Balloon catheters and methods for treating paranasal sinuses

• US 8,764,786 B2
• Filed: 10/09/2012
• Issued: 07/01/2014
• 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.
• Primary Examiner(s): BOLES, SAMEH RAAFAT
• Application Number:
  US13/648,111
• Publication Number:
  US 20130096605A1
• Time in Patent Office: 630 Days
• Field of Search: 606192-196, 606/199
• 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 method of treating a patient'"'"'s nasal sinuses, comprising:

(a) 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 catheter body being closed at a point distally of said slot, and means for providing fluid under pressure at the proximal segment of said tubular catheter body to inflate said balloon;

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

(c) introducing fluid under pressure through said proximal segment of said tubular catheter body to inflate said balloon and dilate said space.

2. The method of claim 1, wherein said tubular catheter body has a bend placing said distal segment at an angle of 70°

to 115°

to said proximal segment.

3. The method of claim 2, wherein said angle is 90°

.

4. The method of claim 2, wherein said space is a 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 balloon is inflated to complete antrostomy of said maxillary ostium.

5. The method of claim 4, 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.

6. The method of claim 2, wherein said space is a prepared opening formed through the patient'"'"'s fontanelle, said opening is formed by bringing a 45°

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.

7. The method of claim 2, wherein said space is a prepared opening formed through the patient'"'"'s lateral nasal wall in the patient'"'"'s inferior meatus.

8. The method of claim 7, wherein prior to said step of pushing 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 prepared 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.

9. The method of claim 1, wherein said distal segment is positioned at an angle of 130°

to 180°

to said proximal segment.

10. The method of claim 9, wherein said distal segment is at an angle of 180°

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

11. The method of claim 10, wherein said space is formed in the patient'"'"'s ethmoid bulla.

12. The method of claim 11, 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 an anterior wall of said ethmoid bulla.

13. The method of claim 12, wherein after said balloon is deflated and withdrawn from said ethmoid bulla, providing a first opening in said ethmoid bulla to receive said distal segment, which when inflated, dilates and thereby removes said ethmoid bulla.

14. The method of claim 13, 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.

15. The method of claim 14, wherein the patient'"'"'s basal lamella of the patient'"'"'s middle turbinate is perforated with a punch to form a second opening, said distal segment is then pushed through said second opening into 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.

16. The method of claim 15, 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, then deflating said balloon and removing said distal segment to complete sinusotomy of said sphenoid sinus.

17. The method of claim 14, 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 catheter body being closed at a point distally of said slot, and means providing fluid under pressure at the proximal segment 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 a 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.