CA2195012A1

CA2195012A1 - Modular intramedullary nail

Info

Publication number: CA2195012A1
Application number: CA002195012A
Authority: CA
Inventors: Harry Lee; Thomas A. Russell; Robert Brosnahan; Anthony James
Original assignee: Individual
Current assignee: Smith and Nephew Inc; Memphis Orthopaedic Design Inc
Priority date: 1994-07-15
Filing date: 1995-07-14
Publication date: 1996-02-01
Also published as: EP0777447B1; JPH11506346A; ATE199121T1; EP0777447A4; AU688085B2; JP3594312B2; AU3099695A; DE69520105D1; WO1996002203A1; EP0777447A1; DE69520105T2; US5620445A

Abstract

A modular intramedullary nail (10) has two or more modular components (12, 14, 16) of varied sizes and designs, which are joined by a Morse taper friction fit (28). Adjacent modular components are prevented from rotating relative to each other, and can be properly aligned when assembled.

Description

CA 0219~012 1997-01-13 W096/02203 PCT~S95/08917 Application for Patent MODULAR INTRAMEDULLARY NAIL
.
Specification l. Field of the Invention:
The present invention relates to an intramedullary nail system for the repair of Iong bone fractures, which has a modular design for enabling a surgeon to assemble a nail or related implant during surgery which most closely fits the patient's needs.

2. Backqround of the Invention:
Intramedullary nails have become the preferred implant treatment in many long bone fracture cases.
As the use of intramedullary nails has become more popular, the design of the implants has advanced so that there are particular designs for different types of fractures. Nails having a particular configuration are desirable for certain indications.
Because of wide variation of the long bones in patients, the particular style of nail is preferably available in a range of lengths, diameters, and ch~r~s. As a result, the surgeon must have at hand a large inventory of styles and sizes-to accommodate the variety of indications. Examples of such styles include, but are not limited to femoral reconstruction, intramedullary hip screw, and femur components of total hips.

CA 0219~012 1997-01-13 Wos6/o22o3 PCT~S95/0~917 One solution to this variation problem is to provide a mo~l~lAr nail system where a surgeon can select various component parts and assemble them to fit a particular patient's needs. Such a system is taught in U.S. patent 4,805,607 to Engelhardt et al.
where a modular intramedullary nail system has elongated base nails and extension members of different lengths and diameters. The base nail is the primary structural component of the system and the extension member is designed to fit on the proximal end of a base nail. By selecting various combinations of base nails and extension members, nails of a desired length and diameter can be constructed. The component parts are locked together by a pair of snap lock springs formed on the proximal end of the base nail, which include engagement tongs with locking barbs at the trailing end which are radially depressed in order to engage a counterbore on the extension member. A screw is inserted through a hole in the modular components after the rod has been implanted for preventing the tongs from disengaging.
The inventors have determined it is advantageous to have a nail system with greater modularity than in a system such as shown in the Engelhardt patent, and one providing an easier and more secure method of attaching the compon~nts, which is assembled without utilizing a screw to hold the components together.
SUMMARY OF THE lNv~N-llON

CA 0219~012 1997-01-13 W096/02203 PCT~S95108917 The present invention is directed to improved intramedullary nails providing a modular intramedullary nail system having at least two, and preferably three modular components. Mo~ll 1 ar components include proximal and distal sections and, if applicable, a central nail section, with each section constructed in a variety of sizes, diameters, and styles for fitting a wide range of anatomies and indications. The modular components of the present invention are quickly and easily assembled having joints of high m~ch~nical and torsio~nal integrity.
The modular components of the present invention preferably include a locking mech~n;sm for connecting and locking together adjacent modular components which can quickly provide a positive lor~ing fit that resists relative twisting or rotational movement between the components as well as translation. The lo~-~ing mech~nicm also includes an facile alignment of components during the assembly process.
More specifically, assembly of the modular components of the present invention is achieved by one moAlllAr component having a bore with a tapered surface adapted to securely engage a cooperating tapered pin surface, with such engagement resulting in a secure connection which is resistant to rotational and translational forces. An example of a modified taper and bore providing such secure conne^tion is a configuration known as a Morse taper. Resistance to relative rotational movement CA 0219~012 1997-01-13 Wos6/o22o3 PCT~S95/08917 is achieved by providing a polygonal projection at the end of the taper. In the illustrated emho~;ment, the cooperating pin and bore are hexagonally ch~re~ to achieve a snug fit.
In a preferred emho~;ment, the components are provided with an alignment mec-h~n;~ to ensure the components are properly assembled. This is achieved, for example, by providing easily observed alignment indicia on the outer surfaces of the component parts, e.g., markings, indentations, tabs, flanges or keys on one component with corresponding indicia on the mating component. Asymmetric tabs, flanges or keys, and corresponding slots, may also be used to ensure the components are aligned in the proper configuration.
In an alternative embodiment, the taper or bore of one component may be adapted to accept more than one type of mated component, with each match corresponding to direct assembly of a specific implant design.

