Shockwave catheters for treating rhinosinusitis

Patent metadata

Field	Value
Publication number	US-12290268-B2
Application number	US-202418620583-A
Country	US
Kind code	B2
Filing date	Mar 28, 2024
Priority date	Mar 31, 2023
Publication date	May 6, 2025
Grant date	May 6, 2025

Abstract

Described herein is a method for treating a narrowed region of a lumen in the ear or nose of a patient. The method includes advancing a catheter within the lumen such that a distal end of the catheter is positioned proximate to the narrowed region, filling a fillable member to expand the fillable member within the lumen, and generating at least one shock wave from at least one shock wave emitter. The at least one shock wave creates one or more fractures in a bony structure of the narrowed region of the lumen that dilate the narrowed region.

First claim

The invention claimed is:

1. A method for treating a narrowed region of a lumen in the ear or nose of a patient, the method comprising:
advancing a catheter within the lumen such that a distal end of the catheter is positioned proximate to the narrowed region, the distal end of the catheter comprising at least one shock wave emitter that is surrounded by a fillable member;
filling the fillable member to expand the fillable member within the lumen; and
generating at least one shock wave from the at least one shock wave emitter, the at least one shock wave creating one or more fractures in a bony structure of the narrowed region of the lumen that dilate the narrowed region.

2. The method of claim 1 , comprising irrigating the lumen to cause one or more bodily fluids to drain out of the lumen via the dilated narrowed region.

3. The method of claim 1 , comprising adjusting a directionality of the at least one shock wave emitter prior to generating the one or more shock waves so that the at least one shock wave is directed toward the bony structure.

4. The method of claim 3 , wherein adjusting the directionality of the at least one shock wave emitter comprises rotating the catheter within the lumen about a center axis of the catheter.

5. The method of claim 3 , wherein adjusting the directionality of the at least one shock wave emitter comprises adjusting an external knob of the catheter to cause the catheter to rotate within the lumen about a center axis of the catheter.

6. The method of claim 3 , wherein adjusting the directionality of the at least one shock wave emitter comprises adjusting the catheter such that an external indicator is oriented along a desired direction.

7. The method of claim 1 , wherein the fillable member comprises a semi-compliant balloon or compliant balloon.

8. The method of claim 1 , wherein filling the fillable member comprises pressurizing the fillable member to a pressure of less than 10 atm.

9. The method of claim 1 , wherein filling the fillable member comprises pressurizing the fillable member to a pressure of up to 6 atm.

10. The method of claim 1 , comprising, after generating the at least one shock wave, increasing the diameter of the lumen in the ear or the nose of the patient by pressurizing the fillable member to a pressure of up to 10 atm.

11. The method of claim 1 , comprising:
at least partially collapsing the fillable member;
advancing the catheter further within the lumen such that the distal end of the catheter is positioned proximate to a different portion of the narrowed region or a further narrowed region;
filling the fillable member to expand the fillable member within the lumen; and
generating at least one shock wave from the at least one shock wave emitter, the at least one shock wave creating one or more fractures in the further narrowed region of the lumen to dilate the further narrowed region.

12. The method of claim 1 , wherein advancing the catheter within the lumen comprises advancing the catheter over a guidewire.

13. The method of claim 1 , wherein the lumen is part of a frontal sinus, a maxillary sinus, a sphenoid sinus, an ethmoid sinus, a sinus ostium, an inferior turbinate, a middle turbinate, a superior turbinate, a nasal cavity, the ostiomeatal complex, or a combination thereof.

14. The method of claim 1 , comprising locating the narrowed region using an imaging sensor of the catheter prior to generating the at least one shock wave.

15. The method of claim 1 , comprising:
advancing an endoscope within the lumen such that a distal end of the endoscope is proximally offset from the distal end of the catheter; and
obtaining one or more images of the distal end of the catheter to locate the narrowed region.

16. The method of claim 1 , wherein the at least one shock wave delivers a therapeutically effective amount of an active agent of a drug to the lumen.

17. The method of claim 16 , wherein the active agent comprises a corticosteroid.

18. The method of claim 16 , wherein the active agent comprises an antibiotic.

19. The method of claim 16 , wherein a drug layer on the fillable member comprises the active agent and one or more adjunctive agents.

20. A device for treating a narrowed region of a lumen in the ear or nose of a patient, the device comprising:
an elongated tube;
at least one shock wave emitter, the at least one shock wave emitter configured to generate at least one shock wave along a working direction;
at least one imaging sensor oriented to capture images along the working direction; and
a fillable member sealed to a distal end of the elongated tube and surrounding the at least one shock wave emitter and the at least one imaging sensor, the fillable member fillable with a conductive fluid.

21. The device of claim 20 , wherein the fillable member comprises a drug coating, and the least one shock wave delivers a therapeutically effective amount of an active agent of a drug to the lumen.

Assignees

• Shockwave Medical Inc

Inventors

• Sariibrahimoglu Kemal
• Hasenberg Thomas Charles
• Wu Show-Mean Steve

Classifications

• A61B90/361 Primary

  Image-producing devices, e.g. surgical cameras · CPC title

• A61B2017/00411

  actuated by application of energy from an energy source outside the body · CPC title

• A61B2217/007

  with irrigation system · CPC title

• A61B2017/00292

  mounted on or guided by flexible, e.g. catheter-like, means · CPC title

• A61B2017/00238

  Type of minimally invasive operation (A61B2017/00805 takes precedence) · CPC title