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

• US 8,870,893 B2
• Filed: 04/29/2010
• Issued: 10/28/2014
• 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:
  US12/769,915
• Publication Number:
  US 20100210901A1
• Time in Patent Office: 1,643 Days
• Field of Search: 606/180, 606/110, 604/164.13, 604/164.09
• US Class Current: 606/110
• 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 device for removing polyps or other tissue from the nose, nasopharynx or paranasal sinus, said device comprising:

a flexible catheter having a distal end and a lumen;

a flexible tube having an open distal end and a lumen extending therethrough, said flexible tube being rotatably disposed within a lumen of the catheter such that the flexible tube may rotate while the catheter does not rotate;

a rotating cutter on the distal end of the flexible tube;

an opening formed in the catheter such that matter may be received through the opening and cut by the rotating cutter;

a moveable retractor apparatus that is operative to retract matter that has entered the opening into contact with the rotating cutter; and

at least one bearing disposed between the catheter and the flexible tube.

2. A device according to claim 1, further comprising a connector for connecting the lumen of the flexible tube to a source of negative pressure such that matter that is cut by the rotating cutter will be suctioned though the open distal end and through the lumen of the flexible tube.

3. A device according to claim 1 wherein the opening in the catheter is a side opening formed in a side of the catheter.

4. A device according to claim 1 further comprising a scope which is useable to view the distal end of the catheter while the device is inserted in the body of a patient.

5. A device according to claim 4 wherein the scope is attached to the exterior of the catheter.

6. A device according to claim 5 wherein the scope is disposed in a lumen on one side of the catheter.

7. A device according to claim 5 further comprising a side lumen on the catheter.

8. A system comprising a device according to claim 7 in combination with a scope positioned in the side lumen.

9. A system comprising a device according to claim 7 in combination with a guidewire positioned in the side lumen.

10. A device according to claim 3 wherein the moveable retractor apparatus comprises an elongate member having a retractor head, said elongate member being advanceable in a distal direction to move the retractor head to a location distal to the side opening and retractable in the proximal direction to move the retractor head in the proximal direction such that the retractor head will propel matter that has entered the opening into contact with the rotating cutter.

11. A device according to claim 3 wherein the catheter has a closed distal tip.

12. A device according to claim 11 further comprising a lumen that extends through the flexible tube and through an opening formed in the distal tip of the catheter.

13. A system comprising a device according to claim 12 in combination with a scope positioned within the lumen that extends through the flexible tube and through an opening formed in the distal tip of the catheter.

14. A system comprising a device according to claim 12 in combination with a guidewire positioned within the lumen that extends through the flexible tube and through an opening formed in the distal tip of the catheter.

15. A device according to claim 1 further comprising an extendable member located on a side of the distal end of the flexible catheter and being configured to laterally deflect the flexible catheter.

16. A device for removing polyps or other tissue from the nose, nasopharynx or paranasal sinus, said device comprising:

a flexible catheter having a distal end and a lumen;

a flexible tube having an open distal end and a lumen extending therethrough, said flexible tube being rotatably disposed within a lumen of the catheter such that the flexible tube may rotate while the catheter does not rotate;

a rotating cutter on the distal end of the flexible tube;

an opening formed in the catheter such that matter may be received through the opening and cut by the rotating cutter, wherein the opening defines a side opening formed in the side of the catheter; and

a moveable retractor apparatus that is operative to retract matter that has entered the opening into contact with the rotating cutter, wherein the moveable retractor apparatus comprises an elongate member having a retractor head, said elongate member being advanceable in a distal direction to move the retractor head to a location distal to the side opening and retractable in the proximal direction to move the retractor head in the proximal direction such that the retractor head will propel matter that has entered the opening into contact with the rotating cutter.