Middle ear magnet implant, attachment device and method, and test instrument and method

Abstract

An attachment device for a middle ear implant includes a first loop adapted to mount over structure in a middle ear. A second loop is connected to the first loop and adapted to mount over an object for use in the middle ear. A related method includes sliding a loop along at least part of a middle ear ossicle or prosthesis such that an object connected to the loop is disposed adjacent the ossicle or prosthesis. A method of testing for a magnet in a middle ear of a patient includes: inserting a coil at least into an outer ear canal of the patient adjacent the middle ear having the magnet; selectably aiming the coil relative to the middle ear; driving the coil with an alternating current signal at each selected aiming; obtaining at least one indication in response to driving the coil with an alternating current signal at each selected aiming; and determining a functional or positional characteristic of the magnet from the obtained indication. This method can be implemented with a plurality of coils. A related test instrument includes: at least one coil; and a connected handle to enable a user of the test instrument to insert the coil(s) into at least the outer ear canal and to direct electromagnetic signals at different directions relative to the middle ear.

What is claimed is:  
     
         1 . Attachment device for electromagnetically responsive middle ear implant, comprising: 
 a first loop configured to mount onto a natural or prosthetic middle ear ossicular structure which transmits mechanical vibrations induced therein to an oval window into an inner ear adjacent the middle ear ossicular structure; and    a second loop connected to the first loop and configured to mount over an electromagnetically responsive object that mechanically vibrates within the middle ear in response to an electromagnetic signal generated spatially separate from the attachment device and the electromagnetically responsive object so that neither the first loop nor the second loop is used in generating the electromagnetic signal.    
     
     
         2 . Attachment device as defined in    claim 1   , wherein the first loop is disposed at an angle to the second loop.  
     
     
         3 . Attachment device as defined in    claim 1   , wherein the first and second loops are not coplanar.  
     
     
         4 . Attachment device as defined in    claim 1   , wherein the second loop is at an angle to the first loop when the first loop is mounted in the middle ear such that a perpendicular line through the second loop is aligned with a longitudinal line of an outer ear canal adjacent the middle ear.  
     
     
         5 . Attachment device as defined in    claim 1   , wherein the second loop is at an angle to the first loop when the first loop is mounted in the middle ear such that a perpendicular line through the second loop is aligned with a longitudinal axis of a transmission coil disposed in an outer ear canal adjacent the middle ear.  
     
     
         6 . Attachment device as defined in    claim 1   , wherein the first loop includes a plurality of turns of wire.  
     
     
         7 . Attachment device as defined in    claim 6   , wherein the second loop includes a respective plurality of turns of wire connected to the plurality of turns of wire of the first loop.  
     
     
         8 . Attachment device as defined in    claim 7   , wherein the first loop is disposed at an angle to the second loop.  
     
     
         9 . Attachment device as defined in    claim 6   , wherein the plurality of turns of wire includes at least three turns having space between adjacent turns.  
     
     
         10 . A middle ear implant that creates mechanical vibrations in response to electromagnetic signals, comprising: 
 a housing configured to be disposed in a middle ear;    a magnet disposed and configured to be in the housing; and    an attachment device configured to connect the housing to at least a partial middle ear ossicle or a prosthesis for the middle ear, the attachment device including: 
 a first loop configured to mount around the at least partial middle ear ossicle or the prosthesis; and  
 a second loop connected to the first loop and disposed around the housing such that the magnet in the housing is oriented to be responsive to electromagnetic signals transmitted into the middle ear when the housing is disposed therein on the attachment device, whereby mechanical vibrations are created, and such that the mechanical vibrations are transmitted to the at least partial middle ear ossicle or prosthesis when the first loop is mounted therearound, 
 wherein the first and second loops are not part of an electrical circuit.  
 
   
     
     
         11 . An implant as defined in    claim 10   , wherein the second loop has a press fit around the housing.  
     
     
         12 . An implant as defined in    claim 10   , wherein the first loop is disposed at an angle to the second loop.  
     
