Optically Coupled Active Ossicular Replacement Prosthesis

• US 20100317914A1
• Filed: 06/14/2010
• Published: 12/16/2010
• Est. Priority Date: 06/15/2009
• Status: Active Grant

• Current Assignee: EarLens Corporation
• Original Assignee: SoundBeam, LLC
• Inventors: Perkins, Rodney C., Puria, Sunil
• Granted Patent: US 9,544,700 B2
• Time in Patent Office: Days
• US Class Current: 600/25
• CPC Class Codes: A61F 2002/183 Ear parts
• CPC Class Codes: H04R 25/606 acting directly on the eardrum, the ossicles or the skull, e.g. mastoid, tooth, maxillary or mandibular bone, or mechanically stimulating the cochlea, e.g. at the oval window

Abstract

An active ossicular replacement device is configured to couple the malleus to the stapes, and conduct sound through the vibratory structures of the ear in response to the transmitted electromagnetic energy. The electromagnetic energy may comprise light so as to decrease interference from sources of noise external to the user. The prosthetic device may comprise an assembly that can be implanted in the middle ear in a manner that simplifies surgery. The assembly may comprise a narrow cross-sectional profile such that the assembly can be positioned in the middle ear through an incision in the eardrum, for example without cutting bone that defines the shape of the ear canal or the shape of the middle ear. The prosthetic device can be sized to the user based on a measurement of the ear.

Claims

1. An active ossicular replacement device, the device comprising:

a first end configured to connect with at least one of an eardrum or a malleus of the ear;

a second end configured to connect with a stapes of the ear, the first end opposite the second end; and

at least one transducer configured to vibrate at least the second end in response to electromagnetic energy.

2. The device of claim 1 wherein the at least one transducer is configured to receive electromagnetic energy transmitted through tissue of the user.

3. The device of claim 2 wherein the tissue comprises tissue of the eardrum of the user.

4. The device of claim 1 wherein the first end, the second end and the at least one transducer comprise an assembly configured for placement in the middle ear between the malleus and the stapes.

5. The device of claim 4 wherein a distance from the first end to the second end is within a range from about 2.5 mm to about 7 mm such that the assembly fits between the malleus and the stapes.

6. The device of claim 1 wherein the first end comprises a recess shaped to receive at least a portion of the malleus.

7. The device of claim 6 wherein the recess comprises a concave surface shaped to receive at least a portion of a manubrium of the malleus extending between a head of the malleus and an umbo.

8. The device of claim 6 wherein the recess extends inward a maximum distance of no more than about 0.6 mm to receive the portion of the manubrium and wherein the recess comprises a width within a range from about 0.7 mm to about 0.9 mm.

9. The device of claim 1 wherein the second end is shaped to couple a head of the stapes.

10. The device of claim 9 wherein the second end comprises a recess shaped to couple the head of the stapes.

11. The device of claim 10 wherein the recess extends inward a distance within a first range from about 0.6 mm to about 0.9 mm and wherein the recess comprises a distance across within a second range from about 1.1 mm to about 1.3 mm.

12. The device of claim 9 wherein the second end is shaped to couple a footplate of the stapes.

13. The device of claim 12 wherein the second end comprises at least one of a flat surface or a convex surface to couple to the footplate of the stapes.

14. The device of claim 1 wherein the at least one transducer comprises a movement transducer comprising at least one of a piezoelectric transducer, a coil, a magnet, a balanced armature transducer, or a photostrictive material.

15. The device of claim 14 wherein the at least one transducer further comprises a second at least one transducer configured to receive the electromagnetic energy transmitted through the eardrum, the second at least one transducer comprising at least one of a photodetector or a coil configured to receive the electromagnetic energy transmitted through the eardrum.

16. The device of claim 15 wherein the second at least one transducer comprises the photodetector and wherein the electromagnetic energy transmitted through the eardrum comprises light.

17. The device of claim 16 wherein the photodetector comprises a first photodetector configured to receive a first at least one wavelength of light and a second photodetector configured to receive a second at least one wavelength of light and wherein the first photodetector and the second photodetector are coupled to the movement transducer to urge the first end toward the second end in response to the first at least one wavelength of light and urge the first end away from the second end in response to the second at least one wavelength of light.

18. The device of claim 17 wherein the movement transducer and the second at least one transducer can be separated by a distance and coupled with at least one electrical conductor extending there between.

19. The device of claim 16 wherein the first end comprises a first cross-sectional size and the photodetector comprises a second cross sectional size and wherein the second cross sectional size is at least about twice the first cross sectional size.

20. The device of claim 16 wherein the device extends from the first end to the second end in a first direction and wherein the at least one photodetector extends in a second direction, the second direction transverse to the first direction.

21. The device of claim 20 wherein photodetector has a surface that extends in the second direction and along a plane substantially perpendicular to the first direction.

22. The device of claim 16 wherein an optical coupler is disposed on the photodetector to receive light scattered by the eardrum and transmit the scattered light to the photodetector.

