Sinus dilation catheter

Patent metadata

Field	Value
Publication number	US-11147908-B2
Application number	US-201916393594-A
Country	US
Kind code	B2
Filing date	Apr 24, 2019
Priority date	Jun 29, 2011
Publication date	Oct 19, 2021
Grant date	Oct 19, 2021

Abstract

A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess or maxillary sinus) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

First claim

What is claimed is:

1. A balloon dilation catheter for dilating sinus drainage pathways, the balloon dilation catheter comprising:
a handle having a proximal end and a distal end, the handle configured to be gripped by an operator;
a substantially rigid inner guide member having a distal end and a proximal end, wherein the substantially rigid inner guide member extends longitudinally from the distal end of the handle for a pre-determined distance;
a suction vent port positioned in the handle, wherein the suction vent port is configured to adjust a suction force at the distal end of the substantially rigid inner guide member;
a shaft slidably arranged with respect to the substantially rigid inner guide member, wherein a distal portion of the shaft includes an inflatable balloon; and
a moveable shaft advancing member positioned adjacent to the suction vent port, wherein the moveable shaft advancing member is configured to advance the shaft along the substantially rigid inner guide member from a retracted state to an extended state.

2. The balloon dilation catheter of claim 1 , wherein the shaft defines a rider lumen and the substantially rigid inner guide member extends through the rider lumen when the moveable shaft advancing member is in the retracted state.

3. The balloon dilation catheter of claim 1 , wherein the handle defines a slot extending along a longitudinal length of the handle, and wherein the moveable shaft advancing member is configured to translate along the slot.

4. The balloon dilation catheter of claim 1 , wherein a distal portion of the substantially rigid inner guide member is malleable and configured to be shaped by the operator into a desired configuration and maintain the desired configuration while the shaft is advanced along the substantially rigid inner guide member.

5. The balloon dilation catheter of claim 1 , wherein the moveable shaft advancing member is coupled to the shaft.

6. The balloon dilation catheter of claim 5 , wherein the moveable shaft advancing member is directly coupled to the shaft.

7. The balloon dilation catheter of claim 1 , wherein the substantially rigid inner guide member has an inner diameter in a range of about 0.020 inches and about 0.050 inches.

8. The balloon dilation catheter of claim 7 , wherein the substantially rigid inner guide member has an inner diameter in a range of about 0.036 inches and about 0.040 inches.

9. The balloon dilation catheter of claim 1 , wherein the substantially rigid inner guide member has a wall thickness in a range of about 0.005 inches and about 0.020 inches.

10. The balloon dilation catheter of claim 9 , wherein the substantially rigid inner guide member has a wall thickness in a range of about 0.008 inches and about 0.012 inches.

11. The balloon dilation catheter of claim 1 , wherein the substantially rigid inner guide member includes a curved distal portion, wherein a radius of curvature of the curved distal portion is between about 0.25 inches and 1.5 inches.

12. The balloon dilation catheter of claim 11 , wherein the substantially rigid inner guide member includes a curved distal portion, wherein a radius of curvature of the curved distal portion is between about 0.75 inches and 1.25 inches.

13. The balloon dilation catheter of claim 1 , wherein a distal portion of the substantially rigid inner guide member extends for a distance of between about 0.5 inches and about 2.0 inches from the distal end of the shaft when the moveable shaft advancing member is in the retracted state.

14. The balloon dilation catheter of claim 13 , wherein a distal portion of the substantially rigid inner guide member extends for a distance of between about 0.75 inches and about 1.25 inches from the distal end of the shaft when the moveable shaft advancing member is in the retracted state.

15. The balloon dilation catheter of claim 14 , wherein a distal portion of the substantially rigid inner guide member extends for a distance of between about 0.8 inches and about 1.2 inches from the distal end of the shaft when the moveable shaft advancing member is in the retracted state.

16. The balloon dilation catheter of claim 1 , wherein the distal end of the substantially rigid inner guide member is atraumatic.

17. The balloon dilation catheter of claim 16 , wherein the distal end of the substantially rigid inner guide member comprises a ball tip having a diameter between 1 and 3 millimeters.

18. The balloon dilation catheter of claim 1 , further including a tracking element configured to communicate a wireless signal to an image guided surgery system.

19. The balloon dilation catheter of claim 1 , wherein the balloon dilation catheter includes a stop that prevents the shaft from advancing past a predetermined position along the substantially rigid inner guide member.

20. The balloon dilation catheter of claim 19 , wherein the stop is configured to prevent the shaft from advancing past the distal end of the substantially rigid inner guide member.

21. The balloon dilation catheter of claim 1 , wherein the proximal end of the substantially rigid inner guide member is secured within the handle.

22. The balloon dilation catheter of claim 1 , wherein the substantially rigid inner guide member is sealed to the handle.

23. The balloon dilation catheter of claim 1 , wherein the substantially rigid inner guide member is sealed to the handle in a press-fit type sealing arrangement.

24. The balloon dilation catheter of claim 1 , wherein the substantially rigid inner guide member is removably coupled to the handle.

25. The balloon dilation catheter of claim 1 , wherein the substantially rigid inner guide member comprises a stainless steel hypotube.

26. The balloon dilation catheter of claim 25 , wherein a guidewire is arranged within a lumen of the stainless steel hypotube.

27. The balloon dilation catheter of claim 26 , wherein the guidewire is a light emitting guidewire.

28. The balloon dilation catheter of claim 1 , wherein the moveable shaft advancing member is coupled to the shaft.

29. The balloon dilation catheter of claim 1 , wherein a distal portion of the substantially rigid inner guide member includes a bend with a distal leg that is between about 10 and about 12 millimeters in length.

30. The balloon dilation catheter of claim 1 , wherein a distal portion of the substantially rigid inner guide member includes a bend of between about 115 and 125 degrees and about 10 to 12 millimeters of the substantially rigid inner guide member is distal to the bend.

31. The balloon dilation catheter of claim 1 , wherein a distal portion of the substantially rigid inner guide member includes a bend of about 135 degrees and about 10 to 12 millimeters of the substantially rigid inner guide member is distal to the bend.

32. The balloon dilation catheter of claim 1 , wherein the balloon dilation catheter is configured to allow a single hand of the operator to grasp the handle and position the substantially rigid inner guide member within an anatomy of a patient, advance the shaft and balloon with respect to the substantially rigid inner guide member, and alter an amount of suction force at the distal end of the substantially rigid inner guide member without the single hand releasing the handle.

33. The balloon dilation catheter of

Assignees

• Entellus Medical Inc

Inventors

• Drontle John R
• Hanson Anthony J
• Lesch Paul

Classifications

• A61B2017/246

  for cleaning of the nose · CPC title

• A61M29/02 Primary

  Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} · CPC title

• A61B17/24

  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 title

• A61M25/0032

  characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts · CPC title

• A61M25/01

  Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence) · CPC title