Abstract:
A first surgical instrument has a bore extending therethrough and includes a handle attachment site. A second surgical instrument is sized and configured for passage through the bore of the first instrument. The handle is adapted for manipulating the first instrument when in use and includes a component configured to removably engage the handle attachment site. The handle includes a passageway accommodating passage of the second instrument through the bore of the first instrument while the first instrument is removably engaged by the handle.

Description:
RELATED APPLICATION  
       [0001]    This application is a divisional of co-pending application Ser. No. 09/014,229, filed Jan. 27, 1998. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The invention generally relates to hand-held surgical instruments and to procedures that deploy these instruments through tissue to access interior regions of the body.  
         BACKGROUND OF THE INVENTION  
         [0003]    There are many different types and styles of hand-held surgical instruments that physicians use to gain access into interior body regions. These instruments are intended to penetrate tissue by the application of pushing forces, twisting forces, or both in combination.  
           [0004]    Often, a single surgical procedure will require the physician to employ different surgical instruments, each possessing a different shape, size, and function. Often, the procedure will require the physician to deploy these instruments in both soft and hard tissue to meet the diagnostic or therapeutic objectives of the procedure. The physician will often need an enhanced mechanical advantage to advance an instrument through tissue, particularly through dense or hard tissue, such as bone.  
           [0005]    The common need to use different instruments in a given procedure, coupled with the absolute need to accurately and reliably deploy each of these different instruments through both soft and hard tissue, often with an enhanced mechanical advantage, complicate the physician&#39;s already difficult task. The need to handle different instruments in different ways for different purposes can distract the physician and lead to wasted effort, which lengthen the overall time of the procedure.  
         SUMMARY OF THE INVENTION  
         [0006]    One aspect of the invention provides a surgical system comprising a cannula instrument, a guide pin instrument, and a handle. The cannula instrument has a bore extending therethrough and includes a handle attachment site. The guide pin instrument is sized and configured for passage through the bore of the cannula instrument. The handle is adapted for manipulating the cannula instrument when in use. The handle includes a component configured to removably engage the handle attachment site and further includes a passageway in the handle that accommodates passage of the guide pin instrument through the bore of the cannula instrument while the cannula instrument is removably engaged by the handle.  
           [0007]    In one embodiment, the guide pin instrument includes a handle.  
           [0008]    According to another aspect of the invention, the system further comprises a third functional instrument sized for passage through the bore of the cannula instrument after the guide pin instrument is removed from the bore of the cannula.  
           [0009]    Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended claims. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1 is a perspective view of a system including different functional instruments and a T-shaped handle that slip-fits into and out of engagement with the instruments, to aid a physician in manipulating the instruments during use;  
         [0011]    [0011]FIG. 2 is an enlarged perspective view of a first type of tapered flange, carried by at least one of the instruments shown in FIG. 1, which slip-fits into and out of the handle;  
         [0012]    [0012]FIG. 3 is an enlarged perspective view of a second type of tapered flange, carried by at least one of the instruments shown in FIG. 1, which slip-fits into and out of the handle;  
         [0013]    [0013]FIG. 4 an end view of the tapered flange shown in FIG. 3, taken generally along line  4 - 4  in FIG. 3;  
         [0014]    [0014]FIG. 5 is a top view of the T-shaped handle shown in FIG. 1;  
         [0015]    [0015]FIG. 6 is a side view of the T-shaped handle shown in FIG. 5;  
         [0016]    [0016]FIG. 7 is a bottom view of the T-shaped handle shown in FIG. 5, showing the first and second sockets of the handle;  
         [0017]    [0017]FIG. 8 is a side perspective view of the handle shown in FIG. 5, being grasped by a physician and ready for use;  
         [0018]    [0018]FIG. 9 is a perspective view of an obturator instrument having a tapered flange of the type shown in FIG. 2 slip-fitted into the first socket of the handle shown in FIGS.  5  to  8 , ready for use;  
         [0019]    [0019]FIG. 10 is an enlarged perspective view, with portions broken away, showing the details of the slip fit engagement between the tapered flange and the first handle socket shown in FIG. 9;  
         [0020]    [0020]FIG. 11 is a perspective view of a cannula instrument having a tapered flange of the type shown in FIGS. 3 and 4 slip-fitted into the second socket of the handle shown in FIGS.  5  to  8 , ready for use;  
         [0021]    [0021]FIG. 12 is an enlarged perspective view, with portions broken away, showing the details of the slip fit engagement between the tapered flange and the second handle socket shown in FIG. 11;  
         [0022]    [0022]FIG. 13 is an enlarged view of the geometries of first and second sockets of the handle shown in FIGS.  5  to  8 ;  
         [0023]    [0023]FIG. 14 is a top view of a kit for storing the one or more functional instruments in association with the handle shown in FIGS.  5  to  8  prior to use;  
         [0024]    [0024]FIG. 15 is an exploded perspective view of the kit shown in FIG. 14;  
         [0025]    [0025]FIGS. 16 and 17 are, respectively, top and side views of a human vertebral body;  
