Medical device and method for treatment of a sinus opening

• US 9,554,817 B2
• Filed: 08/31/2011
• Issued: 01/31/2017
• Est. Priority Date: 09/22/2010
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Goldfarb, Eric A., Newhauser, Richard R. Jr., Jenkins, Thomas R., White, John W., Chow, Mina W. B., Loh, Serena Swei, Pader, Mei Y., Chamness, Scott O., Clauson, Luke W., Newell, Matthew B., Lin, Arthur M.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/222,353
• Publication Number:
  US 20120071856A1
• Time in Patent Office: 1,980 Days
• Field of Search: 606/196, 606/199, 606/191, 606/185, 606/198, 604/96.01, 604/514, 604/509, 600/104
• US Class Current: 1/1
• 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• 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: A61M 3/0295 with inflatable balloon

Abstract

A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism. The guide wire movement mechanism includes an integrated guide wire locking and rotation mechanism configured for rotation of the guide wire and for securely locking and unlocking the guide wire to the guide wire movement mechanism. The balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism.

Claims

1. A medical device for the treatment of a sinus opening, the medical device comprising:

a handle with;

a proximal end;

a distal end; and

a longitudinal axis along the length of the handle;

a guide wire;

a guide catheter attached to the distal end of the handle, the guide catheter having a guide catheter lumen;

a guide wire movement mechanism operatively disposed on the handle;

a balloon catheter;

and

a balloon catheter movement mechanism operatively disposed on the handle;

wherein the handle and the guide catheter lumen are configured for operatively accepting the guide wire and the balloon catheter; and

wherein the guide wire movement mechanism is configured for advancement and retraction of the guide wire disposed at least partially in the handle and the guide catheter lumen through the handle and the guide catheter lumen by user operation of the guide wire movement mechanism; and

wherein the guide wire movement mechanism includes an integrated guide wire locking and rotation mechanism configured for rotation of the guide wire by rotation of the guide wire locking and rotation mechanism relative to the guide wire movement mechanism and the handle, and for securely locking and unlocking the guide wire to the guide wire movement mechanism; and

wherein the guide wire movement mechanism comprises a proximal end and a distal end and a longitudinal axis between the proximal end and the distal end, said guide wire movement mechanism configured to direct the guide wire along the longitudinal axis of guide wire movement mechanism from the proximal end to the distal end of the guide wire movement mechanism and in a direction that is not along the longitudinal axis into the handle distal to the distal end of the guide wire movement mechanism; and

wherein the balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter disposed at least partially in the handle and in the guide catheter lumen through the handle and guide catheter lumen by user operation of the balloon catheter movement mechanism.

2. The medical device of claim 1 wherein the balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism involving translation of the balloon catheter movement mechanism relative to the handle.

3. The medical device of claim 2 wherein the balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism involving longitudinal sliding of the balloon catheter movement mechanism along the handle.

4. The medical device of claim 1 wherein the balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and catheter lumen by user operation of the balloon catheter movement mechanism involving rotation of at least a portion of the balloon catheter movement mechanism.

5. The medical device of claim 1 wherein the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and the catheter lumen by user operation of the guide wire movement mechanism involving translation of the guide wire movement mechanism relative to the handle.

6. The medical device of claim 1 wherein the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and the catheter lumen by user operation of the guide wire movement mechanism involving longitudinal sliding of the guide wire movement mechanism along the handle.

7. The medical device of claim 1 wherein the guide catheter is configured for attachment, detachment and reattachment to the handle.

8. The medical device of claim 1 further including a guide tip, and

wherein the guide tip is configured for attachment, detachment and reattachment of the guide tip to the guide catheter.

9. The medical device of claim 8 wherein the guide catheter and the guide tip are configured for attachment, detachment and reattachment of the guide catheter to the handle.

10. The medical device of claim 1 further comprising an irrigation system for irrigating the paranasal sinus or sinus canal.

11. The medical device of claim 1 further comprising a suction pathway for removal of materials from the paranasal sinus or sinus canal.

12. The medical device of claim 1 further including a guide wire support disposed within the handle,

wherein the guide wire is at least partially disposed within the guide wire support;

and

wherein the guide wire support is configured to prevent buckling of the guide wire within the handle during advancement of the guide wire through the handle.

13. The medical device of claim 12 wherein the guide wire support is generally cylindrical in shape and includes a slit-shaped opening;

and

wherein the slit-shaped opening is configured such that, during advancement of the guide wire, the guide wire enters the guide wire support through the slit-shaped opening.

14. The medical device of claim 1 wherein the guide wire locking and rotation mechanism includes:

a barrel with an axial opening therethrough; and

a collet axle at least partially disposed within the axial opening of the barrel.

15. The medical device of claim 1 wherein the guide wire movement mechanism further includes at least one rail configured for sliding movement of the guide wire mechanism along a length of the handle during advancement and retraction of the guide wire.

16. The medical device of claim 1 wherein the balloon catheter movement mechanism further includes at least one rail configured for sliding movement of the balloon catheter mechanism along a length of the handle during advancement and retraction of the balloon catheter.

17. The medical device of claim 1 wherein the guide wire movement mechanism and the balloon catheter movement mechanism are disposed on the handle in a configuration for single-handed operation of both the guide wire movement mechanism and the balloon catheter movement mechanism by a user.

18. The medical device of claim 17 wherein the guide wire movement mechanism and the balloon catheter movement mechanism are disposed on the handle in an in-line configuration along the length of the handle.

19. The medical device of claim 1 wherein the sinus opening is at least one of a Frontal sinus opening, Maxillary sinus opening, and Sphenoid sinus opening.

20. The medical device of claim 1 wherein the guide wire locking and rotation mechanism is configured for thumb-operated rotation of the guide wire.

21. The medical device of claim 1 wherein the guide wire locking and rotation mechanism is configured for single finger operated rotation of the guide wire.

22. The device of claim 1 wherein the guide wire is an illuminating guide wire.