BRIEF DESCRIPTION OF THE DRAWINGS
In order to acquire a better underst~n~;ng of the invention, reference may be had to a detailed description of exemplary embodiments set forth below, to be considered along with the appended drawings, in which:
Figure l is a plan view of a modular intramedullary designed in accordance with the present invention, in which the modular components are assembled;

CA 0219~012 1997-01-13 W096/02203 PCT~S95108917 Figure 2 is a plan view of view of the modular system shown in Fig. 1, with the distal and proximal sections separated from the central section;
Figure 3 is a plan view, partially in section, of the central section of the modular system showing in particular the female sockets at both ends;
Figure 4 is an end view of the central section shown as line 4-4 in Fig. 3;
Figure 5 is a second end view of the central section shown in Fig. 3;
Figure 6 is a section view looking through a section line 6-6 of Fig. 3;
Figure 7 is an plan view, partially in section, of the proximal end of the modular system shown in Figs. 1 and 2;
Figure 8 is a sectional view of the proximal end shown in Fig. 7, rotated 90 from the view shown in Fig. 7;
Figure 9 is an end view of the proximal end shown as line 9-9 in Figs. 7 and 8;
Figure 10 is a C~con~ end view of the proximal end shown as line 10-10 in Figs. 7 and 8;
Figure ll is a plan view of the distal section of the modular system shown in Figs. 1 and 2;
Figure 12 is an end view of the distal section shown as line 12-12 in Fig. 11;
Figure 13 is a plan view, partially in section, of an alternative locking mech~n;cm for the intramedullary nail system shown in Figs. 1 and 2;

CA 0219~012 1997-01-13 Figures 14 is an end view of the male portion of the alternative locking system shown as line 14-14 of Fig. 13;
Figures 15 is an end view of the female portion of the alternative locking system shown as line 15-15 of Fig. 13;
Figure 16 is another alternative locking mech~n;cm of the intramedullary nail system of the present invention;
Figures 17 is a end view of the alternative locking mech~n;cm shown as line 17-17 of Fig. 16;
Figures 18 is a end view of the alternative locking mech~n;sm shown as line 18-18 of Fig. 16;
Figure 19 is a plan view partially in section, of another alternative locking mech~n;cm in accordance with the present invention;
Figures 20-22 are end views of three male components for the alternative embodiment shown in Fig. 19;
Figure 23 is an end view of the female component for the alternate emho~;ment shown in Fig.
19; and Figure 24 is a plan view of another alternative lock;ng mech~n;sm.
Figure 25 is a plan view of an alternative embodiment having a portion of a hip prosthesis attached to the proximal end of the central section.
Figure 26 is a plan view of an alternative emho~;ment having an intramedullary hip screw attached to the proximal end of the central section.

