Sinus dilation system and method

• US 10,363,401 B2
• Filed: 09/21/2016
• Issued: 07/30/2019
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Vaccaro, Robert K., Carpenter, Charles Franklin Scott, Little, II, David J., Mowlai-Ashtiani, Ali, Nadeau, Matthew J., Oliver, Dana A.
• Primary Examiner(s): Severson, Ryan J.
• Assistant Examiner(s): Knauss, Christian D
• Application Number:
  US15/271,427
• Publication Number:
  US 20170007811A1
• Time in Patent Office: 1,042 Days
• CPC Class Codes: 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
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A sinus dilation instrument useful with a navigation system and including a handle, a rigid probe, a balloon, and an identifier device. The probe extends from the handle, forms a curved segment, and carries the balloon. The identifier device is programmed to generate a signal indicative of an instrument identification assigned to the instrument, and is a frontal, maxillary or sphenoid sinus instrument. The signal is formatted to be recognized by an IGS. Once connected, the IGS recognizes the instrument and can retrieve information indicative of a spatial location of the balloon, for example via an instrument tracking device. A surgeon can “plug and play” the sinus dilation instrument with the IGS to perform a procedure.

Claims

1. A surgical system for dilating a region of a patient'"'"'s nasal sinus system, the system comprising:

a first sinus dilation instrument including;

a handle defining a front end opposite a back end;

a rigid probe extending distally from the front end of the handle, the rigid probe defining;

a rigid proximal end at the front end of the handle,

a rigid distal tip opposite the proximal end,

a rigid curved segment between the proximal end and the distal tip;

a balloon having a distal end, the balloon being secured over the rigid probe adjacent the distal tip, wherein a distance between the distal end of the balloon and the distal tip is invariable;

an inflation path fluidly connected to an interior of the balloon;

wherein a curvature and a longitudinal location of the curved segment is configured to locate the balloon within one of a frontal sinus, a maxillary sinus, and a sphenoid sinus following insertion of the distal tip through a naris of the patient;

a connector associated with the handle and configured to be electronically coupled to an image guidance system of the type to allow for a display of a position of the first sinus dilation instrument within the patient relative to a pre-operative image of the patient'"'"'s anatomy; and

an electronic identifier device electronically coupled to the connector and programmed to generate a signal indicative of an instrument identification assigned to the first sinus dilation instrument and corresponding with a region of the patient'"'"'s sinus system that the first sinus dilation instrument is configured to access and treat with the balloon, the instrument identification selected from the group consisting of a frontal sinus instrument, a maxillary sinus instrument, and a spheroid sinus instrument; and

a second sinus dilation instrument including;

a handle,

a rigid probe extending from the handle and forming a curved segment,

a balloon secured over the rigid probe adjacent a distal tip thereof and fluidly connected to an inflation path,

a connector configured to be electronically coupled to the image guidance system, and

an electronic identifier device electronically coupled to the connector and programmed to generate a signal indicative of an instrument identification assigned to the second sinus dilation instrument and selected from the group consisting of a frontal sinus instrument, a maxillary sinus instrument, and a sphenoid sinus instrument;

wherein the instrument identification of the first sinus dilation instrument is different from the instrument identification of the second sinus dilation instrument;

and further wherein the electronic identifier device of the first sinus dilation instrument is separate from the electronic identifier device of the second sinus dilation instrument.

2. The system of claim 1, wherein the balloon of the first sinus dilation instrument is exteriorly exposed and is disposed over at least a portion of the curved segment of the first sinus dilation instrument.

3. The system of claim 1, wherein the first sinus dilation instrument further includes a sheath forming the balloon of the first sinus dilation instrument and a base extending from a proximal end of the balloon of the first sinus dilation instrument, and further wherein a proximal end of the base is sealed to an exterior surface of the rigid probe of the first sinus dilation instrument.

4. The system of claim 1, wherein the first sinus dilation instrument further includes a marker band formed adjacent a proximal end of the balloon of the first sinus dilation instrument, wherein the marker band is configured to visually identify a spatial location of the balloon of the first sinus dilation instrument relative to the handle of the first sinus dilation instrument.

5. The system of claim 1, wherein the first sinus dilation instrument further includes a tracking device configured to generate tracking information that tracks movement and positioning of the balloon of the first sinus dilation instrument.

6. The system of claim 5, wherein the tracking device is an electromagnetically detectable receiver coil.

7. The system of claim 6, wherein the electromagnetically detectable receiver coil is disposed within the handle of the first sinus dilation instrument.

8. The system of claim 1, further comprising:

a third sinus dilation instrument including;

a handle,

a rigid probe extending from the handle and forming a curved segment,

a balloon secured to the rigid probe adjacent a distal tip thereof and fluidly connected to an inflation path,

a connector configured to be electronically coupled to the image guidance system, and

an electronic identifier device electronically coupled to the connector and programmed to generate a signal indicative of an instrument identification assigned to the third sinus dilation instrument and selected from the group consisting of a frontal sinus instrument, a maxillary sinus instrument, and a sphenoid sinus instrument;

wherein the instrument identification of the third sinus dilation instrument is different from the instrument identification of the first sinus dilation instrument and of the second sinus dilation instrument.

9. The system of claim 8, wherein the first sinus dilation instrument is configured for a frontal sinus procedure, the second sinus dilation instrument is configured for a maxillary sinus procedure, and the third sinus dilation instrument is configured for a sphenoid sinus procedure.

10. The system of claim 9, further comprising:

an image guidance system including a module forming a port configured to receive respective ones of the connectors, wherein the image guidance system is programmed to automatically recognize the instrument identification of the first, second, and third sinus dilation instruments.

11. The system of claim 10, wherein the image guidance system is further configured to generate images of a location of the balloon of the selected one of the first-third sinus dilation instruments relative to the patient'"'"'s anatomy during operation of the system in performing a desired procedure.

12. The system of claim 1, wherein a longitudinal location of the curved segment of the first sinus dilation instrument relative to the corresponding proximal end differs from a longitudinal location of the curved segment of the second sinus dilation instrument relative to the corresponding proximal end.

13. The system of claim 1, wherein a radius of curvature of the curved segment of the first sinus dilation instrument differs from a radius of curvature of the curved segment of the second sinus dilation instrument.

14. The system of claim 1, wherein the balloon is formed by a sheath disposed over the rigid probe, and further wherein the sheath terminates in a tail configured to engage the distal tip and a collar configured to be removably secured to the handle.