Multi-conduit balloon catheter

• US 8,968,269 B2
• Filed: 01/18/2012
• Issued: 03/03/2015
• Est. Priority Date: 09/23/2005
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Becker, Bruce B.
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/353,154
• Publication Number:
  US 20120172835A1
• Time in Patent Office: 1,140 Days
• Field of Search: 604/48, 604/500, 604/514
• US Class Current: 604/514
• 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 method of treating a patient'"'"'s nasal sinuses using a balloon catheter, wherein the balloon catheter comprises an oblong body, a first tube, a second tube, and a third tube, wherein the oblong body has a proximal segment and a distal segment, wherein the oblong body further has an expandable balloon located on the distal segment, wherein the first tube comprises a first lumen having a first flow path, wherein the first lumen terminates at a first port distal to the balloon, wherein the second tube is disposed about the first tube such that a second lumen having a second flow path is defined between an exterior surface of the first tube and an interior surface of the second tube, wherein the second tube terminates at a second port distal to the balloon, wherein the third tube is laterally offset from the first and second tubes such that an exterior surface of the third tube tangentially contacts an exterior surface of the second tube, wherein the third tube comprises a third lumen having a third flow path, wherein the third tube terminates at a third port within the balloon, the method comprising:

(a) inserting an endoscope into the first tube, through the first lumen of the first tube, such that a distal end of said endoscope protrudes from said first tube, wherein the first tube comprises a distal nozzle, wherein the distal end of the said endoscope is aligned with an obliquely angled cutaway on the distal nozzle of the first tube;

(b) pushing the distal segment into a space associated with a nasal sinus of said patient, wherein the balloon is in a deflated state during the act of pushing the distal segment;

(c) inflating the balloon to dilate the space, wherein the act of inflating the balloon comprises communicating fluid through the third flow path and through the third port into the balloon;

(d) irrigating the space, wherein the act of irrigating the space comprises communicating fluid through the first flow path of the first lumen of the first tube and through the first port into the space via the distal nozzle; and

(e) suctioning fluid and material from the space, wherein the act of suctioning fluid and material from the space comprises communicating suction through the second flow path and through the second port into the space.

2. The method of claim 1, wherein said space is formed in the patient'"'"'s ethmoid bulla.

3. The method of claim 1, 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.

4. The method of claim 1, 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.

5. The method of claim 1, 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.

6. The method of claim 1, wherein said space is a prepared opening formed through the patient'"'"'s lateral nasal wall in the patient'"'"'s inferior meatus.

7. The method of claim 6, wherein 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.

8. The method of claim 7, which further comprises:

(a) medially retracting the patient'"'"'s middle turbinate to gain access to the patient'"'"'s middle meatus;

(b) exposing the patient'"'"'s ethmoid infundibulum by removing part of the patient'"'"'s uncinate process; and

,

(c) using a fine cutting forceps to remove the anterior wall of said ethmoid bulla.

9. The method of claim 8, wherein after said inflatable balloon 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.

10. The method of claim 9, 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.

11. The method of claim 10, 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.

12. The method of claim 11, 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.

13. The method of claim 11, 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.

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

(a) providing a balloon catheter having;

(i) an oblong body having a proximal segment and a distal segment, an expandable balloon located on said distal segment, and,

(ii) a first conduit having a first distal nozzle, wherein an endoscope locking feature is formed in a wall of the first conduit, wherein the endoscope locking feature is configured to ensure proper alignment of an endoscope;

(b) inserting said endoscope in said first conduit such that a distal end of said endoscope protrudes from said first distal nozzle, and orienting said endoscope such that a projection of said endoscope engages said endoscope locking feature formed in said wall of said first conduit;

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

(d) viewing said space by way of said endoscope;

(e) irrigating said space through said first conduit; and

,

(f) inflating said balloon to dilate said space.

15. The method of claim 14, 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.

16. A method of treating a patient'"'"'s nasal sinuses using a balloon catheter, wherein the balloon catheter comprises an oblong body, a first lumen, a second lumen, and a third lumen, wherein the oblong body has a proximal segment and a distal segment, wherein the oblong body further has an expandable balloon located on the distal segment, wherein the first lumen defines a first flow path, wherein the first lumen terminates at a first port distal to the balloon, wherein the second lumen is disposed about the first lumen such that a second flow path is defined between an exterior of the first lumen and an interior of the second lumen, wherein the second lumen terminates at a second port distal to the balloon, wherein the third lumen is laterally offset from the first and second lumens, wherein the third lumen defines a third flow path, wherein the third lumen terminates at a third port within the balloon, the method comprising:

(a) inserting a rigidizing member into the first lumen, wherein the first lumen defines a nozzle on a distal end of the first lumen such that the nozzle prevents the rigidizing member from protruding through the nozzle;

(c) pushing the distal segment into a space associated with a nasal sinus of said patient, wherein the balloon is in a deflated state during the act of pushing the distal segment;

(d) inflating the balloon to dilate the space, wherein the act of inflating the balloon comprises communicating fluid through the third flow path and through the third port into the balloon; and

(e) suctioning fluid and material from the space, wherein the act of suctioning fluid and material from the space comprises communicating suction through the second flow path and through the second port into the space;

wherein the space is selected from the group consisting of a prepared opening formed through the patient'"'"'s lateral nasal wall in the patient'"'"'s inferior meatus, a prepared opening formed in the patient'"'"'s ethmoid bulla;

an opening through the patient'"'"'s anterior wall of the patient'"'"'s sphenoid sinus;

an opening defined by the patient'"'"'s nasofrontal duct to the patient'"'"'s frontal sinus; and

a choana.