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

• US 9,241,834 B2
• Filed: 03/21/2014
• Issued: 01/26/2016
• 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.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US14/221,621
• Publication Number:
  US 20140200443A1
• Time in Patent Office: 676 Days
• Field of Search: 604/96.01, 604/101.05, 604/105, 604/103.09
• US Class Current: 1/1
• 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 medical device for accessing a paranasal sinus structure of a patient, comprising:

(a) a handle;

(b) a probing element extending outwardly from said handle to a distal end, said probing element having a distal region terminating in said distal end, wherein the distal end region is malleable so as to be adapted to allow a user to shape the distal end region to match the patient'"'"'s specific anatomy; and

(c) a working device preloaded and slidably positioned over the probing element, the working device being slidable relative to the probing element between a retracted position and an extended position.

2. The medical device according to claim 1, wherein the working device comprises a catheter having an expandable balloon coupled thereto.

3. The medical device according to claim 2, wherein the expandable balloon is positioned at or near a distal end of the catheter.

4. The medical device according to claim 2, wherein the probing device has a length adapted to extend from an exterior of said patient through said patient'"'"'s nasal cavity and sinus ostium, and into a sinus of said patient.

5. The medical device according to claim 4, wherein the sinus is a frontal sinus.

6. The medical device according to claim 4, wherein the sinus is an ethmoid sinus.

7. The medical device according to claim 4, wherein the sinus is a maxillary sinus.

8. The medical device according to claim 4, wherein the sinus is a sphenoid sinus.

9. The medical device according to claim 4, wherein when the distal end of the probing device is positioned within the sinus and the working device is in the extended position, the expandable balloon is configured to be positioned at least partially within the sinus ostium.

10. The medical device according to claim 9, wherein the sinus is a frontal sinus.

11. The medical device according to claim 4, wherein the probing device has a length of between 10 and 30 cm.

12. The medical device according to claim 4, wherein the distal end region of the probing element is at least partially curved, and wherein the working device is slidable over the curved portion of the distal end region of the probing element.

13. The medical device according to claim 12, wherein the expandable balloon is adapted to remodel or change the shape, size or configuration of the sinus ostium when expanded.

14. The medical device according to claim 13, wherein the expandable balloon is adapted to dilate the sinus ostium when expanded.

15. The medical device according to claim 2, wherein the expandable balloon further comprises a first balloon and a second balloon.

16. A medical device for accessing a paranasal sinus structure of a patient, comprising:

(a) a handle;

(b) a probing element extending outwardly from said handle to a distal end, said probing element having a distal region terminating in said distal end, wherein the distal end region is bendable so as to be adapted to allow a user to shape the distal end region to match the patient'"'"'s specific anatomy; and

(c) a working device preloaded and slidably positioned over the probing element, the working device being slidable relative to the probing element between a retracted position and an extended position.

17. The medical device of claim 16, further comprising a stent that is deployable on the paranasal sinus structure by the working device, wherein the working device comprises a catheter having an expandable balloon coupled thereto, wherein the stent is disposed on the expandable balloon in a compressed state.

18. The medical device of claim 17, wherein the stent is configured to expand when the expandable balloon is expanded to an expanded state.

19. The medical device of claim 17, wherein the expandable balloon further comprises a stent deploying balloon and a locator balloon spaced from the stent deploying balloon, wherein the locator balloon is configured to assist a user in locating an anatomical opening in the paranasal sinus.

20. A medical device for accessing a paranasal sinus structure of a patient, comprising:

(a) a handle;

(b) a probing element extending outwardly from said handle to a distal end, said probing element having a distal region terminating in tip at said distal end, wherein the distal end region is configured to allow a user to shape the distal end region to match the patient'"'"'s specific anatomy; and

(c) a working device and slidably positioned over the probing element, the working device being slidable relative to the probing element between a retracted position and an extended position.