Tympanostomy tube delivery device with replaceable shaft portion

• US 10,653,561 B2
• Filed: 12/04/2017
• Issued: 05/19/2020
• Est. Priority Date: 08/12/2014
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: Andreas, Bernard H., Gross, Thomas D.
• Primary Examiner(s): Tanner, Jocelyn C
• Application Number:
  US15/830,473
• Publication Number:
  US 20180085258A1
• Time in Patent Office: 897 Days
• 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 and a handpiece. All or a portion of the shaft assembly is selectively coupleable and removable from the handpiece. The handpiece includes a housing defining an opening that can receive a portion of the shaft assembly. 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 apparatus, comprising:

a shaft assembly including a plurality of shafts and a plurality of cam followers, each shaft from the plurality of shafts coupled to a different cam follower from the plurality of cam followers;

a handpiece including a housing defining an interior space and a fixed opening extending from an exterior of the handpiece to the interior space, the fixed opening having a dimension greater than a lateral dimension of the shaft assembly such that a portion of each cam follower from the plurality of cam followers can be inserted through the fixed opening into the interior space; and

a drive assembly disposed in the interior space and configured to drive the plurality of shafts in a predetermined sequence to deploy a tympanostomy tube in a tympanic membrane.

2. The apparatus of claim 1, wherein the drive assembly includes a cam configured to engage the portion of each cam follower from the plurality of cam followers after the portion of each cam follower from the plurality of cam followers is inserted through the fixed opening into the interior space.

3. The apparatus of claim 1, wherein each cam follower from the plurality of cam followers includes a flange.

4. The apparatus of claim 1, wherein the fixed opening includes an elongate channel, the plurality of cam followers configured to translate in a longitudinal direction along the elongate channel.

5. The apparatus of claim 1, wherein the fixed opening includes a section that is shaped to correspond to a surface of each cam follower from the plurality of cam followers.

6. The apparatus of claim 1, wherein the housing includes two housing portions that are configured to engage one another to collectively define the fixed opening.

7. The apparatus of claim 1, wherein the plurality of shafts includes at least two of:

a shield tube configured to hold the tympanostomy tube;

a cutting dilator tube configured to form an incision in the tympanic membrane and to dilate the incision;

or

a pusher tube configured to drive the tympanostomy tube out of the shield tube and into the incision formed by the cutting dilator,

the shield tube, the cutting dilator tube, and the pusher tube coaxially and slidably disposed within a cannula.

8. The apparatus of claim 1, wherein the plurality of shafts are coaxially and slidably disposed within a tubular member.

9. The apparatus of claim 1, wherein each cam follower from the plurality of cam followers includes a flange, the fixed opening including a plurality of slots, each slot configured to receive a flange of a different cam follower from the plurality of cam followers.

10. The apparatus of claim 1, wherein the fixed opening includes an elongate channel and a plurality of slots, each slot from the plurality of slots disposed along a length of the elongate channel and intersecting the elongate channel.

11. The apparatus of claim 1, wherein the fixed opening includes a channel formed in a proximal end of the housing such that each cam follower from the plurality of cam followers can be slid into the fixed opening via the channel formed in the proximal end of the housing.

12. An apparatus, comprising:

a shaft assembly including a plurality of shafts and a plurality of cam followers, each shaft from the plurality of shafts coupled to a different cam follower from the plurality of cam followers;

a handpiece including a housing defining an interior space and an opening extending from an exterior of the handpiece to the interior space, the opening configured to receive the plurality of cam followers; and

a drive assembly disposed in the interior space and configured to drive the plurality of shafts in a predetermined sequence to deploy a tympanostomy tube in a tympanic membrane, the drive assembly including a cam configured to engage the plurality of cam followers after the plurality of cam followers are received in the opening.

13. The apparatus of claim 12, wherein the opening includes an elongate channel, the plurality of cam followers configured to translate in a longitudinal direction along the elongate channel.

14. The apparatus of claim 12, wherein the opening includes a section that is shaped to correspond to a surface of each cam follower from the plurality of cam followers.

15. The apparatus of claim 12, wherein the housing includes two housing portions that are configured to engage one another to collectively define the fixed opening.

16. The apparatus of claim 12, wherein the plurality of shafts includes at least two of:

a shield tube configured to hold the tympanostomy tube;

a cutting dilator tube configured to form an incision in the tympanic membrane and to dilate the incision;

or

a pusher tube configured to drive the tympanostomy tube out of the shield tube and into the incision formed by the cutting dilator,

the shield tube, the cutting dilator tube, and the pusher tube coaxially and slidably disposed within a cannula.

17. The apparatus of claim 12, wherein the plurality of shafts are coaxially and slidably disposed within a tubular member.

18. The apparatus of claim 12, wherein the opening includes a channel formed in a proximal end of the housing such that each cam follower from the plurality of cam followers can be slid into the fixed opening via the channel formed in the proximal end of the housing.