Balloon catheters and methods for treating paranasal sinuses

• US 8,317,816 B2
• Filed: 09/30/2002
• Issued: 11/27/2012
• 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): Truong, Kevin T
• Assistant Examiner(s): Boles, Sameh
• Application Number:
  US10/259,300
• Publication Number:
  US 20040064150A1
• Time in Patent Office: 3,711 Days
• Field of Search: 606192-196, 606/199, 604/96.01, 600/207
• 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 device for dilating a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity, said device comprising:

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

an inflatable member proximate to said distal segment;

said inflatable member being capable of dilating a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity;

wherein said distal segment is at a preset angle of less than 180 degrees to said proximal segment;

wherein said tubular body is dimensioned and has sufficient stiffness and column strength to enable said inflatable member, when said inflatable member is deflated, to be inserted transnasally through a nasal cavity and pushed, without being supported and guided by a guide wire, snugly into a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity.

2. The device of claim 1, wherein said angle is between approximately 70 degrees and approximately 150 degrees.

3. The device of claim 1, wherein said angle is between approximately 70 degrees and approximately 115 degrees.

4. The device of claim 1, wherein said angle is between approximately 130 degrees and approximately 150 degrees.

5. The device of claim 1, wherein said angle is approximately 90 degrees.

6. The device of claim 1, wherein said inflatable member has a length between approximately 4 millimeters and approximately 30 millimeters.

7. The device of claim 1, wherein said inflatable member has a working inflated diameter between approximately 2 millimeters and approximately 14 millimeters.

8. The device of claim 1, wherein said distal segment is dimensioned to allow it to be rotated within said nasal cavity.

9. The device of claim 1, wherein said body has a rounded bend between said proximal segment and said distal segment.

10. The device of claim 1, wherein said inflatable member comprises a distal neck and a proximal neck wherein said proximal neck is bonded to said distal segment.

11. The device of claim 10, wherein said inflatable member further comprises a working segment located entirely distal to said bend.

12. The device of claim 1, wherein said body has a length between approximately 4 inches and approximately 10 inches.

13. The device of claim 1, wherein said body has a length of approximately 6 inches.

14. The device of claim 1, wherein said device further comprises a luer attached to said proximal end.

15. The device of claim 14, wherein said luer has means for improving a user'"'"'s grip on said device while said inflatable member is being inserted.

16. A device for dilating a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity, said device comprising:

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

an inflatable member proximate to said distal segment;

said inflatable member being capable of dilating a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity;

wherein said distal segment is at a preset angle of less than 180 degrees to said proximal segment;

wherein said tubular body is dimensioned and has sufficient stiffness and column strength, in absence of a rigidizing member or guide wire, to enable said inflatable member, when said inflatable member is deflated, to be inserted transnasally through a nasal cavity and pushed snugly into a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity.

17. The device of claim 16, which further comprises said tubular body having sufficient stiffness and column strength to enable said inflatable member to be directably pushed while substantially maintaining said angle into a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity.

18. The device of claim 16, which further comprises said tubular body having sufficient stiffness and column strength to enable said inflatable member to be pushed, rotated and translated while substantially maintaining said angle into a surgically prepared small, tight opening in a paranasal sinus, an obstructed or narrowed bony duct, opening or ostium between the paranasal sinus and nasal cavity.

19. The device of claim 16, wherein said angle is between approximately 70 degrees and approximately 150 degrees.

20. The device of claim 16, wherein said angle is between approximately 70 degrees and approximately 115 degrees.