CA 0219~012 1997-01-13 W096/02203 PCT~S95/08917 DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
Referring to Figs. 1 and 2, one exemplary emboAiment of the modular intramedullary nail system of the present invention is shown. The term "modularity" for the system of the present invention is used to describe the various sections which are used to make up an assembled nail lO as shown in Fig. 1. The nail lO is formed of two or more, and preferably three discreet sections, a central section 12, a proximal section 14 to form a proximal end P and a distal section 16 to form a distal end D. Alternatively, the nail might be formed of proximal and distal sections without having a central section. When assembled as shown in Fig. 1, the sections form a complete intramedullary nail which in accordance with known surgical procedures can be inserted into a long bone of a patient in order to stabilize a fracture.
Fig. 2 shows the system of Fig. 1 with the three com~onents in a ~i CA ccembled state. As may be appreciated, each of the comro~ents is only one of a number of different sizes and styles available to the physician so that the system shown in Figs. 1 and 2 represent the desired or appropriate system as finally determined by the surgeon.
As shown in Fig. 2, the component sections are separate elements which are manufactured inder~n~ently and need to be assembled in order to form the operative nail. The modularity of this product is advantageous since it permits a surgeon to select the appropriate components for a CA 0219~012 1997-01-13 WO 96/02203 PCI~/US95/08917 particular patient from a variety of sizes, chAres and styles, and assemble those components in order to provide a nail having the proper characteristics for the specific indications.
In general, it is preferred that the proximal and distal ends of the central section have different taper diameters, and correspondingly the proximal and distal components connectable to the cental section have different taper diameters. More preferably, the proximal taper is larger than the distal taper of the cental nail section. The difference in taper diameters prevents improper assembly of modular components, e.g., application to the wrong end of the central section, and also prevents stress risers at points in the proximal end of the central section.
The nail 10 of the present invention has a locking mechAn;~m between adjacent components which is designed so that the pieces may easily be fitted together and locked to each other such that they will resist separation and rotational movement relative to each other when they are subjected to stresses after implantation.
As shown in greater detail in Figs. 3-6, the central section 12 has an elongated portion 18 with flutes 20 on its outer surface and a hollow opening 22 which is generally similar in shape to the outer surface (see Fig. 6).
A socket or female connection 24 is formed in both ends of the central section 12 as shown in Figs. 3-5. The only difference between the two ends CA 0219~012 1997-01-13 W096/02203 PCT~S95/08917 illustrated is that the distal end D has a smaller diameter than the proximal end P. The configuration of both sockets or female portions 24 of the locking me~h~nisms are similar. They include a tapered inner wall 26 which is conical in shape and decreases in diameter from the outer open portion of the socket inwardly. The tapered wall 26 is adapted to mate with a tapered male connection section 28 formed on proximal section 14 or distal section 16 (see Figs. 7, 10, 11, and 12). Preferably, the distal section mates only with the distal end of the central section, and likewise, the proximal section mates only with the proximal end of the central section to ensure proper orientation o~ the implant.
The tapered surfaces 26, 28 are complementary and taper at an equal angle so that the two surfaces form a self-locking fit such as is commonly known as a Morse taper. This type of fitting is characterized by forming a tight friction-fit upon impact.
The proximal and distal sections 14, 16 may be locked into sockets 24 by simply inserting them as shown generally in Fig. 1 and then impacting the outer end of the sections in order to lock the Morse taper. In the preferred embodiment, an impact driver may be used by the surgeon to provide the impact. Such an impact driver is a commercially available product which carries a tooled end portion having, for example, a commercial screw driver or wedge tip (not shown). One driver which has been found appropriate for medical products is supplied CA 0219~012 1997-01-13 WO 96102203 PCT/U:~5;~ 117 by the Starrett Company, which impacts as much as 300 rollnAC of load when it is used.
Although the moA~ r components are illustrated as having female tapers on the central section and cooperating male tapers on the proximal and distal sections, it is understood that any combination of cooperating male and female tapers may be used to achieve the desired connections.
For some indications, e.g., those requiring a large diameter nail, the inside diameter of the nail cannula may be larger than the diameter of the taper. For example, a "bottle bore~ configuration may be used, where the ends of nail segment are compressively swagged to a smaller diameter, that is, the outer surface of the nail segment is simultaneously and uniformly pinc-heA so as to form a tapered diameter required for fitting together the moAlll ~r components.
In order to hold the adjacent components together and to prevent them from twisting relative to each other after implantation in a human bone, the socket or female receptacle is formed with a polygonal, e.g., hexagonal opening 30 on the inner end of the tapered surface 26, which is sized and ch~r~A to mate with a hexagonal male projection 32 formed on the outer end of the male taper 28 (see Fig. 7). The cooperating polygonal, e.g., hexagonal female and male sections 30, 32 are closely machi n~A
