Catheters with non-removable guide members useable for treatment of sinusitis

• US 10,124,154 B2
• Filed: 12/11/2014
• Issued: 11/13/2018
• Est. Priority Date: 06/10/2005
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Evard, Philip C., Muni, Ketan P., Morriss, John H., Chang, John Y
• Primary Examiner(s): Mendez, Manual
• Application Number:
  US14/567,051
• Publication Number:
  US 20150165175A1
• Time in Patent Office: 1,433 Days
• Field of Search: 604514, 604 9601, 6041031, 606196
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Balloon catheter, guide catheter and method for dilating openings in paranasal sinuses. A non-removable guide member (e.g., guidewire) extends from the distal end of the balloon catheter. The non-removable guide member initially passes through the opening of the paranasal sinus and is followed by the catheter body on which the balloon is mounted. The balloon is then inflated causing dilation of the opening of the paranasal sinus. In some embodiments, the non-removable guide member may be shapeable so that the operator may place the non-removable guide member in a desired shape prior to insertion of the balloon catheter. In some embodiments, the length of the non-removable guide member may be adjustable such that the operator may adjust the length of the non-removable guide member prior to insertion of the balloon catheter.

Claims

1. A method for dilating an opening of a paranasal sinus in a human or animal subject, said method comprising the steps of:

A) providing a balloon catheter comprising a distal end, a balloon that extends along a longitudinal axis, and a non-removable guide member that extends from the distal end of the catheter, wherein the non-removable guide member is configured to bend relative to the longitudinal axis of the balloon;

B) trans-nasally inserting the balloon catheter and causing a distal portion of the non-removable guide member to pass through an opening of the paranasal sinus;

C) moving the balloon catheter to a location where the balloon is positioned within the opening of the paranasal sinus; and

D) inflating the balloon to cause dilation of the opening of the paranasal sinus.

2. A method according to claim 1 wherein, prior to performance of Steps B-D, a guide catheter having a distal end is inserted trans-nasally and positioned adjacent to the opening of the paranasal sinus and wherein Step B comprises inserting the balloon catheter through the guide catheter and causing the non-removable guide member to pass through the opening of the paranasal sinus.

3. A method according to claim 2, wherein the guide catheter has a curved portion and wherein the method further comprises advancing the curved portion of the guide catheter around an existing anatomical structure to facilitate placement of the guide catheter adjacent to the opening of the paranasal sinus, wherein the curved portion has a curve of about 70 degrees to about 135 and wherein the curve is advanced around the uncinate process such that the distal end of the guide catheter becomes positioned within or adjacent to an opening into a maxillary sinus.

4. A method according to claim 2, wherein the guide catheter has a curved portion and wherein the method further comprises advancing the curved portion of the guide catheter around an existing anatomical structure to facilitate placement of the guide catheter adjacent to the opening of the paranasal sinus, wherein the curved portion has a curve of 30 degrees to about 100 degrees and wherein the curve is advanced around the frontal recess such that the distal end of the guide catheter becomes positioned within or adjacent to an opening into a frontal sinus.

5. A method according to claim 2, wherein the guide catheter has a curved portion and wherein the method further comprises advancing the curved portion of the guide catheter around an existing anatomical structure to facilitate placement of the guide catheter adjacent to the opening of the paranasal sinus, wherein the curved portion has a curve of 0 degrees to about 45 degrees and wherein the guide catheter is advanced to a position where the distal end of the guide catheter becomes positioned within or adjacent to an opening into a sphenoid sinus.

6. A method according to claim 2 further comprising the steps of deflating the balloon, removing the balloon catheter and introducing another device through the guide catheter.

7. A method according to claim 2 wherein the balloon catheter further comprises an endoscopically visualizable marker located near the proximal end of the balloon and the method further comprises the step of visualizing the position of the endoscopically visualizable marker to ensure that the balloon has completely exited the distal end of the guide catheter.

