Methods and devices for facilitating visualization in a surgical environment

• US 7,559,925 B2
• Filed: 09/15/2006
• Issued: 07/14/2009
• Est. Priority Date: 09/15/2006
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Facteau, William M., Goldfarb, Eric, Chang, John Y., Morriss, John
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Lloyd; Emily M
• Application Number:
  US11/522,497
• Publication Number:
  US 20080082045A1
• Time in Patent Office: 1,033 Days
• Field of Search: 600/585, 607/92, 604/510
• US Class Current: 604/510
• CPC Class Codes: A61B 1/00126 optical, e.g. for light supply cables
• CPC Class Codes: A61B 1/063 for monochromatic or narrow-band illumination
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• 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 2017/246 for cleaning of the nose
• CPC Class Codes: A61B 2018/2222 Fibre material or composition
• CPC Class Codes: A61B 2018/2244 Features of optical fibre cables, e.g. claddings
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2562/228 Sensors with optical connectors
• 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 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/09008 : having a balloon
• CPC Class Codes: A61M 2025/09083 : having a coil around a core
• CPC Class Codes: A61M 2025/09125 : Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/09166 : having radio-opaque features
• CPC Class Codes: A61M 2025/09175 : having specific characteristics at the distal tip
• CPC Class Codes: A61M 2029/025 : characterised by the guiding element
• CPC Class Codes: A61M 25/0105 : Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: G02B 23/2469 : using optical fibres
• CPC Class Codes: G02B 6/0006 : Coupling light into the fibre in general G02B6/4298
• CPC Class Codes: G02B 6/0008 : the light being emitted at the end of the fibre
• CPC Class Codes: G02B 6/04 : formed by bundles of fibres G02B6/24 takes precedence
• CPC Class Codes: G02B 6/1228 : Tapered waveguides, e.g. integrated spot-size transformers for coupling with fibres G02B6/305
• CPC Class Codes: G02B 6/125 : Bends, branchings or intersections
• CPC Class Codes: G02B 6/241 : Light guide terminations
• CPC Class Codes: G02B 6/262 : Optical details of coupling light into, or out of, or between fibre ends, e.g. special fibre end shapes or associated optical elements
• CPC Class Codes: G02B 6/4292 : the light guide being disconnectable from the opto-electronic element, e.g. mutually self aligning arrangements

Abstract

Devices and methods for visually confirming the positioning of a distal end portion of an illuminating device placed within a patient include inserting a distal end portion of an illuminating device internally into a patient, emitting light from the distal end portion of the illuminating device, observing transillumination resulting from the light emitted from the distal end portion of the illuminating device that occurs on an external surface of the patient, and correlating the location of the observed transillumination on the external surface of the patient with an internal location of the patient that underlies the location of observed transillumination, to confirm positioning of the distal end portion of the illuminating device.

Claims

1. A method of performing a minimally invasive surgical procedure, said method comprising the steps of:

inserting a distal end portion of an illuminating guidewire internally into a paranasal sinus of a patient,

emitting light from the distal end portion of the illuminating guidewire within the paranasal sinus, wherein a proximal end portion of the illuminating guidewire is connected to a power source to enable the distal end portion to emit light;

observing a transillumination spot resulting from the light emitted from the distal end portion of the illuminating guidewire that occurs on an external surface of the patient, wherein the transillumination spot is sufficiently smaller than the sinus;

correlating the location of the observed transillumination spot on the external surface of the patient with an internal location of the patient that underlies the location of the observed transillumination spot, to confirm positioning of the distal end portion of the illuminating guidewire;

advancing a working device over the guidewire so that a proximal end of the guidewire extends proximally from the working device;

positioning a working end of the working device at a target location in an opening into the paranasal sinus; and

performing a surgical procedure with the working device at the target location to enlarge the opening into the paranasal sinus.

2. The method of claim 1, further comprising:

disconnecting the proximal end portion of the illuminating guidewire from the power source; and

removing the working device from the patient and from the guidewire.

3. The method of claim 2, further comprising:

advancing a second working device over the guidewire so that the proximal end of the guidewire extends proximally from the second working device; and

reconnecting the proximal end portion of the illuminating guidewire to the power source so that the distal end portion of the guidewire again emits light.

