Multi-conduit balloon catheter

• US 20070073269A1
• Filed: 10/04/2005
• Published: 03/29/2007
• Est. Priority Date: 09/23/2005
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Becker, Bruce
• Granted Patent: US 8,114,113 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• 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 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 3/0295 with inflatable balloon

Abstract

A suctioning and irrigating sinus balloon catheter is provided for treating a patient'"'"'s paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities and choana. The catheter has a number of fluid carrying conduits to provide irrigation, suction and inflation/deflation to the distally mounted balloon. 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, choana or sinus to be excised. Some catheters can be hand bendable by the surgeon. Some catheters provide the capability of threading an endoscope through one of the conduits. 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, choana, and/or to dilate sinus cavities to remove them.

Claims

1. A catheter for dilating a space in a patient, said catheter comprises:

an oblong body having a proximal segment and a distal segment;

a balloon member secured to said distal segment;

a first conduit in fluid communication with said balloon, whereby fluid under a given pressure in said first conduit inflates said balloon; and

,

a second conduit having a distal port outside said balloon.

2. The catheter of claim 1, which further comprises said conduit being adapted to provide suction at said port.

3. The catheter of claim 1, which further comprises said conduit being adapted to provide irrigation at said port.

4. The catheter of claim 1, wherein said first and second conduits are formed into a multi-channel fluid buss extending between said proximal and distal segments.

5. The catheter of claim 1, wherein said first conduit terminates at a first conduit opening inside said balloon.

6. The catheter of claim 1, wherein said balloon has a substantially barbell shape when inflated.

7. The catheter of claim 1, wherein said second conduit has a distal terminus at said port and wherein said port is located a first distance from a distal neck of said balloon.

8. The catheter of claim 1, wherein said balloon annularly surrounds a portion of said second conduit.

9. The catheter of claim 1, which further comprises a third conduit having a distal port outside said balloon.

10. The catheter of claim 9, wherein said second conduit and said third conduit are coaxial.

11. The catheter of claim 9, wherein said second conduit and said third conduit are non-coaxial.

12. The catheter of claim 1, wherein the catheter has a stiffness which renders it hand bendable.

13. The catheter of claim 1, wherein the catheter has a stiffness which renders it non-hand bendable.

14. The catheter of claim 1, wherein said catheter has a bend.

15. The catheter of claim 14, wherein said balloon has a proximal neck extending over said bend.

16. The catheter of claim 1, wherein said body further comprises axial gradation markings.

17. The catheter of claim 1, wherein said second conduit has an inner diameter selected to allow passage of an endoscope therethrough.

18. The catheter of claim 17, wherein said device further comprises means for angularly securing said endoscope to said catheter.

19. The catheter of claim 18, wherein said means comprise at least one projection extending radially from a section of said endoscope.

20. The catheter of claim 1, wherein said catheter further comprises an angular orientation indicator.

21. The catheter of claim 17, wherein said second conduit is shaped to have an angular cutaway forming said port.

22. The catheter of claim 1, wherein said second conduit is formed of a stainless steel hypotube with a wall thickness of at least 0.010″

.

23. The catheter of claim 1, wherein said distal segment is at an angle of between about 0 degrees and about 130 degrees to said proximal segment.

24. The catheter of claim 1, wherein said distal segment is at an angle of between about 0 degrees and about 90 degrees to said proximal segment.

25. The catheter of claim 1, wherein said distal segment is at an angle of about 0 degrees to said proximal segment, whereby said catheter body is straight.

26. A kit for use in the treatment of a patient'"'"'s nasal sinuses, said kit comprises:

a first balloon catheter having an oblong body; and

,

a catheter bending tool having a given bend radius and a first surface shaped and dimensioned to intimately contact and bear against a portion of said body.

27. The kit of claim 26, wherein said given bend radius is at least 0.5 centimeter.

28. The kit of claim 26, wherein said kit further comprises an endoscope having a minimum bend radius which is greater than said given bend radius of said tool.

