Dilation instrument with malleable guide and dilation catheter with integral position sensor

Patent metadata

Field	Value
Publication number	US-11839729-B2
Application number	US-201916532671-A
Country	US
Kind code	B2
Filing date	Aug 6, 2019
Priority date	Oct 5, 2018
Publication date	Dec 12, 2023
Grant date	Dec 12, 2023

Abstract

An apparatus includes a handle assembly, a guide tube, and a dilation catheter. The guide tube extends distally from the handle assembly. At least a distal portion of the guide tube is malleable. The dilation catheter is slidably positioned in the guide tube. The dilation catheter includes a distal end, a dilator, and a position sensor. The position sensor is configured to generate a signal indicating a position of the position sensor in three-dimensional space. The dilation catheter is configured to translate relative to the guide tube.

First claim

We claim:

1. An apparatus comprising:
(a) a handle assembly including:
(i) an inflation port,
(ii) a data port, the data port comprising a cable port, and
(iii) a slider;

(b) a guide tube extending distally from the handle assembly, the guide tube having a distal end, at least a distal portion of the guide tube comprising a malleable stainless steel hypotube, the guide tube defining a first central longitudinal axis; and
(c) a dilation catheter coupled with the slider and slidably positioned in the guide tube, the dilation catheter defining a second central longitudinal axis, the second central longitudinal axis being laterally offset from the first central longitudinal axis of the guide tube, the slider being operable to drive the dilation catheter longitudinally relative to the handle assembly between a retracted position and an advanced position, the dilation catheter including:
(i) a distal end configured to be positioned at or proximal to the distal end of the guide tube when the dilation catheter is in the retracted position, the distal end of the dilation catheter being further configured to be positioned distal to the distal end of the guide tube when the dilation catheter is in the advanced position,
(ii) a dilator comprising a balloon, the inflation port being configured to couple the dilator with an external fluid source, and
(iii) a position sensor, the position sensor being configured to generate a signal indicating a position of the position sensor in three-dimensional space, the position sensor being longitudinally interposed between the distal end of the dilation catheter and the dilator, the position sensor comprising a wire coil positioned coaxially about the second central longitudinal axis, the data port being further configured to couple the position sensor with an external image guided surgery system via a cable coupled with the cable port,
the dilation catheter being configured to translate relative to the guide tube,
the guide tube defining an inner diameter, the dilation catheter defining an outer diameter, the guide tube and the dilation catheter cooperating to define a gap between the inner diameter of the guide tube and the outer diameter of the dilation catheter, and
the gap being sized to provide:
(A) a fluid path for an irrigation device through the gap,
(B) a fluid path for a suction device through the gap, and
(C) advancement of a guidewire along the gap, the gap being sized to provide advancement of the guidewire along the gap, the guidewire being positioned lateral to the dilation catheter.

2. The apparatus of claim 1 , further comprising a fluid source in fluid communication with the inflation port, the dilator being configured to receive fluid from the fluid source to thereby transition from a non-expanded state to an expanded state.

3. The apparatus of claim 1 , a proximal portion of the guide tube comprising the malleable stainless steel hypotube, the malleable stainless steel hypotube extending to the handle, the distal portion of the guide tube being configured to be bent by a separate bending instrument and to thereafter maintain a bend.

4. An apparatus comprising:
(a) a handle assembly including a slot, the handle assembly including:
(i) a slider configured to longitudinally advance along the slot,
(ii) a fluid port, and
(iii) a data port;

(b) a guide tube extending distally from the handle assembly, at least a distal portion of the guide tube being malleable stainless steel, the guide tube including an inner surface defining an inner diameter, the guide tube further defining a central longitudinal axis; and
(c) a dilation catheter slidably positioned in the guide tube, the dilation catheter being coupled with the slider, the slider being operable to translate the dilation catheter relative to the guide tube, the dilation catheter including:
(i) a distal end configured to be positioned at or proximal to a distal end of the guide tube when the dilation catheter is in a retracted position and further configured to be positioned distal to the distal end of the guide tube when the dilation catheter is in an advanced position,
(ii) a dilator in fluid communication with the fluid port, the dilator being configured to transition between a non-expanded state and an expanded state, the dilator being sized to fit within a Eustachian tube when in the non-expanded state and is sized to dilate the Eustachian tube when in the expanded state,
(iii) a position sensor in communication with the data port, the position sensor being configured to generate a signal indicating a position of the position sensor in three-dimensional space, the position sensor being longitudinally interposed between the dilator and the distal end of the dilation catheter, and
(iv) a shaft, the shaft defining a central longitudinal axis, the central longitudinal axis of the shaft being laterally offset from the central longitudinal axis of the guide tube, a first portion of the shaft being positioned to contact the inner surface of the guide tube, a second portion of the shaft defining a gap between an outer surface of the second portion of the shaft and the inner surface of the guide tube;
the gap being sized to provide:
(A) a fluid path for irrigation fluid through the gap,
(B) a fluid path for suction through the gap, and
(C) advancement of another instrument along the gap,

the distal portion of the guide tube being configured to maintain a first bend such that each of the dilator, fluid path for irrigation, fluid path for suction, and the other instrument achieves a first exit angle, the distal portion of the guide tube being further configured to transition from the first bend to a second bend such that each of the dilator, fluid path for irrigation, fluid path for suction, and the other instrument achieves a second exit angle, each of the first and second bends being angularly offset from the central longitudinal axis of the guide tube, the distal portion of the guide tube being configured to maintain each of the first and second bends, the first exit angle being configured for placement of the dilator during dilation of a maxillary sinus ostium, the second exit angle being configured for placement of the dilator during dilation of a frontal sinus.

Assignees

• Acclarent Inc

Inventors

• Ebrahimi Babak
• Shameli Ehsan
• Matlock George L
• Thinnes Jr John H
• Akbarian Fatemeh

Classifications

• A61M29/02 Primary

  Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} · CPC title

• A61B17/24

  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 · CPC title

• A61B34/20

  Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis · CPC title

• A61F11/20

  Ear surgery · CPC title

• A61M25/0105

  Steering means as part of the catheter or advancing means; Markers for positioning (systems for detection of markers A61B) · CPC title