Shapeable guide catheters and related methods

• US 9,700,326 B2
• Filed: 04/30/2014
• Issued: 07/11/2017
• 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., Pader, Mei
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US14/265,888
• Publication Number:
  US 20140330074A1
• Time in Patent Office: 1,168 Days
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/1657 Bone breaking devices
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/16 Bite blocks
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0012 : with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• 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 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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

Abstract

Shapeable guide catheters and methods for manufacturing and using such shapeable guide catheters. In one embodiment, the shapeable guide catheter comprises a tubular member having a shapeable region, a malleable shaping member attached to the shapeable region such that, when the shape of the shapeable region is changed from a first shape to a second shape, the shaping member will plastically deform to thereafter substantially hold the shapeable region in the second shape, a tubular outer jacket disposed about the outer surface of the tubular member and a tubular inner jacket disposed within the lumen of the tubular member. The shapeable region of the guide catheter may be manually formed into a desired shape before insertion of the guide catheter into the body. In some embodiments, the guide catheter is sized to be inserted through a nostril of a human patient and used to guide the transnasal insertion of another device (e.g., a guidewire, catheter, etc.) to a desired location within the nose, throat, ear or cranium of the subject.

Claims

1. A method for dilating an opening in a head of a human or animal subject with a shapeable guide member, wherein the shapeable guide member includes a shapeable region having a malleable member and a tubular member, the method comprising:

(a) bending the malleable member of the shapeable region to a desired shape to facilitate advancement of a distal end of the guide member to a desired location, wherein the malleable member is attached to the tubular member, wherein the shapeable region is located closer to a distal end of the guide member than to a proximal end of the guide member, wherein the malleable member of the shapeable region substantially retains the desired shape after bending and holds the shapeable region in the desired shape, wherein the act of bending is performed by a human operator;

(b) inserting the guide member, distal end first, into a head of the subject to position the distal end of the guide member at or near the opening in the head of the subject;

(c) advancing a balloon along the guide member to position the balloon within the opening in the head of the subject; and

(d) expanding the balloon within the opening in the head of the subject to thereby dilate the opening.

2. The method of claim 1, wherein the opening in the head of the subject comprises a paranasal sinus opening.

3. The method of claim 1, wherein the opening in the head of the subject comprises a Eustachian tube.

4. The method of claim 1, wherein the act of expanding the balloon comprises remodeling a tissue forming the opening.

5. The method of claim 4, wherein the act of remodeling the tissue comprises breaking or remodeling bone forming the opening.

6. The method of claim 5, wherein the act of remodeling the tissue comprises breaking bone forming the opening.

7. The method of claim 1, further comprising deflating the balloon, wherein the opening remains dilated after deflating the balloon.

8. The method of claim 1, wherein the malleable member is configured to be more easily bendable in one plane than in another plane and the method further comprises discerning a direction of the desired curve of the shapeable region when the desired curve is inserted into the head of the subject.

9. A method for dilating an opening in a head of a human or animal subject with a shapeable guide member, wherein the shapeable guide member includes a shapeable region having a malleable member, the method comprising:

(a) bending the malleable member of the shapeable region to a desired shape to facilitate advancement of a distal end of the guide member to a desired location, wherein the malleable member of the shapeable region substantially retains the desired shape after bending and holds the shapeable region in the desired shape;

(b) inserting the guide member into a head of the subject to position the distal end of the guide member at or near the opening in the head of the subject, wherein the opening is positioned between a first cavity and a second cavity, and wherein the opening has a smaller diameter than each of the first and second cavities;

(c) positioning a balloon within the opening in the head of the subject between the first and second cavities; and

(d) expanding the balloon within the opening in the head of the subject to thereby dilate the opening by remodeling the opening with the expanded balloon.

10. A method for dilating an opening in a head of a human or animal subject with a shapeable guide member, wherein the shapeable guide member includes a shapeable region having a malleable member, the method comprising:

(a) bending the malleable member of the shapeable region to a desired curve to facilitate advancement of a distal end of the guide member to a desired location, wherein the malleable member of the shapeable region substantially retains the desired curve after bending and holds the shapeable region in the desired curve, wherein the desired curve is configured to enable positioning of the distal end of the guide member through the middle meatus of the subject, around the uncinate process of the subject, and into the hiatus semilunaris of the subject;

(b) inserting the guide member into a head of the subject a first rotational orientation to pass the distal end of the guide member by the middle turbinate of the subject;

(c) rotating the guide catheter to a second rotational orientation to hook the distal end of the guide member around the uncinate process of the subject and position the distal end of the guide member at or near the opening in the head of the subject;

(d) advancing a balloon along the guide member to position the balloon within the opening in the head of the subject; and

(e) expanding the balloon within the opening in the head of the subject to thereby dilate the opening.