29. In a sinus balloon catheter device comprising proximal and distal sections, a balloon mounted to said distal section, and a first conduit for inflating said balloon, an improvement which comprises a second conduit having a distal port outside said balloon.

30. 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, or choana, 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.

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

providing a balloon catheter having an oblong body having a proximal segment, a distal segment, and a first inflation/deflation supply conduit in fluid communication with a balloon mounted on said distal segment;

pushing said distal segment with said balloon deflated into a space associated with a nasal sinus of said patient; and

introducing fluid under pressure into said supply conduit to inflate said balloon and dilate said space.

32. The method of claim 31, wherein said balloon catheter further comprises a second conduit.

33. The method of claim 32, which further comprises suctioning debris from said nasal sinus through said second conduit.

34. The method of claim 32, which further comprises irrigating said nasal sinus through said second conduit.

35. The method of claim 33, which further comprises irrigating said nasal sinus through said second conduit at a time when said suctioning is not occuring.

36. The method of claim 31, which further comprises bending said body to an angle of between about 0 degrees and 130 degrees prior to said pushing.

37. The method of claim 32, which further comprises inserting an endoscope through said second conduit.

38. The method of claim 32, wherein said balloon catheter further comprises a third conduit, and wherein said method further comprises:

suctioning debris from said nasal sinus through said second conduit; and

,

irrigating said nasal sinus through said third conduit.

39. The method of claim 31, wherein said body is flexible, and said method further comprises threading said body onto a rigidizing member having sufficient stiffness and column strength to enable said catheter, when said balloon is deflated, to be pushed into said space of said nasal sinus system.

40. The method of claim 31, wherein said tubular catheter body has a bend placing said distal segment at an angle of between about 60 degrees and about 130 degrees to said proximal segment.

41. The method of claim 40, wherein said angle is about 90 degrees.

42. The method of claim 31, 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.

43. The method of claim 42, wherein prior to said step of pushing said distal segment through said maxillary ostium, said method further comprises:

medially retracting the patient'"'"'s middle turbinate 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.

44. The method of claim 31, 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.

45. The method of claim 31, wherein said space is a prepared opening formed through the patient'"'"'s lateral nasal wall in the patient'"'"'s inferior meatus.

46. The method of claim 45, wherein prior to said step of pushing, 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.

47. The method of claim 31, wherein said distal segment is positioned at an angle of between about 0 degrees and about 60 degrees to said proximal segment.

48. The method of claim 47, wherein said distal segment is at an angle of about 0 degrees to said proximal segment, whereby said catheter body is substantially straight.

49. The method of claim 31, wherein said space is formed in the patient'"'"'s ethmoid bulla.

50. The method of claim 49, which further comprises:

medially retracting the patient'"'"'s middle turbinate 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.

51. The method of claim 50, 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.

52. The method of claim 51, 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.

53. The method of claim 52, 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.

54. The method of claim 53, 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 opening of said sphenoid sinus, the deflating said balloon and removing said distal segment to complete sinusotomy of said sphenoid sinus.

55. The method of claim 31, wherein said space is an opening through the patient'"'"'s anterior wall of the patient'"'"'s sphenoid sinus;

and wherein said method further comprises deflating said balloon and removing said distal segment to complete sinusotomy of said sphenoid sinus.

56. The method of claim 31, wherein said space is the patient'"'"'s nasofrontal duct to the patient'"'"'s frontal sinus;

and wherein said method further comprises deflating said balloon and removing said distal segment to complete sinusotomy of said frontal sinus.

57. The method of claim 52, 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 between about 60 degrees and about 130 degrees to said 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 and frontal sinus, deflating said balloon of said second balloon catheter, and removing said distal segment of said second balloon catheter to complete a frontal sinusotomy.

58. The method of claim 31, wherein said space is a choana, said distal segment with said balloon deflated being pushed into the choana, said choana being dilated when said inflatable member is inflated.

59. An 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.