Methods and devices for facilitating visualization in a surgical environment

• US 9,603,506 B2
• Filed: 06/05/2009
• Issued: 03/28/2017
• Est. Priority Date: 09/15/2006
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Goldfarb, Eric, Morriss, John, Chang, John Y., Facteau, William M.
• Primary Examiner(s): Dougherty, Sean
• Application Number:
  US12/479,332
• Publication Number:
  US 20090240112A1
• Time in Patent Office: 2,853 Days
• Field of Search: 604/510
• US Class Current: 1/1
• 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 sinusitis treatment system comprising:

(a) an illuminating guidewire device having a proximal end, the proximal end comprising a proximal end portion, and a distal end, the distal end comprising a flexible distal end portion and being configured to be inserted through a nostril and into a paranasal sinus of a patient, the illuminating guidewire device having sufficient length to extend from the proximal end located outside the patient to the distal end located within the paranasal sinus of the patient, the illuminating guidewire device comprising;

(i) a distal tip on the flexible distal end portion; and

(ii) at least one light emitting element configured to project light distally through the distal tip on the flexible distal end portion;

(b) a guide device having a first lumen configured to receive the illuminating guidewire device; and

(c) a balloon catheter having;

(i) a balloon; and

(ii) a lumen, wherein the lumen is sized for passage over the illuminating guidewire device to position the balloon of the catheter within an opening into the paranasal sinus;

wherein the balloon is operable to pass within and through the first lumen of the guide device in an unexpanded configuration such that the balloon catheter is operable to extend from a distal end of the guide device so as to position the balloon distally of the guide device, wherein the balloon is configured to remain in the unexpanded configuration when positioned distally of the guide device prior to introduction of a fluid into the balloon, wherein the balloon is configured to expand upon introduction of fluid into the balloon.

2. A system as in claim 1, wherein the at least one light emitting element comprises a distal end of at least one illumination fiber.

3. A system as in claim 2, wherein the distal end of the at least one illumination fiber is configured to emit light from the distal tip of the flexible distal end portion.

4. A system as in claim 2, wherein the distal end of the at least one illumination fiber is positioned proximally of the distal tip of the flexible distal end portion.

5. A system as in claim 4, wherein a flexible distal portion of the flexible distal end portion extends distally of the distal end of the at least one illumination fiber.

6. A system as in claim 1, the illuminating guidewire device further comprising at least one structure extending from the proximal end of the illuminating guidewire device through the proximal end portion and at least part of the flexible distal end portion to connect the at least one light emitting element with a power source, wherein the power source is a light source.

7. A system as in claim 1, the illuminating guidewire device further comprising at least one structure extending from the proximal end of the illuminating guidewire device through the proximal end portion and at least part of the flexible distal end portion to connect the at least one light emitting element with a power source, wherein the at least one light emitting element comprises a distal end of at least one laser fiber, and wherein the at least one structure comprises the at least one laser fiber running proximally of the distal end to the proximal end of the illuminating guidewire device.

8. A system as in claim 7, wherein the power source is a laser light source.

9. A system as in claim 1, wherein the flexible distal end portion of the illuminating guidewire device has an outside diameter configured and dimensioned to pass through an ostium of a sinus.

10. A system as in claim 9, wherein the flexible distal end portion has an outside diameter less than about 0.038 inches.

11. A system as in claim 1, wherein the flexible distal end portion of the illuminating guidewire device comprises a flexible coil and a core support extending internally of, and fixed to, the coil.

12. A system as in claim 1, wherein the flexible distal end portion of the illuminating guidewire device includes a bend, such that a proximal part of the flexible distal end portion is substantially aligned with a longitudinal axis of the guide device, and a distal part of the flexible distal end portion is angled with respect to the longitudinal axis.

13. A system as in claim 1, wherein the at least one light emitting element is configured to generate strobed, flashing or flickering light.

14. A system as in claim 13, wherein a structure for generating strobed, flashing or flickering light includes a rotating shutter.

15. A system as in claim 1, wherein the at least one light emitting element comprises a light emitting diode.

16. A system comprising:

(a) an illuminating guidewire having a proximal end and a distal end, the distal end being configured to be inserted through a nostril and into a paranasal sinus of a patient, the illuminating guidewire having sufficient length to extend from the proximal end located outside the patient to the distal end located within the paranasal sinus of the patient, the illuminating guidewire comprising a flexible body terminating at a distal tip, wherein the distal tip includes a light emitting feature configured to project light distally from the distal tip;

(b) a guide device having a lumen configured to accommodate the illuminating guidewire; and

(c) a dilation catheter comprising an expandable dilator, wherein the expandable dilator is movable within and through the lumen of the guide device relative to the guide device in an unexpanded configuration and relative to the illuminating guidewire to position the expandable dilator relative to the paranasal sinus, wherein the dilator is configured to remain in the unexpanded configuration when positioned distally of the guide device prior to introduction of a fluid into the dilator, wherein the dilator is configured to expand upon introduction of fluid into the dilator.

17. A system as in claim 16, wherein the lumen of the guide device is further configured to receive the dilation catheter.

18. A system as in claim 16, wherein the dilation catheter is configured to be advanced over the illuminating guidewire.

19. A system comprising:

(a) an illuminating guidewire having a proximal end and a distal end, the distal end being configured to be inserted through a nostril and into a paranasal sinus of a patient, the illuminating guidewire having sufficient length to extend from the proximal end located outside the patient to the distal end located within the paranasal sinus of the patient, the illuminating guidewire distally terminating at a distal tip, wherein the distal tip includes a light emitting feature configured to project light distally from the distal tip;

(b) a guide device having a lumen configured to accommodate the illuminating guidewire; and

(c) a dilation catheter comprising an expandable dilator, wherein the expandable dilator is movable within and through the lumen of the guide device and over the illuminating guidewire in an unexpanded configuration to position the expandable dilator relative to the paranasal sinus, wherein the balloon is configured to remain in the unexpanded configuration when positioned distally of the guide device prior to introduction of a fluid into the balloon, wherein the balloon is configured to expand upon introduction of fluid into the dilator.