TYMPANIC MEMBRANE PRESSURE EQUALIZATION TUBE DELIVERY SYSTEM

• US 20110015645A1
• Filed: 07/15/2010
• Published: 01/20/2011
• Est. Priority Date: 07/15/2009
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Gross, Thomas Daniel, Morriss, John H., Clopp, Mathew D., Ha, Hung V., Liu, Greg, Vrany, Julie D., Walker, Jeffrey A., Girotra, Rohit, Knodel, Bryan, Andreas, Bernard H.
• Granted Patent: US 8,864,774 B2
• Time in Patent Office: Days
• US Class Current: 606/109
• 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: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor

Abstract

Systems and methods are provided for automatically forming an incision in a tympanic membrane of an ear and placing a tympanic membrane pressure equalization tube into the incision. The systems include a housing with a shaft extending therefrom. A mechanism is disposed within the housing. A distal end of the shaft is placed against a tympanic membrane, and the mechanism is triggered to causes the tympanic membrane to be automatically incised and dilated and a tympanic membrane pressure equalization tube to be placed in the dilated incision.

Claims

1. A system for forming an incision in a tympanic membrane and delivering a pressure equalization tube into the incision, the system comprising:

a housing including a handle;

an elongate shaft assembly coupled with the housing, the shaft assembly comprising;

an outer shaft having a blunt distal tip portion

a cutter linearly moveable within the outer shaft;

a pusher slidably disposed over the cutter within the outer shaft;

a pressure equalization tube slidably disposed about the cutter at a distal end of the pusher;

a shield slidably disposed over the pusher and the pressure equalization tube; and

a dilator slidably disposed over the shield;

a cam assembly comprising;

a cam shaft rotationally coupled within the housing, the cam shaft including a first cam profile, a second cam profile, a third cam profile, and a fourth cam profile;

a first cam follower moveably coupled to the first cam profile, the first cam follower attached to the cutter;

a second cam follower moveably coupled to the second cam profile, the second cam follower attached to the pusher;

a third cam follower moveably coupled to the third cam profile, the third cam follower attached to the shield;

a fourth cam follower moveably coupled to the fourth cam profile, the fourth cam follower attached to the dilator;

a spring biased between the housing and the cam shaft, the spring having a wound position which places a torsional load on the cam shaft, and a released position; and

a release member moveably coupled to the cam shaft, the release member having a first position which maintains the spring in the wound position and a second position which allows the spring to move into the released position;

wherein when the release member is moved into the released position, the spring is released to move the cam shaft and cause the cam followers to linearly move respective portions of the shaft assembly to form an incision in a tympanic membrane using the cutting member, dilate the incision using the dilator, and advance the pressure equalization tube out of the shield and into the incision using the pusher.

2. The system of claim 1, wherein the housing comprises a first housing portion and a second housing portion, and wherein each housing portion is a molded clamshell.

3. The system of claim 2, wherein the housing portions form a camshaft chamber, a cam follower chamber, a spring chamber, and a trigger mechanism chamber.

4. The system of claim 1, wherein the outer shaft is constructed from rigid tubing.

5. The system of claim 1, wherein the outer shaft comprises an outer wall, an inner wall, and a space therebetween in which negative pressure may be applied.

6. The system of claim 5, wherein the negative pressure may be used to actuate the release member.

7. The system of claim 1, wherein the cutting member comprises an elongate wire with a diamond headed tip.

8. The system of claim 1, wherein the shield comprises an elongate tube.

9. The system of claim 1, wherein the pressure equalization tube comprises a grommet with a lumen, a medial flange, and a lateral flange.

10. The system of claim 9, wherein the medial and lateral flanges are compressed within the shield.

11. The system of claim 10, wherein the pressure equalization tube includes internal wire scaffolding.

12. The system of claim 10, wherein the pressure equalization tube is constructed from an elastomeric material and includes flexible portions between the lumen and flanges.

13. The system of claim 10, wherein the flanges include notches that facilitate compression of the tube within the shield.

14. The system of claim 1, wherein the pusher comprises an elongate tube.

15. The system of claim 1, wherein the dilator comprises an elongate tube with a distal tip, the distal tip being capable of expanding from narrow position to an open position.

