Balloon catheters and methods for treating paranasal sinuses

• US 20040064150A1
• Filed: 09/30/2002
• Published: 04/01/2004
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Becker, Bruce B.
• Granted Patent: US 8,317,816 B2
• Time in Patent Office: Days
• US Class Current: 606/196
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A set of sinus balloon catheters are provided for treating a patient'"'"'s paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities. These include a balloon catheter with a bend placing a distal segment at 90° to a proximal segment and a balloon catheter which is substantially straight. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, or sinus to be excised. The catheters have appropriate inflated working diameters and appropriate outer diameters with the balloon deflated that will enable the catheter to be pushed into the respective prepared opening, natural ostium or duct, or sinus cavity to be excised. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, and/or to dilate sinus cavities to remove them.

Claims

1. A balloon catheter for dilating a space in a patient'"'"'s nasal sinus system, which is one of a prepared opening, an ostium or duct, or a sinus cavity to be excised, comprising:

a tubular catheter body having a proximal end, a proximal segment, a distal end, and a distal segment;

a balloon member disposed about said distal segment, said distal segment having a slot;

said catheter body being closed at a point distally of said slot;

means for applying fluid under pressure to said proximal end of said catheter body, said fluid under pressure flowing through said slot to inflate said balloon for dilating said space; and

said catheter body being formed of a hypotube of sufficient stiffness and column strength to enable said catheter, when said inflatable member is deflated, to be pushed into said space of said nasal sinus system.

2. A balloon catheter of claim 1, wherein said catheter body is formed of a stainless steel hypotube with a wall thickness of at least 0.035″

.

3. A balloon catheter of claim 2, wherein said catheter body has an outer diameter of 0.083″

and an inner diameter of 0.039″

with a wall thickness of 0.044″

.

4. A balloon catheter of claim 1, wherein said distal segment has a rounded bend placing said distal segment at the angle of 70°

to 115°

to said proximal segment.

5. A balloon catheter of claim 4, wherein said distal segment is at an angle of 90°

to said proximal segment.

6. A balloon catheter of claim 1, wherein said distal segment is at an angle of 130°

to 180°

to said proximal segment.

7. A balloon catheter of claim 6, wherein said distal segment is at an angle of 180°

to said proximal segment, whereby said catheter body is straight.

8. A method of treating a patient'"'"'s nasal sinuses, comprising:

providing a balloon catheter having a tubular catheter body with a proximal segment, a distal segment, a balloon mounted around said distal segment, a slot through a wall of said distal segment, said tubular body being closed at a point distally of said slot, and means for providing fluid under pressure at the proximal end of said tubular catheter body to inflate said balloon;

pushing said distal segment with said balloon deflated into a space associated with a nasal sinus of said patient, said catheter body having sufficient stiffness and column strength to be pushed into said space; and

introducing fluid under pressure through said proximal end of said tubular catheter body to inflate said balloon and dilate said space.

9. The method of claim 8, wherein said tubular catheter body has a bend placing said distal segment at an angle of 70°

to 115°

to said proximal segment.

10. The method of claim 9, wherein said angle is 90°

11. The method of claim 9, wherein said space is the maxillary ostium of the patient'"'"'s maxillary sinus, said distal segment with said balloon deflated being pushed through said maxillary ostium into said maxillary sinus, said maxillary ostium being dilated when said inflatable member is inflated to complete antrostomy of said maxillary ostium.

12. The method of claim 9, wherein prior to said step of pushing said distal segment through said maxillary ostium, said patient'"'"'s middle turbinate is retracted medially to gain access to the patient'"'"'s middle meatus, and exposing the patient'"'"'s ethmoid infundibulum by removing part of the patient'"'"'s uncinate process.

13. The method of claim 9, wherein said space is a prepared opening formed through the patient'"'"'s fontanelle, said opening is formed by bringing a 45 degree upbiting Blakesely punch into the patient'"'"'s nasal cavity along the patient'"'"'s lateral nasal wall just superior to the patient'"'"'s inferior turbinate, pushing said punch through said fontanelle to create said opening through said fontanelle and wherein said distal segment with said balloon deflated is pushed into said prepared opening and said balloon is inflated to dilate said prepared opening.

