System and method for the simultaneous automated bilateral delivery of pressure equalization tubes

1. A system for deploying a tympanostomy tube in a tympanic membrane in an ear of a patient, the system comprising:

(a) a cutting tool having a proximal end and a distal end, the distal end capable of penetrating the tympanic membrane;

(b) a sheath having a proximal end and a distal end, wherein the sheath can selectively cover the distal end of the cutting tool;

(c) an actuation assembly movably supporting the cutting tool, the sheath, and the tympanostomy tube, the actuation assembly being operable to cause relative movement between:

(i) the cutting tool and the sheath to at least one of expose the distal end of the cutting tool for penetrating the tympanic membrane and cover the distal end of the cutting tool for removing the system from the ear; and

(ii) the tympanostomy tube and at least one of the cutting tool and the sheath to deploy the tympanostomy tube in the penetrated tympanic membrane; and

(d) a first locking mechanism including at least one leg biased toward a radially expanded configuration, the at least one leg being radially compressed in an unlocked state and radially expanded in a locked state, wherein the at least one leg can restrict proximal movement of the tympanostomy tube after deployment in the locked state.

2. The system of claim 1 , further comprising the tympanostomy tube, wherein the tympanostomy tube includes a flange for at least one of expanding a hole penetrated in the tympanic membrane by the cutting tool during deployment and maintaining the tympanostomy tube at a deployment position relative to the tympanic membrane after deployment.

3. The system of claim 2 , wherein the tympanostomy tube has a proximal end, a distal end, and a longitudinal axis therebetween, wherein the flange extends transverse to the longitudinal axis.

4. The system of claim 1 , wherein the actuation assembly is configured to retract the cutting tool relative to the tympanostomy tube after the tympanic membrane is penetrated.

5. The system of claim 1 , wherein the at least one leg of the first locking mechanism includes two legs biased toward a radially expanded configuration.

6. The system of claim 1 , wherein the at least one leg of the first locking mechanism can remain in the locked state while the cutting tool is retracted.

7. The system of claim 1 , wherein the actuation assembly is operable to retract the sheath relative to the cutting tool.

8. The system of claim 1 , further comprising a spring operably coupled to the sheath, wherein the spring biases the sheath in a distal direction.

9. The system of claim 1 , further comprising a stop member, wherein the actuation assembly is configured to retract the sheath in a proximal direction relative to the cutting tool until the sheath contacts the stop member.

10. The system of claim 1 , further comprising a support structure for maintaining alignment between the actuation assembly and the ear of the patient.

11. The system of claim 1 , further comprising a second locking mechanism to prevent the movement of at least one of the cutting tool and the sheath to enable independent movement of the cutting tool and the sheath.

12. The system of claim 11 , wherein the second locking mechanism is configured to restrict movement of the sheath from a locked position.

13. The system of claim 12 , wherein the cutting tool is configured to move relative to the sheath when the second locking mechanism is in the locked position.

14. The system of claim 1 , wherein the distal end of the cutting tool has a spear-like geometry that can create a straight hole without flaps in the tympanic membrane upon penetration.

15. The system of claim 1 , wherein the distal end of the cutting tool has a hypo-needle-like geometry that can create a curved hole without flaps in the tympanic membrane upon penetration.

16. The system of claim 1 , wherein the distal end of the cutting tool has a trocar-needle-like geometry that can create a wye-pattern hole with at least one flap in the tympanic membrane upon penetration.

17. A disposable actuator system for deploying a tympanostomy tube in a tympanic membrane of a patient, the system comprising:

(a) a tube assembly including:

(i) a cutting tool for penetrating the tympanic membrane;

(ii) a sheath for selectively covering the cutting tool; and

(iii) the tympanostomy tube predisposed inside the sheath,

wherein the tube assembly is operable to transition between a first state and a second state, the cutting tool being covered by the sheath in the first state and at least a portion of the cutting tool being exposed for penetrating the tympanic membrane and deploying the tympanostomy tube in the second state;

(b) an actuation mechanism for coupling the actuator system to a drive system operable to transition the tube assembly from the first state to the second state; and

(c) a first locking mechanism including at least one leg biased toward a radially expanded configuration, the at least one leg being radially compressed in an unlocked state and radially expanded in a locked state, wherein the at least one leg can restrict proximal movement of the tympanostomy tube after deployment in the locked state.

18. The system of claim 17 , wherein the tympanostomy tube is disposed at least one of inside the cutting tool and around the cutting tool inside the sheath.

19. A method for deploying a tympanostomy tube in a tympanic membrane in an ear canal of a patient, the method comprising:

(a) inserting a distal portion of an actuation assembly into the ear canal of the patient, the actuation assembly movably supporting a cutting tool, a sheath, and the tympanostomy tube, the sheath covering a distal end of the cutting tool during the insertion;

(b) operating the actuation assembly to advance the cutting tool relative to the sheath to penetrate the tympanic membrane with the distal end of the cutting tool;

(c) operating the actuation assembly to advance the tympanostomy tube relative to the sheath for deployment in the penetrated tympanic membrane and to actuate a locked state of a first locking mechanism, the first locking mechanism including at least one leg biased toward a radially expanded configuration, the at least one leg being radially compressed in an unlocked state and radially expanded in the locked state, for restriction of proximal movement by the tympanostomy tube after the deployment; and

(d) withdrawing the distal portion of the actuation assembly from the ear canal of the patient, the sheath covering the distal end of the cutting tool during the withdrawal.

20. The method of claim 19 , further comprising at least one of:

operating the actuation assembly to retract the cutting tool relative to the sheath prior to (c); and

operating the actuation assembly to retract the cutting tool relative to the sheath and the deployed tympanostomy tube after (c).