Stapedial Prosthesis and Method of Implanting the Same

Abstract

A stapedial prosthesis includes a body defining a bucket and a shaft, and a bail handle coupled to the bucket. The bucket is preferably adjustable in diameter to fit the incus lenticular process. The shaft preferably has a varying diameter, with a central portion of a smaller diameter than a distal portion which aids in depth perception during implantation and reduces mass to permit better sound energy transmission by the prosthesis. The bail handle is preferably spring-loaded and preferably constructed of titanium. The bail handle is preferably coupled to the body without crimping, twisting or welding and preferably biases the incus toward the bucket. A method of implanting a stapedial prosthesis is also provided.

1 . A stapedial prosthesis sized to be implanted as a replacement for the stapes between the incus and the oval window of the middle ear, comprising: 
 a) a bucket sized to at least partially receive a portion of the incus, said bucket including holes for receiving a handle;    b) a shaft coupled to said bucket and having a length sufficient to extend from the incus to the oval window; and    c) a handle including ends spring-loaded into said bucket so as to cause said handle to remain in a fixed position relative to said bucket unless manipulated.    
   
   
       2 . A stapedial prosthesis according to  claim 1 , wherein: 
 said handle does not extend all the way through said bucket.    
   
   
       3 . A stapedial prosthesis according to  claim 2 , wherein: 
 said handle is coupled to said bucket without welding, twisting or crimping.    
   
   
       4 . A stapedial prosthesis according to  claim 2 , wherein: 
 said handle is spring loaded against an outer surface of said bucket.    
   
   
       5 . A stapedial prosthesis according to  claim 1 , wherein: 
 said handle is constructed of titanium.    
   
   
       6 . A stapedial prosthesis according to  claim 2 , wherein: 
 said handle is U-shaped.    
   
   
       7 . A stapedial prosthesis according to  claim 1 , wherein: 
 said bucket includes a rim and a notch in said rim.    
   
   
       8 . A stapedial prosthesis according to  claim 1 , wherein: 
 said bucket has a wall with a plurality of slots defining wall segments, and said wall segments are manipulatable by a surgeon to adjust an inner dimension of said bucket.    
   
   
       9 . A stapedial prosthesis sized to be implanted as a replacement for the stapes between the incus and the oval window of the middle ear, comprising: 
 a) a bucket having an initial size that at least partially receives a portion of an incus and having a wall with a plurality of slots defining wall segments, said bucket being reducible in size by surgeon manipulation of at least one of said wall segments so as to contact the portion of the incus positioned therein so as to grip the incus after the incus is at least partially received therein;    b) a shaft having a length sufficient to extend from the incus to the oval window; and    c) a bail handle coupled to said bucket.    
   
   
       10 . A stapedial prosthesis according to  claim 9 , wherein: 
 said slots are approximately 0.1-mm wide.    
   
   
       11 . A stapedial prosthesis according to  claim 9 , wherein: 
 said slots define arcs about a circumference of the bucket which are substantially smaller than arcs traversed by the wall segments defined by the slots.    
   
   
       12 . A stapedial prosthesis according to  claim 9 , wherein: 
 said arcs defined by said slots are smaller than said arcs defined by said wall segments by a factor of at least four.    
   
   
       13 . A stapedial prosthesis according to  claim 9 , wherein: 
 said bucket has a closed bottom portion.    
   
   
       14 . A stapedial prosthesis sized to be implanted as a replacement for the stapes between the incus and the oval window of the middle ear, comprising: 
 a) a body defining a bucket for at least a portion of the incus;    b) a rotatable bail handle coupled to said bucket; and    a) a shaft having a length sufficient to extend from a portion of the incus to the oval window, said shaft having a central portion and first and second end portions, said central portion having a diameter of approximately 0.3-mm, said first end portion having a diameter of approximately 0.4-mm to 0.8-mm, and said second end portion being coupled to said bucket.    
   
   
       15 . A stapedial prosthesis according to  claim 14 , wherein: 
 said first end portion includes structure for tissue ingrowth.    
   
   
       16 . A stapedial prosthesis according to  claim 14 , wherein: 
 said first end portion has a length not exceeding 1-mm.    
   
   
       17 . A stapedial prosthesis according to  claim 14 , wherein: 
 said first end portion has a length greater than 0.3-mm.    
   
   
       18 . A stapedial prosthesis according to  claim 14 , wherein: 
 said central portion has a length at least approximately 2.4 times a length of said first end.    
   
   
       19 . A stapedial prosthesis according to  claim 14 , wherein: 
 said body, said bail and said shaft are all made of titanium.    
   
   
       20 . A stapedial prosthesis sized to be implanted as a replacement for the stapes between the incus and the oval window of the middle ear, comprising: 
 a) a bucket with a cavity sized to at least partially receive a portion of an incus and having a radial center, said bucket including a wall with openings therein;    b) a shaft coupled to said bucket, said shaft having a length sufficient to extend from the incus to the oval window; and    c) a handle element coupled to said bucket at said openings, said handle element having ends which are detached from each other but located within the body, but do not extend to or past said radial center of said body.    
   
   
       21 . A stapedial prosthesis according to  claim 20 , wherein: 
 said bucket, said shaft and said handle element are all made from titanium.    
   
   
       22 . A stapedial prosthesis sized to be implanted as a replacement for the stapes between the incus and the oval window of the middle ear, comprising: 
 a) a bucket with a cavity sized to at least partially receive a portion of an incus;    b) a shaft coupled to said bucket and having a length sufficient to extend from the incus to the oval window; and    c) a handle element having first and second ends, said handle element coupled to said bucket, and first and second ends (i) each being uncoupled from the other, (ii) each being located within said body, and (iii) each not passing the other within said bucket.    
   
   
       23 . A stapedial prosthesis according to  claim 22 , wherein: 
 said bucket, said shaft and said handle element are all made from titanium.