14. The method of claim 9, wherein said space is a prepared opening formed through the patient'"'"'s lateral nasal wall in the patient'"'"'s inferior meatus.

15. The method of claim 14, wherein prior to said step of punching said distal segment with said balloon deflated, said prepared opening is formed by displacing the patient'"'"'s inferior turbinate medially, introducing a sharp dissector into the patient'"'"'s nasal cavity, and using said dissector to perforate the patient'"'"'s lateral nasal wall in said inferior meatus to form said opening and wherein said distal segment with said balloon deflated is pushed into said prepared opening and said balloon is inflated to dilate said prepared opening.

16. The method of claim 8, wherein said distal segment is positioned at an angle of 130 to 180 degrees to said proximal segment.

17. The method of claim 16, wherein said distal segment is at an angle of 180 degrees to said proximal segment, whereby said catheter body is substantially straight.

18. The method of claim 17, wherein said space is formed in the patient'"'"'s ethmoid bulla.

19. The method of claim 18, wherein prior to said step of pushing said distal segment with said balloon deflated into said ethmoid bulla, the patient'"'"'s middle turbinate is retracted medially to gain access to the patient'"'"'s middle meatus, exposing the patient'"'"'s ethmoid infundibulum by removing part of the patient'"'"'s uncinate process, and using a fine cutting forceps to remove the anterior wall of said ethmoid bulla.

20. The method of claim 19, wherein after said inflatable member is deflated and withdrawn from said ethmoid bulla, providing said opening in said ethmoid bulla to receive said distal segment, which when inflated, dilates and thereby removes said ethmoid bulla.

21. The method of claim 20, wherein said inflated balloon is then deflated and said distal segment is then withdrawn from the space formerly occupied by said ethmoid bulla, said distal segment with said balloon deflated is then pushed into the patient'"'"'s anterior ethmoid air cells, forming the patient'"'"'s ethmoid sinus, lying posterior to said space formerly occupied by said ethmoid bulla, said balloon is then inflated dilating said anterior ethmoid air cells and thereby removing said anterior ethmoid air cells, and said balloon is then deflated, and said distal segment is then removed from the space formerly occupied by said anterior ethmoid air cells, completing an ethmoidectomy of the anterior ethmoid sinus.

22. The method of claim 21, wherein the patient'"'"'s basal lamella of the patient'"'"'s middle turbinate is perforated with a punch to form an opening, said distal segment is then pushed through said opening into said posterior ethmoid air cells and said balloon is inflated to dilate and remove said posterior ethmoid cells completing an ethmoidectomy of said posterior ethmoid sinus.

23. The method of claim 22, wherein after said anterior and posterior ethmoidectomies are completed, inserting said distal segment through the patient'"'"'s anterior wall of the patient'"'"'s sphenoid sinus, the balloon is then inflated for dilation and removal of said sphenoid sinus, the deflating said balloon and removing said distal segment to complete sinusotomy of said sphenoid sinus.

24. The method of claim 21, wherein after said ethmoidectomy of said anterior ethmoid sinus is completed and the patient'"'"'s nasofrontal duct is exposed, providing a second balloon catheter having a tubular catheter body with a proximal segment, a distal segment, a balloon member mounted around said distal segment, a slot through the wall of said distal segment, said tubular body being closed at a point distally of said slot, and means providing fluid under pressure at the proximal end of said tubular catheter body to inflate said balloon, said tubular catheter body having a bend placing said distal segment at an angle of 70°

to 115°

to proximal segment, pushing said distal segment of said second balloon catheter with said balloon of said second balloon catheter deflated into said frontonasal duct, inflating second balloon catheter to dilate said frontonasal duct, deflating said balloon of said second balloon catheter, and removing said distal segment of said second balloon catheter to complete a frontal sinusotomy.

25. Apparatus for treating prepared openings and natural ostia or ducts providing flow paths from natural sinus cavities, and excising sinus cavities, comprising:

a set of balloon catheters including catheters which are angled and catheters which are substantially straight, said catheters having appropriate inflated working diameters, and which have appropriate outer diameters with the balloon deflated that will enable the catheter in question to be pushed into the respective prepared opening, natural ostium or duct or sinus cavity to be excised.