Sinus dilation system and method

• US 9,463,307 B2
• Filed: 12/21/2012
• Issued: 10/11/2016
• 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, David J. II, Mowlai-Ashtiani, Ali, Nadeau, Matthew J., Oliver, Dana A.
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): KNAUSS, CHRISTIAN D
• Application Number:
  US13/725,716
• Publication Number:
  US 20140180328A1
• Time in Patent Office: 1,390 Days
• US Class Current: 1/1
• 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 first handle defining a front end opposite a back end;

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

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

a first distal tip opposite the proximal end,

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

a first balloon secured over the first rigid probe adjacent the first distal tip, wherein a spatial location of the first balloon relative to the first curved segment is fixed;

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

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

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

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

a second sinus dilation instrument including;

a second handle,

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

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

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

a second electronic identifier device electronically coupled to the second connector and programmed to generate a second signal indicative of a second 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 first instrument identification of the first sinus dilation instrument is different from the second instrument identification of the second sinus dilation instrument;

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

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

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

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

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

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

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

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

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

10. The system of claim 1, wherein the first balloon is transitionable between a deflated state and an inflated state, and further wherein the first balloon and the first rigid probe are configured such that the first balloon defines a maximum outer diameter of the first sinus dilation instrument adjacent the first 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 first balloon, wherein the marker band is configured to visually identify a spatial location of the first balloon relative to the first handle.

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

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 first handle.

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

18. The system of claim 1, further comprising:

a third sinus dilation instrument including;

a third handle,

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

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

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

a third electronic identifier device electronically coupled to the third connector and programmed to generate a third signal indicative of a third 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 third instrument identification of the third sinus dilation instrument is different from the first instrument identification of the first sinus dilation instrument and of the second instrument identification of the second sinus dilation instrument.

19. The system of claim 18, 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.

20. The system of claim 19, 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.

21. The system of claim 20, wherein the image guidance system is further configured to generate images of a location of the corresponding 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.

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

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

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