System and method for the simultaneous bilateral treatment of target tissues within the ears using a guide block structure

• US 8,425,488 B2
• Filed: 05/16/2007
• Issued: 04/23/2013
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Clifford, Anton, Liu, Greg, Morriss, John, Makower, Joshua, Facteau, William, Goldfarb, Eric, Chang, John Y.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US11/749,733
• Publication Number:
  US 20080262468A1
• Time in Patent Office: 2,169 Days
• Field of Search: 604/27, 604/48, 604/500, 604/501, 604/514, 604/77, 604/94.01, 604/164.01, 604/264, 604/275, 604/278, 604/285, 604/93.01, 604/20, 604/21, 604/28, 604/39, 604/43, 604/45, 604/35, 604/73, 604/173, 606/109
• US Class Current: 604/501
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61M 2210/0662 Ears
• 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: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Systems and methods for treating a patient having a head with a first ear and a second ear, function by mounting a support structure to the head of the patient; aligning the support structure with a target tissue in an ear canal of the first ear; stabilizing the support structure relative to the target tissue by injecting a material into the canal and hardening the material; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Claims

1. A method for treating a patient, the patient having a head with a first ear and a second ear, the method comprising:

placing a conformable guide block in an ear canal of the first ear such that the guide block conforms to a shape of the ear canal to form a substantially fluid tight seal with the ear canal;

stabilizing the guide block in the ear canal by injecting a material into the ear canal and hardening the material to form a fluid tight seal between the material and the ear canal;

passing a fluid including an anesthetic agent through a first lumen through the guide block into a sealed space between the guide block and a tympanic membrane;

allowing at least one of extra fluid or air to escape from the sealed space between the guide block and the tympanic membrane through a second lumen through the guide block;

applying current to the fluid in the sealed space using an electrode extending through the guide block to cause the anesthetic agent to move at least partially through the tympanic membrane via iontophoresis; and

providing negative pressure relief in the ear canal through the second lumen during the removal of the guide block from the ear canal.

2. The method of claim 1, wherein the material comprises an impression material, and wherein the method further comprises aligning the guide block with the tympanic membrane, without touching the tympanic membrane while the impression material is in a workable state.

3. The method of claim 2, further comprising imaging the tympanic membrane with an image capture device extending through a third lumen of the guide block, wherein the alignment of the guide block with the first ear is performed with reference to a display of a captured image.

4. The method of claim 1, further comprising measuring a distance from the guide block to the tympanic membrane.

5. The method of claim 4, wherein measuring the distance comprises using two laser beams to coincide a spot or crosshair on the tympanic membrane.

6. The method of claim 1, wherein the guide block and the hardened material are included in a support system having an interface, and wherein the interface replaceably receives a measurement module, a treatment module including a treatment device, and/or an iontophoresis module including the electrode.

7. The method of claim 1, further comprising:

advancing a tympanic membrane treatment device through the guide block after anesthetizing the tympanic membrane; and

performing a treatment procedure on the tympanic membrane using the treatment device.

8. The method of claim 7, wherein the treatment device comprises a combined myringotomy/ear tube placement device, and wherein performing the treatment procedure comprises placing a tube through the tympanic membrane.

9. The method of claim 1, further comprising repeating all of the steps in an ear canal of the second ear.

10. The method of claim 9, wherein all the steps are performed on the first ear and then all the steps are performed on the second ear.

11. The method of claim 9, wherein at least some of the steps are performed on the first and second ears at the same time.

12. The method of claim 9, further comprising coupling the guide blocks used in the first and second ears to a support structure coupled with the patient'"'"'s head.

13. The method of claim 9, further comprising performing a treatment procedure on the tympanic membrane of each of the first and second ears.

14. The method of claim 13, wherein the treatment procedure comprises placing a tube through each of the tympanic membranes.

15. The method of claim 1, wherein a surface tension of the fluid is maintained in the second lumen to prevent the fluid from exiting the first lumen when applying current.

16. The method of claim 1, wherein placing the conformable guide block comprises observing a deflection of a hair-like element against the tympanic membrane to determine a range between the guide block and the tympanic membrane, the hair-like element extending from the guide block.