps.

### Claim 15 (depends on 14)

The apparatus of claim 14, wherein the rollers are deformable, wherein the barrel member comprises a bore having internal surfaces configured to deform the rollers inwardly to thereby grip the guidewire based on an angular position of the barrel member relative to the first and second end caps.

### Claim 16 (depends on 15)

The apparatus of claim 15, wherein the bore has a set of arcuate surfaces joined by rounded corners, wherein the arcuate surfaces are configured to deform the rollers inwardly.

### Claim 17 (depends on 14)

The apparatus of claim 14, further comprising at least one pin, wherein the at least one pin couples the barrel member with at least one of the end caps via an arcuate recess, wherein the arcuate recess and the pin cooperate to provide relative angular movement between the barrel member and the at least one of the end caps as the barrel member is rotated through a first range of angular motion, wherein the arcuate recess and the pin further cooperate to provide concomitant angular movement of the barrel member and the at least one of the end caps as the barrel member is rotated through a second range of angular motion.

### Claim 18

An apparatus comprising:
(a) an instrument body;
(b) a shaft assembly extending distally from the instrument body;
(c) a dilation catheter, wherein the dilation catheter is slidable relative to the shaft assembly, wherein the dilation catheter comprises an expandable dilator;
(d) a guidewire, wherein the guidewire is slidable relative to the shaft assembly;
(e) an actuator assembly, wherein the actuator assembly is operable to translate the dilation catheter relative to the shaft assembly; and
(f) a guidewire locking assembly fixedly secured to the instrument body, wherein the guidewire locking assembly is further configured to selectively lock the longitudinal position of the guidewire relative to the instrument body.

### Claim 19 (depends on 18)

The apparatus of claim 18, wherein the guidewire locking assembly comprises:
(i) a frame,
(ii) a first shoe, and
(iii) a second shoe, wherein the frame is configured to urge the first and second shoes toward each other to thereby grip the guidewire.

### Claim 20 (depends on 19)

The apparatus of claim 19, wherein the guidewire locking assembly further comprises at least one resilient member configured to cooperate with the frame member to thereby urge the first and second shoes toward each other to thereby grip the guidewire.