16. The system of claim 15, wherein the distal tip comprises a plurality of members which are spring biased in the narrow position and can be forcibly opened into the open position.

17. The system of claim 1, wherein the cam shaft comprises an elongate cylinder, with first and second ends rotationally attached to the housing, a mid-section therebetween, and a spring holder extending from the second end.

18. The system of claim 15, wherein the cam profiles each comprise a patterned groove in the mid-section.

19. The system of claim 1, wherein the cam followers each comprise a block which is slidably housed in the housing, each block including a drive pin for following a respective cam profile.

20. The system of claim 19, wherein the blocks are arranged linearly with respect to the elongate shaft.

21. The system of claim 1, wherein a link couples the release member to the camshaft, and wherein the release member pushes the link to release the camshaft when moved into the second position.

22. The system of claim 1, wherein a link couples the release member to the camshaft, and wherein the release member, when moved laterally, releases the link to release the camshaft when moved into the second position.

23. The system of claim 1, wherein the release member is selected from the group comprising a button, a trigger or a switch.

24. A method for forming an incision and placing a pressure equalization tube in a tympanic membrane of an ear, the method comprising:

contacting a blunt distal end of a shaft of a tube delivery device with a tympanic membrane;

advancing a cutter out of the shaft distal end to form an incision in the tympanic membrane, wherein a dilator is disposed over at least a portion of the cutter;

advancing a shield disposed over the cutter and within the dilator out of the shaft distal end and into the incision to dilate the dilator, wherein the shield is disposed over a pressure equalization tube;

retracting the cutter into the shaft;

retracting the shield into the shaft, thereby releasing a distal flange of the pressure equalization tube such that it assumes an expanded configuration; and

pushing the pressure equalization tube out of the shield using a pusher disposed within the shield, thereby releasing a proximal flange of the pressure equalization tube such that it assumes an expanded configuration;

wherein, after being pushed out of the shield, a middle portion of the pressure equalization tube is disposed within the incision in the tympanic membrane and the distal and proximal flanges are disposed on opposite sides of the incision.

25. The method of claim 26, wherein the steps of retracting the shield and pushing the equalization tube occur simultaneously.

26. The method of claim 24, wherein the advancing, retracting and pushing steps are initiated by pressing a button on the tube delivery device.

27. The method of claim 26, further comprising moving a safety member on the tube delivery device from an off position to an on position before pushing the button.

28. The method of claim 26, further comprising removing a safety lock member from the delivery device before pushing the button.

29. The method of claim 24, wherein advancing the cutter comprises rotating a camshaft of the tube delivery device to a first cam position which causes a first cam follower to extend the cutter out of the outer shaft and also causes the fourth cam follower to extend the dilator out of the outer shaft.

30. The method of claim 29, wherein advancing the shield and retracting the cutter comprises rotating the camshaft to a second cam position which causes a second cam follower to move the shield out of the shaft to expand a distal portion of the dilator and also causes the first cam follower to move the cutting member back into the shaft.

31. The method of claim 30, wherein retracting the shield comprises rotating the camshaft to a third cam position which causes the second cam follower to move the shield back into the outer shaft and also causes a fourth cam follower to move the dilator back into the outer shaft, and also causes a third cam follower to move and push the pressure equalization tube partly out of the outer shaft.

32. The method of claim 31, wherein pushing the pressure equalization tube comprises rotating the cam shaft to a final position which causes the third cam follower to further move the pusher and further push the pressure equalization tube partly out of the outer shaft.

33. The method of claim 32, wherein the cam shaft is rotated from the first position to the final position in a single continuous motion.

34. The method of claim 32, wherein the steps of pushing the pressure equalization tube and retracting the shield occur simultaneously.

35. The method of claim 32, wherein contacting the blunt distal end comprises applying negative pressure to the tympanic membrane with the blunt distal end of the shaft to elevate the TM and enhance contact of the distal end of the shaft with the tympanic membrane.

36. The method of claim 35 wherein the applied negative pressure actuates rotation of the camshaft.