Methods and apparatus for treating disorders of the ear nose and throat

• US 8,414,473 B2
• Filed: 09/16/2009
• Issued: 04/09/2013
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Jenkins, Thomas, Goldfarb, Eric, Vo, Tom Thanh, Makower, Joshua, Heiser, Ronda M., Larsen, Christopher, Harfe, Daniel T., Wood, Robert N. Jr.
• Primary Examiner(s): LaBalle, Clayton E
• Assistant Examiner(s): Fenwick, Warren K
• Application Number:
  US12/561,147
• Publication Number:
  US 20100099946A1
• Time in Patent Office: 1,301 Days
• Field of Search: 600/101, 600/104, 600/116, 600/122, 600/137, 396/17
• US Class Current: 600/104
• CPC Class Codes: A61B 1/0014 Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
• CPC Class Codes: A61B 1/126 provided with means for cleaning in-use
• 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 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61M 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/10186 One-way valves
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device for dilating an ostium of a paranasal sinus of a human or animal subject may include: a handle; an elongate shaft having a proximal end coupled with the handle and extending to a distal end; a guidewire disposed through at least a portion of the shaft lumen; a dilator having a non-expanded configuration and an expanded configuration; and a slide member coupled with at least one of the guidewire or the dilator through the longitudinal opening of the shaft for advancing the guidewire and/or the dilator relative to the shaft.

Claims

1. A device for dilating an ostium of a paranasal sinus of a human or animal subject, the device comprising:

a handle;

an elongate shaft having a proximal end coupled with the handle and extending to a distal end, wherein the shaft includes a lumen and a longitudinal opening extending from the lumen to an outer surface of the shaft along at least part of a length between the proximal and distal ends;

a guidewire disposed through at least a portion of the shaft lumen;

a dilator having a non-expanded configuration and an expanded configuration, wherein at least a portion of the dilator is disposed over the guidewire and within the shaft lumen; and

a slide member coupled with at least one of the guidewire or the dilator through the longitudinal opening of the shaft for advancing the guidewire and/or the dilator relative to the shaft;

wherein the slide is capable of axial rotation relative to the elongate shaft to rotate the guidewire and/or the dilator.

2. The device of claim 1, wherein the distal end of the elongate shaft includes an elongate tubular element in connection with the elongate shaft.

3. The device of claim 1, wherein the distal end of the shaft is insertable through a nostril of the subject'"'"'s nose.

4. The device of claim 1, further comprising a piercing member coupled with the distal end of the shaft for piercing a hole into a paranasal sinus of the subject, wherein the distal end of the shaft is insertable through the hole.

5. The device of claim 1, further comprising a fluid reservoir attached to the elongate shaft, wherein the fluid reservoir is in fluid communication with the dilator.

6. The device of claim 5, further comprising a trigger coupled with the fluid reservoir, wherein actuating the trigger causes fluid in the fluid reservoir to inflate the dilator into the expanded configuration.

7. A device for accessing an ostium of a paranasal sinus of a human or animal subject, the device comprising:

a handle;

an elongate shaft having a proximal end coupled with the handle and extending to a distal end, and a longitudinal lumen extending at least partway from the proximal end to the distal end;

a device advancing member coupled with at least one of the handle or the elongate shaft and configured to couple with and advance at least one device through the lumen of the shaft and at least partway into an ostium of a paranasal sinus;

wherein the device advancing member comprises;

two rollers configured to hold and advance the device; and

an actuator coupled with the two rollers to move the rollers.

8. The device of claim 7, further comprising a guidewire extending through at least part of the shaft lumen, wherein the device advancing member is configured to couple with and advance the guidewire through the lumen and through the ostium of the paranasal sinus.

9. The device of claim 7, further comprising a balloon dilation catheter extending through at least part of the shaft lumen, wherein the device advancing member is configured to couple with and advance the balloon dilation catheter through the lumen and at least partway into the ostium of the paranasal sinus.

10. The device of claim 7, wherein the device advancing member comprises a slide member.

11. A system for dilating an anatomical structure within the ear, nose or throat of a human or animal subject, the system comprising:

an endoscope;

an elongate tubular guide removably coupled with the endoscope;

a handle coupled with at least one of the endoscope or the elongate tubular guide for grasping the endoscope, coupled with the elongate tubular guide, in one hand; and

a dilator slidably disposed in the elongate tubular guide, wherein the dilator has a non-expanded configuration for passing through the elongate tubular guide and an expanded configuration for dilating the anatomical structure;

wherein the endoscope comprises a rigid, swing prism endoscope.

12. The system of claim 11, further comprising:

a first clip attached to the endoscope;

a second clip attached to the elongate tubular guide; and

a connection member for connecting the first and second clips.

