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

• US 9,826,999 B2
• Filed: 04/08/2013
• Issued: 11/28/2017
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Jenkins, Thomas R., Goldfarb, Eric, Vo, Tom Thanh, Makower, Joshua, Wood, Robert N., Heiser, Ronda M., Larsen, Christopher, Harfe, Daniel T.
• Primary Examiner(s): Miles, Jonathan
• Application Number:
  US13/858,580
• Publication Number:
  US 20130261388A1
• Time in Patent Office: 1,695 Days
• 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) a handle comprising a proximal end and a distal portion;

(b) an elongate guide shaft extending distally from the handle, wherein the elongate guide shaft defines a guide shaft lumen, said elongate shaft comprising a proximal portion and a distal end, wherein the distal end comprises a preformed fixed bend;

(c) a guidewire slidably positioned within the guide shaft lumen;

(d) a dilator configured to transition between a non-expanded configuration and an expanded configuration, wherein the dilator is configured to fit in an ostium of a paranasal sinus in the non-expanded configuration, wherein the dilator is longitudinally slidable relative to the elongate guide shaft and relative to the guidewire; and

(e) a first slide member coupled with the dilator, wherein the first slide member is located between the proximal end and the distal portion of the handle, wherein the first slide member is slidable relative to the handle, wherein the first slide member is operable to slide the dilator longitudinally relative to the elongate guide shaft past the preformed fixed bend to a position that is distal of a tip of the elongate guide shaft without dilating the dilator, wherein the preformed fixed bend is configured to not change shape as the dilator moves past the preformed fixed bend.

2. The device of claim 1, wherein the dilator is slidably positioned within the guide shaft lumen.

3. The device of claim 1, further comprising a second slide member coupled with the guidewire, wherein the second slide member is slidable relative to the handle, wherein the second slide member is operable to slide the guidewire longitudinally relative to the elongate guide shaft.

4. The device of claim 3, wherein the second slide member is further operable to rotate the guidewire relative to the elongate guide shaft.

5. The device of claim 1, wherein the elongate guide shaft defines a longitudinal opening extending from the guide shaft lumen to an outer surface of the elongate guide shaft.

6. The device of claim 5, wherein the elongate guide shaft further includes a distal end and a proximal end, wherein at least one end of the longitudinal opening terminates at a longitudinal position located between the distal end and the proximal end of the elongate guide shaft.

7. The device of claim 5, wherein the first slide member is coupled with the dilator through the longitudinal opening.

8. The device of claim 1, wherein the handle defines a longitudinal opening.

9. The device of claim 8, wherein the first slide member is coupled with the dilator through the longitudinal opening.

10. The device of claim 1, further comprising a piercing member coupled with a distal end of the elongate guide shaft, wherein the piercing member is configured to pierce a hole into a paranasal sinus, wherein the distal end of the elongate guide shaft is configured to fit through a hole formed by the piercing member.

11. The device of claim 1, further comprising a fluid reservoir in fluid communication with the dilator.

12. The device of claim 11, further comprising an actuator coupled with the fluid reservoir, wherein the actuator is operable to drive fluid from the fluid reservoir to the dilator to thereby inflate the dilator into the expanded configuration.

13. The device of claim 1, wherein the bend comprises a curve.

14. The device of claim 1, wherein the bend comprises an oblique angle.

15. The device of claim 1, wherein the elongate guide shaft has a distal end, wherein the first slide member is operable to position a distal portion of the dilator distal to the distal end of the elongate guide shaft.

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

(a) a handle comprising a proximal end, wherein the handle defines a laterally presented slot located distal relative to the proximal end;

(b) an elongate guide shaft extending distally from the handle, wherein the elongate guide shaft defines a guide shaft lumen, wherein the elongate guide shaft comprises a distal end wherein the distal end comprises a fixed bend;

(c) a guidewire slidably positioned within the guide shaft lumen;

(d) a dilation device comprising a dilator shaft, a dilator, and a sliding member, wherein the sliding member is configured to slide relative to the handle, wherein the sliding member is disposed within the laterally presented slot defined by the handle, wherein the dilator is configured to transition between a non-expanded configuration and an expanded configuration, wherein the dilator is configured to fit in an ostium of a paranasal sinus in the non-expanded configuration, wherein the dilator is longitudinally slidable past the fixed bend and out of a distal end of the elongate guide shaft, wherein the fixed bend is configured to not change shape as the dilator moves past the fixed bend, wherein the dilatation device is slidable relative to the guidewire; and

(e) a hub positioned between the elongate guide shaft and the handle.

17. The device claim 16, further comprising a slide member slidably disposed relative to the handle, wherein the slide member is coupled with the dilator, wherein the slide member is operable to slide the dilator relative to the elongate guide shaft.

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

(a) a handle comprising a proximal end and a distal end, wherein the handle defines a channel between the proximal end and the distal end;

(b) an elongate guide shaft extending distally from the handle, wherein the elongate guide shaft defines a guide shaft lumen, wherein the elongate guide shaft has a distal end with a preformed fixed bend;

(c) a guidewire slidably positioned within the guide shaft lumen;

(d) a dilator configured to transition between a non-expanded configuration and an expanded configuration, wherein the dilator is configured to fit in an ostium of a paranasal sinus in the non-expanded configuration, wherein the dilator is longitudinally slidable relative to the elongate guide shaft and relative to the guidewire;

(e) an inflation port, wherein the inflation port is in fluid communication with the dilator; and

(f) a slide member comprising a portion which extends laterally from the channel at a location in-between the proximal end and the distal end of the handle, wherein the slide member is mechanically coupled to the dilator such that the dilator is configured to slide longitudinally relative to the elongate guide shaft in response to longitudinal advancement of the slide member.