Ossicular prosthesis adjusting device

Abstract

An ossicular prosthesis delivery system having an ossicular prosthesis including an enlarged head and a shaft axially, moveably mounted to the head to adjust shaft length. An elongate main body having an operating portion, including a cylindrical through bore, connected to an adjusting portion, including a generally semi-cylindrical upwardly opening channel coaxial with the bore. An end wall at a distal end of the adjusting portion includes a through passage coaxial with the channel and an upwardly opening cavity. An elongate cylindrical plunger has a claw at one end. The plunger is received in the bore with the claw in the channel and an opposite end extending outwardly of the operating portion. The ossicular prosthesis' shaft is positioned in the channel with the head received in the cavity and the plunger is rotatable in the bore to capture the shaft and is reciprocally moveable in the bore to adjust shaft length of the ossicular prosthesis.

1. An ossicular prosthesis adjusting device comprising:
 an elongate main body including an outer wall, a semicircular end wall, and a longitudinally extending through channel, the outer wall being cylindrical at an operating portion and generally semi-cylindrical at an adjusting portion, the adjusting portion including a radially opening cavity at a distal end, and the end wall located at the distal end and having a through slot smaller in cross section than the channel, the cavity being disposed in the end wall; and  
 an elongate plunger having a longitudinal axis and a claw at one end, the plunger being received in the channel with the claw in the adjusting portion and an opposite end extending outwardly of the operating portion so that, in use, an ossicular prosthesis shaft can be inserted in the channel at the adjusting portion with a head of the ossicular prosthesis received in the cavity and the plunger is rotatable about its longitudinal axis in the channel to capture the shaft and is reciprocally moveable in the channel to adjust shaft length of the ossicular prosthesis.  
 
     
     
       2. The ossicular prosthesis adjusting device of  claim 1  wherein the main body and the plunger are of plastic construction. 
     
     
       3. The ossicular prosthesis adjusting device of  claim 1  wherein the main body includes a longitudinally extending slit through the outer wall. 
     
     
       4. The ossicular prosthesis adjusting device of  claim 1  further comprising a cylindrical shield telescopically received on the main body overlying the channel. 
     
     
       5. The ossicular prosthesis adjusting device of  claim 1  wherein the main body includes a reference marker adjacent the channel. 
     
     
       6. The ossicular prosthesis adjusting device of  claim 1  wherein the plunger is cylindrical and includes a notch at the one end to provide an end wall, the end wall being bifurcated to define the claw. 
     
     
       7. The ossicular prosthesis adjusting device of  claim 1  wherein the main body includes a semicircular end wall at the distal end, the end wall having a through slot smaller in cross section than the channel and the cavity is disposed in the end wall. 
     
     
       8. An ossicular prosthesis adjusting device comprising:
 an elongate main body comprising an operating portion, including a cylindrical through bore, connected to an adjusting portion, including a generally semi-cylindrical upwardly opening channel coaxial with the bore, and an end wall at a distal end of the adjusting portion including a through passage coaxial with the channel and an upwardly opening cavity; and  
 an elongate cylindrical plunger having a claw at one end, the plunger being received in the bore with the claw in the channel and an opposite end extending outwardly of the operating portion so that, in use, an ossicular prosthesis shaft can be inserted in the channel with a head of the ossicular prosthesis received in the cavity and the plunger is rotatable in the bore to capture the shaft and is reciprocally moveable in the bore to adjust shaft length of the ossicular prosthesis.  
 
     
     
       9. The ossicular prosthesis adjusting device of  claim 8  wherein the main body and the plunger are of plastic construction. 
     
     
       10. The ossicular prosthesis adjusting device of  claim 8  further comprising a longitudinally extending slit through the main body. 
     
     
       11. The ossicular prosthesis adjusting device of  claim 8  further comprising a cylindrical shield telescopically received on the main body overlying the channel. 
     
     
       12. The ossicular prosthesis adjusting device of  claim 8  wherein the main body includes a reference marker adjacent the channel. 
     
