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

• US 8,425,457 B2
• Filed: 12/29/2009
• Issued: 04/23/2013
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: John, Chang Y., Joshua, Makower
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US12/649,050
• Publication Number:
  US 20100100181A1
• Time in Patent Office: 1,211 Days
• Field of Search: 604 9902- 9903, 604/96.01, 604/101.01, 604/101.03, 604/919
• US Class Current: 604/101.03
• 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. An anterior/posterior occlusion and access device for use in the diagnosis and/or treatment of sinusitis or a disorder of the ear, nose or throat, said device comprising:

a tube having an anterior end, a posterior end and at least one lumen;

an anterior occluder at a first location on the tube;

a posterior occluder at a second location on the tube, said second location being posterior to said first location;

a working device insertion opening located anterior to the anterior occluder for insertion of a working device into a working device lumen; and

a working device exit opening located between the anterior occluder and the posterior occluder and connected to a working device lumen such that a device advanced through the working device lumen may exit the catheter through the working device exit opening; and

at least one additional element selected from the group consisting of a) at least one moveable suction port for suctioning blood, fluid or debris from a plurality of locations between the anterior occluder and posterior occluder and/or b) separate infusion and suction lumens in addition to said working device lumen, said infusion lumen being connected to an infusion port located between the anterior occluder and the posterior occluder and said suction lumen being connected to a suction port located between the anterior occluder and the posterior occluder, such that fluid may be infused through the infusion lumen into a location between the anterior and posterior occluders at the same time that fluid is being suctioned through the suction lumen from a location between the anterior and posterior occluders;

device being deployable such that i) the anterior occluder occludes the nostril or nasal cavity on one side of the intranasal septum ii) the posterior occluder occludes the nasopharynx at a location posterior to the intranasal septum and iii) a working device may be inserted through the working device insertion opening and advanced out of the working device exit opening to a location within the nose, nasopharynx or paranasal sinus.

2. A device according to claim 1 wherein the anterior occluder comprises a balloon.

3. A device according to claim 1 wherein the posterior occluder comprises a balloon.

4. A device according to claim 1 which includes at least first and second working device exit openings such that a working device may be selectively advanced out of either the first or second working device exit opening.

5. A system that comprises a nasal access and occlusion device according to claim 1 in combination with at least one working device selected from the group consisting of:

a guidewire;

a guide catheter;

a guide catheter shaped to advance into the ostium of a paranasal sinus;

a balloon catheter,

apparatus for delivery of a stent;

apparatus for delivery of a substance-eluting stent;

implantable apparatus for exerting pressure on bone or soft tissue to cause reshaping of the bone or soft tissue;

apparatus for cutting tissue;

apparatus for ablating tissue;

apparatus for debulking tissue;

apparatus for cauterizing tissue;

apparatus for dilating a passageway;

apparatus for delivering a cryogen;

apparatus for delivering a radiographic contrast agent,

apparatus for delivering a diagnostic or therapeutic substance;

a cannula;

an endoscope;

a sensor;

a light;

a diagnostic device;

a therapeutic device.

6. A device according to claim 1 further comprising at least one suction port located on the tube between the anterior occluder and the posterior occluder such that fluid or debris may be aspirated though the aspiration port and through a lumen of the tube.

7. A system comprising a device according to claim 1 in combination with an anterior nasal occlusion and access device that is positionable on the other side of the nasal septum, said anterior nasal occlusion and access device comprising:

an anterior occluder for occluding the nostril or nasal cavity on one side of the nasal septum; and

a working device insertion opening through which a working device may be inserted and advanced past the anterior occluder to a location within the nose, nasopharynx or paranasal sinus.

8. A system according to claim 7 wherein the anterior occluder of the anterior nasal occlusion and access device comprises a balloon.

9. A device according to claim 1 further comprising a valve associated with the working device insertion opening, said valve being configured to prevent backflow out of the working device opening when no working device is inserted through said working device insertion opening.

10. A system according to claim 7 further comprising a valve associated with the working device insertion opening of the anterior nasal occlusion and access device that is positionable on the other side of the nasal septum, said valve being configured to prevent backflow out of the working device opening when no working device is inserted through said working device insertion opening.