Patent Document

CROSS REFERENCE TO RELATED APPLICATION 
     This application claims priority to and the full benefit of U.S. Provisional Application Ser. No. 61/228,252, filed Jul. 24, 2009, and titled “Surgical Instruments For Cutting Cavities in Intramedullary Canals,” the entire contents of which are incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     Surgical instruments and procedures are disclosed for selectively forming cavities in intramedullary (IM) canals of bones. 
     BACKGROUND 
     For purposes of this disclosure, the anatomy of a bone of a human or mammal can be divided into three principal segments: (1) the outer cortical bone that provides a rigid outer structure and weight bearing capabilities of the bone; (2) cancellous bone tissue disposed between the cortical bone and the intramedullary (IM) canal; and (3) the IM canal that passes axially through the cortical bone and cancellous bone tissue. Cancellous bone is substantially weaker than cortical bone. The boundary between the cancellous bone and the outer cortical bone structure is often referred to as the cortical wall. 
     Certain bone fractures are repaired surgically by clearing a cavity in the IM canal of the fractured bone that traverses the fracture site and installing a filler material and/or other structures in the cavity. Surgical instruments are available for forming such cavities in vertebrae. For example, some instruments include an expandable body or balloon for forming a cavity in the cancellous bone tissue of vertebrae. The expandable body or balloon compresses the cancellous bone to form the cavity. The cavity receives the filler material, which provides interior structural support for cortical bone while the cortical bone heals. Because such devices are not intended to cut bone, at least a small cavity must be cut or otherwise formed in the cancellous bone in a separate procedure in order to initially insert the balloon-like device. 
     It is frequently desirable to form a larger cavity in an IM canal and cancellous bone than can be formed with devices designed to compress and/or displace cancellous bone or material disposed in the IM canal, rather than cutting and removing such material. However, the concept of cutting and removing cancellous bone without damaging the cortical wall or cortical bone structure is problematic. Specifically, the diameters of IM canals and cortical walls are not constant, but highly irregular and non-circular. The IM canal and cortical wall often have oblong profiles that vary in dimension and geometry not only from individual to individual, but also along the length of a bone axis. As a result, drilling cancellous bone with a conventional surgical drill or a rotating cutting tool can cause damage to the cortical wall, especially along narrower portions of an IM canal and cortical wall. 
     Further, as cancellous bone is much weaker than cortical bone, conventional drilling instruments used in the IM canal have the potential to quickly drill through cancellous bone before unintentionally reaching the cortical wall and surrounding cortical bone. While one advantage of the above-described balloon compression devices is that the danger of damaging the cortical wall is minimal because cancellous bone is not cut, the above-described compression devices provide no means for forming larger cavities by cutting cancellous bone tissue safely without damaging the surrounding cortical wall. Further, the above-described balloon compression devices provide no means for removing cancellous bone tissue, which may be necessary for the formation of larger cavities within the IM canal. 
     In contrast, conventional drilling/reaming devices may be used to form the cavity. However, when using a conventional drilling/reaming device, the surgeon must be concerned with the pre-selected drill/reamer being too large for any part of the IM canal. If the drill/reamer is not properly selected, the cortical bone along an area where the cortical wall inner diameter is smaller than that of the drill/reamer may be unintentionally cut. Further, due to variations in the inner diameter of the cortical bone, the surgeon may be forced to select a drill bit or reamer size that is smaller than desired to avoid cutting cortical bone. As a result, the cavity may be smaller than desired. 
     Finally, another disadvantage to the prior art drilling/reaming devices is that an entry port for providing access to the IM canal must be axial with the IM canal. Typically, the entry port is drilled at the end of the bone through the joint. Often, this results in the removal of significant amounts of healthy cortical bone to reach the IM canal, and breaching an articular surface, which leads to joint pain. Further, if the fracture site is at an axial mid-point of the bone, more than half of the IM canal must be traversed to complete the procedure. Thus, it would be advantageous to provide a surgical instrument for forming cavities in IM canals that can utilize non-traditional entry port locations with an angled trajectory relative to the bone axis. 