4. The method of claim 1, further comprising observing the transillumination spot on the external surface of the patient decrease in dimension while the distal end portion emits light and while advancing the distal end portion of the illuminating guidewire through an ostium of the paranasal sinus and into the paranasal sinus.

5. The method of claim 1, wherein the guidewire emits light such that the transillumination spot observed on the external surface of the patient is smaller than a diffuse transillumination area associated with an illumination source disposed outside an ostium of the paranasal sinus.

6. The method of claim 1, further comprising moving the distal end portion within the sinus, wherein the transillumination spot is sufficiently smaller than the sinus to confirm movement of the distal end portion within the paranasal sinus.

7. The method of claim 1, further comprising viewing advancement of the guidewire using an endoscope disposed outside an ostium of the paranasal sinus and oriented toward the ostium, and distinguishing between the transillumination spot and a diffuse transillumination area generated by the endoscope by observing the external surface of the patient.

8. The method of claim 1, further comprising advancing the illuminating guidewire further into the paranasal sinus so that the distal end portion approaches or contacts a wall of the paranasal sinus and thus decreases a diameter of the transillumination spot observed on the external surface of the patient.

9. The method of claim 1, further comprising again confirming positioning of the distal end portion within the paranasal sinus, after advancement of the working device and without fluoroscopy, by observing the external transillumination spot after the working device is positioned at the target location.

10. The method of claim 9, wherein:

the guidewire is advanced through a lumen of an introducer device into the nasal cavity,

the distal end portion of the guidewire guides advancement distally from the introducer device toward and into an ostium of the paranasal sinus while the ostium is beyond a field of view of an endoscope disposed alongside the introducer device,

the distal end portion emits light while advancing the distal end portion from the introducer device into the paranasal sinus so as to direct advancement by observing the external surface of the patient without fluoroscopy, and

advancing the working device comprises advancing the working portion over the guidewire and within the lumen of the introducer device.

11. The method of claim 1, wherein positioning the working end of the working device comprises positioning a balloon of a balloon dilation catheter within the opening into the paranasal sinus, and wherein performing the surgical procedure comprises expanding the balloon to enlarge the opening.

12. The method of claim 1, additionally comprising differentiating between different paranasal sinus locations based on transition movement of the spot and a resting location of the spot.

13. The method of claim 12, further comprising identifying a maxillary sinus location by observing the spot moving across a cheek region, and stopping in a region on a roof of a mouth.

14. The method of claim 1, further comprising differentiating between different paranasal sinus locations based on an intensity of the spot.

15. The method of claim 14, further comprising identifying a maxillary sinus location by observing the spot intensity diminish in a cheek region, and increase in a region on a roof of a mouth.

16. The method of claim 1, additionally comprising tracking the positioning of the distal end portion by observing an amount of spot movement.

17. The method of claim 16, wherein the amount of spot movement is limited by curling of the distal end portion after colliding with a sinus wall.

18. A method of enlarging an opening into a paranasal sinus, the method comprising:

advancing an introducing device through a nostril of a patient to a position where a distal end of the introducing device is near an opening of a paranasal sinus;

advancing a distal end portion of an illuminating guidewire through the introducing device and into the paranasal sinus while a proximal end of the illuminating guidewire is connected to a power source;

monitoring a position of the distal end portion of the illuminating guidewire distally of the distal end of the introducing device by observing movement of a transillumination spot on an external surface of the patient that results from the light emitted by the distal end portion during the advancement of the distal end portion into the paranasal sinus, wherein the transillumination spot is sufficiently smaller than the sinus;

advancing a balloon dilation catheter over the guidewire to position a balloon of the catheter in the opening into the paranasal sinus; and

expanding the balloon to enlarge the opening into the paranasal sinus.

19. The method of claim 18, further comprising correlating the location of the observed transillumination spot on the external surface of the patient with an internal location of the patient that underlies the location of the observed transillumination spot.

20. The method of claim 18, wherein the external surface is on the face of the patient.

21. The method of claim 18, wherein the external surface is on the palate of the patient.

22. The method of claim 18, wherein the paranasal sinus is differentiated from other locations by observing a relative amount of space within which the spot diverts.

23. The method of claim 22, wherein the spot diverts with a curling movement.

24. The method of claim 18, wherein the paranasal sinus is differentiated from other locations by observing spot movement and spot intensity on the external surface.