Features to improve and sense tympanic membrane apposition by tympanostomy tube delivery instrument

• US 10,219,950 B2
• Filed: 04/04/2016
• Issued: 03/05/2019
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: Andreas, Bernard H., Girotra, Rohit, Walker, Jeffrey A., Gross, T. Daniel, Clopp, Mathew D., Kermani, Mahyar Z., Baron, Scott J.
• Primary Examiner(s): Miles, Wade
• Application Number:
  US15/090,353
• Publication Number:
  US 20160213519A1
• Time in Patent Office: 1,065 Days
• 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 having an annular distal face, 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) at least one exposed electrode positioned at the distal end of the shaft assembly, wherein the at least one exposed electrode is (i) operable to detect a physical parameter associated with the distal end of the shaft assembly as the distal end of the shaft assembly is advanced toward and into engagement with a tympanic membrane and (ii) comprises an annular electrode disposed on the annular distal face of the distal end of the shaft assembly.

2. The apparatus of claim 1, further comprising a controller in communication with the at least one exposed electrode.

3. The apparatus of claim 2, further comprising a ground pad, wherein the controller is operable to detect electrical resistance or impedance between the at least one exposed electrode and the ground pad.

4. The apparatus of claim 2, wherein the controller is operable to detect a capacitance associated with the at least one exposed electrode.

5. The apparatus of claim 4, wherein the controller is operable to control a feedback device based on the capacitance associated with the at least one exposed electrode,

the feedback device operable to indicate when the distal end of the shaft assembly engages with the tympanic membrane.

6. The apparatus of claim 2, wherein the controller includes a capacitance meter, the capacitance meter configured to detect the capacitance between the at least one exposed electrode and the tympanic membrane.

7. The apparatus of claim 2, wherein the controller includes a capacitor.

8. 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 the tympanic membrane based on information from a sensor.

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

10. The apparatus of claim 9, wherein the pusher defines a lumen, wherein the vacuum source is operable to communicate suction through the lumen of the pusher.

11. The apparatus of claim 9, further comprising a controller, wherein the controller is in communication with the at least one exposed electrode, 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 a sensor indicating one or more conditions associated with engagement between the distal end of the shaft assembly and a tympanic membrane.

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

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

14. The apparatus of claim 1, wherein the distal end of the shaft assembly includes an annular ridge formed of an electrically insulative material, the annular ridge protruding about the outer perimeter of the annular electrode.

15. An apparatus comprising:

(a) a shaft assembly having a distal end having an annular distal face, 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) at least one exposed electrode comprising an annular electrode disposed on the annular distal face of the distal end of the shaft assembly; and

(d) a controller, the controller operable to apply a voltage to the at least one exposed electrode such that the controller can detect a capacitance formed between the at least one electrode and a tympanic membrane.

16. The apparatus of claim 15, further comprising a user feedback device operable to alert an operator of a change in the capacitance formed between the at least one exposed electrode and the tympanic membrane.

17. A method comprising:

(a) disposing a shaft assembly proximate a tympanic membrane of a patient such that a capacitance is formed by a distal end of the shaft assembly and the tympanic membrane, the distal end having an annular distal face, the shaft assembly comprising;

(i) a cannula,

(ii) a pusher operable to translate relative to the cannula, and

(iii) at least one exposed electrode including an annular electrode disposed on the annular distal face of the distal end of the shaft assembly;

(b) advancing the shaft assembly into engagement with the tympanic membrane of the patient;

(c) detecting a change in the capacitance formed by the distal end of the shaft assembly and the tympanic membrane; and

(d) operating, in response to the detecting, the pusher of the shaft assembly to drive a pressure equalization tube positioned within the shaft assembly out of 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; and

(c) at least one exposed electrode positioned at the distal end of the shaft assembly, wherein the at least one exposed electrode is (i) operable to detect a physical parameter associated with the distal end of the shaft assembly as the distal end of the shaft assembly is advanced toward and into engagement with a tympanic membrane and (ii) disposed within an inner diameter of the distal end of the shaft assembly.