     Accordingly, a need exists for an IM canal cavity forming device and method that can safely form cavities in IM canals without causing damage to cortical walls. There is also need for such devices that can remove cancellous bone tissue, marrow and other materials from the IM canal so that larger cavities can be formed. A need also exists for an IM canal cavity forming device that is of relatively simple construction and inexpensive to manufacture, that can be operated either manually or by a powered surgical drill, and that provides the surgeon with increased ability to create a cavity safely within the IM canal without damaging the surrounding healthy cortical bone. Further, it would be advantageous for such a device to be flexible and capable of entering the IM canal through an angled entry port, as opposed to an axial entry port at the end of the bone, i.e., through a joint. 
     SUMMARY OF THE DISCLOSURE 
     Surgical instruments and procedures are disclosed that enable the injection of an optimal amount of curable resin or putty and/or the placement of an internal fixation device including balloon/expandable devices in an IM canal of a fractured bone. The disclosed instruments enable a surgeon to clear at least a portion of the IM canal of cancellous bone and marrow across the fracture site. As a result, the surgeon can safely create a cavity for injecting or placing curable resin, putty, and/or an internal fixation device without damaging the cortical wall. The disclosed surgical instruments are able to cut cancellous bone in the IM canal without substantially damaging or cutting the cortical wall regardless of profile irregularities of the IM canal. Flexible cutting arms of the disclosed instruments are sufficiently resilient to cut cancellous material while being sufficiently elastic to deform when contacting cortical bone. The disclosed instruments may be used through an entry portal that it is not coaxial with the bone shaft or IM canal. For example, the disclosed instruments can be used with an angled trajectory of up to 45 degrees or up to 90 degrees relative to the bone axis. 
     In a general aspect, a surgical instrument for cutting a cavity in an intramedullary canal of a bone includes a shaft having a proximal end and a plurality of flexible cutting arms, and a distal nose section. The flexible cutting arms are formed from a shape memory material and define a relaxed effective outer diameter that is greater than effective outer diameters of the shaft and the distal nose section, the flexible cutting arms are compressible radially to a compressed effective outer diameter about equal to or less than the effective outer diameters of the shaft and distal nose section. 
     In another general aspect, a surgical instrument for cutting a cavity in an intramedullary canal of a bone includes a shaft comprising a proximal end and a distal end. The distal end of the shaft is coupled to a plurality of flexible helical cutting arms. The plurality of flexible helical cutting arms couple the shaft to a distal nose section. The flexible helical cutting arms are formed from a shape memory material and define a relaxed effective outer diameter that is greater than effective outer diameters of the shaft and the distal nose section. The flexible helical cutting arms are compressible radially to a compressed effective outer diameter about equal to or less than effective outer diameters of the shaft and distal nose section. 
     Implementations can include one or more of the following features. For example, the distal nose section includes a drill tip. The shape memory material is a shape memory alloy. The flexible cutting arms have a width, a thickness, and are characterized by a ratio of width to thickness ranging from about 5:1 to about 2:1. The flexible cutting arms are configured to cut cancellous bone and are configured to substantially not cut cortical bone. An expansion force exerted by the cutting arms when the cutting arms are released from the compressed effective outer diameter to the relaxed effective outer diameter ranges from about 1.0 lbf to about 8.0 lbf. Each flexible cutting arm is helical and rotates at an angle from between about negative 60 degrees to about 60 degrees from a longitudinal axis of the instrument. The flexible cutting arms are left-hand helical. The shaft comprises at least one of a biocompatible polymer, a steel cable and a twisted wire. 
     In another general aspect, a surgical instrument for cutting a cavity in an intramedullary canal of a bone includes a shaft and a plurality of flexible and helical cutting arms. The flexible and helical cutting arms are formed from a shape memory alloy and define a relaxed effective outer diameter that is greater than an effective outer diameter of the shaft. The flexible cutting arms are compressible radially to a compressed effective outer diameter about equal to or less than the effective outer diameter of the shaft. An expansion force exerted by the flexible and helical cutting arms is from about 1.0 lbf to about 8.0 lbf. 