8. A method according to claim 1 wherein the method is carried out to dilate the natural ostium of a maxillary sinus of an adult human subject and wherein Step D comprises inflating the balloon to a diameter of about 3 mm to about 10 mm.

9. A method according to claim 1 wherein the method is carried out to dilate an opening of a maxillary sinus that has previously been medically or surgically altered in an adult human subject and wherein Step D comprises inflating the balloon to a diameter of about 7 mm to about 30 mm.

10. A method according to claim 1 wherein the method is carried out to dilate the natural ostium of a frontal sinus in an adult human subject and wherein Step D comprises inflating the balloon to a diameter of about 3 mm to about 10 mm.

11. A method according to claim 1 wherein the method is carried out to dilate an opening of a frontal sinus that has previously been medically or surgically altered in an adult human subject and wherein Step D comprises inflating the balloon to a diameter of about 3 mm to about 30 mm.

12. A method according to claim 1 wherein the method is carried out to dilate the natural ostium of a sphenoid sinus in an adult human subject and wherein Step D comprises inflating the balloon to a diameter of about 3 mm to about 10 mm.

13. A method according to claim 1 wherein the method is carried out to dilate an opening of a sphenoid sinus that has previously been medically or surgically altered in an adult human subject and wherein Step D comprises inflating the balloon to a diameter of about 3 mm to about 30 mm.

14. A method according to claim 1 wherein the method is carried out to dilate the natural ostium of an ethmoid sinus in an adult human subject and wherein Step D comprises inflating the balloon to a diameter of about 3 mm to about 12 mm.

15. A method according to claim 1 wherein the method is carried out to dilate an opening of an ethmoid sinus that has previously been created or altered by a prior medical or surgical procedure and wherein Step D comprises inflating the balloon to a diameter of about 3 mm to about 20 mm.

16. A method according to claim 1 wherein the balloon catheter further comprises at least one position indicating element useable to determine when the balloon is positioned within the opening of the paranasal sinus and wherein the method further comprises:

using said at least one position indicating element to determine when the balloon is positioned within the opening of the paranasal sinus.

17. A method according to claim 16 wherein the non-removable guide member extends through the portion of the catheter shaft on which the balloon is located and wherein said at least one position indicating element comprises one or more radiographically visible members that indicate the position of the balloon and wherein the step of using said at least one position indicating element to determine when the balloon is positioned within the opening of the paranasal sinus comprises radiographically imaging the one or more radiographically visible members on the non-removable guide member.

18. A method according to claim 1 wherein at least a portion of the non-removable guide member is shapeable and wherein the method further comprises the step of imparting a shape to the shapeable region of the non-removable guide member.

19. A method for dilating an opening of a paranasal sinus in a human or animal subject, said method comprising the steps of:

A) providing;

i) a balloon catheter comprising a balloon with a distal end and a non-removable guide member that extends from the distal end of the balloon, and

(ii) a guide catheter comprising a curved portion and a distal end;

B) trans-nasally inserting the distal end of the guide catheter to a position adjacent to an opening of the paranasal sinus;

C) advancing the balloon catheter within the guide catheter and causing a distal portion of the non-removable guide member to pass through the curved portion and the distal end of the guide catheter into the opening of the paranasal sinus;

D) advancing the balloon catheter to a location where the balloon is positioned within the opening of the paranasal sinus; and

E) inflating the balloon to cause dilation of the opening of the paranasal sinus.

20. A method for dilating an opening of a paranasal sinus in a human or animal subject, said method comprising the steps of:

A) providing a balloon catheter comprising a distal end, a balloon and a non-removable guide member that extends from the distal end of the balloon catheter;

B) trans-nasally inserting the balloon catheter and causing a distal portion of the non-removable guide member to pass through an opening of the paranasal sinus and bend relative to the distal end of the balloon catheter;

C) moving the balloon catheter to a location where the balloon is positioned within the opening of the paranasal sinus; and

D) inflating the balloon to cause dilation of the opening of the paranasal sinus.