æo that little if any relative twisting movement takes place between the adjacent modular components after the nail 10 is implanted. Obviously, other CA 0219~012 1997-01-13 W096/02203 PCT~S95108917 ~hArefi may be used for these mating components in order to prevent this twisting action from taking place. The cooperating angular mating components may be used to align adjacent components in one or more preferred orientations, simply by rotating the comron~nts relative to each other.
In a preferred embodiment, the mating angular projection and socket are asymmetrical. As illustrated in Figs. 27 and 28, the hexagonal projection 32 and its corresponding socket 30 may be rounded at one facet 130, 132. Such asymmetry permits the cooperating ends to fit together only in a desired orientation and prevents incorrect alignment of component parts.
As shown in Fig. 7, the proximal end is provided with a pair of openings 34 in order to accommodate screws for holding the nail 10 relative to the bone in which it is implanted. As shown in Fig. 8, the proximal section 14 includes a hollow center oreni~g 36 and a threaded female receptacle 38 for receiving a tool (not shown) for removing the nail if n~c~s~ry. A notch 42 is formed at the outer end of the distal section 14 which cooperates with a tool (not shown) for inserting the nail in the bone of the patient.
A preferred embodiment of the distal section 16 is shown in Figs. 11 and 12 where, in addition to the tapered surface 28 and hexagonal projection 32, the outer surface includes elongated flutes 44 and an opening 46 which extends along the axis of the CA 0219~012 1997-01-13 WO 96/02203 PCT/US9~;/08917 proximal section 16. A pair of openings 48, 50 are provided to accommodate anchoring screws.
As shown in Figs. 1 and 2, a pair of alignment arrows 53 are formed on the outer surface of the adjacent compo~nts in order to indicate to the surgeon the proper alignment of the sections relative to each other. These arrows may be scratched, etched or otherwise marked on the outer surface of the various sections. Any type of indicia which provide for a visual or mech~;cal indication of the proper orientation between the adjacent sections may be used.
Another way to insure proper alignment is by using a design such as that shown in the embodiment of Fig. 13 where adjacent nail sections 52, 54 have cooperating male and female sections in the form of a tapered outer surface 56 and a tapered inner surface 58 for providing a Norse taper fit as described above. However, as shown best in Figs. 14 and 15, the male tapered surface 56 has a projection 60 formed on its outer surface which is sized and ch~pe~ to fit into a slot 62 which extends from the surface of the tapered receptacle 58. The cooperation between the projection 60 and slot 62 provides resistance against any relative twisting between the adjacent components 52, 54 as well as to insure that the components are properly aligned when they are assembled.
Another emho~;ment of the locking mec~n;~m is shown in Figs. 16-18 where adjacent components 64, 66 have cooperating male and female tapers 68, 70 CA 0219~012 1997-01-13 W096/02203 PCT~S~5/08917 which lock together as A i~cllcced above. Instead of a projection 60 as shown in Fig. 13, a pair of flanges 72 are formed adjacent to the male taper 68, which fit into a pair of slots 74 formed adjacent to the female taper 70.
Another alternative locking mech~n;sm is shown in Figs. 19-23 where adjacent sections 76, 78 are provided with cooperating male and female tapers 80, 82. The female taper 82 has a series of slots 84-88, shown in Fig. 23, which cooperate with variouss~reC of projections formed on the male taper 80 shown in Figs. 20-22. For example, the projections 90 shown in Fig. 20 mate with the slots 88 shown in Fig. 23, the projections 92 in Fig. 21 with the slots 84 in Fig. 23 and the projections 94 in Fig.
22 with the slots 86 in Fig. 23. Each of the sets of projections 90, 92 and 94 are different shapes and configurations so that only the projections designed to fit in a cooperating set of slots will allow insertion in those slots. This insures proper alignment between each individual component section 76 in the proper orientation without any mismatching. The use of the slots and projections also prevent relative twisting movement between the 2~ components after they are implanted in the human body.
Another emhoA;ment for insuring rotational stability between adjacent components as shown in Fig. 24 where the adjacent components 96, 98 have cooperating male and female tapered surfaces 100, 102 which are offset at an angle a relative to the W096/02203 PCT~S95108917 longitll~inAl axis of the components 96, 98, so that proper aiignment and resistance against relative twisting movement are provided. This angled taper embodiment may also be employed to connect modular components resulting in the axis of either or both of the proximal or distal sections 14, 16 being oriented at an angle relative to the axis of the central section 12.
As shown in the exemplary embodiments of the invention described above, a modular nail system is provided with a positive and sure locking mechAn;sm between adjacent components where they remain aligned after implantation because of the various ways of preventing translational or rotational motion between them. The Morse taper lock provided between the components is easy to connect and disco~ect by using an impact tool as described above or other type of device. Alignment is achieved by various indicia on the outer surface of the adjacent sections or by various mating configurations in order to make sure that prior to implantation the sections are properly oriented relative to each other.
In an alternative emho~; ment illustrated in Figures 25 and 26, the modular proximal section of the system described may be an endo-recon type hip implant 110 or an intramedullary hip screw 112.
The foregoing description should be considered exemplary of the invention and not restrictive. It should also be understood that improvements and modifications can be made to the invention without W096/02203 PCT~S95/08917 departing from the spirit and scope of the invention as defined in the appended claims.