     In another general aspect, a method of repairing a bone fracture, the bone comprising a cortical wall, an intramedullary canal and a fracture site, includes drilling an entry port in the bone that is spaced apart from a fracture site, the entry port providing access to an intramedullary canal of the fractured bone, the entry port having a diameter greater than effective outer diameters of a shaft and a distal nose section of a surgical instrument for forming a cavity in the intramedullary canal, compressing flexible cutting arms of the surgical instrument, inserting at least a portion of the surgical instrument into the intramedullary canal through the entry port, and forming a cavity in the intramedullary canal proximate the fracture site. 
     Implementations can include one or more of the following features. For example, the distal nose section comprises a drill tip and drilling the entry port in the bone comprises rotating the surgical instrument while the drill tip engages the bone. Forming the cavity comprises rotating the surgical instrument so that the flexible cutting arms cut cancellous bone, the flexible cutting arms being configured to substantially not cut cortical bone. Allowing the flexible cutting arms to expand towards a relaxed effective outer diameter within the intramedullary canal due to an expansion force applied, at least in part, by a spring effect of the material of the flexible cutting arms, the expansion force being from about 1.0 lbf to about 8.0 lbf. The expansion force is insufficient to allow the flexible cutting arms to substantially cut cortical bone. Removing material from the intramedullary canal through a lumen disposed in the shaft of the surgical instrument. Irrigating the intramedullary canal by dispensing irrigation fluid through a lumen disposed in the shaft of the surgical instrument. Withdrawing the surgical instrument through the entry port, injecting a curable resin through the entry port into the cavity, and allowing the resin to cure. The entry port is drilled in a non-articular surface of the bone, and inserting at least a portion of the surgical instrument comprises bending the shaft of the surgical instrument. 
     In another general aspect, a method of forming a cavity in a bone, the bone having cortical wall, cancellous bone, an intramedullary canal, and a fracture site, includes drilling an entry port in the bone that is spaced apart from the fracture site, the entry port providing access to the intramedullary canal of the fractured bone, inserting a surgical instrument through the entry port to the intramedullary canal by compressing flexible cutting arms of the surgical instrument, rotating the surgical instrument to remove cancellous bone without substantially damaging the cortical wall, and moving the surgical instrument within the intramedullary canal to create a cavity. The cavity can substantially follow the shape of the cortical wall. 
     The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features will be apparent from the description and drawings, and from the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-sectional view of a surgical instrument for cutting cancellous bone in an IM canal. 
         FIG. 2  is a side view of the surgical instrument of  FIG. 1 . 
         FIG. 3  is an end view of the surgical instrument of  FIG. 1 . 
         FIGS. 4-6  are enlarged detail views of an end section of the surgical instrument of  FIG. 1 . 
         FIG. 7  is a partial perspective view of the surgical instrument of  FIG. 1 . 
         FIGS. 8 and 9  are partial side views of a surgical instrument. 
         FIGS. 10 and 11  illustrate a leaf spring structure. 
         FIG. 12  is a side view of a surgical cutting device. 
         FIG. 13  is an end view of the device of  FIG. 12 . 
         FIG. 14  is a sectional view taken along line  14 - 14  of  FIG. 12 . 
         FIG. 15  is a perspective view of the surgical instrument of  FIG. 12 . 
         FIG. 16  is a partial side view of the surgical instrument of  FIG. 12 . 
         FIG. 17  illustrates a surgical instrument coupled to a surgical drill. 
         FIGS. 18 and 19  illustrate use of a surgical instrument. 
         FIG. 20  illustrates a surgical instrument with multiple lumens for delivering irrigation fluid and removing cuttings. 
         FIG. 21  is a partial view of a surgical instrument. 
