Devices, systems and methods for treating disorders of the ear, nose and throat

• US 7,645,272 B2
• Filed: 10/29/2007
• Issued: 01/12/2010
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Lamson, Theodore C., Walke, Amrish Jayprakash, Chang, John Y., Vrany, Julia D.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Hall; Deanna K
• Application Number:
  US11/926,326
• Publication Number:
  US 20080097515A1
• Time in Patent Office: 806 Days
• Field of Search: 604509-510, 604/103.04, 604/103.05, 604/96.01, 604/164.01, 604/164.09, 604/164.1, 604/164.11, 604/164.13
• US Class Current: 604/509
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1608 the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other
• CPC Class Codes: A61B 17/1679 for the ear
• CPC Class Codes: A61B 17/1688 for the sinus or nose
• 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• 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 5/065 : Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 50/13 : Trolleys, e.g. carts
• CPC Class Codes: A61B 50/15 : Mayo stands; Tables
• CPC Class Codes: A61B 50/20 : Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 90/16 : Bite blocks
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 11/202 : Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• 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 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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

Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies. Access and occluding devices may be used to facilitate insertion of working devices such asendoscopes, wires, probes, needles, catheters, balloon catheters, dilation catheters, dilators, balloons, tissue cutting or remodeling devices, suction or irrigation devices, imaging devices, sizing devices, biopsy devices, image-guided devices containing sensors or transmitters, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting or delivering devices and implants, etc.

Claims

1. A method for treating sinusitis of a patient having a paranasal sinus with an associated ostium, the ostium being a natural paranasal sinus ostium that has not previously been surgically altered, the natural paranasal sinus ostium formed by mucosa with unfractured bone underlying the mucosa, the method comprising the steps of:

advancing an elongate guide having a preset shape, a distal end and a lumen to a position within or near the natural paranasal sinus ostium;

advancing a balloon of a balloon catheter through the lumen of the elongate guide and positioning the balloon catheter and guide such that the balloon is located beyond the distal end of the guide and within the natural paranasal sinus ostium;

enlarging the natural paranasal sinus ostium to an enlarged ostium by inflating the balloon within the natural paranasal sinus ostium sufficiently to break, remodel, or rearrange the bone underlying the mucosa of the ostium; and

deflating the balloon, removing the balloon catheter from the enlarged ostium, and removing the elongate guide from near the ostium, the enlarging of the ostium being performed so that, after the deflating of the balloon and removing of the balloon catheter and the elongate guide, the sinusitis of the patient is mitigated.

2. A method according to claim 1 wherein the guide has a curve and wherein the advancing step comprises advancing the balloon through the lumen of the guide and around the curve.

3. A method according to claim 2 wherein at least a portion of the guide is malleable and wherein the method further comprises the step of:

shaping a malleable portion of the guide.

4. A method according to claim 3 wherein the guide comprises a flexible guide catheter and a malleable outer tube through which the balloon catheter extends.

5. A method according to claim 1 wherein the inserting step comprises:

inserting the elongate guide to a first position; and

advancing a guidewire through the lumen of the elongate guide such that the guidewire extends into or through the natural paranasal sinus ostium;

and wherein the advancing step further comprises;

advancing the balloon catheter over the guidewire to a position where the balloon is positioned within the natural paranasal sinus ostium.

6. A method according to claim 5 further comprising the step of:

advancing a tubular sheath over the guidewire.

7. A method according to claim 6 further comprising the step of:

removing the guidewire leaving the tubular sheath in place.

8. A method according to claim 7 further comprising the step of infusing or aspirating matter through the tubular sheath.

9. A method according to claim 7 further comprising the step of inserting a different guidewire through the tubular sheath.

10. A method according to claim 6 wherein the tubular sheath having a lumen and a curved portion is inserted through the lumen of the elongate guide to a position where the curved portion of the tubular sheath extends out of the distal end of the elongate guide;

and

the guidewire is advanced through the lumen of the curved tubular sheath such that the guidewire extends into or through the natural paranasal sinus ostium.

11. A method according to claim 1 wherein a distal end of the balloon catheter is bent or angled.

12. A method according to claim 1 further comprising using an endoscope for visualization.

13. A method according to claim 1 further comprising advancing the balloon through a lumen of a stabilizing member.

14. A method according to claim 1 wherein the natural paranasal sinus ostium is a maxillary sinus ostium.

15. A method according to claim 1 wherein the natural paranasal sinus ostium is a frontal sinus ostium.

16. A method according to claim 1 further comprising treating an ethmoid sinus.

17. A method according to claim 1 wherein the balloon catheter has at least one distance marking or marker band.

18. A method according to claim 1, wherein the balloon comprises a cylindrical balloon having a first end and a second end with a cylindrical surface therebetween, and wherein the inflation of the balloon within the natural paranasal sinus ostium radially expands the cylindrical surface against the surrounding ostium.

19. The method according to claim 18, wherein the first end of the balloon extends into the paranasal sinus during the radial expansion of the balloon against the ostium, and wherein the first end of the balloon within the paranasal sinus is smaller than the paranasal sinus when the balloon is expanded so that the expanded balloon is separated from the mucosa of the paranasal sinus away from the ostium.

20. The method according to claim 18, wherein a diameter of the inflated cylindrical balloon is sufficiently greater than a diameter of the natural paranasal sinus ostium that inflation of the balloon breaks, remodels, or rearranges the unfractured bone underlying the mucosa of the ostium.

21. The method according to claim 1, wherein the enlarging of the ostium, the deflating of the balloon, and the removing of the balloon catheter are included in a procedure performed while the patient is disposed in a clinical working environment.

22. The method of claim 1, wherein the enlarging of the ostium is performed so that, after the deflating of the balloon and removing of the balloon catheter and the elongate guide, outflow from the paranasal sinus is enhanced such that the sinusitis of the patient is mitigated.

23. The method of claim 1, wherein the enlarging of the ostium is performed so that, after the deflating of the balloon and removing of the balloon catheter and the elongate guide, drainage of mucus from the paranasal sinus is enhanced such that the sinusitis of the patient is mitigated.