     
         13 . An implant as defined in    claim 10   , wherein the first and second loops are not coplanar.  
     
     
         14 . An implant as defined in    claim 10   , wherein the second loop is at an angle to the first loop when the first loop is mounted over the ossicle such that an axial line through the magnet is substantially aligned with a longitudinal line of an outer ear canal adjacent the middle ear.  
     
     
         15 . An implant as defined in    claim 10   , wherein the second loop is at an angle to the first loop when the first loop is mounted over the ossicle such that an axial line through the magnet is substantially aligned with a longitudinal axis of a transmission coil disposed in an outer ear canal adjacent the middle ear.  
     
     
         16 . An implant as defined in    claim 10   , wherein the first loop includes a wire segment disposed in three spaced turns.  
     
     
         17 . An implant as defined in    claim 16   , wherein the second loop includes a respective wire segment disposed in four turns, the respective wire segment continuous with the first segment of the first loop.  
     
     
         18 . An implant as defined in    claim 17   , wherein the first loop is disposed at an angle to the second loop.  
     
     
         19 . An implant as defined in    claim 18   , wherein the angle is about 30 ° defined between respective axial lines of the first and second loops.  
     
     
         20 . A method of mounting an object in a middle ear, comprising sliding a loop along at least part of a middle ear ossicle or a prosthesis for a middle ear such that an object connected to the loop is disposed adjacent the ossicle or prosthesis.  
     
     
         21 . A method as defined in    claim 20   , further comprising applying a fibrin clot to the loop when the loop is on the at least part of a middle ear ossicle.  
     
     
         22 . A method as defined in    claim 20   , wherein the loop is slid over at least part of the stapes of the middle ear.  
     
     
         23 . A method as defined in    claim 20   , further comprising positioning the loop on the ossicle or the prosthesis such that there is space between the object and the body of the middle ear cavity.  
     
     
         24 . A method as defined in    claim 20   , wherein: 
 the method further comprises disconnecting the incus of the middle ear from the stapes of the middle ear; and    sliding the loop includes sliding the loop onto the stapes.    
     
     
         25 . A method as defined in    claim 24   , further comprising reapposing the incus and the stapes.  
     
     
         26 . A method as defined in    claim 25   , further comprising applying a fibrin clot to the loop on the reapposed incus and stapes.  
     
     
         27 . A method as defined in    claim 26   , further comprising positioning the loop on the reapposed incus and stapes such that there is space between the body of the middle ear cavity and the object.  
     
     
         28 . A method as defined in    claim 24   , further comprising applying a fibrin clot to the loop on the stapes.  
     
     
         29 . A method as defined in    claim 28   , further comprising positioning the loop on the stapes such that there is space between the body of the middle ear cavity and the object.  
     
     
         30 . A method as defined in    claim 24   , further comprising positioning the loop on the stapes such that there is space between the body of the middle ear cavity and the object.  
     
     
         31 . A method of testing for a magnet in a middle ear of a patient, comprising: 
 inserting a coil into an outer ear canal of the patient adjacent the middle ear having the magnet;    selectably aiming the coil within the outer ear canal toward different locations of the middle ear;    driving the coil with an alternating current signal at each of the aimed locations;    obtaining at least one indication from the patient regarding the relative strengths of sensations perceived by the patient in response to driving the coil with an alternating current signal at each of the aimed locations; and    determining a location of the magnet from the obtained at least one indication.    
     
     
         32 . A method as defined in    claim 31   , further comprising: 
 selectably aiming the coil within the outer ear canal at different angles towards the determined location of the magnet;    driving the coil with an alternating current signal at each of the aimed angles;    obtaining at least one indication from the patient regarding the relative strengths of sensations perceived by the patient in response to driving the coil with an alternating current signal at each of the aimed angles; and    determining an orientation of the magnet from the at least one indication obtained in response to driving the coil with an alternating current signal at each of the aimed angles.    
     
     
         33 . A method as defined in    claim 32   , wherein selectably aiming the coil within the outer ear canal toward different locations of the middle ear includes aiming the coil at each of four quadrants of a tympanic membrane at the end of the outer ear canal.  
     