     
    
    
     DETAILED DESCRIPTION 
     Turning to  FIG. 1 , a surgical instrument  20  is shown that includes a flexible shaft  21  with a proximal end  22  and a distal end  23 . The proximal end  22  of the shaft  21  may be coupled to a connector for connecting the shaft  21  to surgical drilling instrument, such as the drill  24  of  FIG. 17 . Alternatively, the proximal end  22  of the shaft  21  may be coupled to a handle or other suitable device for assisting or allowing a surgeon to rotate the instrument  20 . Any of these components can also be made as an integral part of the instrument. The distal end  23  the shaft  21  may be coupled directly or indirectly to an expandable cutting device  25  which, as shown in  FIGS. 1-3 , includes four flexible cutting arms  26 . The number of cutting arms  26  may vary but two or more cutting arms  26  are preferred. The cutting arms  26  may be coupled directly or indirectly to a distal nose section  27 . For example, a distal shaft or collar section  28  may be disposed between the cutting arms  26  and the distal nose section  27 . The distal nose section  27  comprises a drill tip with a brad point tip. Exemplary details of a suitable drill tip  27  for use with the instrument  20  are illustrated in  FIGS. 4-6 . A variety of designs for the drill tip  27  may be employed as will be apparent to those skilled in the art. The design specifics of the drill tip  27  are not essential to an understanding of this disclosure. The drill tip  27  may be used to drill an entry port  41  ( FIGS. 18-19 ) through cortical bone which allows the expandable cutting device  25  to enter the IM canal. While the drill tip  27  is primarily used to drill an entry port  41 , the drill tip  27  may also be used to remove initial amounts of cancellous bone and marrow prior to forming a cavity by rotating the instrument  20  and flexible cutting arms  26 . In some implementations, the distal nose can include a trocar, spade drill, diamond point spade drill, or a half round drill. 
     In  FIG. 7 , the shaft  21   a  is coupled to a collar  31  at its distal end  23   a . The cutting arms  26   a  couple the collar  31  to a distal collar  32 , which, in turn, couples the expandable cutting device  25   a  to the distal nose section or drill tip  27 . Thus, in the device  20   a  illustrated in  FIG. 7 , the shaft  21   a  and cutting device  25   a  may be fabricated or formed separately and coupled together during assembly. 
       FIGS. 12-16  illustrate a surgical instrument  20   b  that has a cutting device  25   b  with helical arms  26   b .  FIG. 21  illustrates a shaft  21   c  that passes through the cutting arms  26   c  and collars  31   c  and  32   c . Regardless of the shaft construction and the cutting device construction, the surgical instruments  20 - 20   c  include flexible shafts  21 - 21   c  that are coupled to an expandable cutting device  25 - 25   c  at distal ends  23 - 23   c  of the shafts  21 - 21   c  and a drill attachment connector or handle is coupled to the proximal ends  22  of the shafts  21 - 21   c.    
     The shafts  21 - 21   c , cutting arms  26 - 26   c , optional collars  31 ,  32 ,  31   c ,  32   c , optional distal shaft section  28  and optional drill tip  27  may be fabricated from a single piece of flexible material, such as a shape memory material. For example, the shaft  21  and cutting arms  26  are fabricated from a single piece of nitinol (nickel-titanium shape memory alloy (SMA)). Other suitable shape memory materials include, but are not limited to, alloys of titanium-palladium-nickel, nickel-titanium-copper, gold-cadmium, iron-zinc-copper-aluminum, titanium-niobium-aluminum, uranium-niobium, hafnium-titanium-nickel, iron-manganese-silicon, nickel-titanium, nickel-iron-zinc-aluminum, copper-aluminum-iron, titanium-niobium, zirconium-copper-zinc, and nickel-zirconium-titanium. The shape memory alloys may be suitable for the fabrication of surgical instruments for cutting cancellous bone without cutting cortical bone. Other suitable shape memory materials other than metallic alloys and polymers are possible as will be apparent to those skilled in the art. Furthermore, in some implementations with different requirements, such as where substantial radial collapse of the cutting device  25 - 25   c  and cutting arms  26 - 26   c  is not required, the arms  26 - 26   c  could be made from other metals or plastics. 
