Medical device and method for treatment of a sinus opening

• US 10,383,992 B2
• Filed: 01/09/2017
• Issued: 08/20/2019
• 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, Jr., Richard R., 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): Carpenter, William R
• Application Number:
  US15/402,104
• Publication Number:
  US 20170120019A1
• Time in Patent Office: 953 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: 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 handle has proximal and distal ends and a longitudinal axis along the length of the handle. The guide catheter is attached to the distal end of the handle and has a catheter lumen. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism and the balloon catheter movement mechanism are both operatively disposed on the handle. In addition, 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. Moreover, 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. Furthermore, 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 method for treating a sinus opening, the method comprising:

(a) inserting a medical device for the treatment of a sinus opening partially into a patient'"'"'s anatomy, wherein the medical device includes;

(i) a handle having a proximal end and a distal end,

(ii) a guide wire integrated with the handle,

(iii) a guide wire movement mechanism slidably positioned between the proximal end of the handle and the distal end of the handle,

(iv) a guide wire locking and rotation mechanism integrated with the guide wire movement mechanism,

(v) a balloon catheter, and

(vi) a balloon catheter movement mechanism positioned between the proximal end of the handle and the distal end of the handle;

(b) positioning the medical device in the sinus opening;

(c) advancing a guide wire of the medical device into the patient'"'"'s sinus via user operation of the guide wire movement mechanism of the medical device, wherein the balloon catheter movement mechanism and the guide wire movement mechanism remain positioned between the proximal end of the handle and the distal end of the handle during the act of advancing the guide wire;

(d) rotating the guide wire within the patient'"'"'s anatomy via user operation of the guide wire locking and rotation mechanism of the guide wire movement mechanism;

(e) repeating the guide wire advancing and rotating steps to position the guide wire in the sinus opening;

(f) advancing a balloon catheter of the medical device along the guide wire via user operation of the balloon catheter movement mechanism of the medical device, wherein the balloon catheter movement mechanism and the guide wire movement mechanism remain positioned between the proximal end of the handle and the distal end of the handle during the act of advancing the balloon catheter; and

(g) treating the sinus opening via inflation of the balloon catheter.

2. The method of claim 1 wherein the advancing of the guide wire includes user operation of the guide wire movement mechanism involving translation of the guide wire movement mechanism relative to the handle.

3. The method of claim 1 wherein the advancing of the guide wire includes user operation of the guide wire movement mechanism involving longitudinal sliding of a rail of the guide wire movement mechanism along the handle.

4. The method of claim 1 wherein the advancing of the balloon catheter includes user operation of the balloon catheter movement mechanism involving translation of the balloon catheter movement mechanism relative to the handle.

5. The method of claim 1 wherein the advancing of the balloon catheter includes user operation of the balloon catheter movement mechanism involving longitudinal sliding of the balloon catheter movement mechanism along handle.

6. The method of claim 5 wherein the guide wire locking and rotation mechanism is configured for thumb-operated rotation of the guide wire.

7. The method of claim 1 further including:

attaching, prior to the inserting step, a detachable guide tip to the medical device in an orientation configured to guide the guide wire and the balloon catheter into the sinus opening to be treated.

8. The method of claim 1 further including:

attaching, prior to the inserting step, a detachable guide catheter to the medical device in an orientation configured to guide the guide wire and the balloon catheter into the sinus opening to be treated.

9. The method of claim 1 wherein the patient'"'"'s anatomy is a nostril.

10. The method of claim 1 wherein the sinus opening is one of a Frontal sinus opening, Maxillary sinus opening, and Sphenoid sinus opening.

11. The method 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 user operation of both the guide wire movement mechanism and the balloon catheter movement mechanism by a user.

12. The method of claim 11 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.

13. The method of claim 1 further including irrigating the sinus opening using the medical device.

14. The method of claim 13 wherein the irrigating is accomplished using an irrigation cartridge installed in the medical device.

15. The method of claim 13 wherein the irrigating is accomplished using an irrigation balloon catheter incorporated into the medical device.

16. The method of claim 1 further including suctioning the sinus opening using the medical device.

17. A method of treating an anatomical passageway within a head of a patient, the anatomical passageway being selected from the group consisting of the nasal anatomy, the paranasal sinus ostium, a paranasal sinus, and a Eustachian tube opening, the method comprising:

inserting a guide into a head of a patient, the guide extending distally from a handle assembly of a medical device, the handle assembly including;

(i) a body,

(ii) a first actuator, the first actuator being integrated with the body, wherein the first actuator is movable relative to the body,

(iii) a second actuator, the second actuator being movably coupled with the first actuator such that the second actuator is movable relative to the first actuator and relative to the body, and

(iv) a third actuator, the third actuator being integrated with the body, wherein the third actuator is movable relative to the body;

advancing a guide wire of the medical device into the head of the patient, the act of advancing a guide wire of the medical device into the head of the patient including moving the first actuator relative to the body of the handle assembly;

rotating the guide wire within the head of the patient, the act of rotating the guide wire within the head of the patient including rotating the second actuator relative to the first actuator and relative to the body of the handle assembly;

advancing the guide wire into the anatomical passageway, the act of advancing the guide wire into the anatomical passageway including moving the first actuator relative to the body of the handle assembly;

advancing a dilation catheter of the medical device along the guide wire into the anatomical passageway, the act of advancing the dilation catheter of the medical device along the guide wire into the anatomical passageway including moving the third actuator relative to the body of the handle assembly; and

expanding a dilator of the dilation catheter to thereby dilate the anatomical passageway.

18. The method of claim 17, wherein the second actuator comprises barrel and collet axle, wherein the barrel is operable to translate relative to the collet axle to selectively lock the guide wire relative to the second actuator.

19. The method of claim 17, wherein the third actuator is positioned proximally in relation to the first and second actuators.