     
       13. The ossicular prosthesis adjusting device of  claim 8  wherein the plunger includes a notch at the one end to provide an end wall, the end wall being bifurcated to define the claw. 
     
     
       14. An ossicular prosthesis adjusting device comprising:
 an elongate main body including a generally semi-cylindrical upwardly opening channel, a first end wall at an operating end including a through opening coaxial with the channel and a second end wall at an adjusting end including a through passage coaxial with the channel and an upwardly opening cavity; and    an elongate cylindrical plunger having a claw at one end, the plunger being received in the through opening with the claw in the channel and an opposite end extending outwardly of the main body so that, in use, an ossicular prosthesis shaft can be inserted in the channel with a head of the ossicular prosthesis received in the cavity and the plunger is rotatable in the channel to capture the shaft and is reciprocally moveable in the through opening to adjust shaft length of the ossicular prosthesis.    
     
     
       15. The ossicular prosthesis adjusting device of  claim 14  wherein the main body and the plunger are of plastic construction. 
     
     
       16. The ossicular prosthesis adjusting device of  claim 14  further comprising a cylindrical shield telescopically received on the main body overlying the channel. 
     
     
       17. The ossicular prosthesis adjusting device of  claim 14  wherein the main body includes a reference marker adjacent the channel. 
     
     
       18. The ossicular prosthesis adjusting device of  claim 14  wherein the plunger includes a notch at the one end to provide an end wall, the end being bifurcated to define the claw. 
     
     
       19. An ossicular prosthesis assembly kit comprising:
 an ossicular prosthesis including an enlarged head and a shaft axially, moveably mounted to the head to adjust shaft length;  
 an elongate main body comprising an operating portion, including a cylindrical through bore and a longitudinally extending slit through the operating portion, connected to an adjusting portion, including a generally semi-cylindrical upwardly opening channel coaxial with the bore, and an end wall at a distal end of the adjusting portion including a through passage coaxial with the channel and an upwardly opening cavity; and  
 an elongate cylindrical plunger having a claw at one end, the plunger being received in the bore with the claw in the channel and an opposite end extending outwardly of the operating portion, the ossicular prosthesis shaft being positioned in the channel with the head received in the cavity and the plunger is rotatable in the bore to capture the shaft and is reciprocally moveable in the bore to adjust shaft length of the ossicular prosthesis.  
 
     
     
       20. The ossicular prosthesis assembly kit of  claim 19  wherein the main body and the plunger are of plastic construction. 
     
     
       21. The ossicular prosthesis assembly kit of  claim 19  further comprising a longitudinally extending slit through the main body. 
     
     
       22. The ossicular prosthesis assembly kit of  claim 19  further comprising a cylindrical shield telescopically received on the main body overlying the channel. 
     
     
       23. The ossicular prosthesis assembly kit of  claim 19  wherein the main body includes a reference marker adjacent the channel. 
     
     
       24. The ossicular prosthesis assembly kit of  claim 19  wherein the plunger includes a notch at the one end to provide an end wall, the end wall being bifurcated to define the claw. 
     
     
       25. A combination of an ossicular prosthesis for use in the middle ear and an adjuster therefor, comprising:
 ( a )  an ossicular prosthesis including,  
 ( i )  a first ossicular engaging element including an enlarged flat first head fixed in shape and sized for placement within the middle ear in contact with an ossicular structure,    
 ( ii )  a flexible sleeve permanently attached to the first head,    
 ( iii )  a shaft that interferes with the sleeve, the shaft movable through the sleeve upon application of a sufficient push pull force between the shaft and sleeve and retained by the sleeve upon removal of the sufficient relative push pull force, and    
 ( iv )  a second ossicular engaging element fixed to the shaft, and    
   ( b )  an adjuster including,  
   a main body having structure that axially retains the first head against axial movement in opposing axial directions, and    
   an elongate plunger having a first end removably longitudinally coupled relative to the shaft, the plunger movable in a single plane relative to the structure that axially retains the first head,    
     wherein the shaft length can be adjusted by moving the plunger relative to the main body in the single plane.     
     