     The flexibility of the shafts  21 - 21   c , is provided by a small shaft diameter and by selecting a material having a modulus of elasticity falling within a desired range. In addition to fabricating the shafts  21 - 21   c  from a shape memory alloy as described above, the shafts  21 - 21   c  may also be fabricated from a high-strength biocompatible polymer, such as polyetheretherketone (PEEK), polyethereketone (PEK), high density polyethylene (HDPE), or a polyamide such as nylon. As will be apparent to those skilled in the art, other suitable polymers are available. 
     The expandable cutting device  25  illustrated in  FIGS. 1-3 and 7  comprises two or more expandable elongated cutting arms  26 . Referring to  FIGS. 1-2 , the cutting arms  26  are disposed between the distal end  23  of the shaft  21  and the optional distal shaft section  28  or the distal nose section or drill tip  27 . As shown in  FIG. 7 , the cutting arms  26  may be disposed between a pair of collars  31 ,  32 . Alternatively, the cutting arms  26  can be coupled to a pair of collars  31   a ,  32   a  that are slidably received over the distal end  23   a  of a continuous shaft  21   b , as illustrated in  FIG. 21 . In the device  20   c  of  FIG. 21 , one or more pins or other attachment mechanisms may hold the collars  31   c ,  32   c  in place on the shaft  21   c.    
     The cutting arms  26 - 26   c  may form a cage-like structure. For some applications, the shape memory material or alloy used to fabricate the arms  26 - 26   c  should exhibit elastic properties. The designs illustrated in  FIGS. 1-3, 7, 12-16, and 21  exploit the elastic properties of shape memory alloys to allow the cutting arms  26 - 26   c  expand outward upon entry in the IM canal to their original shape. The cutting arms  26 - 26   c  are also designed to be sufficiently flexible so that harder cortical bone will cause the arms to deflect in a radially-inward direction and to not cut cortical bone. In contrast, the arms  26 - 26   c  are sufficiently resilient to cut cancellous bone and other weaker materials disposed within the cortical wall. 
     The cutting arms  26 - 26   c  can be machined using traditional techniques such as chemical etching, laser cutting, or milling, among other techniques. The cage structure of the expandable cutting devices  25 - 25   c  can be formed by placing a cutting device into a fixture that compresses the cutting arms  26 - 26   c  axially and causes the cutting arms  26 - 26   c  to expand radially outward to the desired relaxed profile or relaxed diameter (compare  FIGS. 8 and 9 ). The fixture and cutting devices  25 - 25   c  may then be placed in an oven at a temperature of about 842° F. (450° C.) for about 15 minutes, followed by water quenching shortly after removal from the oven. This process causes the cutting arms or elements  26 - 26   c  to be shaped into a desired profile. The cutting arms  26 - 26   c  may be sharpened on at least one lateral surface  33  ( FIG. 3 ),  33   b  ( FIG. 16 ) to enable cutting of cancellous bone material. The benefit of the sharpening the cutting arms  26 - 26   c  is to provide a smoother cutting operation by reducing chatter or vibration when cutting, and by requiring a lower cutting torque. 
     To selectively cut cancellous bone material and not cut cortical bone material, the cutting arms must have the appropriate combination of resilience, or strength, and elasticity. Generally, the flexible cutting arms  26  should have a ratio of width (w) to thickness (t) ranging from about 5:1 to about 2:1 and ratio of length (L) to width (w) ranging from about 20:1 to about 6:1. In one example, the material of the cutting arms  26  is nitinol and the elements have a cross-sectional thickness (t) of about 0.014 in (0.356 mm), a width (w) of about 0.056 in (1.42 mm) and a length (L) of about 0.75 in (19.05 mm) (see also  FIG. 8 ). These dimensions are an example that allow the cutting arms  26 - 26   c  to be strong enough to cut cancellous material as the cutting device  25  rotates while being flexible enough to compress radially when the arms  26 - 26   c  engage cortical bone. The dimensions will vary depending upon the anatomy or size of IM canal in which a cavity is to be formed. 
