Method and System for Eustachian Tube Dilation

• US 20130274715A1
• Filed: 03/14/2013
• Published: 10/17/2013
• Est. Priority Date: 04/13/2012
• Status: Abandoned Application

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Chan, Randy S., Ha, Hung V., Nguyen, Andy, Muni, Ketan P.
• Application Number:
  US13/826,454
• Publication Number:
  US 20130274715A1
• Time in Patent Office: Days
• US Class Current: 604/514
• 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 2017/00787 Surgery of the ear
• 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: A61F 11/20 Ear surgery
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/0675 Eustachian tube
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

A device and method for dilating a Eustachian tube of a patient is disclosed. The device includes a guide catheter and a balloon dilation catheter. The balloon dilation catheter has an actuator that prevents injury to the middle ear. The balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter. The method involves advancing the guide catheter and balloon dilation catheter through a nasal passage of the patient to dilate a portion of the Eustachian tube.

Claims

1. A device for dilating a Eustachian tube of a patient, the device comprising:

a guide catheter having an first elongate shaft, the first elongate shaft having a proximal end and a distal end and a lumen therebetween, the guide catheter having a proximal hub attached to the proximal end of the first elongate shaft; and

a balloon dilation catheter having a second elongate shaft, the second elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator for one-handed advancement of the catheter coupled to the second elongate shaft between the second elongate shaft proximal end and the second elongate shaft distal end and that separates the second elongate shaft into a proximal portion and a distal portion, the actuator having a proximal side and a distal side;

wherein the balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter.

2. The device of claim 1, wherein the balloon dilation catheter comprises an inflatable balloon and a proximal connecter, and wherein the proximal connector comprises an inflation port in fluid communication with an inflation lumen of the balloon catheter.

3. The device of claim 2, wherein the proximal connector further comprises an injection port.

4. The device of claim 3 wherein the inflation port comprises a first type of connector and the injection port comprises a second type of connector different from the first type of connector.

5. The device of claim 1, wherein the guide catheter elongate shaft has a bend with an angle of between about 45 degrees and about 65 degrees.

6. The device of claim 1, wherein the guide catheter elongate shaft has a bend with an angle of about 55.

7. The device of claim 1, wherein a distal end of the balloon dilatation catheter shaft has a bulbous tip.

8. The device of claim 1, wherein the balloon dilation catheter comprises:

a flexible proximal portion

a rigid middle portion; and

a flexible distal portion.

9. The device of claim 8, wherein the rigid distal portion comprises a hypotube.

10. A method for dilating a Eustachian tube of a patient, the method comprising:

advancing a guide catheter having an first elongate shaft, the first elongate shaft having a proximal end and a distal end and a lumen therebetween, the guide catheter having a proximal hub attached to the proximal end of the first elongate shaft through a nasal passage of the patient to position the guide catheter adjacent the Eustachian tube; and

advancing a balloon dilation catheter having a second elongate shaft and a balloon attached to the second elongate shaft, the second elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator coupled to the second elongate shaft between the second elongate shaft proximal end and the elongate shaft distal end and that separates the second elongate shaft into a proximal portion and a distal portion, the actuator having a proximal side and a distal side through the lumen of the guide catheter until the distal side of the actuator is adjacent to the proximal end of the guide catheter;

expanding the balloon to dilate a portion of the Eustachian tube;

collapsing the balloon; and

removing the guide catheter and balloon dilation catheter from the patient, wherein the dilated portion of the Eustachian tube remains at least partially dilated after removal of the device.

11. The method of claim 10, wherein the guide catheter includes a distal portion with bend of between about 45 degrees and about 65 degrees.

12. The method of claim 10, wherein the opening of the Eustachian tube comprises a pharyngeal ostium of the Eustachian tube, and wherein the balloon dilation catheter is advanced to position the balloon in the pharyngeal ostium.

13. The method of claim 10, further comprising:

advancing an endoscope through the nasal passage; and

viewing at least one of the advancing, expanding, collapsing or removing steps using the endoscope.

14. The method of claim 13, wherein viewing includes viewing a marker on the balloon dilation catheter, and wherein the method further comprises approximating a location of the balloon dilation catheter relative to the opening of the Eustachian tube based on a distance of the marker from a proximal end of the dilator.

