SINUS DILATION SYSTEM AND METHOD

• US 20140180328A1
• Filed: 12/21/2012
• Published: 06/26/2014
• 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., Little, David J. II, Mowlai-Ashtiani, Ali, Nadeau, Matthew J., Oliver, Dana A., Carpenter, Charles Franklin Scott
• Granted Patent: US 9,463,307 B2
• Time in Patent Office: Days
• US Class Current: 606/196
• 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 proximal end at the front end of the handle,

a distal tip opposite the proximal end,

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

a balloon secured to the rigid probe adjacent the distal tip;

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 a patient;

a connector associated with the handle and configured to be electronically coupled to an 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 first sinus dilation instrument and corresponding with a region of a patient'"'"'s sinus system 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 sphenoid sinus instrument.

2. The system of claim 1, wherein the balloon is formed of a semi-compliant material configured to expand to a preformed shape.

3. The system of claim 1, wherein the balloon is disposed over at least a portion of the curved segment.

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

5. The system of claim 4, wherein the inflation path is defined, at least in part, between the exterior surface of the probe and the base.

6. The system of claim 5, wherein the rigid probe forms an inflation lumen extending from a proximal end opening to a side port that is fluidly open to the exterior surface, and further wherein the proximal end of the sheath is sealed to the rigid probe proximal the side port.

7. The system of claim 6, wherein a wall thickness of the balloon is less than a wall thickness of the base.

8. The system of claim 4, wherein the sheath further forms a tail extending from the balloon opposite the base and configured to receive the distal tip.

9. The system of claim 1, wherein the balloon is expandable from a deflated state to an inflated state, and further wherein the balloon is configured such that in the deflated state, the balloon conforms to the rigid probe and forms at least one pleat.

10. The system of claim 1, wherein the balloon is transitionable between a deflated state and an inflated state, and further wherein the balloon and the rigid probe are configured such that the balloon defines a maximum outer diameter of the first sinus dilation instrument adjacent the distal tip, the maximum outer diameter in the deflated state being not greater than about 3 mm.

11. The system of claim 10, wherein the maximum outer diameter in the inflated state is in the range of about 5 mm to about 7 mm.

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

13. The system of claim 1, wherein at least a portion of the rigid probe tapers in outer diameter in a direction from the proximal end toward the distal tip such that an outer diameter of the rigid probe at the distal tip is less than an outer diameter of the rigid probe at the proximal end.

14. The system of claim 1, wherein the first sinus dilation instrument further includes a tracking device configured to generate tracking information.

15. The system of claim 14, wherein the tracking device is an electromagnetically detectable receiver coil.

16. The system of claim 15, wherein the electromagnetically detectable receiver coil is disposed within the handle.

17. The system of claim 1, wherein the handle and the rigid probe are a single, homogenous body.

18. The system of claim 1, wherein the system further comprises:

a second 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,

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 surgical instrument;

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

19. The system of claim 18, 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,

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 procedure identification of the first sinus dilation instrument and of the second sinus dilation instrument.

20. The system of claim 19, 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.

21. The system of claim 20, 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.

22. The system of claim 21, 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 a patient'"'"'s anatomy during operation of the system in performing a desired procedure.

23. The system of claim 18, 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.

24. The system of claim 18, 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.

25. The system of claim 1, wherein the balloon is formed by a sheath slidably 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.

26. A method of dilating a region of a patient'"'"'s nasal sinus system, the method comprising:

receiving a sinus dilation instrument configured for accessing the region of the patient'"'"'s nasal sinus system, the sinus dilation instrument including;

a handle,

a rigid probe extending distally from the handle, the rigid probe defining;

a proximal end attached to the handle,

a distal tip opposite the proximal end,

a curved segment between the proximal end and the distal tip,

a balloon secured to the rigid probe adjacent the distal tip,

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

a connector associated with the handle and configured to be electronically coupled to an image guidance system,

an electronic identifier device electronically coupled to the connector and programmed to generate a signal indicative of an instrument identification assigned to the sinus dilation instrument and corresponding with a region of a patient'"'"'s sinus system the 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 sphenoid sinus instrument;

electronically coupling the connector to an image guidance system, wherein the image guidance system automatically recognizes the instrument identification of the sinus dilation instrument;

deflating the balloon;

inserting the distal tip through a naris of the patient;

pushing the distal tip end along the nasal sinus system of the patient to a target site;

wherein the step of pushing includes reviewing images generated by the image guidance system and indicative of a location of the balloon relative to the patient'"'"'s anatomy;

inflating the balloon to dilate the target site;

deflating the balloon after dilating the target site; and

removing the sinus dilation instrument from the patient.

27. The method of claim 26, wherein the step of receiving a sinus dilation instrument includes:

selecting the sinus dilation instrument from a set of sinus dilation instruments including a first sinus dilation instrument, a second sinus dilation instrument, and a third sinus dilation instrument;

wherein the first-third sinus dilation instruments each include a rigid probe forming a curved segment and an electronic identifier device programmed to generate a signal indicative of an instrument identification assigned to the corresponding sinus dilation instrument;

and further wherein the curved segment differs for each of the first-third sinus dilation instruments;

and even further wherein the instrument identification assigned to the first-third sinus dilation instruments differs and is recognized by the image guidance system.

28. The method of claim 27, wherein the first sinus dilation instrument is configured to access a frontal sinus via a naris of the patient, the second sinus dilation instrument is configured to access a maxillary sinus via a naris of the patient, and the third sinus dilation instrument is configured to access a sphenoid sinus via a naris of the patient.