Tympanostomy tube delivery device with rotatable

• US 10,195,086 B2
• Filed: 08/11/2014
• Issued: 02/05/2019
• Est. Priority Date: 08/11/2014
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: Van, Nga K., Clopp, Mathew D., Baron, Scott J., Gross, Thomas D.
• Primary Examiner(s): Tanner, Jocelin C
• Application Number:
  US14/456,080
• Publication Number:
  US 20160038342A1
• Time in Patent Office: 1,639 Days
• CPC Class Codes: A61B 2090/038 during shipment
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor

Abstract

An instrument comprises a shaft assembly, a handpiece body, and a drive assembly. The shaft assembly comprises a plurality of coaxially arranged shafts and a tympanostomy tube. The shaft assembly further includes a flexible section. The shaft assembly extends distally from the handpiece body. The drive assembly is operable to drive the shafts of the shaft assembly in a predetermined sequence to deploy the tympanostomy tube. One or more of the shafts are configured to translate along the flexible section of the shaft assembly as a part of the predetermined sequence to deploy the tympanostomy tube.

Claims

1. An instrument comprising:

a handpiece body;

a shaft assembly extending distally from the handpiece body and rotatable relative to the handpiece body, the shaft assembly including an elongate tube with a plurality of shafts coaxially and slidably disposed therein, the elongate tube having (1) a bendable section that can bend within a plane between a linear state and a bent state, (2) a proximal section disposed proximal to the bendable section and defining a longitudinal axis, and (3) a tip disposed distal to the bendable section and configured to engage a tympanic membrane of a patient;

a thumbwheel coupled to the elongate tube and operable to rotate the elongate tube about the longitudinal axis defined by the proximal section of the elongate tube to change an angle of the tip; and

a drive assembly disposed within the handpiece body that can longitudinally translate the plurality of shafts relative to the elongate tube of the shaft assembly including through the bendable section when the bendable section is in the bent state in a predetermined sequence to at least one of pierce the tympanic membrane or deploy a tympanostomy tube into the tympanic membrane.

2. The instrument of claim 1, wherein the thumbwheel and the shaft assembly form a unitary component.

3. The instrument of claim 1, wherein the bendable section defines a plurality of cutouts extending around a portion of the bendable section such that a solid longitudinally extending member extends along a length of the bendable section.

4. The instrument of claim 3, wherein the bendable section includes a plurality of ribs and the longitudinally extending member, the plurality of ribs and the longitudinally extending member defining the plurality of cutouts.

5. The instrument of claim 1, wherein at least one shaft of the plurality of shafts can maintain a neutral axis throughout the bendable section when the bendable section is in the bent state.

6. The instrument of claim 1, wherein the bendable section of the elongate tube is malleable such that the bendable section can remain in the bent state without a continuously applied force.

7. The instrument of claim 1, wherein at least one of the elongate tube or a shaft of the plurality of shafts includes nylon.

8. The instrument of claim 1, wherein at least one of the elongate tube or a shaft of the plurality of shafts includes polyether ether ketone (PEEK).

9. The instrument of claim 1, wherein the plurality of shafts of the shaft assembly includes at least one of a piercer that can pierce the tympanic membrane or a pusher that can deploy the tympanostomy tube into the tympanic membrane.

10. The instrument of claim 1, wherein lubricant is disposed on at least one surface of at least one shaft of the plurality of shafts.

11. The instrument of claim 1, wherein the tip is configured to engage with the tympanic membrane without requiring significant pressure to be applied against the tympanic membrane.

12. The instrument of claim 1, wherein the tip of the elongate tube is obliquely angled relative to a central axis of the elongate tube.

13. The instrument of claim 1, wherein at least one of a portion of the elongate tube or the tip includes at least one of nylon or polyether ether ketone (PEEK).

14. An apparatus, comprising:

a handpiece body;

a shaft assembly extending distally from the handpiece body and rotatable relative to the handpiece body, the shaft assembly including an elongate tube and a plurality of shafts coaxially and slidably disposed within the elongate tube, the elongate tube having (1) a bendable section that can bend within a plane between a linear state and a bent state, (2) a proximal section disposed proximal to the bendable section and defining a longitudinal axis, and (3) a tip disposed distal to the bendable section and configured to engage a tympanic membrane of a patient;

a thumbwheel coupled to the elongate tube and operable to rotate the elongate tube to move the tip in a path around the longitudinal axis defined by the proximal section of the elongate tube; and

a drive assembly disposed within the handpiece body that can longitudinally translate the plurality of shafts relative to the elongate tube of the shaft assembly in a predetermined sequence to at least one of pierce the tympanic membrane or deploy a tympanostomy tube into the tympanic membrane.

15. The apparatus of claim 14, wherein:

the drive assembly can longitudinally translate at least one shaft of the plurality of shafts relative to the elongate tube including through the bendable section when the bendable section is in the bent state.

16. The apparatus of claim 14, wherein the bendable section defines a plurality of cutouts extending around a portion of the bendable section such that a solid longitudinally extending member extends along a length of the bendable section.

17. The apparatus of claim 14, wherein the thumbwheel and the shaft assembly form a unitary component.

18. The apparatus of claim 14, wherein the thumbwheel is further configured to rotate the elongate tube to change an angle of the tip.

19. An instrument comprising:

a handpiece body;

a shaft assembly including an elongate tube and a plurality of shafts coaxially and slidably disposed within the elongate tube, the elongate tube having (1) a bendable section that can bend within a plane between a linear state and a bent state, (2) a proximal section disposed proximal to the bendable section, and (3) a distal tip configured to engage a tympanic membrane of a patient;

a tympanostomy tube disposed within the elongate tube distal to the bendable section;

a thumbwheel coupled to the elongate tube and operable to rotate the elongate tube to (1) change an angle of the tip and (2) move the tympanostomy tube relative to the proximal section of the elongate tube; and

a drive assembly disposed within the handpiece body that can longitudinally translate the plurality of shafts relative to the elongate tube of the shaft assembly including through the bendable section when the bendable section is in the bent state in a predetermined sequence to at least one of pierce the tympanic membrane or deploy the tympanostomy tube into the tympanic membrane.

20. The instrument of claim 19, wherein the plurality of shafts of the shaft assembly are coupled to the handpiece body for rotation about a central longitudinal axis of the elongate tube, the bendable section of the elongate tube being configured to remain in the bent state during rotation of the shaft assembly about the central longitudinal axis of the elongate tube.

21. The instrument of claim 19, further comprising a pushbutton disposed on the handpiece body and operable to actuate the drive assembly, the thumbwheel disposed distally of the pushbutton.