Balloon catheters and methods for treating paranasal sinuses

• US 9,457,175 B2
• Filed: 09/04/2015
• Issued: 10/04/2016
• 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:
  US14/845,622
• Publication Number:
  US 20160058990A1
• Time in Patent Office: 396 Days
• US Class Current: 1/1
• 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 using a dilator to treat a patient, wherein the dilator comprises:

(i) a first tubular elongate member body having a proximal segment and a distal segment,

(ii) a balloon mounted located at the distal segment of the first tubular elongate member body, and

(iii) a port located at the proximal segment of the first tubular elongate member body, wherein the port is configured to provide fluid under pressure to inflate the balloon;

wherein the method comprises;

(a) pushing the distal segment of the first tubular elongate member body via the proximal segment of the first tubular elongate member body to position the distal segment of the first tubular elongate member body into a space associated with a nasal sinus of the patient, wherein the balloon is in a deflated state during the act of pushing, the first tubular elongate member body having sufficient stiffness and column strength to be pushed into the space; and

(b) introducing fluid under pressure through the proximal segment of the first tubular elongate member body to inflate the balloon and dilate the space.

2. The method of claim 1, wherein the first tubular elongate member body has a bend placing the distal segment at an angle of 70°

to 115°

to the proximal segment.

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

.

4. The method of claim 1, wherein the space is a maxillary ostium of the patient'"'"'s maxillary sinus, wherein the act of introducing fluid under pressure through the proximal segment of the first tubular elongate member body to inflate the balloon and dilate the space comprises dilating the maxillary ostium being to complete antrostomy of the maxillary ostium.

5. The method of claim 4, further comprising:

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

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

wherein the acts of retracting the patient'"'"'s middle turbinate and exposing the patient'"'"'s ethmoid infundibulum are performed before the act of pushing the distal segment of the tubular elongate member.

6. The method of claim 1, further comprising preparing the space by forming an opening through the patient'"'"'s fontanelle, wherein the act of forming comprises:

(i) 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, and

(ii) pushing the punch through the fontanelle to create the opening through the fontanelle;

wherein the act of pushing the distal segment of the first tubular elongate member body comprises pushing the distal segment of the first tubular elongate member body via the proximal segment of the first tubular elongate member body to position the distal segment of the first tubular elongate member body into the formed opening through the patient'"'"'s fontanelle.

7. The method of claim 1, wherein the 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, further comprising:

(a) displacing the patient'"'"'s inferior turbinate medially;

(b) introducing a sharp dissector into the patient'"'"'s nasal cavity; and

(c) using the dissector to perforate the patient'"'"'s lateral nasal wall in the inferior meatus to form the prepared opening through the patient'"'"'s lateral nasal wall in the patient'"'"'s inferior meatus;

wherein the acts of displacing the patient'"'"'s inferior turbinate, introducing a sharp dissector, and using the dissector are performed before the act of pushing the distal segment of the tubular elongate member.

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

to 180°

to the proximal segment.

10. The method of claim 1, wherein the distal segment includes a slot, wherein the first tubular elongate member body is closed at a point distal to the slot.

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

12. The method of claim 11, further comprising:

(a) retracting the patient'"'"'s middle turbinate is medially 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 an anterior wall of the ethmoid bulla;

wherein the acts of retracting the patient'"'"'s middle turbinate, exposing the patient'"'"'s ethmoid infundibulum, and using a fine cutting forceps are performed before the act of pushing the distal segment of the tubular elongate member.

13. The method of claim 12, further comprising removing the ethmoid bulla.

14. The method of claim 13, further comprising, after removing the ethmoid bulla:

(a) pushing the distal segment of the first tubular elongate member body into one of the patient'"'"'s anterior ethmoid air cells lying posterior to the space formerly occupied by the ethmoid bulla,

(b) inflating the balloon to dilate the anterior ethmoid air cells and thereby remove the anterior ethmoid air cells;

(c) deflating the balloon; and

(d) removing the distal segment from the space formerly occupied by the anterior ethmoid air cell.

15. The method of claim 14, further comprising:

(a) perforating the patient'"'"'s basal lamella of the patient'"'"'s middle turbinate to form a second opening;

(b) pushing the distal segment of the first tubular elongate member body into a posterior ethmoid air cell;

(c) inflating the balloon is inflated to dilate and remove the posterior ethmoid cell;

(d) deflating the balloon; and

(e) removing the distal segment from the space formerly occupied by the posterior ethmoid air cell.

16. The method of claim 15, further comprising, after removing the distal segment from the space formerly occupied by the anterior ethmoid air cell and removing the distal segment from the space formerly occupied by the posterior ethmoid air cell:

(a) inserting the distal segment of the first tubular elongate member body through the patient'"'"'s anterior wall of the patient'"'"'s sphenoid sinus;

(b) inflating the balloon for dilation and removal of the sphenoid sinus;

(c) deflating the balloon; and

(d) removing the distal segment to complete sinusotomy of the sphenoid sinus.

17. The method of claim 14, further comprising, after removing the distal segment from the space formerly occupied by the anterior ethmoid air cell:

(a) providing a second balloon elongate member, wherein the second balloon elongate member comprises;

(i) a second tubular elongate member body having a proximal segment and a distal segment,

(ii) a balloon mounted located at the distal segment of the second tubular elongate member body, and

(iii) a port located at the proximal segment of the second tubular elongate member body, wherein the port is configured to provide fluid under pressure to inflate the balloon;

(b) pushing the distal segment of the second tubular elongate member body via the proximal segment of the second tubular elongate member body into a frontonasal duct, wherein the balloon of the second balloon elongate member is in a deflated state during the act of pushing the distal segment of the second tubular elongate member body;

(c) inflating the balloon of the second balloon elongate member to dilate the frontonasal duct;

(d) deflating the balloon of the second balloon elongate member; and

(e) removing the distal segment of the second tubular elongate member body to complete a frontal sinusotomy.

18. The method of claim 1, wherein the dilator comprises a catheter.