USRE40853E1 - Ossicular prosthesis adjusting device - Google Patents

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.

Description

FIELD OF THE INVENTION

This invention relates to ossicular prosthesis used for replacement and reconstruction and, more particularly to an adjusting device for an adjustable length ossicular prosthesis.

BACKGROUND OF THE INVENTION

Due to disease, trauma, or congenital malformation, the ossicles of the middle ear are sometimes damaged. If this damage results in a discontinuity of bone between the tympanic membrane and the oval window, no sound conducts and hearing loss results. Some or all of these ossicles can be replaced with a small prosthesis.

The use of middle ear prosthesis for reconstructing the ossicular chain has gone through a myriad of changes over the years. Since each ear has different anatomical dimensions, the length of middle ear prosthesis varies, from 2 mm to 8 mm, on average, with each patient. The most recent trend in otology is the use of titanium prostheses. These are commonly offered as a fixed length prosthesis or an adjustable type prosthesis. The fixed length means that the prosthesis is a one piece design and has a determined length at the time of manufacture. These types of prostheses have to be stocked in the operating room and present a high volume of inventory available for each given surgery. Adjustable type prostheses are manufactured in the maximum length dimension and can be adjusted to proper length by the surgeon at the time of surgery. The advantage of the adjustable type prosthesis is that a hospital need only stock minimum levels of inventory.

The current method of adjusting these types of prosthesis is manual. The surgeon uses an instrument or fingers to slide the head of the prosthesis up or down the shaft to a determined length. Once the correct dimension is reached, the surgeon crimps the head to the shaft to create a fixed length prosthesis. This type of procedure creates two problems. The first is the adjustment process itself. It is extremely difficult to manipulate these micro-sized implants with the hands or specialty instruments. Also, during the crimping process, the head may move from the exact position the surgeon selected. The second problem is unwanted handling of a sterile implant. Because the surgeon has to adjust the length of the implant using his fingers or an instrument, contamination issues increase. There is also the possibility that the prosthesis could be bent or deformed during handling.

The present invention is directed to enhancements in delivery and adjusting for an adjustable type ossicular prosthesis.

SUMMARY OF THE INVENTION

In accordance with the invention, there is provided an ossicular prosthesis adjusting device.

Broadly, there is disclosed in accordance with one aspect of the invention an ossicular prosthesis adjusting device comprising an elongate main body including an outer wall and a longitudinally extending through channel. The outer wall is cylindrical at an operating portion and generally semi-cylindrical at an adjusting portion. The adjusting portion includes a radially opening cavity at a distal end. An elongate plunger has a claw at one end. The plunger is 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 can be inserted in the channel adjusting portion with a head received in the cavity and the plunger is rotatable in the channel to capture the shaft and is reciprocally moveable in the channel to adjust shaft length of the ossicular prosthesis.

It is a feature of the invention that the main body and the plunger are of plastic construction.

It is another feature of the invention that the main body includes a longitudinally extending slit though the outer wall.

It is still another feature of the invention to provide a cylindrical shield telescopically received on the main body overlying the channel.

It is a further feature of the invention that the main body includes a reference marker adjacent the channel.

It is still another feature of the invention that the plunger is cylindrical and includes a notch at one end to provide an end wall, the end wall being bifurcated to define the claw.

It is still a further feature of the invention that the main body includes a semi-circular end wall at the distal end. The end wall has a through slot smaller in cross section than the channel and the cavity is disposed in the end wall.

There is disclosed in accordance with another aspect of the invention 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. 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 so that, in use, an ossicular prosthesis shaft can be inserted in the channel with a 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.

There is disclosed in accordance with a further aspect of the invention 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 includes 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. An elongate cylindrical plunger has a claw at one end. The plunger is 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 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.

There is disclosed in accordance with yet another aspect of the invention an ossicular prosthesis delivery system 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 comprises 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.

Further features and advantages of the invention will be readily apparent from the specification and from the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an ossicular prosthesis delivery system in accordance with the invention including an ossicular prosthesis and an ossicular prosthesis adjusting device in accordance with the invention;

FIG. 2 is a perspective view similar toFIG. 1 with a protective shield removed;

FIG. 3 is a perspective view of a main body of the ossicular prosthesis adjusting device ofFIG. 1;

FIG. 3A is a plan view of the main body ofFIG. 3;

FIG. 3B is a sectional view taken along theline3B—3B ofFIG. 3A;

FIG. 3C is an end view taken along theline3C—3C ofFIG. 3B;

FIG. 4 is a perspective view of a plunger of the ossicular prosthesis adjusting device ofFIG. 1;

FIG. 5 is an elevation view of the ossicular prosthesis ofFIG. 1;

FIGS. 6 and 7 comprise partial perspective views, similar toFIG. 2, illustrating rotation of the plunger for selectively capturing the ossicular prosthesis in the main body; and

FIGS. 8 and 9 comprise perspective views illustrating reciprocal movement of the plunger relative to the main body for adjusting shaft length of the ossicular prosthesis.