     Additional methodologies for calculating other appropriate dimensions of the cutting arms  26 - 26   c  include consideration of moment of inertia (I), expansion force (P) and the deflection (δ) of the cutting arms  26 - 26   c . Specifically, the behavior of the cutting arms  26 - 26   c  of the expandable cutting device  25 - 25   c  can be predicted by treating the arms  26 - 26   c  as a leaf spring  35 , illustrated in  FIGS. 10 and 11 . The body of leaf spring  35  has a length (L), a width (w), and a thickness (t). Using a traditional beam deflection calculation, the amount of deflection (δ) can be expressed as Equation 1.
 
δ= PL   3 /48 EI   (1)
 
     In equation 1, (I) is the moment of inertia and (E) is the modulus of elasticity. For nitinol, E can range from about 5.8×10 6  psi (40.0 GPa) to about 10.9×10 6  psi (75.2 GPa). Referring to  FIG. 11 , the moment of inertia (I) can be calculated from Equation 2.
 
 I=wt   3 /12  (2)
 
     To allow for ease of insertion of the instruments  20 - 20   c  into an IM canal, the expansion force (P) of the arms  26 - 26   c  should not be excessive. However, to expand adequately in the IM canal, the expansion force (P) must be above a minimum value. Therefore, the design of the arms  26 - 26   c  should provide an optimal expansion force (P). Through laboratory experimentation, the expansion force can range from about 1.0 lbf to about 8.0 lbf (from about 4.45 N to about 35.59 N). 
     By substituting Equation 2 into Equation 1 and solving for P, the expansion force (P) can be expressed as equation 3.
 
δ= PL   3 /4 Ewt   3 , and therefore  P= 4δ Ewt   3   /L   3   (3)
 
     As another example, if L=0.65 in (15.61 mm), w=0.060 in (1.52 mm), t=0.018 in (0.457 mm), and δ=0.085 in (2.16 mm), then an expansion force of P=2.51 lbf is provided by equation 3, which falls within the range of from about 1.0 lbf to about 8.0 lbf (from about 4.45 N to about 35.59 N). As δ and P are proportional when w, t, and L, are fixed, the deflection δ can be increased by about 300% by changing the size of the fixture used during the heat treatment process before P approaches the 8.0 lbf upper limit for the dimensions recited immediately above. The value of deflection δ desired in a give implementation will be dependent upon the particular bone being treated and the size of the IM canal. In other implementations, the dimensions and parameters discussed above can vary greatly, as will be apparent to those skilled in the art. 
       FIGS. 12-16  illustrate another surgical instrument  20   b  with a flexible shaft  21   b  having a proximal end  22  and a distal end  22 . The distal end  23   b  of the shaft  21   b  is coupled to an expandable cutting device  25   b  with helical cutting arms  26   b . The helical cutting arms  26   b  also include opposing sides or cutting edges  33   b . The helical cutting arms  26   b  reduce tensile and shear stresses at the bases  29  ( FIG. 16 ) of the cutting arm  26   b  so as to reduce the possibility of device failure. The helix formed by the helical cutting arms  26   b  can be designed to optimize the ease of cutting. The helix can be left-hand helical or right-hand helical and can be formed at an angle from about negative 60 degree to about 60 degrees from a longitudinal axis of the surgical instrument. For example, left-hand helical cutting arms in a right-hand cut may be used. 