Claims

WE CLAIM:

1. A modular intramedullary nail, comprising:
a) a proximal nail component;
b) a distal nail component;
c) a central nail component having proximal and distal end portions that are respectively connected during use to the proximal and distal nail components to define therewith upon assembly a modular intramedullary nail unit having a generally smooth continuous outer surface of generally uniform outer diameter and that is free of sharp curves, enabling the assembled nail unit to be surgically inserted into a patient's intramedullary canal;
d) connecting portions for securing the proximal and distal nail components to the respective proximal and distal end portions of the central nail component, the connecting portions including corresponding male and female conical connector sections, the conical connector sections being tapered at about the same angle so they can be fitted and secured together;
e) the connecting portions including self orienting interlocking portions on the proximal and distal nail components adjacent the conical sections for resisting relative rotational movement between the components;
f) said interlocking portions comprising at least in part a plurality of flat surfaces carried by the male conical connector section and a correspondingly shaped plurality of flat surfaces carried by the female connector section; and g) wherein the central nail component is much larger than either of the proximal or distal nail components.

2. The modular nail of claim 1, further including alignment means associated with the connector means for assuring proper alignment between the components.

3. The modular nail of claim 2, wherein the proximal and distal nail components are elongated hollow members.

4. The modular nail of claim 1, wherein the connecting portions have male and female connector sections that are generally frusto-conical in shape.

5. The modular nail of claim 1, wherein the alignment means includes indicia formed in the adjacent outer surface apertures of the first and second nail components.

6. The modular nail of claim 1, wherein the self-orienting interlocking portions includes at least one set of cooperating shaped projections and slots on the male and female connector sections.

7. The modular nail of claim 6, wherein at least one shaped projection and slot are formed on the tapered connector sections.

8. The modular nail of claim 6, wherein at least one shaped projection and slot are formed adjacent to the tapered connector section.

9. The modular nail of claim 8, wherein at least two different shaped slots are formed adjacent to one of the tapered connector sections, each of which cooperates with a different shaped projection formed on a cooperating tapered section.

10. The modular nail of claim 1, wherein the alignment means and movement resistance means include forming the tapered surfaces about an axis oriented at an angle relative to the axes of the first and second nail components.

11. The modular nail of claim 1, wherein the self-orienting locking portions include a shaped projection on the male connector section and a corresponding shaped socket on the female connector section, the projection and socket each being shaped to prevent relative rotational movement when they are assembled.

12. The modular nail of claim 11, wherein the shaped projection and socket are hexagonal.