Optically coupled active ossicular replacement prosthesis

• US 9,544,700 B2
• Filed: 06/14/2010
• Issued: 01/10/2017
• Est. Priority Date: 06/15/2009
• Status: Active Grant

• Current Assignee: EarLens Corporation
• Original Assignee: EarLens Corporation
• Inventors: Puria, Sunil, Perkins, Rodney C.
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): LANNU, JOSHUA DARYL DEANON
• Application Number:
  US12/814,998
• Publication Number:
  US 20100317914A1
• Time in Patent Office: 2,402 Days
• Field of Search: 600/25, 181/126, 181128-130, 381/23.1, 381312-331, 623/10, 623/24, 607 55- 57
• US Class Current: 1/1
• 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 ossicular replacement device, the device comprising:

a lateral component comprising a first end configured to connect with a malleus of an ear, the lateral component comprising a first mass;

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

at least one output transducer configured to vibrate at least the second end in response to an electromagnetic energy driving signal;

wherein the at least one output transducer, the lateral component and the medial component are discrete components, coupled to each other, and configured to provide a passive mode and an active mode, in the passive mode the device passively transmits vibration from the malleus to the stapes when no driving signal is transmitted to the at least one output transducer and in the active mode the device actively vibrates the stapes with an amplified energy from an energy sensing device when the driving signal is transmitted to the at least one output transducer in order to transmit the sound to a user; and

wherein the at least one output transducer is coupled to the lateral component and the medial component to vary the distance in order to vibrate the ear and wherein the first mass is greater than the second mass in order to move the second end more than the first end to decrease feedback when the at least one output transducer varies the distance and vibrates the stapes to transmit the sound to the user.

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 an eardrum of the user.

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

5. The device of claim 4 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.

6. The device of claim 4 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.

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

8. The device of claim 7 wherein the second end comprises a recess shaped to couple the head of the stapes.

9. The device of claim 8 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.

10. The device of claim 7 wherein the second end is shaped to couple a footplate of the stapes.

11. The device of claim 10 wherein the second end comprises at least one of a flat surface or a convex surface to couple to the footplate of the stapes.

12. 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.

13. The device of claim 12 wherein the at least one transducer further comprises a second at least one transducer configured to receive 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.

14. The device of claim 13 wherein the second at least one transducer comprises the photodetector and wherein the electromagnetic energy transmitted through the eardrum comprises light.

15. The device of claim 14 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.

16. The device of claim 15 wherein the movement transducer and the second at least one transducer are configured to be separated by a distance and coupled with at least one electrical conductor extending there between.

17. The device of claim 14 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.

18. The device of claim 14 wherein the device extends from the first end to the second end in a first direction and wherein the photodetector extends in a second direction, the second direction transverse to the first direction.

19. The device of claim 18 wherein the photodetector has a surface that extends in the second direction and along a plane substantially perpendicular to the first direction.

20. The device of claim 1, wherein the first end is further configured to connect with an eardrum of the ear.

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

at least one photodetector configured to receive a light signal;

a lateral component configured to connect with a malleus of an ear, the lateral component comprising a first end configured to orient toward an eardrum;

a medial component configured to connect with a stapes of the ear, the medial 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 lateral component, and the medial component wherein the at least one photodetector, the lateral component and the medial component are discrete components, coupled to each other, and configured to provide a passive mode and an active mode, in the passive mode the device passively transmits vibration from the malleus to the stapes when no electromagnetic energy driving signal is transmitted to the at least one photodetector and in the active mode the device actively vibrates the stapes with an amplified energy from the at least one photodetector when the driving signal is transmitted to the at least one photodetector in order to transmit sound to the user.

22. The device of claim 21 wherein the first end, the second end and the transducer comprise an assembly configured for placement in a middle ear between the malleus and the stapes.

23. The device of claim 22 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.

24. The device of claim 21 wherein an optical coupler is disposed on the at least one photodetector to receive light scattered by an eardrum and transmit the scattered light to the at least one photodetector.

25. The device of claim 24, wherein 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.

26. The device of claim 21 wherein the at least one 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.

27. The device of claim 21 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 light energy.

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

30. The device of claim 21 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 34 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. The device of claim 21 wherein the at least one photodetector 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.

40. The device of claim 39 wherein the first detector is coupled to the transducer with a first polarity and the second detector is coupled to the transducer with a second polarity opposite the first polarity.

41. The device of claim 21, wherein the lateral component is further configured to connect with an eardrum of the ear.

42. The device of claim 21, wherein the transducer is configured to vary the distance from the first end to the second end in response to the light signal.

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

a lateral component comprising a first end configured to connect with a malleus of the ear;

a medial component comprising a second end configured to connect with a stapes of the ear;

wherein said lateral and medial components are discrete components;

means for a passive mode to passively transmit vibration from the malleus to the stapes wherein in the passive mode the device passively transmits vibrations when no electromagnetic energy driving signal is transmitted to at least one output transducer; and

means for an active mode to actively vibrate the stapes with an amplified energy from an energy sensing device when the driving signal is transmitted to the at least one output transducer and moving the second end more than the first end to decrease feedback when the at least one transducer vibrates the stapes to transmit the sound to the user.

44. The device of claim 43, wherein the at least one output transducer is further configured to connect with an eardrum of the ear.