     The optional brad drill tip  27  can have a diameter that is slightly larger than a diameter of the shaft  21 - 21   c  or that is larger than a diameter of the cutting arms  26 - 26   c  when the cutting arms  26 - 26   c  are compressed. A slightly larger diameter of the drill tip  27  enables the drill tip  27  to create an entry portal  41  in cortical bone  42  to allow for passage of the remainder of the instrument  20 - 20   c  into the IM canal  46 , as illustrated in  FIGS. 18 and 19 . The drill tip  27  will also prove useful in reaming an IM canal  46  that is smaller than expected or has an endosteal surface profile that is smaller than expected. Incorporating a drill tip  27  on the device allows for the user to create the non-axial pilot/entry hole  41  in the cortical wall  42  to gain an access portal to the IM canal  46  and fracture site  47 . Thus, a separate drilling tool may not be needed to create the entry portal  41  as the proximal end  22  of the shaft  21 - 21   c  may be coupled to a surgical drill  24  as shown in  FIGS. 17, 19, and 20 . The tip  27  also allows for cutting a pathway in the IM canal where a minimum diameter in desired. For example, to accommodate a specific sized implant, such as a nail, the tip  27  can be used to drill a hole in the IM canal for receiving the nail. 
     The shafts  21 - 21   c  may include a lumen  43  ( FIGS. 18-20 ) to allow for suction and debris removal or, alternatively, for the delivery of irrigation fluid. As shown in  FIG. 20 , the shaft  21  may be disposed within an outer lumen  51  that can be used for suction or for the delivery of irrigation fluid. In the embodiment illustrated in  FIG. 20 , the shaft  21  may also accommodate an inner lumen  43  and be disposed axially within an outer lumen  51 . The outer lumen  51  and the inner lumen  43  may each be connected to a reservoir of irrigation fluid or a suction pump shown schematically at  52 ,  53  respectively. The bi-directional arrows  54 ,  55  are intended to indicate that the outer lumen  51  and inner lumen  43  can be used for either suction or irrigation or both if only a single lumen  43 ,  51  is utilized. A surgical drill  24  is also shown schematically in  FIG. 20  that is coupled to the proximal end  22  of the shaft  21 . 
     The components of the instruments  20 - 20   c  can be coupled to one another by a variety of means such as welding, pinning, adhesive bonds, mechanical locks (retaining ring), etc. The cutting arms  26 - 26   c , in addition to having at least one sharpened edge  33 ,  33   c  may include serrations, relief angles, and dual sharpened edges. Further, a series of the expandable cutting devices  25 - 25   c  may be disposed along the length of the shaft  21 - 21   c . As noted above, the cage structure of the expandable cutting device  25 - 25   c  and/or the drill tip  27  can be an integral with the shaft  21 - 21   c.    
     The arms  26 - 26   c  of the disclosed cutting devices  25 - 25   c  are designed to have a high moment of inertia I in the direction of rotation and a lower moment of inertia I in the transverse radially inward direction. The disclosed designs for the arms  26 - 26   c  permit the arms  26 - 26   c  to be strong enough to cut cancellous bone in an IM canal  46  when rotating, but elastic enough in a radial direction such that when the arms  26 - 26   c  encounter a hard tissue such as cortical bone, the arms  26 - 26   c  will be deflected in a radially inward direction thereby causing no or minimal trauma to the cortical bone  42 . As a result, cancellous bone in the non-symmetrical non-circular cross-sectional IM canal  46  is cut without substantial trauma or removal of cortical bone  42 . 
       FIG. 17  illustrates the flexibility of the shaft  21  connected to the drill  24 . The use of flexible but adequately stiff shafts  21 - 21   c  allows for advancement of the devices  20 - 20   c  through an IM canal  46  towards a fracture site  47  and the creation of non-traditional (i.e., non-axial) entry ports such as the one shown at  41  in  FIGS. 18-19 . Using a material such as reinforced PEEK or other biocompatible polymer for the shafts  21 - 21   c , or other structures such as steel cable or twisted wire, offers an inexpensive solution as compared to other flexible shafts fabricated from nitinol, other shape memory alloys or laser cut metal shafts. 
     While only certain embodiments have been set forth, alternatives and modifications will be apparent from the above description to those skilled in the art. These and other alternatives are considered equivalents and within the spirit and scope of this disclosure and the appended claims.

Technology Category: 1