     
       26. A combination according to  claim 25 , wherein:
   the structure that axially retains the enlarged head is a cavity defined in the main body.     
     
     
       27. A combination according to  claim 25 , wherein:
   the plunger is movable parallel relative to the structure that axially retains the enlarged head.     
     
     
       28. A combination according to  claim 27 , wherein:
   the plunger is non - rotationally reciprocally movable relative to the structure that axially retains the enlarged head.     
     
     
       29. A combination according to  claim 27 , wherein:
   the plunger is axially rotatable within a bore of the main body.     
     
     
       30. A combination according to  claim 25 , wherein:
   the plunger radially engages the shaft of the prosthesis.     
     
     
       31. A combination according to  claim 25 , wherein:
   the adjuster and the prosthesis are provided together in sterile packaging.     
     
     
       32. A combination of an ossicular prosthesis for use in the middle ear and an adjuster therefor, comprising:
 ( a )  an ossicular prosthesis including,  
 ( i )  a shaft having first and second ends,    
 ( ii )  a first ossicular engaging element including an enlarged flat first head fixed in shape and sized for placement within the middle ear in contact with an ossicular structure, the first ossicular engaging element longitudinally displaceable on a first end of the shaft, and    
 ( iii )  a second ossicular engaging element different in shape and size from the first ossicular engaging structure, the second ossicular engaging element fixed at the second end of the shaft; and    
   ( b )  an adjuster including,  
   a main body having a length, a channel formed in the main body parallel with the length, a retaining structure at the end of the channel, the retaining structure defining a slot oriented transverse to the length that axially retains the first ossicular engagement structure against axial movement in opposing axial directions, and a plurality of distance indication markers provided on the main body along at least one side of the channel, each distance indication marker provided at a referenced distance from the retaining structure, and    
   an elongate plunger closely received within the channel, the plunger movable within the channel in a single plane, and having a first end coupled relative to the shaft,    
     wherein a distance between the first and second ossicular engaging elements can be adjusted by moving the plunger within the channel relative to the retaining structure.     
     
     
       33. A combination according to  claim 32 , wherein:
   the retaining structure includes a bifurcated end wall of the plunger.     
     
     
       34. A combination according to  claim 32 , wherein:
   the shaft is non - threaded.     
     
     
       35. A combination according to  claim 32 , wherein:
   the plunger is provided in a first rotational orientation in which to receive the shaft and the second ossicular engagement element of the otological prosthesis, and a second rotational orientation in which to capture the shaft and the second ossicular engagement element of the otological prosthesis.     
     
     
       36. A combination according to  claim 35 , wherein:
   the first and second rotational orientations are no more than  180 ° apart.     
     
     
       37. A combination according to  claim 32 , wherein:
   the adjuster and the prosthesis are provided together in a sterile package.     
     
     
       38. A combination of an ossicular prosthesis and an adjuster therefor, comprising:
 ( a )  an ossicular prosthesis including,  
 ( i )  a first ossicular engagement element including an enlarged flat first head fixed in shape,    
 ( ii )  a flexible sleeve permanently attached to the first ossicular engagement element,    
 ( iii )  a shaft provided with longitudinally displaced alternating enlarged and reduced portions with respectively larger and smaller cross - sectional diameters that are adapted to interlock with the sleeve, the shaft movable through the sleeve upon application of a sufficient relative longitudinal force thereto and retained by the sleeve upon removal of the sufficient relative longitudinal force, and    
 ( iv )  a second ossicular engagement element fixed to the shaft; and    
   ( b )  an adjuster including,  
   a main body having a length, a channel parallel with the length, and a retaining structure at the end of the channel, the retaining structure defining a slot oriented transverse to the length that axially retains the first ossicular engagement structure against axial movement in opposing axial directions, and    
   an elongate plunger closely received within the channel, the plunger movable within the channel in a single plane, and having a first end coupled relative to the shaft,    
     wherein a distance between the first and second ossicular engaging elements can be adjusted by moving the plunger within the channel relative to the retaining structure.