FEATURES TO IMPROVE AND SENSE TYMPANIC MEMBRANE APPOSITION BY TYMPANOSTOMY TUBE DELIVERY INSTRUMENT

• US 20140276906A1
• Filed: 03/14/2013
• Published: 09/18/2014
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Andreas, Bernard H., Girotra, Rohit, Walker, Jeffrey A., Gross, T. Daniel, Kermani, Mahyar Z., Baron, Scott J., Clopp, Matthew D.
• Granted Patent: US 9,320,652 B2
• Time in Patent Office: Days
• US Class Current: 606/109
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor

Abstract

A tympanostomy tube delivery device comprises a shaft assembly, a pressure equalization tube, and a sensor. The shaft assembly comprises a cannula and a pusher operable to translate relative to the cannula. The pressure equalization tube is positioned within the shaft assembly. The pusher is operable to drive the pressure equalization tube out of the shaft assembly. The sensor is operable to detect a physical parameter associated with engagement between the distal end of the shaft assembly and a tympanic membrane. A controller may activate a feedback device to inform an operator that the distal end of the shaft assembly has achieved suitable apposition with the tympanic membrane, based on information from the sensor.

Claims

1. An apparatus comprising:

(a) a shaft assembly having a distal end, wherein the shaft assembly comprises;

(i) a cannula, and

(ii) a pusher operable to translate relative to the cannula;

(b) a pressure equalization tube positioned within the shaft assembly, wherein the pusher is operable to drive the pressure equalization tube out of the shaft assembly; and

(c) a sensor, wherein the sensor is operable to detect a physical parameter associated with engagement between the distal end of the shaft assembly and a tympanic membrane.

2. The apparatus of claim 1, wherein the sensor is operable to detect a deformation in the shaft assembly.

3. The apparatus of claim 2, wherein the sensor comprises a strain gauge.

4. The apparatus of claim 1, wherein the sensor comprises a pressure sensor operable to sense fluid pressure.

5. The apparatus of claim 1, further comprising a controller in communication with the sensor, wherein the sensor comprises at least one exposed electrode positioned at the distal end of the shaft assembly.

6. The apparatus of claim 5, wherein the distal end of the shaft assembly has an annular distal face, wherein the at least one exposed electrode comprises an annular electrode extending along the annular distal face of the distal end of the shaft assembly.

7. The apparatus of claim 6, further comprising a ground pad, wherein the controller is operable to detect electrical resistance or impedance between the annular electrode and the ground pad.

8. The apparatus of claim 6, wherein the controller is operable to detect a capacitance associated with the annular electrode.

9. The apparatus of claim 5, wherein the distal end of the shaft assembly has an annular distal face, wherein the at least one exposed electrode comprises a plurality of discrete electrodes positioned at respective locations along the annular distal face of the distal end of the shaft assembly.

10. The apparatus of claim 9, further comprising a ground pad, wherein the controller is operable to detect electrical resistance or impedance between each of the discrete electrodes and the ground pad.

11. The apparatus of claim 9, wherein the discrete electrodes form pairs located in diametrically opposing positions along the annular distal face of the distal end of the shaft assembly, wherein the controller is operable to detect electrical resistance or impedance between the electrodes in each pair.

12. The apparatus of claim 1, further comprising a user feedback feature, wherein the user feedback feature is operable to alert an operator to one or more conditions associated with engagement between the distal end of the shaft assembly and a tympanic membrane based at least in part on information from the sensor.

13. The apparatus of claim 1, further comprising a vacuum source operable to draw a tympanic membrane against the distal end of the shaft assembly.

14. The apparatus of claim 13, wherein the pusher defines a lumen, wherein the vacuum source is operable to communicate suction through the lumen of the pusher.

15. The apparatus of claim 13, further comprising a controller, wherein the controller is in communication with the sensor, wherein the controller is in further communication with the vacuum source, wherein the controller is configured to deactivate the vacuum source based at least in part on information from the sensor indicating one or more conditions associated with engagement between the distal end of the shaft assembly and a tympanic membrane.

16. The apparatus of claim 1, wherein the distal end of the shaft assembly is beveled.

17. The apparatus of claim 1, further comprising an imaging device disposed within the shaft assembly.

18. An apparatus comprising:

(a) a shaft assembly having a distal end, wherein the shaft assembly comprises;

(i) a cannula, and

(ii) a pusher operable to translate relative to the cannula;

(b) a pressure equalization tube positioned within the shaft assembly, wherein the pusher is operable to drive the pressure equalization tube out of the shaft assembly;

(c) a vacuum source coupled with the shaft assembly, wherein the vacuum source is operable to provide suction at the distal end of the shaft assembly; and

(d) a sensor, wherein the sensor is operable to detect a physical parameter associated with a vacuum level the distal end of the shaft assembly.

19. An apparatus comprising:

(a) a shaft assembly containing a tympanostomy tube, wherein the shaft assembly has a distal end, wherein the shaft assembly is operable to deliver the tympanostomy tube through the distal end and into a tympanic membrane of a patient; and

(b) a light pipe configured to convey light toward the distal end of the shaft assembly, wherein the light pipe is configured to darken in response to contact between the distal end of the shaft assembly and a tympanic membrane of a patient.

20. The apparatus of claim 19, wherein the distal end of the shaft assembly has a distal edge, wherein the light pipe terminates in the distal edge of the shaft assembly.