Mechanically registered videoscopic myringotomy/tympanostomy tube placement system

• US 20060155304A1
• Filed: 05/06/2004
• Published: 07/13/2006
• Est. Priority Date: 04/26/2001
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Fenestra Medical, Inc.
• Inventors: Jones, Christopher, Kaplan, Aaron V., Tartaglia, Joseph, Vaughan, Robert
• Granted Patent: US 7,704,259 B2
• Time in Patent Office: Days
• US Class Current: 606/109
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor

Abstract

Devices, systems, methods, and kits for treating the tissue structures of the ear make use of a guide structure that can mechanically register a treatment probe with a target region of a target tissue, the guide structure being fittingly received in an auditory canal and often comprising a conformable body such as a compressible foam, or the like. The guide structure may include an articulating mechanism for selectively orienting the treatment probe toward the target region of, for example, a tympanic membrane. The guide structure may also support a videoscopic image capture device, illumination transmitting optical fibers, an aiming beam transmitter, and the like. Such structures facilitate myringotomy, tympanostomy tube placement, and the like, under local anesthesia in a doctor'"'"'s office.

Claims

1. A system for treating an ear of a patient having a tympanic membrane and a tissue surface, the system comprising:

a guide structure having a proximal orientation and a distal orientation, the guide structure having a positioning surface;

a tympanic membrane treatment probe oriented by the guide structure, the guide structure maintaining registration of the treatment probe with a target region of the tympanic membrane when the positioning surface engages the tissue surface of the ear.

2. The system of claim 1, the tissue surface comprising an auditory canal, wherein the guide structure comprises a conformable body insertable into the auditory canal.

3. The system of claim 2, wherein a shaft is rotatable within the conformable body about an axis, the treatment probe oriented eccentrically relative to the axis so that rotation of the shaft selectively registers the treatment probe with the target region.

4. The system of claim 3, wherein the shaft is laterally flexible to conform with a bend of the auditory canal during rotation of the shaft.

5. The system of claim 4, wherein the treatment probe is laterally flexible to conform with a bend of the auditory canal during rotation of the shaft.

6. The system of claim 2, wherein the conformable body comprises a foam, further comprising an agent disposed on or in the foam, the agent comprising at least one member selected from the group consisting of a local anesthetic agent, an antibacterial agent, an antibiotic agent, and a cerumenolytic agent.

7. The system of claim 2, wherein the conformable body comprises at least one member of the group consisting of a balloon and a solid elastomer.

8. The system of claim 1, further comprising an image capture device supported by the guide structure for imaging the tympanic membrane, the image capture device coupled to a monitor.

9. The system of claim 8, further comprising an illumination source carried by the guide structure for illuminating the tympanic membrane.

10. The system of claim 1, further comprising a light transmitter directing a light beam distally, the beam aligned with the treatment probe to verifying registration of the treatment probe with the target region.

11. The system of claim 1, wherein the treatment probe comprises a probe shaft disposed in a lumen of the guide structure, the probe shaft coupled to an actuator accessible when the positioning surface engages the tissue surface, the probe shaft advancing coaxially with the lumen in response to the actuator.

12. The system of claim 11, wherein the treatment probe has a distal tip for piercing the tympanic membrane.

13. The system of claim 12, wherein the distal tip comprises a surgically sharp distal edge.

14. The system of claim 12, further comprising a tympanostomy tube releasably carried on the probe shaft proximally of the tip.

15. The system of claim 14, wherein a distal surface of the distal tip is contiguous with a distal surface of the tympanostomy tube

16. The system of claim 14, wherein the tympanostomy tube comprises a proximal flange and a distal flange with a tubular body therebetween, the tubular body having an elongate opening with a first cross-sectional dimension and a second cross-sectional dimension greater than the first, the tip of the probe shaft having a distally oriented edge oriented along the height, the distal surface of the distal flange of the tympanostomy tube angling proximally and radially outwardly.

17. The system of claim 11, wherein a limit surface of the treatment probe inhibits axial movement of the shaft after the probe pierces the tympanic membrane.

18. The system of claim 11, wherein the limit surface inhibits advancement of a proximal flange of the tympanostomy tube into a middle ear.

19. The system of claim 11, wherein the lumen is selectively repostionable relative to the positioning surface for selective registration of the treatment probe with the target region.

20. The system of claim 1, further comprising a cerumen clearing lumen oriented distally from the guide structure.

21. The system of claim 1, further comprising an aspiration lumen advanceable with the probe into the middle ear.

22. The system of claim 1, the guide structure further comprising a proximal body having a distal surface oriented toward an external ear of the patient and an exposed proximal surface, the proximal body comprising a muff manipulatable by a system operator to position the guide structure and register the treatment probe with the target region under remote imaging, the muff inhibiting direct optical visualization of the tympanic membrane.