     
         34 . A method as defined in    claim 33   , wherein: 
 determining a location of the magnet from the obtained indications includes selecting the quadrant of the tympanic membrane for which the patient gave an indication of the strongest response; and    selectably aiming the coil within the outer ear canal at different angles towards the determined location of the magnet includes selectably aiming the coil at different angles towards the selected quadrant of the tympanic membrane.    
     
     
         35 . A method of testing for a magnet in a middle ear of a patient, comprising: 
 inserting a coil at least into the patient's outer ear canal that is adjacent the middle ear having the magnet;    selectably aiming the coil relative to the middle ear;    driving the coil with an alternating current signal at each selected aiming;    obtaining at least one indication in response to driving the coil with an alternating current signal at each selected aiming; and    determining a functional or positional characteristic of the magnet from the obtained at least one indication.    
     
     
         36 . A method as defined in    claim 35   , wherein obtaining at least one indication includes obtaining at least one indication from the patient regarding whether sensations are perceived by the patient in response to driving the coil with an alternating current signal at each selected aiming and regarding the relative strengths of any such sensations.  
     
     
         37 . A method as defined in    claim 35   , wherein selectably aiming the coil includes aiming the coil at different regions of a tympanic membrane at the end of the outer ear canal.  
     
     
         38 . A method as defined in    claim 35   , wherein selectably aiming the coil includes selectably aiming the coil at different angles towards a selected region of a tympanic membrane at the end of the outer ear canal.  
     
     
         39 . A method of testing for a magnet in a middle ear of a patient, comprising: 
 inserting a plurality of coils at least into the patient's outer ear canal that is adjacent the middle ear having the magnet;    driving each of the coils one at a time with an alternating current signal;    obtaining at least one indication in response to driving each of the coils with an alternating current signal; and    determining a functional or positional characteristic of the magnet from the obtained at least one indication.    
     
     
         40 . A method as defined in    claim 39   , wherein obtaining at least one indication includes obtaining at least one indication from the patient regarding whether sensations are perceived by the patient in response to driving the coils with an alternating current signal and regarding the relative strengths of any such sensations.  
     
     
         41 . A method as defined in    claim 39   , wherein the plurality of coils are disposed relative to each other such that each coil is aimed at a different respective region of a tympanic membrane at the end of the outer ear canal when the coils are inserted to a selected position within the outer ear canal.  
     
     
         42 . A method as defined in    claim 39   , wherein the plurality of coils are disposed relative to each other such that each coil is aimed at a different respective angle towards a selected region of a tympanic membrane at the end of the outer ear canal when the coils are inserted to a selected position within the outer ear canal.  
     
     
         43 . A test instrument for a magnet implanted in a middle ear of a patient, comprising: 
 at least one coil; and    a handle connected to the at least one coil to enable a user of the test instrument to insert the at least one coil into at least an outer ear canal adjacent the middle ear of the patient and to direct electromagnetic signals at different directions relative to the middle ear.    
     
     
         44 . A test instrument as defined in    claim 43   , further comprising an oscillator connected to the at least one coil to generate the electromagnetic signals.  
     
     
         45 . A test instrument as defined in    claim 44   , wherein the handle includes: 
 a body adapted to be gripped by a hand of the user; and    a shank extending at an angle to the body and having the at least one coil connected thereto.    
     
     
         46 . A test instrument as defined in    claim 45   , wherein the at least one coil includes a coil having a longitudinal axis aligned with the shank of the handle.  
     
     
         47 . A test instrument as defined in    claim 45   , wherein the at least one coil includes a plurality of coils disposed at different angles to the shank of the handle.  
     
     
         48 . A test instrument as defined in    claim 43   , wherein the handle includes: 
 a body adapted to be gripped by a hand of the user; and    a shank extending at an angle to the body and having the at least one coil connected thereto.    
     
     
         49 . A test instrument as defined in    claim 48   , wherein the at least one coil includes a coil having a longitudinal axis aligned with the shank of the handle.  
     
