TYMPANOSTOMY TUBE DELIVERY DEVICE WITH REPLACEABLE SHAFT PORTION

• US 20160045370A1
• Filed: 08/12/2014
• Published: 02/18/2016
• Est. Priority Date: 08/12/2014
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Andreas, Bernard H., Gross, Thomas D.
• Granted Patent: US 9,833,360 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00438 connectable to a finger
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• 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 handpiece. All or a portion of the shaft assembly is selectively coupleable and removable from the handpiece. The shaft assembly comprises a cannula, a piercer/dilator tube, a shield tube, and a pusher tube operable to translate relative to the cannula. The pressure equalization tube is positioned within the shield tube of the shaft assembly. The piercer/dilator tube and the shield tube are operable to pierce the tympanic membrane and dilate an opening formed therein. The pusher tube is operable to drive the pressure equalization tube out of the shield tube of the shaft assembly and into the opening formed in the tympanic membrane. Upon completion of the procedure, all or a portion of the shaft assembly may then be removed and replaced.

Claims

1. An instrument, comprising:

(a) a shaft assembly, wherein the shaft assembly comprises a plurality of coaxially arranged shafts and a tympanostomy tube, wherein two or more of the shafts include respective cam followers; and

(b) a handpiece body, wherein the shaft assembly extends distally from the handpiece body, wherein the handpiece body includes an opening configured to removably receive the two or more of the shafts and the respective cam followers; and

(c) a drive assembly operable to drive the shafts of the shaft assembly in a predetermined sequence to deploy the tympanostomy tube, wherein the drive assembly comprises a cam configured to engage the cam followers upon insertion of the two or more shafts in the opening.

2. The instrument of claim 1, wherein the entire shaft assembly is selectively removable and coupleable with the handpiece body.

3. The instrument of claim 1, wherein only a portion the shaft assembly is selectively removable and coupleable with the handpiece body.

4. The instrument of claim 1, wherein the opening comprises an elongate channel.

5. The instrument of claim 4, wherein the channel is configured to be coupled with the shaft assembly in a snap-fit manner.

6. The instrument of claim 4, wherein the channel comprises a plurality of slots configured to receive the cam followers.

7. The instrument of claim 4, wherein the cam followers are configured to slide within the channel.

8. The instrument of claim 1, wherein the opening comprises a distal opening.

9. The instrument of claim 1, wherein the two or more of the shafts comprise a piercer/dilator tube, a shield tube, a pusher tube, and a cannula.

10. The instrument of claim 9, wherein the piercer/dilator tube, the shield tube, the pusher tube, and the cannula are selectively removable and coupleable with the handpiece body.

11. The instrument of claim 9, wherein the shield tube and the pusher tube are selectively removable and coupleable with the handpiece body.

12. The instrument of claim 9, wherein the cannula is coupled to the handpiece body.

13. The instrument of claim 9, wherein the pusher tube is disposed within the shield tube, wherein the shield tube is disposed within the piercer/dilator tube, and wherein the piercer/dilator tube is disposed within the cannula.

14. The instrument of claim 1, wherein the two or more of the shafts comprise a piercer/dilator tube, wherein the piercer/dilator tube comprises a plurality of resilient leaves.

15. The instrument of claim 14, wherein at least one of the resilient leaves comprises a sharp distal tip configured to pierce a tympanic membrane.

16. The instrument of claim 1, wherein the shaft assembly comprises features configured to maintain a distance between the two or more of the shafts upon insertion of the two or more shafts in the opening.

17. An instrument, comprising:

(a) a shaft assembly, wherein the shaft assembly comprises a plurality of coaxially arranged shafts, wherein at least one shaft of the plurality of coaxially arranged shafts comprises a distal end having a piercing element, wherein the shaft with the piercing element further includes a cam follower;

(b) a handpiece body, wherein the shaft assembly extends distally from the handpiece body, wherein the handpiece body includes a laterally presented channel configured to removably receive the two or more of the shafts and the cam follower; and

(c) a drive assembly operable to drive the shaft with the piercing element, wherein the drive assembly comprises a cam configured to engage the cam follower upon insertion of the two or more shafts in the opening.

18. A method of piercing and dilating a tympanic membrane using an instrument, the instrument comprising a shaft assembly comprising one or more shafts, a handpiece body having an opening configured to removably receive the one or more shafts, and a drive assembly configured to drive at least one of the one or more shafts in a predetermined sequence, the method comprising the steps of:

(a) inserting the one or more shafts through the opening of the handpiece body, wherein the step of inserting the one or more shafts causes the at least one of the one or more shafts to engage the drive assembly;

(b) actuating the drive assembly to thereby drive the at least one of the one or more shafts to thereby pierce a tympanic membrane; and

(c) removing the one or more shafts from the handpiece body after completion of the procedure.

19. The method of claim 18, wherein the one or more shafts comprises at least a piercer/dilator tube.

20. The method of claim 19, wherein the step of actuating further comprises deploying a tympanostomy tube in the tympanic membrane.