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

• US 10,842,978 B2
• Filed: 10/10/2018
• Issued: 11/24/2020
• 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, Manuel A
• Application Number:
  US16/156,112
• Publication Number:
  US 20190105480A1
• Time in Patent Office: 776 Days
• 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 of dilating an opening within a nose, ear, or throat of a human or animal subject, said method comprising the steps of:

(A) providing a balloon and a non-removable guide member, wherein the balloon comprises a distal end, wherein the balloon defines a longitudinal axis, wherein the non-removable guide member extends distally from the distal end of the balloon, wherein the non-removable guide member is configured to bend relative to the longitudinal axis of the balloon;

(B) inserting a distal portion of the non-removable guide member to pass through the opening within the nose, ear, or throat;

(C) moving the balloon to a location where the balloon is positioned within the opening within the nose, ear, or throat; and

(D) inflating the balloon to cause dilation of the opening within the nose, ear, or throat.

2. The method of claim 1, wherein the inserting a distal portion of the non-removable guide member to pass through the opening within the nose, ear, or throat further comprises inserting the distal portion of the non-removable guide member to pass through an ostium of a paranasal sinus.

3. The method of claim 2, wherein the inserting the distal portion of the non-removable guide member to pass through an ostium of a paranasal sinus further comprises inserting the distal portion of the non-removable guide member to pass through the ostium of a maxillary sinus.

4. The method of claim 2, wherein prior to the 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.

5. The method of claim 4, wherein Step B further comprises inserting the non-removable guide member to pass through the opening of the paranasal sinus.

6. The method of claim 1, wherein the inserting a distal portion of the non-removable guide member to pass through the opening within the nose, ear, or throat further comprises inserting the distal portion of the non-removable guide member to pass through the opening into a Eustachian tube.

7. The method of claim 1, wherein the inserting a distal portion of the non-removable guide member to pass through the opening within the nose, ear, or throat further comprises inserting the distal portion of the non-removable guide member to pass through the opening into a larynx.

8. The method of claim 1, wherein the inserting a distal portion of the non-removable guide member to pass through the opening within the nose, ear, or throat further comprises inserting the distal portion of the non-removable guide member to pass through the opening into a choana.

9. The method of claim 1, wherein providing the non-removable guide member further comprises providing a non-removable guide member comprising a guidewire.

10. The method of claim 9, wherein providing the guidewire further comprises providing a core wire and an outer coil.

11. The method of claim 10, wherein providing the guidewire further comprises providing an inner coil.

12. The method of claim 10, wherein providing the core wire further comprises providing a proximal portion, a distal portion, and a tapered portion between the proximal portion and the distal portion.

13. The method of claim 1, wherein providing the balloon further comprising a providing an elongated flexible catheter shaft attached to the balloon.

14. The method of claim 13, wherein providing the balloon and elongated flexible catheter shaft further comprises providing a proximal luer hub attached to the elongated flexible catheter shaft.

15. The method of claim 13, wherein providing the balloon and elongated flexible catheter shaft further comprises providing a marker attached to the elongated flexible catheter shaft.

16. A method of dilating an opening within a nose, ear, or throat of a human or animal subject, said method comprising the steps of:

(A) providing a device comprising a balloon and a guidewire non-removably attached to the balloon, wherein the guidewire extends distally from a distal end of the balloon, wherein the balloon defines a longitudinal axis, wherein the guidewire is configured to bend relative to the longitudinal axis of the balloon;

(B) inserting a distal portion of the guidewire to pass through the opening within the nose, ear, or throat;

(C) moving the balloon to a location where the balloon is at least partially positioned through the opening within the nose, ear, or throat; and

(D) inflating the balloon to cause dilation of the opening within the nose, ear, or throat.

17. The method of claim 16, wherein providing the device further comprises an elongated flexible catheter shaft attached to the balloon.

18. The method of claim 17, wherein providing the device further comprises a luer in fluid communication with the balloon.

19. A method of dilating an opening within a nose, ear, or throat of a human or animal subject, said method comprising the steps of:

(A) providing a balloon and a flexible guidewire non-removably attached to the balloon, wherein the flexible guidewire extends distally from a distal end of the balloon, wherein the balloon defines a longitudinal axis;

(B) inserting a distal portion of the flexible guidewire to pass through the opening within the nose, ear, or throat;

(C) moving the balloon through the opening within the nose, ear, or throat to a desired location; and

(D) inflating the balloon to cause dilation of the opening within the nose, ear, or throat.

20. The method of claim 19, wherein providing the flexible guidewire further comprises providing the flexible guidewire comprising an inner core and an outer coil.