Systems and methods for sinus access

• US 10,688,289 B2
• Filed: 06/10/2019
• Issued: 06/23/2020
• Est. Priority Date: 06/12/2018
• Status: Active Grant

• Current Assignee: Intersect ENT International GmbH (Baxter International Inc.)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Finson, Sean, Stankus, John Joseph
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US16/436,363
• Publication Number:
  US 20190374751A1
• Time in Patent Office: 379 Days
• Field of Search: 600249, 600178, 600104, 600137, 606193, 606167, 606170, 606191, 606 2, 606 3
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

This application is generally related to systems and methods for accessing the paranasal sinuses and other passages of the nose, ear, and throat. The systems and methods generally employ devices capable of maintaining a fixed handle orientation with respect to the patient while generating the appropriate applicator deflection angle required to rotationally align or orient the applicator tip to the intended target tissue/anatomy for treatment. Methods are also described for deploying drug delivery devices within these body structures using the systems to treat medical conditions associated therewith.

Claims

1. A system for accessing and dilating one or more target tissue sites associated with a paranasal sinus, comprising:

a delivery device, comprising;

an applicator, the applicator having a proximal end, a deflectable distal end, a distal tip, a device lumen, and a pullwire lumen;

a handle, mechanically coupled to the applicator proximal end and having a first fluid connection port;

an expandable member configured to move through the device lumen to a position at or adjacent to the deflectable distal end, and having an interior volume in fluid communication with the first fluid connection port;

an adjustment knob rotatably coupled to, and concentrically disposed about, the applicator proximal end; and

a pullwire having a proximal end and a distal end, extending through the pullwire lumen, where the pullwire distal end is attached to the applicator distal tip and the pullwire proximal end is coupled to the adjustment knob; and

an inflation and deflation device, comprising;

a syringe barrel, having a second fluid connection port, the second fluid connection port configured to be in fluid communication with the first fluid connection port;

a plunger arranged to reversibly move a length within the syringe; and

a locking mechanism configured to limit the length the plunger can depress within the syringe.

2. The system of claim 1, wherein the adjustment knob is configured to rotate to deflect the deflectable distal end of the applicator to a deflection angle that provides access to the target tissue site.

3. The system of claim 1, wherein the expandable member further comprises a drug coating, the drug coating including a therapeutic agent, wherein the therapeutic agent comprises mometasone furoate or pharmaceutically acceptable salts, solvates, hydrates, esters, free base, enantiomers, racemates, polymorphs, amorphous, or crystal forms thereof.

4. The system of claim 1, wherein the inflation and deflation device further comprises a housing, wherein the locking mechanism comprises a pair of pawls configured to extend outward and physically interface with the housing.

5. A system for accessing one or more target tissue sites associated with a paranasal sinus, comprising:

an applicator, the applicator having a proximal end, a deflectable distal end, a distal tip, a device lumen, and a pullwire lumen;

a handle mechanically coupled to the applicator proximal end;

an adjustment knob rotatably coupled to, and concentrically disposed about, the applicator proximal end; and

a pullwire having a proximal end and a distal end, extending through the pullwire lumen, where the pullwire distal end is attached to the applicator distal tip and the pullwire proximal end is coupled to the adjustment knob.

6. The system of claim 5, wherein the adjustment knob is configured to rotate to deflect the deflectable distal end of the applicator to a deflection angle that provides access to the target tissue site.

7. The system of claim 5, wherein the handle includes a first fluid connection port and wherein the system further comprises an expandable member configured to move through the device lumen to a position at or adjacent to the deflectable distal end, and having an interior volume in fluid communication with the first fluid connection port.

8. The system of claim 5, further comprising a guidewire, wherein the handle further comprises a housing and an elongate slot disposed within the housing, the elongate slot having a travel length, and a finger slide coupled to the guidewire and movable along the travel length to advance the guidewire through the applicator.

