Devices, systems and methods for diagnosing and treating sinusitis and other disorders of the ears, nose and/or throat

• US 7,727,186 B2
• Filed: 10/25/2007
• Issued: 06/01/2010
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Chang, John Y.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Hall; Deanna K
• Application Number:
  US11/924,473
• Publication Number:
  US 20080097295A1
• Time in Patent Office: 950 Days
• Field of Search: 604/96.01, 604/99.03, 604/101.01, 604/101.03, 604/919, 604/101.05, 604/104, 606/196, 606/192
• US Class Current: 604/96.01
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• 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 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/22061 : for spreading elements apart
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments
• CPC Class Codes: A61B 2017/320064 : with tissue or sample retaining means
• CPC Class Codes: A61B 2018/00327 : Ear, nose or throat
• CPC Class Codes: A61B 2018/00595 : Cauterization
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1405 : Electrodes having a specific shape
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61F 11/20 : Ear surgery
• CPC Class Codes: A61F 13/2005 : specially adapted for the nose cavity
• CPC Class Codes: A61F 2/18 : Internal ear or nose parts, e.g. ear-drums implants for middle ear ventilation or drainage A61F11/202
• CPC Class Codes: A61F 2/186 : Nose parts
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61M 16/0434 : Cuffs
• 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
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/005 : for contrast media
• CPC Class Codes: A61N 1/0541 : Cochlear electrodes

Abstract

Sinusitis, enlarged nasal turbinates, tumors, infections, hearing disorders, allergic conditions, facial fractures and other disorders of the ear, nose and throat 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, endoscopic studies and transillumination studies. Access and occluder devices may be used to establish fluid tight seals in the anterior or posterior nasal cavities/nasopharynx and to facilitate insertion of working devices (e.g., scopes, guidewires, catheters, tissue cutting or remodeling devices, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc.

Claims

1. A method for treating sinusitis and/or a disorder of a nasal cavity in a patient, the method comprising:

advancing a catheter through a nostril of the patient to position an anterior occluder of the catheter at a first position in the nostril and a posterior occluder of the catheter at a second position posterior to the first position, wherein the catheter extends between the anterior and posterior occluders;

expanding the posterior and anterior occluders to form fluid tight seals with tissue of the patient at the first and second positions;

passing a substance through the catheter into an area of the patient between the fluid tight seals;

collapsing the occluders;

performing a treatment on at least one of a paranasal sinus, a paranasal sinus ostium or a nasal cavity using a treatment device;

removing the catheter from the patient;

advancing a guide device into the nostril;

advancing a balloon dilation catheter over or through the guide to position a balloon of the balloon dilation catheter in a paranasal sinus ostium;

expanding the balloon to expand the ostium;

deflating the balloon; and

removing the balloon dilation catheter from the patient.

2. A method as in claim 1, wherein the anterior and posterior occluders comprise inflatable balloons, and wherein expanding the occluders comprises inflating the balloons.

3. A method as in claim 2, wherein inflating the balloons comprises:

inflating the posterior balloon via a first inflation lumen of the catheter; and

inflating the anterior balloon via a second inflation lumen of the catheter after the posterior balloon is inflated,

wherein the method further comprises visualizing inflation of at least the posterior balloon using an endoscope positioned in the patient'"'"'s nostril.

4. A method as in claim 1, wherein the first position comprises a nostril and wherein the second position is selected from the group consisting of a posterior choanae, a nasopharynx and a pharynx of the patient.

5. A method as in claim 1, further comprising removing the substance from the patient via the catheter.

6. A method as in claim 5, wherein the substance is passed into the patient via a first lumen of the catheter and the substance is removed from the patient via a second lumen of the catheter.

7. A method as in claim 5, wherein the substance comprises an anesthetic solution and wherein the solution is removed after at least a portion of the area between the two seals has been anesthetized.

8. A method as in claim 7, wherein performing the treatment comprises:

advancing a balloon dilation catheter through the catheter to position a balloon of the balloon dilation catheter in a paranasal sinus ostium;

expanding the balloon to expand the ostium;

deflating the balloon; and

removing the balloon dilation catheter from the patient.

9. A method as in claim 8, wherein the balloon dilation catheter is advanced through a lumen of the catheter.

10. A method as in claim 5, wherein the substance comprises irrigation fluid.

11. A method as in claim 1, wherein passing the substance comprises passing at least some of the substance into a paranasal sinus of the patient, and wherein the treatment is directed to sinusitis.

12. A method for treating sinusitis and/or a disorder of a nasal cavity in a patient, the method comprising:

advancing a catheter through a nostril of the patient to position an anterior occluder of the catheter at a first position in the nostril and a posterior occluder of the catheter at a second position posterior to the first position, wherein the catheter extends between the anterior and posterior occluders;

expanding the posterior and anterior occluders to form fluid tight seals with tissue of the patient at the first and second positions;

passing a therapeutic substance through the catheter into an area of the patient between the fluid tight seals;

removing at least one of the therapeutic substance, mucus or blood from the area between the fluid tight seals via the catheter;

removing the catheter from the patient;

advancing a guide device into the nostril;

advancing a balloon dilation catheter over or through the guide to position a balloon of the balloon dilation catheter in a paranasal sinus ostium;

expanding the balloon to expand the ostium;

deflating the balloon; and

removing the balloon dilation catheter from the patient.

13. A method as in claim 12, wherein the anterior and posterior occluders comprise inflatable balloons, and wherein expanding the occluders comprises inflating the balloons.

14. A method as in claim 13, wherein inflating the balloons comprises:

inflating the posterior balloon via a first inflation lumen of the catheter; and

inflating the anterior balloon via a second inflation lumen of the catheter after the posterior balloon is inflated,

wherein the method further comprises visualizing inflation of at least the posterior balloon using an endoscope positioned in the patient'"'"'s nostril.

15. A method as in claim 12, wherein the first position comprises a nostril and wherein the second position is selected from the group consisting of a posterior choanae, a nasopharynx and a pharynx of the patient.

16. A method as in claim 12, wherein the substance is passed into the patient via a first substance passing lumen and the substance is removed from the patient via a second substance passing lumen.

17. A method as in claim 16, wherein at least some of the substance is removed from the patient at the same time that some of the substance is being passed into the patient.

18. A method as in claim 12, wherein the substance is selected from a group consisting of irrigation solutions, anesthetics, antimicrobial agents, steroids, antiinflammatories, cytokine inhibitors, vasoconstrictors, mucolytics, antihistamines, bone modifying agents, ipratropium, furosemide, hyperosmolar agents, antitumor agents, cells, genes and gene delivery vehicles.