Deflectable guide catheters and related methods

• US 10,188,413 B1
• Filed: 05/16/2007
• Issued: 01/29/2019
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Morriss, John H., Makower, Joshua, Pader, Mei, Vrany, Julia D., Goldfarb, Eric, Chan, Randy S.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Wilson, Larry R
• Application Number:
  US11/804,308
• Time in Patent Office: 4,276 Days
• Field of Search: 604 9501, 604 9503- 9505, 604158, 60416401, 60416403, 604528, 604534
• 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 2017/00305 Constructional details of the flexible means
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• 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 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0155 with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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

Abstract

Deflectable guide catheters and methods, including methods for using defectable guide catheters to perform transnasal procedures within the ear, nose, throat, paranasal sinuses or cranium. Some deflectable guide catheters of the present invention comprise a substantially rigid tube, a helical spring attached to and extending from the distal end of the substantially rigid tube, a tubular plastic inner jacket, an outer plastic jacket substantially covering at least the helical spring member. The spring member is deflectable to cause the distal portion of the guide catheter to deflect to a curved configuration. In embodiments for transnasal use the deflectable guide catheter may have a length of less than 25 cm.

Claims

1. A method comprising:

(a) advancing a guide catheter into a head of a patient along a first path through a nostril of the patient in a first direction, wherein the guide catheter comprises a longitudinally extending distal deflection portion, wherein the distal deflection portion of the guide catheter comprises a lumen extending therethrough to a distal opening and a resilient member, wherein the resilient member biases the lumen of the distal deflection portion to a first configuration;

(b) providing a proximal assembly coupled with the guide catheter and a pull member connected to a distal end of the resilient member, wherein the proximal assembly is located outside the patient'"'"'s body when the distal deflection portion of the guide catheter is in the head of the patient, wherein the proximal assembly comprises a control member operatively connected to the pull member, wherein the control member is configured to proximally pull the pull member and the resilient member connected thereto in order to deflect the lumen of the distal deflection portion from the first configuration to a second configuration;

(c) positioning the distal deflection portion of the guide catheter at or near a desired location of a first anatomical structure within the head of the patient, wherein the head of the patient has an anatomy with the first anatomical structure defining a passageway, wherein the first anatomical structure prevents access to a second anatomical structure within the head via the first path;

(d) retracting the control member proximally to proximally pull the pull member in conjunction with the resilient member to thereby deflect the lumen of the distal deflection portion from the first configuration to the second configuration;

(e) moving the distal opening of the guide catheter along a second path in a second direction transverse to the first direction such that the distal deflection portion advances around the first anatomical structure of the anatomy such that the distal deflection portion is in contact with the first anatomical structure of the anatomy about the passageway and the distal opening aligns with the passageway of the anatomy; and

(f) advancing a guidewire through the deflected lumen of the guide catheter to contact or pass through the desired location and the second anatomical structure.

2. A method according to claim 1, wherein the guide catheter is deflected before it is advanced into the nostril.

3. A method according to claim 1, wherein the distal deflection portion of the guide catheter is positioned at or near the desired location before the wide catheter is deflected.

4. A method according to claim 1, wherein positioning the distal deflection portion comprises further advancing the guide catheter after it has been deflected.

5. A method according to claim 1, further comprising deflecting the lumen of the distal deflection portion from the second configuration to a third configuration, wherein the first configuration comprises one curve in the distal portion and the second configuration comprises two curves in the distal portion.

6. A method according to claim 1, wherein the desired location comprises a maxillary sinus ostium and wherein advancing the guide catheter comprises advancing the distal deflection portion past a uncinate process in a nasal cavity in the head of the patient, wherein the deflected lumen of the distal deflection portion of the guide catheter causes the distal deflection portion to curve around the uncinate process, and wherein positioning the distal deflection portion of the guide catheter comprises advancing the guide catheter to a position where the distal deflection portion is adjacent to or within the maxillary sinus ostium.

7. A method according to claim 6, wherein the distal deflection portion of the guide catheter forms a curve of from about 0 degrees to about 90 degrees in the first configuration, and wherein the distal deflection portion forms a curve of from about 90 degrees to about 110 degrees in the second configuration.

8. A method according to claim 1, wherein the desired location comprises a frontal sinus ostium and wherein advancing the guide catheter comprises advancing the distal deflection portion into a frontal sinus outflow tract, wherein the deflected lumen of the distal deflection portion of the guide catheter causes the distal deflection portion to curve, and wherein positioning the distal deflection portion of the guide catheter comprises advancing the guide catheter to a position where the distal deflection portion is adjacent to or within the frontal sinus ostium.

9. A method according to claim 8, wherein the distal deflection portion of the guide catheter forms a curve of from about 0 degrees to about 60 degrees in the first configuration, and wherein the distal portion forms a curve of from about 60 degrees to about 90 degrees in the second configuration.

10. A method according to claim 1 wherein the desired location is selected from the group consisting of a natural ostium of a paranasal sinus, a man-made opening into a paranasal sinus, a paranasal sinus, a Eustachian tube, an opening into an Eustachian tube, and a nasolacrimal duct.

11. A method according to claim 1, wherein the lumen of the distal deflection portion of the guide catheter is deflected to form an angle in the distal deflection portion of between about 1 degree and about 115 degrees.

12. A method according to claim 1, further comprising providing a second catheter, wherein the second catheter comprises a dilator and wherein the method further comprises using the dilator to dilate the second anatomical structure.

13. A method according to claim 12, wherein the dilator comprises a balloon.

14. A method according to claim 12, wherein the second anatomical structure comprises an opening of a paranasal sinus.

15. A method according to claim 1, further comprising using a scope coupled with the guide catheter to view one or more anatomical structures.

16. A method according to claim 1, further comprising removing the guide catheter from the patient'"'"'s nostril, wherein, prior to or during removal of the guide catheter from the patient'"'"'s nostril, the method further comprises deflecting the lumen of the distal deflection portion of the guide catheter from the second configuration to a third configuration.

17. A method according to claim 16, wherein the third configuration is substantially the same as the first configuration.

18. The method of claim 1, wherein the distal deflection portion has a decreasing outer diameter to the distal opening.

19. A method comprising:

(a) advancing a guide catheter into a head of the patient along a first path through a nostril of a patient;

(b) providing a deflection member coupled with the guide catheter, wherein the deflection member is configured to deflect a distal portion of the guide catheter from a first configuration to a second configuration;

(c) positioning a distal end of the guide catheter at or near a first anatomical structure within the head that defines a passageway, wherein the distal end has a distal opening, wherein the first anatomical structure prevents access to a second anatomical structure within the head via the first path;

(d) using the deflection member coupled with the guide catheter to deflect the distal portion of the guide catheter from the first configuration to the second configuration;

(e) advancing the distal portion of the guide catheter along a second path into a position around the first anatomical structure such that the distal portion of the guide catheter is in contact with the first anatomical structure about the passageway and the distal opening aligns with the passageway of the first anatomical structure, wherein the second path is generally transverse to the first path; and

(f) advancing a guidewire through the guide catheter to contact or pass through or into the second anatomical structure.