DETAILED DESCRIPTION OF THE INVENTION

Referring toFIGS. 1 and 2, an ossicularprosthesis delivery system10 comprises anossicular prosthesis12 and an adjustingdevice14. The adjustingdevice14 comprises amain body16, aplunger18 and aprotective shield20.

Referring toFIGS. 3,3A,3B and3C, themain body16 is of elongate one piece plastic construction including anouter wall22 between afirst end wall24 and asecond end wall26. Theouter wall16 is cylindrical at an operatingportion28 adjacent thefirst end wall24 and semi-cylindrical cylindrical at an adjustingportion30 proximate thesecond end wall26. The operatingportion28 includes a cylindrical throughbore32. The adjustingportion30 includes a semi-cylindrical upwardly openingchannel34 coaxial with the throughbore32. Thesecond end wall26 forms ashoulder36 at the juncture with thechannel34. Asemi-circular notch38 in thesecond end wall26 is coaxial with thechannel34. An upwardly openingcavity40 is provided in thesecond end wall26. A plurality ofcircumferential slots42 extends around theouter wall22 at the adjustingportion30, each a select distance from thecavity40. A pair of longitudinally extendingslits44 extend through upper and lower halves of the operating portion of theouter wall22.

Referring toFIG. 4, theplunger18 is of elongate one piece plastic construction and comprises acylindrical rod46 including anotch48 at afirst end50 to provide anend wall52. Theend wall52 is frusto circular and is bifurcated by aslot54 to define aclaw56. An oppositesecond end58 is used for manipulating theplunger18, as described below.

Anexemplary ossicular prosthesis12 is illustrated in greater detail in FIG.5. Theossicular prosthesis12 includes anenlarged head60 and ashaft62. Asmaller head64 is affixed to adistal end65 of theshaft62. Theenlarged head60 includes asleeve66 for receiving theshaft62. Particularly, theshaft62 extends through thesleeve66 and thehead60 to provide simple length adjustment. Theossicular prosthesis12 may otherwise be as generally described in U.S. Pat. No. 6,186,625 6,168,625, the specification of which is hereby incorporated by reference herein. As is apparent, other adjustable prostheses could be used with the adjustingdevice14 in accordance with the invention.

In an exemplary embodiment of the invention, theossicular prosthesis12 includes ahead60 which is generally oval shaped viewed at its end having dimensions on the order of 0.1 inches wide, 0.14 inches high and 0.01 inches thick. Theshaft12 andsmall head64 are together about 0.25 inches in length. Themain body16 is about ¾ inch long and ¼ inch diameter. Theplunger18 is about 1 inch long and 0.12 inches in diameter. The throughbore32 is slightly larger than the plunger to receive the plunger so that theplunger18 is rotatable and reciprocally moveable in the throughbore32, as described below.

As generally shown inFIGS. 1 and 2, theplunger18 is received in the throughbore32 with theclaw56 in thechannel34. Theopposite end58 extends outwardly of the operatingportion28 beyond thefirst end wall24. Referring toFIG. 6, the mainbody adjusting portion34 accepts the profile of theossicular prosthesis12. Particularly, theenlarged head60 is received in thecavity40. Theshaft62 is received in the upwardly openingchannel34 with theshaft62 extending through theclaw slot54 so that the shaftsmaller head64 is captured in thenotch48. Theplunger18 can be rotated as generally illustrated inFIG. 7 so that theclaw56 is rotated until thenotch48 opens sidewardly or downwardly to retain theshaft62 and thusossicular prosthesis12 in themain body16. Thereafter, and with reference toFIGS. 8 and 9, theplunger18 is reciprocally moveable in thebore32 to adjust shaft length of the ossicular prosthesis. This is illustrated by comparingFIG. 8 in which theclaw56 is proximate the middle one of thereference markers42 andFIG. 9 where theclaw56 is proximate the endmost of thereference markers42 and theshaft62 extends further outwardly relative to thehead60.

Theslits44 through theouter wall22 compensate for variances in tolerance of thepusher18. Theslits44 provide smooth consistent motion of the reciprocal movement of thepusher18. Theslits44 also act as a lock. When the surgeon grasps the mainbody operating portion28, the pressure of the fingers lock the plusher18 in position so that it will not move.