9. The system of claim 8, wherein the guidewire further comprises two or more optical fibers arranged in a braided arrangement, and a flexible metal wire.

10. The system of claim 7, wherein the expandable member further comprises a drug coating, the drug coating including a therapeutic agent, wherein the therapeutic agent comprises mometasone furoate or pharmaceutically acceptable salts, solvates, hydrates, esters, free base, enantiomers, racemates, polymorphs, amorphous, or crystal forms thereof.

11. The system of claim 6, wherein the deflection angle ranges from about 0 degrees to about 120 degrees.

12. The system of claim 5, wherein the target tissue sites comprises a paranasal sinus ostium, a paranasal sinus cavity, a paranasal sinus passageway, or a combination thereof, and wherein the paranasal sinus is a maxillary sinus, a frontal sinus, a sphenoid sinus, or an ethmoid sinus.

13. The system of claim 5, wherein the applicator has an outside diameter ranging from about 2 mm to about 10 mm.

14. A method for accessing one or more target tissue sites associated with a paranasal sinus, comprising:

advancing a system to the target tissue site, wherein the system comprises;

an applicator comprising a proximal end, a distal end, a device lumen, a pullwire lumen, and an expandable device;

a handle fixedly attached to the applicator proximal end;

a single pullwire attached to the applicator distal tip and extending proximally through the pullwire lumen;

a guidewire; and

an adjustment knob concentrically disposed about the applicator proximal end;

deflecting the distal end of the applicator to a deflection angle by retracting the single pullwire;

accessing the target tissue site with the applicator at the deflection angle;

advancing the expandable device within the device lumen and over the guidewire; and

expanding the device to contact the target tissue site of the paranasal sinus.

15. The method of claim 14, wherein rotating the adjustment knob linearly translates the pullwire.

16. The method of claim 14, further comprising adjusting the deflection angle of the deflectable distal end of the applicator by rotating the adjustment knob.

17. The method of claim 14, further comprising locking the deflection angle of the applicator and subsequently unlocking the deflection angle of the applicator.

18. The method of claim 17, further comprising adjusting the deflection angle when a different target tissue site is accessed.

19. The method of claim 14, wherein the deflection angle ranges from about 0 degrees to about 120 degrees.

20. The method of claim 14, wherein the system further comprises an inflation and deflation device comprising:

a housing;

a syringe barrel, having a second fluid connection port, the second fluid connection port configured to be in fluid communication with the first fluid connection port;

a plunger arranged to reversibly move a length within the syringe; and

a locking mechanism configured to limit the length the plunger can depress within the syringe.

21. The method of claim 20, wherein the locking mechanism comprises a pair of pawls configured to extend outward and physically interface with the housing.

22. The method of claim 14, wherein repeating the steps of advancing the device over the guidewire and expanding the device occurs at the same or different target tissue site of the paranasal sinus.

23. The method of claim 14, wherein contact of the expandable device to the target tissue site delivers a therapeutic agent to the target tissue site.

24. The method of claim 20, wherein the expandable device comprises an expandable balloon having a drug coating.

25. The method of claim 24, wherein the drug coating comprises mometasone furoate or pharmaceutically acceptable salts, solvates, hydrates, esters, free base, enantiomers, racemates, polymorphs, amorphous, or crystal forms thereof.

26. The method of claim 24, further comprising using a protection mechanism to minimize loss of the drug coating while accessing the target tissue site.

27. The method of claim 26, wherein the protection mechanism comprises deployment of the expandable balloon through an applicator having a flared distal end and/or deployment of the expandable balloon through a device lumen formed of or coated with a lubricious polymer.

28. The method of claim 14, wherein the target tissue site comprises a paranasal sinus ostium, a paranasal sinus cavity, a paranasal sinus passageway, or a combination thereof, and wherein the paranasal sinus is a maxillary sinus, a frontal sinus, a sphenoid sinus, or an ethmoid sinus.