System and Method for the Simultaneous Automated Bilateral Delivery of Pressure Equalization Tubes

• US 20110288559A1
• Filed: 06/21/2011
• Published: 11/24/2011
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Shahoian, Erik James
• Granted Patent: US 8,702,722 B2
• Time in Patent Office: Days
• US Class Current: 606/109
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Systems and methods for treating a patient having a head with a first ear and a second ear, function by aligning a first device with a tympanic membrane of the first ear; inputting a command to an input device operatively coupled to the first device to generate a signal; and actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane.

Claims

1. A method for treating a patient, the patient having a head with a first ear and a second ear, the method comprising:

aligning a first device with a tympanic membrane of the first ear;

inputting a command to an input device operatively coupled to the first device to generate a signal;

actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane, the penetrator defined by a tube with a cutting edge and including a receptacle; and

deploying a tympanostomy tube with the device, wherein the tympanostomy tube is radially constrained within the receptacle of the penetrator, and wherein the tympanostomy tube expands radially when released so as to inhibit expulsion.

2. The method of claim 1, wherein the input device is movably coupled to the first device so as to isolate a command movement and inhibit deviation from the alignment.

3. The method of claim 1, further comprising:

aligning a second device with a tympanic membrane of the second ear; and

actuating the second device in response to the signal so as to drive a penetrator of the device through the tympanic membrane of the second ear, penetration of the tympanic membranes being synchronized by circuitry coupling the input device to the devices.

4. The method of claim 1, further comprising advancing the tympanostomy tube with the penetrator and the penetrator retracting back into the ear canal after releasing the tympanostomy tube.

5. The method of claim 4, wherein the signal comprises an electrical signal, the device comprising an electromechanical mechanism effecting axial movement of the penetrator.

6. The method of claim 5, wherein the device comprises a first spring urging the penetrator distally through the tympanic membrane and a second spring urging the tympanostomy tube free of the penetrator and the penetrator proximally of the tympanic membrane, wherein the first and second springs are restrained prior to the signal and wherein the signal effects sequential release of the first spring and the second spring.

7. The method of claim 6, further comprising damping the axial movement of the penetrator.

8. The method of claim 6, wherein the first and second springs are restrained by associated first and second electrically fusable members, and wherein the fusable members are coupled to the input device with a flex circuit bent around the axis.

9. The method of claim 5, wherein the first device comprises a shape memory alloy actuator coupled to an electrical driving circuit.

10. The method of claim 1, wherein the first device comprises a hydraulic actuator, an electromagnetic actuator, and/or a permanent magnet actuator.

12. The method of claim 6, wherein the first device is contained within a housing having an axial length of less than 15 mm and a maximum transverse dimension of less than 5 mm.

13. The method of claim 1, wherein the actuation of the penetrator has a stroke, and further comprising measuring an axial distance between the tympanic membrane and the penetrator so that the stroke penetrates the tympanic membrane by a desired amount.

14. The method of claim 1, wherein the patient is sitting upright.

11. (canceled)

15. A system for treating a patient, the patient having a head with a first ear and a second ear, each ear having a tympanic membrane, the system comprising:

an input device configured to generate a signal in response to entry of a command; and

a penetrator defining a tube with a cutting edge and having a receptacle, a proximal end, a distal end, and an axis therebetween, the distal end sharpened for penetration through a tympanic membrane;

an actuation mechanism movably supporting the penetrator and coupled with the input device, the actuation mechanism changing from a ready state to a pierce state in response to the signal so as to penetrate the tympanic membrane when aligned therewith; and

a tympanostomy tube supported by the actuation mechanism, wherein the tympanostomy tube is radially constrained within the receptacle of the penetrator, and wherein the tympanostomy tube expands radially when released.

16. The system of claim 15, further comprising a support system configured for maintaining alignment between the actuation mechanism and the head of the patient, wherein the input device is movably coupled to the first device so as to isolate a command movement and inhibit deviation from the alignment.

17. The system of claim 16, further comprising:

another penetrator alignable with a tympanic membrane of the second ear;

another actuation mechanism supporting the other penetrator, the other actuation mechanism effecting axial movement of the other penetrator in response to the signal so as to drive the other penetrator through the tympanic membrane of the second ear; and

circuitry coupling the input device to the actuation mechanisms such that penetration of the tympanic membranes is synchronized.

18. The system of claim 15, wherein the tympanostomy tube advances with the penetrator and the penetrator retracting back into the ear canal after releasing the tympanostomy tube.

19. The system of claim 18, wherein the signal comprises an electrical signal, the actuation mechanism comprising an electromechanical mechanism configured for effecting axial movement of the penetrator.

20. The system of claim 19, wherein the device comprises a first spring for urging the penetrator distally through the tympanic membrane and a second spring urging the tympanostomy tube free of the penetrator and the penetrator proximally, wherein the first and second springs are restrained prior to the signal and wherein the signal effects sequential release of the first spring and the second spring.

21. The system of claim 20, further comprising a damper coupled to the actuation mechanism so as to damp the axial movement of the penetrator.

22. The system of claim 21, wherein the first and second springs are releasably restrained by associated first and second electrically fusable members, and wherein the fusable members are coupled to the input device with a flex circuit, the flex circuit being bent around the axis.

23. The system of claim 19, wherein the first device comprises a shape memory alloy actuator coupled to an electrical driving circuit.

24. The system of claim 15, wherein the first device comprises a hydraulic actuator, an electromagnetic actuator, and/or a permanent magnet actuator.

26. The system of claim 15, wherein the penetrator and actuation mechanism are contained within a housing having an axial length of less than 15 mm and a maximum transverse dimension of less than 5 mm.

25. (canceled)

27. A system for treating a tympanic membrane of a patient, comprising:

a tube with a cutting edge configured to penetrate through a tympanic membrane and including a receptacle;

an actuation mechanism associated with the tube with cutting edge; and

a tympanostomy tube supported by the actuation mechanism, the tympanostomy tube having a first constrained configuration and a second expanded configuration and being retained in the first constrained configuration within the receptacle.

28. The system of claim 27, wherein the tympanostomy tube expands radially to the second expanded configuration when released from the receptacle.

29. The system of claim 27, wherein the tympanostomy tube includes a plurality of interrupted medial flanges.

30. The system of claim 27, wherein the tympanostomy tube includes a flange with a cut-out formed therein.

31. The system of claim 27, wherein the tympanostomy tube is configured about the tube with cutting edge.

32. The system of claim 27, wherein the tympanostomy tube includes a distal end with a radially extending flange.

33. The system of claim 32, wherein the tympanostomy tube includes a proximal end with a radially extending flange.

34. The system of claim 27, wherein the tympanostomy tube has a distal end including a tapered structure.

35. The system of claim 27, wherein the tympanostomy tube has a distal end including flexible internal flanges.