Shapeable guide catheters and related methods

• US 8,932,276 B1
• Filed: 05/16/2007
• Issued: 01/13/2015
• 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:
  US11/804,309
• Time in Patent Office: 2,799 Days
• Field of Search: 264/285, 264/339, 264/DIG.30, 264/DIG.66, 425/2, 604/516, 604/528, 600/114
• US Class Current: 604/528
• 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 advancing a device to a desired location in an ear, nose or throat of a patient without removing normal anatomical structures, the method comprising:

intraoperatively bending, by a user, a shapeable region of a guide catheter to a desired shape to facilitate advancement of a distal end of the guide catheter to the desired location without removing normal anatomical structures, wherein the shapeable region is located closer to the distal end than to a proximal end of the guide catheter;

advancing the guide catheter into a head of the patient to position a distal end of the catheter at or near the desired location, wherein the shapeable region retains substantially the desired shape during advancement; and

advancing a first device through a lumen of the guide catheter to the desired location.

2. 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 of a paranasal sinus or air cell, a paranasal sinus or air cell, a Eustachian tube, an opening of a Eustachian tube, a nasolacrimal duct, the pituitary gland, a pathological lesion, a tumor, an abscess, a mucocoele, a polyp, a cyst, a fracture, and other disease-affected tissue.

3. A method according to claim 1, wherein bending the shapeable region of the guide catheter comprises forming a curve or bend in the shapeable region at between about 1 cm to about 2 cm from the distal end of the guide catheter.

4. A method according to claim 3, wherein forming the curve or bend comprises forming an angle in the shapeable region of between about 1 degree and about 115 degrees.

5. A method according to claim 1, wherein the desired location comprises a maxillary sinus or an opening into a maxillary sinus, and wherein forming the shapeable region comprises forming a curve of between about 90 degrees and about 110 degrees within about 1 cm of the distal end of the guide catheter.

6. A method according to claim 5, wherein advancing the guide catheter comprises advancing the distal end of the guide catheter around an uncinate process to a position near or within a maxillary sinus ostium without removing or substantially modifying the uncinate process.

7. A method according to claim 1, wherein the desired location comprises a frontal sinus or an opening into a frontal sinus, and wherein forming the shapeable region comprises forming a curve of between about 60 degrees and about 90 degrees within about 2 cm of the distal end of the guide catheter.

8. A method according to claim 7, wherein advancing the guide catheter comprises advancing the distal end of the guide catheter into a frontal sinus recess without substantially modifying the middle turbinate.

9. A method according to claim 1, wherein the desired location comprises an ethmoid air cell or an opening into an ethmoid air cell, and wherein forming the shapeable region comprises forming a curve of between about 0 degrees and about 90 degrees within about 2 cm of the distal end of the guide catheter.

10. A method according to claim 9, further comprising forming a man-made opening in the ethmoid air cell, wherein advancing the guide catheter comprises advancing the distal end of the guide catheter to a position near or within the man-made opening.

11. A method according to claim 1, wherein the desired location comprises a sphenoid sinus or an opening into a sphenoid sinus, and wherein forming the shapeable region comprises forming a curve of between about 0 degrees and about 30 degrees within about 2 cm of the distal end of the guide catheter.

12. A method according to claim 11, wherein advancing the guide catheter comprises advancing the distal end of the guide catheter to a location near or within a sphenoid sinus ostium without substantially modifying a middle turbinate.

13. A method according to claim 1, wherein advancing the first device through the lumen of the guide catheter comprises advancing a guidewire through the lumen.

14. A method according to claim 13, further comprising advancing a second device over the guidewire.

15. A method according to claim 14, wherein the second device comprises a dilation catheter, and wherein the method further comprises dilating an opening or anatomical passageway using the dilation catheter.

16. A method according to claim 15, wherein dilating the opening comprises inflating a balloon of the dilation catheter.

17. A method according to claim 15, wherein dilating the opening comprises dilating an opening of a paranasal sinus.

18. A method according to claim 17, wherein the opening of a paranasal sinus comprises a natural opening.

19. A method according to claim 17, wherein the opening of a paranasal sinus comprises a natural opening that has been modified by prior surgery or prior dilation.

20. A method according to claim 19, further comprising modifying the natural opening by surgery or dilation.

21. A method according to claim 15, wherein the opening or anatomical structure comprises a man-made opening in a paranasal sinus or air cell.

22. A method according to claim 21, further comprising creating the man-made opening in a paranasal sinus or air cell.

23. A method according to claim 22, wherein the step of creating the man-made opening a paranasal sinus or air cell comprises performing an ethmoidectomy, ethmoidotomy or other procedure that forms an opening into at least one ethmoid air cell.