     
         50 . A test instrument as defined in    claim 48   , wherein the at least one coil includes a plurality of coils disposed at different angles to the shank of the handle.  
     
     
         51 . A test instrument as defined in    claim 43   , wherein the at least one coil includes a coil having a longitudinal axis aligned with the handle.  
     
     
         52 . A test instrument as defined in    claim 43   , wherein the at least one coil includes a plurality of coils disposed at different angles to the handle.  
     
     
         53 . Attachment device for mounting a magnet in a middle ear, comprising: 
 a first loop configured to mount on natural or prosthetic ossicular structure in a middle ear;    a second loop connected to the first loop and configured to mount around a magnet so that the magnet, the second loop and the first loop mechanically vibrate together in response within the middle ear to an electromagnetic signal; and    wherein the second loop is not part of an electrical circuit.    
     
     
         54 . Attachment device for electromagnetically responsive middle ear implant, comprising: 
 a first loop configured to mount on natural or prosthetic ossicular structure in a middle ear;    a second loop connected to the first loop and configured to mount over an electromagnetically responsive object to mechanically vibrate in response within the middle ear to an electromagnetic signal; and    wherein the second loop is not part of an electrical circuit.    
     
     
         55 . Attachment device for a magnetic middle ear hearing system having an electromagnetic signal generating unit which is separate from the attachment device, the attachment device comprising: 
 a first loop configured to mount onto natural or prosthetic ossicular structure in a middle ear; and    a second loop connected to the first loop and configured to mount over an electromagnetically responsive object to mechanically vibrate in response within the middle ear to an electromagnetic signal propagated by the electromagnetic signal generating unit disposed mechanically separate and spaced from the attachment device.    
     
     
         56 . Attachment device for middle ear implant, consisting of: 
 a first coiled-wire loop configured to mount on natural or prosthetic ossicular structures in a middle ear; and    a second coiled-wire loop connected to the first loop and configured to hold a transducer;    wherein the transducer attaches to the natural or prosthetic ossicular structures through the connection of the second loop and the first loop.    
     
     
         57 . Attachment device for mounting a magnet in a middle ear, comprising: 
 a first loop for mounting over natural or prosthetic ossicular structure in a middle ear; and    a second loop, connected in continuous extension from the first loop, for holding the magnet.    
     
     
         58 . Attachment device for middle ear implant, comprising: 
 a first loop configured to mount on pre-existing ossicular structure;    a second loop configured to hold a transducer; and    wherein the first and second loops are formed from a continuous length of biocompatible wire.    
     
     
         59 . An implant for a middle ear, comprising: 
 a housing;    a magnet disposed in the housing; and    an attachment device for connecting the housing to at least a partial middle ear ossicle, the attachment device including: 
 non-necrotizing means for mounting at least partially around the at least partial middle ear ossicle such that blood supply to the at least partial middle ear ossicle is maintained; and  
 holding means connected to the non-necrotizing means and disposed around the housing so that the housing and the magnet therein are attached to the at least partial middle ear ossicle through the cooperative association of the non-necrotizing means and the holding means when the non-necrotizing means is mounted on the at least partial middle ear ossicle.  
   
     
     
         60 . Attachment device for middle ear implant that includes a magnet-containing housing and that increases amplitude of movement of at least a natural living ossicular portion communicating with an oval window into an inner ear, the attachment device comprising: 
 a first multiple-turn wire loop that mounts on the natural living ossicular portion, wherein the first loop is configured to be biologically compatible so that blood supply to the natural living ossicular portion is maintained when the first loop is mounted thereon and further wherein turns of the first loop are spaced and provide a scaffold for soft tissue of the ossicular portion to grow into and attach to; and    a second multiple-turn wire loop connected to the first loop to hold the magnet-containing housing within the second loop, wherein the second loop is not part of an electrical circuit but has a mechanically constrictive effect that provides a press-fit onto the magnet-containing housing so that the magnet-containing housing does not move independently from the ossicular portion when the attachment device and the magnet-containing housing are mounted thereon.