Method of dilating tissue of a sinus drainage pathway

• US 8,585,729 B2
• Filed: 03/13/2012
• Issued: 11/19/2013
• Est. Priority Date: 04/21/2006
• Status: Active Grant

• Current Assignee: Entellus Medical Incorporated (Stryker Corporation)
• Original Assignee: Entellus Medical Incorporated (Stryker Corporation)
• Inventors: Keith, Peter T., Ressemann, Thomas V., Truitt, Theodore O.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/419,311
• Publication Number:
  US 20120172912A1
• Time in Patent Office: 616 Days
• Field of Search: 606/191, 606/196, 606/199
• US Class Current: 606/196
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Claims

1. A method of dilating tissue of a sinus drainage pathway in a patient, comprising:

directing a distal tip of a wire guide through a nasal passage and into a first test position within the sinus system of the patient, wherein the wire guide extends through a guide catheter and wherein a proximal end of the guide catheter is removably secured to a distal end of a handle and the wire guide extends through a steering device, and wherein the handle defines a recess that opens along a longitudinal length of a side surface of the handle, and wherein advancing the wire guide includes sliding the steering device distally along the recess of the handle in a direction parallel to a major longitudinal axis of the handle, and wherein directing the distal tip of the wire guide includes rotating the wire guide relative to the handle by rotating the steering device and wherein the steering device is configured to allow rotation of the wire guide through complete revolutions;

emitting light at or adjacent the distal tip of the wire guide at the first test position;

externally viewing the light through skin of the patient to confirm whether the first test position and the distal tip of the wire guide is within a desired cavity of the sinus system;

repositioning the distal tip of the wire guide to a second test position if externally viewing the light does not confirm that the first test positions is within the desired cavity;

directing a distal portion of a balloon catheter out the distal end of the guide catheter and into the desired location within a drainage pathway of the desired cavity, wherein the distal portion of the balloon catheter includes an inflatable balloon; and

inflating the balloon to dilate tissue of the sinus drainage pathway at the desired location.

2. The method of claim 1, wherein an ambient level of light in an environment surrounding the patient is reduced when the light through the skin of the patient is externally viewed as compared to the ambient level of light during any of the remaining operations.

3. The method of claim 1, wherein the wire guide is disposed within the balloon catheter when the balloon is inflated at the desired location.

4. The method of claim 1, wherein a fiber optic catheter is disposed over the wire guide.

5. The method of claim 4, wherein the light viewed through the skin of the patient is emitted from a distal tip of the fiber optic catheter.

6. The method of claim 1, wherein the handle is configured to receive the wire guide and wherein the steering device is configured to advance the wire guide through the guide catheter while the steering device advances with the wire guide.

7. The method of claim 6, wherein the handle is held with one hand while an endoscope is held with a second hand, wherein the steering device is configured to advance the wire guide through the handle.

8. The method of claim 7, further including manipulating a knob disposed on the endoscope to direct a viewing field of the endoscope towards a sinus ostium.

9. A method of dilating tissue of a sinus drainage pathway in a patient, comprising:

directing a distal tip of a wire guide through a nasal passage wherein the wire guide extends through a guide catheter and into a first test position of the patient, wherein the first test position is suspected of being within a desired paranasal sinus cavity of the patient, wherein a proximal end of the guide catheter is secured to a distal end of a handle and the wire guide extends through a steering device, and wherein the handle defines a recess that opens along a longitudinal length of a side surface of the handle, and wherein advancing the wire guide includes sliding the steering device distally along the recess of the handle in a direction parallel to a major longitudinal axis of the handle, and wherein directing the distal tip of the wire guide includes rotating the wire guide relative to the handle by rotating the steering device and wherein the steering device is configured to allow rotation of the wire guide through complete revolutions;

emitting light at the first test position;

externally viewing the light through skin of the patient to confirm whether the first test position is within the desired paranasal sinus cavity;

repositioning the distal tip of the wire guide to a second test position if externally viewing the light does not confirm that the first test position is within the desired paranasal sinus cavity;

directing a distal portion of a balloon catheter out the distal end of the guide catheter and into the desired location within a drainage pathway of the desired paranasal sinus cavity after confirming that the distal tip of the wire guide is within the desired paranasal sinus cavity, wherein the distal portion of the balloon catheter includes an inflatable balloon; and

inflating the balloon to dilate tissue of the drainage pathway at the desired location.

