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

• US 7,654,997 B2
• Filed: 04/21/2004
• Issued: 02/02/2010
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Exploramed Nc2, Inc.
• 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:
  US10/829,917
• Publication Number:
  US 20050240147A1
• Time in Patent Office: 2,113 Days
• Field of Search: 604/167.03, 604/103.02, 604/96.01, 623/1.11, 606/196, 606/199
• US Class Current: 604/509
• 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 by marking A61B2090/395
• 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 enlarging an ostium of a paranasal sinus of a subject, said method comprising the steps of:

placing in the subject'"'"'s head a port device having a lumen through which a balloon catheter may be inserted;

positioning a light emitting portion of a light emitting instrument within the paranasal sinus;

emitting light from the light emitting portion of the light emitting instrument;

observing the emitted light;

advancing a balloon dilation catheter through the port device to a location within the ostium of paranasal sinus; and

inflating a balloon of the balloon catheter to expand the ostium and modify bone that directly underlies mucosa of the ostium.

2. A method according to claim 1 further comprising an additional step selected from the group consisting of:

i) delivering an imageable or traceable substance;

ii) delivering a therapeutically effective amount of a therapeutic substance;

iii) implanting a stent, tissue remodeling device, substance delivery implant or other therapeutic apparatus;

iv) cutting, ablating, debulking, cauterizing, heating, lasing, dilating or otherwise modifying tissue;

v) grafting or implanting cells or tissue;

vi) reducing, setting, screwing, applying adhesive to, affixing, decompressing or otherwise treating a fracture;

vii) delivering a gene or gene therapy preparation;

viii) cutting, ablating, debulking, cauterizing, heating, lasing, forming an osteotomy in or otherwise modifying bony or cartilaginous tissue within paranasal sinus or elsewhere within the nose;

ix) remodeling or changing the shape, size or configuration of a sinus ostium of another paranasal sinus or other anatomical structure that affects drainage from one or more paranasal sinuses;

x) removing puss or aberrant matter from the paranasal sinus or elsewhere within the nose; and

xi) delivering histamine, an allergen or another substance that causes secretion of mucous by tissues within a paranasal sinus to permit assessment of drainage from the sinus.

3. A method according to claim 1 further comprising the step of:

suctioning fluid from the nose, nasopharynx or paranasal sinus.

4. A method according to claim 1 wherein the placing step comprises inserting a guide catheter;

and, thereafter, the advancing step comprises inserting the balloon dilation catheter through the guide catheter.

5. A method according to claim 1 further comprising using a scope to visualize an anatomical structure within the nose or paranasal sinus.

6. A method according to claim 5 wherein the scope is used to guide, facilitate or verify positioning of the balloon dilation catheter.

7. A method according to claim 4 wherein a scope is used to guide, facilitate or verify positioning of the guide catheter.

8. A method according to claim 1 wherein the inflating step further comprises implanting a stent.

9. A method according to claim 8 wherein the stent is positioned at least partially within the ostium of the paranasal sinus.

10. A method according to claim 8 wherein the stent comprises a substance eluting stent.

11. A method according to claim 10 wherein the substance eluting stent elutes a therapeutically effective amount of at least one substance selected from the group consisting of:

an antibiotic;

an antifungal;

an antiparacytic;

an antimicrobial;

a steroid;

a vasoconstrictor;

a leukotriene inhibitor;

an IgE inhibitor;

an anti-inflammatory;

a mast cell stabilizer;

an antihistamine;

an imunomodulator;

a chemotherapeutic agent;

an antineoplastic agent;

a mucolytic agent;

an agent that thins or otherwise changes the viscosity of mucous;

a substance that facilitates remodeling of soft tissue and/or bone and/or cartilage.

12. A method according to claim 1 further comprising implanting a device that will change the size, shape, configuration or position of soft tissue, bone or cartilage.

13. A method according to claim 12 wherein the implanted device can be adjusted one or more times after implantation and wherein the method further comprises the step of adjusting the implanted device at least one time subsequent to implantation.

14. A method according to claim 1 wherein the inflating step further comprises enlarging or modifying a nasal meatus or other passageway within the nose or nasopharynx.

15. A method according to claim 1 further comprising introducing a diagnostically or therapeutically effective amount of a diagnostic or therapeutic substance to a location within the nose, nasopharynx or paranasal sinus. to be inserted through the port device while preventing blood or other fluid from backflowing out of the port device, at least when no working device is inserted through the port device.

16. A method according to claim 15 wherein the substance is contained in a substance delivery implant and wherein the using step comprises implanting the substance delivery implant at a location within the nose, nasopharynx or paranasal sinus.

17. A method according to claim 15 wherein the using step comprises injecting the substance at a location within the nose, nasopharynx or paranasal sinus.

