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

• US 8,123,722 B2
• Filed: 10/29/2007
• Issued: 02/28/2012
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Chang, John Y., Makower, Joshua, Vrany, Julia D., Lamson, Theodore C., Walke, Amrish Jayprakash
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US11/926,467
• Publication Number:
  US 20080234720A1
• Time in Patent Office: 1,583 Days
• Field of Search: 600/101, 604/96.01, 604/103.05, 604/103.1, 604/104
• US Class Current: 604/104
• 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 dilating an opening between a nasal cavity and a paranasal sinus of a human or animal subject, said method comprising:

inserting a direct viewing apparatus into a nostril of the patient;

advancing a guide device to a first location within the nasal cavity or paranasal sinus while viewing the guide device using the direct viewing apparatus;

advancing a dilation device over or through the guide device to a second location within the opening between the nasal cavity and paranasal sinus while viewing the dilation device using an indirect viewing apparatus which is distinct from and operates independently of the direct viewing apparatus; and

expanding the dilation device to dilate the opening.

2. A method according to claim 1 wherein the direct viewing apparatus comprises a scope.

3. A method according to claim 1 wherein the direct viewing apparatus comprises a video camera sized for insertion into the nares or nasal cavity.

4. A method according to claim 1 wherein the indirect viewing apparatus comprises an imaging apparatus.

5. A method according to claim 1 wherein the indirect viewing apparatus comprises at least one apparatus selected from the group consisting of a fluoroscope, a fluoroscope with C-arm, a magnetic resonance imaging device, a tomographic device, a CT scanner, an electromagnetic navigational and/or guidance system, a PET scanner, a combination CT/PET scanner and an optical coherence tomography device.

6. A method according to claim 1 wherein the guide device is selected from the group consisting of guidewires and guide catheters.

7. A method according to claim 1 wherein the dilation device is selected from the group consisting of balloon catheters, dilation catheters, and mechanical dilators.

8. A method for expanding an opening into a paranasal sinus of a patient, the method comprising:

inserting an endoscope into a nostril of the patient'"'"'s nose;

advancing a guide catheter into the nostril and to a first location within a nasal cavity or paranasal sinus of the patient while viewing the guide device using the endoscope;

advancing a balloon dilation catheter through the guide catheter to position the catheter'"'"'s balloon in an opening into the paranasal sinus;

expanding the balloon of the balloon catheter to expand the opening into the paranasal sinus; and

viewing the balloon expansion using an indirect viewing apparatus which is distinct from and operates independently of the direct viewing apparatus.

9. A method as in claim 8, wherein inserting the endoscope comprises inserting a flexible endoscope.

10. A method as in claim 8, wherein advancing the guide catheter comprises advancing a distal end of the guide catheter to a location near an opening of a paranasal sinus selected from the group consisting of a frontal sinus, a maxillary sinus and a sphenoid sinus.

11. A method as in claim 8, further comprising advancing a guidewire through the guide catheter to position a distal end of the guidewire in the paranasal sinus before advancing the balloon catheter, wherein the balloon catheter is advanced over the guidewire and through the guide catheter.

12. A method as in claim 8, further comprising viewing the advancing of the balloon catheter using the indirect viewing apparatus.

13. A method as in claim 8, further comprising viewing the advancing of the balloon catheter using the direct viewing apparatus.

14. A method as in claim 8, wherein viewing the balloon expansion comprises using an indirect viewing apparatus selected from the group consisting of a fluoroscope, a fluoroscope with C-arm, a magnetic resonance imaging device, a tomographic device, a CT scanner, an electromagnetic navigational and/or guidance system, a PET scanner, a combination CT/PET scanner and an optical coherence tomography device.

15. A method for expanding an opening into a paranasal sinus of a patient, the method comprising:

inserting an endoscope into a nostril of the patient'"'"'s nose;

advancing a guide catheter into the nostril and to a first location within a nasal cavity or paranasal sinus of the patient while viewing the guide device using the endoscope;

advancing a balloon dilation catheter through the guide catheter to position the catheter'"'"'s balloon in an opening into the paranasal sinus;

expanding the balloon of the balloon catheter to expand the opening into the paranasal sinus; and

viewing at least one of advancing the guide catheter, advancing the balloon catheter or expanding the balloon using an indirect viewing apparatus located outside the patient and which is distinct from and operates independently of the direct viewing apparatus.