As described, theplunger18 uses a catch and release feature described relative toFIGS. 6 and 7 so that theshaft62 of theprosthesis12 can be secured to theplunger18. The catch and release feature is activated by rotating theplunge18 approximately 180°, although lesser rotation can be used. Particularly, theclaw56 provided on theplunger18 slides within thechannel34 of themain body16 to capture thedistal end65 of the prosthesis shaft including thesmaller head64. Because theshaft62 is thus secured to the plunger, when the plunger is depressed or extended, theshaft62 moves with theplunger18. This movement is parallel to themain body18 and perpendicular to thestationery head60. Adjustment in length occurs when theshaft62 is moved in relationship to the fixed position of thehead60. Theprotective shield20, seeFIG. 1, is positioned around the outer diameter of the main body at the adjustingportion30. Thisshield20 protects theprosthesis head60 from undesired shock movements during transport, as well as stabilizes theprosthesis12 within the adjustingdevice14. Theprosthesis12 rests in the adjustingdevice14 at its longest length.

Thus, in accordance with the invention, the operation of adjustment is a simple mechanical push pull operation in either direction, as shown inFIGS. 8 and 9. The surgeon will grasp themain body16 at the adjustingportion30 with a finger grip and use another finger on theplunger18 to slide theplunger18 to a desired length. Thereference markers42 provide a reference point for the surgeon. A separate measuring device is used to determine the final measurement of prosthesis adjustment.

The adjustingdevice14 is intended to be a single use disposable item. The adjustingdevice14 is advantageously supplied as a component with theprosthesis12 to form thedelivery system10. Thedelivery system10 can be provided in sterile packaging ready for adjustment and implantation.

In the illustrated embodiment of the invention, themain body16 is illustrated as being generally cylindrical. As is apparent, theouter wall22 may take various shapes. Theplunger18 and throughbore32 andcavity34 are advantageously generally cylindrical to provide for both reciprocal and rotational movement of theplunger18 relative to themain body16. As is apparent, if only reciprocal movement is required, then an alternative cross-sectional shape can be used.

Thus, in accordance with the invention, there is provided an ossicular prosthesis delivery system that can be delivered to a surgeon in a sterile condition and pre-loaded with a prosthesis.

Claims (38)

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 ofclaim 1 wherein the main body and the plunger are of plastic construction.

3. The ossicular prosthesis adjusting device ofclaim 1 wherein the main body includes a longitudinally extending slit through the outer wall.

4. The ossicular prosthesis adjusting device ofclaim 1 further comprising a cylindrical shield telescopically received on the main body overlying the channel.

5. The ossicular prosthesis adjusting device ofclaim 1 wherein the main body includes a reference marker adjacent the channel.

6. The ossicular prosthesis adjusting device ofclaim 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 ofclaim 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 ofclaim 8 wherein the main body and the plunger are of plastic construction.

10. The ossicular prosthesis adjusting device ofclaim 8 further comprising a longitudinally extending slit through the main body.

11. The ossicular prosthesis adjusting device ofclaim 8 further comprising a cylindrical shield telescopically received on the main body overlying the channel.

12. The ossicular prosthesis adjusting device ofclaim 8 wherein the main body includes a reference marker adjacent the channel.

13. The ossicular prosthesis adjusting device ofclaim 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 ofclaim 14 wherein the main body and the plunger are of plastic construction.

16. The ossicular prosthesis adjusting device ofclaim 14 further comprising a cylindrical shield telescopically received on the main body overlying the channel.

17. The ossicular prosthesis adjusting device ofclaim 14 wherein the main body includes a reference marker adjacent the channel.

18. The ossicular prosthesis adjusting device ofclaim 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 ofclaim 19 wherein the main body and the plunger are of plastic construction.

21. The ossicular prosthesis assembly kit ofclaim 19 further comprising a longitudinally extending slit through the main body.

22. The ossicular prosthesis assembly kit ofclaim 19 further comprising a cylindrical shield telescopically received on the main body overlying the channel.

23. The ossicular prosthesis assembly kit ofclaim 19 wherein the main body includes a reference marker adjacent the channel.

24. The ossicular prosthesis assembly kit ofclaim 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 toclaim 25, wherein:

the structure that axially retains the enlarged head is a cavity defined in the main body.

27. A combination according toclaim 25, wherein:

the plunger is movable parallel relative to the structure that axially retains the enlarged head.

28. A combination according toclaim 27, wherein:

the plunger is non-rotationally reciprocally movable relative to the structure that axially retains the enlarged head.

29. A combination according toclaim 27, wherein:

the plunger is axially rotatable within a bore of the main body.

30. A combination according toclaim 25, wherein:

the plunger radially engages the shaft of the prosthesis.

31. A combination according toclaim 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 toclaim 32, wherein:

the retaining structure includes a bifurcated end wall of the plunger.

34. A combination according toclaim 32, wherein:

the shaft is non-threaded.

35. A combination according toclaim 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 toclaim 35, wherein:

the first and second rotational orientations are no more than180° apart.

37. A combination according toclaim 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.

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