15. The method of claim 10, further comprising applying at least one substance to the Eustachian tube using the balloon dilation catheter.

16. A method for dilating a Eustachian tube of a patient having a nostril, the method comprising:

advancing a balloon dilation catheter having an elongate shaft and a balloon attached to the elongate shaft, the elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator coupled to the elongate shaft between the elongate shaft proximal end and the elongate shaft distal end and that separates the elongate shaft into a proximal portion and a distal portion, the actuator having a proximal side and a distal side, through the nostril of the patient until the distal side of the actuator is adjacent to the nostril of the patient;

expanding the balloon to dilate a portion of the Eustachian tube;

collapsing the balloon; and

removing the balloon dilation catheter from the nostril of the patient, wherein the dilated portion of the Eustachian tube remains at least partially dilated after removal of the device.

17. The method of claim 16, wherein the opening of the Eustachian tube comprises a pharyngeal ostium of the Eustachian tube, and wherein the balloon dilation catheter is advanced to position the balloon in the pharyngeal ostium.

18. The method of claim 16, further comprising:

advancing an endoscope through the nasal passage; and

viewing at least one of the advancing, expanding, collapsing or removing steps using the endoscope.

19. The method of claim 16, wherein viewing includes viewing a marker on the balloon dilation catheter, and wherein the method further comprises approximating a location of the balloon dilation catheter relative to the opening of the Eustachian tube based on a distance of the marker from a proximal end of the dilator.

20. The method of claim 16, further comprising applying at least one substance to the Eustachian tube using the balloon dilation catheter.

21. The method of claim 20 wherein the substance is selected from the group consisting of contrast agents, antimicrobials, anesthetics, vasoconstrictors, analgesics, agent, a corticosteroids, anti-inflammatories, decongestants, mucous thinners, expectorants, mucolytics, surfactants, antihistamines, cytokine inhibitors, leucotriene inhibitors, IgE inhibitors, immunomodulators, allergens, hemostatic agents, antiproliferatives, cytotoxic agents, proteins, stem cells, genes and gene therapy preparations

22. A device for dilating a Eustachian tube of a patient, the device comprising:

a guide catheter having a first elongate shaft, the first elongate shaft having a proximal end and a distal end and a lumen therebetween, the guide catheter having a proximal hub attached to the proximal end of the elongate shaft; and

a balloon dilation catheter having a second elongate shaft, the second elongate shaft having a proximal end and a distal end, the balloon dilation catheter having an actuator for one-handed advancement of the catheter coupled to the second elongate shaft between the second elongate shaft proximal end and the second elongate shaft distal end and that separates the second elongate shaft into a proximal portion and a distal portion;

wherein the balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted through the guide catheter lumen when the actuator is fully deployed.

23. The device of claim 22 wherein the proximal hub comprises a handle.

24. A device for accessing the Eustachian tube through the nose of a human patient, said device comprising:

a guide catheter comprising an elongate shaft has a bend angle of between about 45 degrees and about 65 degrees, and having a proximal end and a distal end and a lumen therebetween, and a proximal hub attached to the proximal end of the elongate shaft;

wherein the proximal hub is positioned on the elongate shaft such that when the guide catheter is positioned fully within the nose of the human patient, the proximal hub abuts the nose of the human patient.

25. The device of claim 24 wherein the lumen of the elongate shaft is further adapted for delivering at least one substance therethrough.

26. A balloon dilation catheter for accessing and treating the Eustachian tube through the nose of a human patient, said the balloon dilation catheter comprising:

an elongate shaft, the elongate shaft having a proximal end and a distal end and inflation lumen therebetween;

an actuator for one-handed advancement of the catheter coupled to the elongate shaft between the elongate shaft proximal end and the elongate shaft distal end, the actuator positioned on the elongate shaft such that when the balloon dilation catheter is positioned fully within the nose of the human patient, the actuator abuts the nose of the human patient;

an inflatable balloon; and

a proximal connecter comprising an inflation port in fluid communication with an inflation lumen of the elongate shaft and an injection port.

27. The catheter of claim 26 wherein the inflation port comprises a first type of connector and the injection port comprises a second type of connector different from the first type of connector.