13. The system of claim 11, wherein the endoscope and elongate tubular guide, coupled together, are sized to pass into a nostril of the subject'"'"'s nose.

14. The system of claim 11, wherein the endoscope and elongate tubular guide, coupled together, are sized to pass into a hole punctured into a paranasal sinus of the subject, the system further comprising a piercing member coupled with at least one of the endoscope or the elongate tubular guide for forming the hole.

15. The system of claim 11, further comprising a guidewire disposed through a guidewire lumen extending through at least part of the dilator.

16. The system of claim 15, further comprising a guidewire advancing member coupled with the elongate tubular guide for advancing the guidewire relative to the elongate tubular guide.

17. The system of claim 11, further comprising an endoscope cleaner coupled with the endoscope, the endoscope cleaner comprising:

a sheath disposed over at least part of the endoscope; and

a tube coupled with the sheath to connect the sheath with a source of cleaning fluid.

18. A method for dilating an opening in a paranasal sinus of a human or animal subject, the method comprising:

holding an elongate, tubular, at least partially rigid guide in one hand using a handle, wherein a balloon dilation catheter resides within a lumen of the guide and extends through the handle;

advancing a distal end of the guide to a position near an opening in a paranasal sinus of a human or animal subject, wherein the balloon catheter resides within the lumen of the guide during advancement;

advancing the balloon dilation catheter through the guide to position a balloon of the balloon dilation catheter in the paranasal sinus opening; and

expanding the balloon to dilate the opening;

wherein advancing the balloon dilation catheter comprises advancing the balloon dilation catheter into an ostium of the paranasal sinus selected from the group consisting of a maxillary sinus, a sphenoid sinus, a frontal sinus and an ethmoid sinus.

19. The method of claim 18, wherein advancing the balloon dilation catheter comprises advancing an advancement member coupled with the handle and the catheter.

20. The method of claim 18, further comprising advancing a guidewire through the distal end of the guide and through the opening into the paranasal sinus, wherein the guidewire resides within a lumen of the balloon catheter during advancement of the guide into the subject, and wherein the balloon catheter is advanced through the distal end of the guide over the guidewire.

21. The method of claim 20, further comprising:

emitting light from a distal end of the guidewire; and

viewing the emitted light from outside the subject to confirm that the distal end of the guidewire is located in the paranasal sinus before advancing the balloon dilation catheter.

22. The method of claim 18, further comprising holding an endoscope with the handle, wherein the endoscope and the guide are coupled with the handle, and wherein the endoscope and the guide are advanced into the subject.

23. The method of claim 22, further comprising viewing at least one of the distal end of the guide or the balloon of the balloon catheter, using the endoscope.

24. The method of claim 23, further comprising changing a viewing angle of the endoscope by adjusting a swing prism in the endoscope.

25. The method of claim 18, wherein dilating the opening comprises dilating a naturally occurring ostium of the paranasal sinus.

26. The method of claim 18, wherein dilating the opening comprises dilating a manmade opening into the paranasal sinus, and wherein the method further comprises forming the manmade opening.

27. The method of claim 18, wherein expanding the balloon comprises inflating the balloon with fluid by activating an inflation member coupled with the handle.

28. A method for dilating an ostium of a paranasal sinus of a human or animal subject, the method comprising:

holding an elongate, tubular, at least partially rigid guide and a balloon catheter disposed at least partially within the guide in one hand using a handle;

advancing a distal end of the guide to a position near an opening in a paranasal sinus of a human or animal subject, wherein the balloon catheter resides within the lumen of the guide during advancement;

advancing an advancement member coupled with the handle and the balloon dilation catheter to advance the balloon catheter through the distal end of the guide to position a balloon of the balloon dilation catheter in the opening; and

expanding the balloon to dilate the opening;

wherein the guide is advanced through an opening in a canine fossa of the subject'"'"'s head into a maxillary sinus, the method further comprising forming the canine fossa opening using a piercing tool.

29. The method of claim 28, wherein the guide is advanced through an opening in a wall of a maxillary sinus of the subject'"'"'s head, the method further comprising forming the maxillary sinus wall opening using a piercing tool.

30. The method of claim 28, wherein a guidewire is further housed in a lumen of the balloon dilation catheter during advancement of the guide and balloon dilation catheter into the subject, the method further comprising advancing the guidewire through the ostium before advancing the balloon dilation catheter over the guidewire.

31. The method of claim 28, further comprising:

holding an endoscope with the handle, wherein the endoscope, guide and balloon catheter are advanced into the subject together; and

viewing at least one of the distal end of the guide or the balloon of the balloon catheter using the endoscope.

32. The method of claim 31, further comprising changing a viewing angle of the endoscope by adjusting a swing prism in the endoscope.