10. The method of claim 9, wherein the light is emitted before the distal portion of the balloon catheter is directed out of the distal end of the guide catheter.

11. The method of claim 10, wherein the distal portion of the balloon catheter is directed over the wire guide and into the desired location.

12. The method of claim 11, further comprising directing the distal end of the guide catheter while viewing the distal end of the guide catheter with an endoscope, and actuating a knob disposed on the endoscope to reposition a viewing field of the endoscope towards a sinus ostium.

13. The method of claim 12, wherein the handle is removably secured to the guide catheter and wherein the handle is configured to receive the wire guide and wherein the steering device advances the wire guide through the guide catheter.

14. The method of claim 13, further including directing the distal tip of the wire guide through the handle and into the guide catheter.

15. The method of claim 14, wherein the proximal end of the guide catheter includes a hub and the hub is removably secured to a distal end of the handle with a frictional fit.

16. The method of claim 15, wherein the handle is held in a first hand and the endoscope is held in a second hand.

17. The method of claim 16, wherein an ambient level of light in an environment surrounding the patient is reduced when the light through the skin of the patient is externally viewed as compared to the ambient level of light during any of the remaining method operations.

18. The method of claim 11, wherein the handle is removably secured to the guide catheter and wherein the handle is configured to receive the wire guide and wherein the steering device rotates with the wire guide as the wire guide rotates within the guide catheter.

19. The method of claim 18, further including directing the distal tip of the wire guide through the handle and into the guide catheter.

20. The method of claim 19, wherein the proximal end of the guide catheter includes a hub and the hub is removably secured to a distal end of the handle with a frictional fit.

21. The method of claim 20, wherein the steering device advances the wire guide through the guide catheter while the steering device advances with the wire guide.

22. The method of claim 21, wherein the steering device is configured to both rotate and advance the wire guide within the guide catheter.

23. The method of claim 22, wherein the handle is held in a first hand and an endoscope is held in a second hand, and wherein the distal end of the guide catheter is directed to a desired location within a nasal passageway of the patient while observing through the endoscope.

24. The method of claim 23, wherein the light is externally viewed through the skin of the patient at ambient level of light that is reduced as compared to the ambient level of light used when conducting any of the remaining method operations.

25. A method of dilating tissue of a sinus drainage pathway in a patient, comprising:

directing a distal tip of a wire guide through a nasal passage wherein the wire guide extends through a guide catheter and into a first test position of the patient, wherein the first test position is suspected of being within a desired paranasal sinus cavity of the patient, and wherein a proximal end of the guide catheter is secured to a distal end of a handle and the wire guide extends through a steering device, and wherein the handle defines a recess that opens along a longitudinal length of a side surface of the handle, and wherein advancing the wire guide includes sliding the steering device distally along the recess of the handle in a direction parallel to a major longitudinal axis of the handle, and wherein directing the distal tip of the wire guide includes rotating the wire guide relative to the handle by rotating the steering device and wherein the steering device is configured to allow rotation of the wire guide through complete revolutions;

emitting light at the first test position;

externally viewing the light through skin of the patient to confirm that the first test position is not within a desired paranasal sinus cavity;

repositioning the distal tip of the wire guide to a second test position, wherein the second test position is suspected of being within the desired paranasal sinus cavity of the patient;

externally viewing the light through skin of the patient to confirm that the second test position is within the desired paranasal sinus cavity;

directing a distal portion of a balloon catheter out the distal end of the guide catheter and into a desired location within a drainage pathway of the desired paranasal sinus cavity after confirming that the distal tip of the wire guide is within the desired paranasal sinus cavity, wherein the distal portion of the balloon catheter includes an inflatable balloon; and

inflating the balloon to dilate tissue of the drainage pathway at the desired location.

26. The method of claim 25, wherein the handle is configured to receive the wire guide and wherein the steering device is configured to advance with the wire guide relative to the guide catheter.