23. The device of claim 22 the optical coupler comprises an optically transmissive material and an optical surface to receive the scattered light, the optical surface comprising one or more of a frustum of a cone, a frustum of a pyramid, a concave surface, a toric surface, a cylindrical surface, a lenslet array, a spherical lenslet array, or a cylindrical lenslet array.

24. The device of claim 16 wherein the photodetector comprises a surface profile to fit the eardrum and wherein the surface profile comprises one or more of a frustum of a cone, a frustum of a pyramid, a concave surface, a concave spherical surface, or a concave cylindrical surface.

25. The device of claim 1 further comprising a first component comprising the first end and a second component comprising the second end, the first end separated from the second end by a distance, wherein the at least one transducer is coupled to the first component and the second component to vary the distance and vibrate the ear.

26. The device of claim 25 wherein the first component comprises a first mass and the second component comprises a second mass, the first mass greater than the second mass such that the second end moves more than the first end to decrease feedback when the at least one transducer vibrates the ear to transmit the sound to the user.

27. The device of claim 1 further comprising a substantially rigid elongate structure extending between the first end and the second end to couple the first end to the second end.

28. The device of claim 27 further comprising a mass coupled to the at least one transducer to move the mass opposite the substantially rigid elongate structure in response to the electromagnetic energy.

29. The device of claim 28 wherein the mass is substantially contained within the substantially rigid elongate structure.

30. The device of claim 1 further comprising a joint disposed between the first and the second end.

31. The device of claim 30 wherein the joint comprises at least one of a ball and socket joint or a U-joint.

32. The device of claim 30 wherein the joint is configured to rotate between the first end and the second end.

33. The device of claim 30 wherein the joint is configured to limit rotation of the first end relative to the second end.

34. The device of claim 33 wherein the joint is configured to limit rotation of the first end relative to the second end with a stop.

35. The device of claim 33 wherein the stop comprises a first beveled surface of a first component of the joint configured to contact a second beveled surface of a second component of the joint to limit motion to within a predetermined range.

36. The device of claim 35 wherein the range comprises +/−

30 degrees.

37. The device of claim 30 further comprising a second joint disposed between the first end and the second end.

38. The device of claim 37 wherein the second joint comprises a telescopic joint.

39. An active ossicular replacement device to transmit a sound to a user, the device comprising:

at least one photodetector configured to receive a light signal;

a first component configured to connect with at least one of an eardrum or a malleus of the ear, the first component comprising a first end configure to orient toward the eardrum;

a second component configured to connect with a stapes of the ear, the second component comprising a second end configured to orient toward the stapes opposite the first end, the first end separated from the second end by a distance; and

a transducer coupled to the at least one photodetector, the first component, and the second component, the transducer configured to change the distance from the first end to the second end in response to the light signal to vibrate the ear and transmit the sound to the user.

40. The device of claim 39 wherein the at least one detector comprises a first detector responsive to a first at least one wavelength of light and a second detector responsive to a second at least one wavelength of light and wherein the transducer is configured to urge the first end toward the second end to decrease the distance in response to the first at least one wavelength of the light and to urge the first end away from the second end to increase the distance in response to the second at least one wavelength of light.

41. The device of claim 40 wherein the first detector is coupled to the transducer with a first a first polarity and the second detector is coupled to the transducer with a second polarity opposite the first polarity.

42. A method of transmitting sound to an ear of a user, the method comprising:

transmitting electromagnetic energy through the eardrum of the user to an active ossicular replacement device, wherein the active ossicular replacement device is coupled to at least a stapes of the ear and vibrates in response to the electromagnetic energy transmitted through the eardrum.

43. The method of claim 42 wherein the device extends between at least one of a malleus or an eardrum of the ear and the stapes.

44. The method of claim 43 wherein the device comprises a length extending between the at least one of the malleus or the eardrum and the stapes and wherein the length increases in response to a first at least one wavelength of light and decreases in response to a second at least one wavelength of light to transmit the sound to the user.

45. The method of claim 42 wherein the device is coupled to the malleus at a location between a head of the malleus and an umbo, such that occlusion is decreased.

46. A method of providing an active ossicular placement device to an ear of a user, the ear having an eardrum, the method comprising:

placing the active ossicular replacement device in a middle ear with a first end connected to at least one of a malleus or the eardrum of the user and a second end connected to a stapes of the user, wherein the active ossicular replacement device is configured to vibrate in response to electromagnetic energy transmitted through eardrum.

47. The method of claim 46 wherein the first end of the device is coupled to the malleus at a location between a head of the malleus and an umbo where the eardrum connects to the malleus, such that occlusion is decreased.

48. The method of claim 46 wherein an incision is made in the eardrum and an incus is removed from the middle ear through the incision and wherein the active ossicular placement device is positioned on the stapes through the incision.

49. The method of claim 48 wherein the eardrum comprises an annulus and the incision extends at least partially within the annulus.

50. The method of claim 48 wherein the incision heals and wherein the electromagnetic energy is transmitted through the eardrum when the incision has healed.

51. A device to transmit sound to an ear of a user, the device comprising:

means for transmitting the sound to the ear of the user.