18. A method according to claim 15 wherein the substance is selected from the group consisting of:

an imageable contrast agent;

a diagnostic indicator agent;

an antibiotic;

an antifungal;

an antiparacytic;

an antimicrobial;

a steroid;

a vasoconstrictor;

a leukotriene inhibitor;

an IgE inhibitor;

an anti-inflammatory;

a mast cell stabilizer;

an antihistamine;

an imunomodulator;

a chemotherapeutic agent;

an antineoplastic agent;

a mucolytic agent;

an agent that thins or otherwise changes the viscosity of mucous; and

a substance that facilitates remodeling of soft tissue and/or bone and/or cartilage.

19. A method according to claim 1 wherein the port device further comprises a valve that is operative to allow the balloon dilation catheter

advancing a working device comprising a balloon through the port device to a location within an ostium of a paranasal sinus;

and

inflating the balloon to cause dilation of the ostium and modification of bone adjacent to the ostium without removing tissue.

20. A method according to claim 1 wherein the positioning step comprises advancing the light emitting instrument through the paranasal sinus ostium.

21. A method according to claim 1 wherein the light emitting instrument comprises an endoscope.

22. A method according to claim 20 wherein the advancing step comprises advancing the balloon catheter through a channel of the endoscope.

23. A method for treating sinusitis or another disorder affecting a paranasal sinus, said method comprising the steps of:

placing a port device in the nostril or nasal cavity, said port device having a lumen through which a working device may be inserted;

positioning a light emitting portion of a light emitting instrument within a paranasal sinus;

emitting light from the light emitting portion of the light emitting instrument;

observing the emitted light;

24. A method according to claim 23 further comprising the step of:

suctioning fluid from the nose, nasopharynx or paranasal sinus.

25. A method according to claim 23 wherein the placing step comprises inserting a guide catheter;

and, thereafter, the advancing step comprises inserting the working device through the guide catheter.

26. A method according to claim 23 further comprising using a scope to visualize an anatomical structure within the nose or paranasal sinus.

27. A method according to claim 23 further comprising using a scope to guide, facilitate or verify positioning of another working device.

28. A method according to claim 25 wherein a scope is used to guide, facilitate or verify positioning of the guide catheter.

29. A method according to claim 23 wherein the inflating step further comprises implanting a stent.

30. A method according to claim 29 wherein the stent is positioned at least partially within the ostium.

31. A method according to claim 29 wherein the stent comprises a substance eluting stent.

32. A method according to claim 31 wherein the substance eluting stent elutes a therapeutically effective amount of at least one substance selected from the group consisting of:

an antibiotic;

an antifungal;

an antiparacytic;

an antimicrobial;

a steroid;

a vasoconstrictor;

a leukotriene inhibitor;

an IgE inhibitor;

an anti-inflammatory;

a mast cell stabilizer;

an antihistamine;

an imunomodulator;

a chemotherapeutic agent;

an antineoplastic agent;

a mucolytic agent;

an agent that thins or otherwise changes the viscosity of mucous;

a substance that facilitates remodeling of soft tissue and/or bone and/or cartilage.

33. A method according to claim 23 further comprising introducing a diagnostically or therapeutically effective amount of a diagnostic or therapeutic substance to a location within the nose, nasopharynx or paranasal sinus.

34. A method according to claim 33 wherein the substance is contained in a substance delivery implant.

35. A method according to claim 23 further comprising injecting a therapeutic or diagnostic substance at a location within the nose, nasopharynx or paranasal sinus.

36. A method according to claim 35 wherein the substance is selected from the group consisting of:

an imageable contrast agent;

a diagnostic indicator agent;

an antibiotic;

an antifungal;

an antiparacytic;

an antimicrobial;

a steroid;

a vasoconstrctor;

a leukotriene inhibitor;

an IgE inhibitor;

an anti-inflammatory;

a mast cell stabilizer;

an antihistamine;

an imunomodulator;

a chemotherapeutic agent;

an antineoplastic agent;

a mucolytic agent;

an agent that thins or otherwise changes the viscosity of mucous; and

a substance that facilitates remodeling of soft tissue and/or bone and/or cartilage.

37. A method according to claim 23 wherein the port device further comprises a valve that is operative to allow the working device to be inserted through the port device while preventing blood or other fluid from backflowing out of the port device, at least when no working device is inserted through the port device.

38. A method according to claim 23 wherein the positioning step comprises advancing the light emitting instrument through the paranasal sinus ostium.

39. A method according to claim 23 wherein the light emitting instrument comprises an endoscope.

40. A method according to claim 23 wherein the advancing step comprises advancing the working device through a channel of the endoscope.