         [0026]    [0026]FIG. 18 is a top view of a vertebral body during insertion of a spinal needle assembly to begin a bone access procedure;  
         [0027]    FIGS.  19  to  21  are top views showing subsequent steps, after insertion of the spinal needle assembly shown in FIG. 18, of inserting a guide pin component into the vertebral body;  
         [0028]    [0028]FIG. 22 is a perspective view showing a subsequent step, after insertion of the guide pin component shown in FIGS.  19  to  21 , which uses the handle shown in FIGS.  5  to  8  to aid in the deployment of an obturator instrument over the guide pin component;  
         [0029]    [0029]FIG. 23 is a top view of the vertebral body, with the obturator instrument shown in FIG. 22 deployed;  
         [0030]    [0030]FIG. 24 is a perspective view showing a subsequent step, after insertion of the obturator instrument shown in FIG. 22, which uses the handle shown in FIGS.  5  to  8  to aid in the deployment of a cannula instrument over the obturator instrument;  
         [0031]    [0031]FIG. 25 is a top view of the vertebral body, with the cannula instrument shown in FIG. 24 deployed;  
         [0032]    [0032]FIG. 26 is a perspective view showing a subsequent step, after insertion of the cannula instrument shown in FIG. 24, which removes the obturator instrument from the cannula instrument, to leave the cannula instrument and guide pin component in place;  
         [0033]    [0033]FIG. 27 is a top view of the vertebral body, after the obturator removal step shown in FIG. 26, leaving the cannula instrument and guide pin component in place;  
         [0034]    [0034]FIG. 28 is a perspective view showing a subsequent step, after removal of the obturator instrument shown in FIG. 26, which uses the handle shown in FIGS.  5  to  8  to aid in the deployment of a drill bit instrument through the cannula instrument along the guide pin component;  
         [0035]    [0035]FIG. 29 is a top view of the vertebral body, as the drill bit instrument shown in FIG. 28 is deployed with aid of the handle to open a passage into the interior volume of the vertebral body;  
         [0036]    [0036]FIG. 30 is a perspective view showing a subsequent step, after removal of the drill bit instrument and guide pin component shown in FIG. 28, of deploying a catheter instrument carrying a diagnostic or therapeutic element through the cannula instrument into the vertebral body;  
         [0037]    [0037]FIG. 31 is a top view of the vertebral body, as the diagnostic or therapeutic element carried by the catheter component shown in FIG. 30 is deployed into the interior volume of the vertebral body;  
         [0038]    [0038]FIG. 32 is a top view of a round handle, which can be used in association with the functional instruments shown in FIG. 1, in generally the same fashion as the T-shaped handle shown in FIGS.  5  to  8 ;  
         [0039]    [0039]FIG. 33 is a side view of the round handle shown in FIG. 32;  
         [0040]    [0040]FIG. 34 is a bottom view of the round handle shown in FIG. 32, showing the first and second sockets of the handle;  
         [0041]    [0041]FIG. 35 is a perspective view of an elliptical, anvil-style handle, which can be used in association with the functional instruments shown in FIG. 1 when greater tapping or compression force is required to advance an instrument, particularly through hard tissue, like bone;  
         [0042]    [0042]FIG. 36 is a rear side perspective view of the anvil-style handle shown in FIG. 35, showing the first and second sockets of the handle;  
         [0043]    [0043]FIG. 37 is a rear elevation view of the anvil-style handle shown in FIG. 35, showing the first and second sockets of the handle;  
         [0044]    [0044]FIG. 38 is a front elevation view of the anvil-style handle shown in FIG. 35; and  
         [0045]    [0045]FIG. 39 is a perspective view of an alternative system including different functional instruments and a T-shaped handle that slip-fits into and out of engagement with the instruments, to aid a physician in manipulating the instruments during use. 
     
    
       [0046]    The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.  
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0047]    [0047]FIG. 1 shows a system  10  for penetrating tissue. The system includes one or more functional instruments  12 ,  14 , and  16  and a handle  18 . The handle  18  engages at least one of the functional instruments  12 ,  14 , and  16  in a removable, slip fit fashion to aid a physician in manipulating the instrument  12 ,  14 , or  16  during use.  
         [0048]    I. The Instruments  
         [0049]    The number and type of instruments  12 ,  14 , and  16  can vary. FIG. 1 shows three representative instruments  12 ,  14 , and  16 , each having a different size and function.  
         [0050]    The first, second, and third instruments  12 ,  14 , and  16  share some common features, although they are intended, in use, to perform different functions. The first, second and third instrument  12 ,  14 , and  16  each comprises an elongated, cylindrical body  20  having a proximal end  22  and a distal end  24 . The first, second, and third instrument  12 ,  14 , and  16  are each made of a rigid, surgical grade plastic or metal material.  
         [0051]    A. The Obturator Instrument  
         [0052]    The first instrument  12  functions as an obturator. Its distal end  24  is tapered to present a penetrating surface  26 . In use, the surface  26  is intended to penetrate soft tissue in response to pushing or twisting forces applied by the physician at the proximal end  22 .  
         [0053]    The proximal end  22  of the obturator instrument  12  presents a flanged surface  28 . As also shown in an enlarged view in FIG. 2, the flanged surface  28  tapers from a larger outer diameter to a smaller outer diameter in the direction of the proximal end  22 . The flanged surface  28  includes an array of circumferentially spaced teeth  30  with intermediate flutes  32 .  
         [0054]    An interior lumen  34  extends through the obturator instrument  12  from the distal end  24  to the proximal end  22 . The interior lumen  34  is sized to accommodate a conventional surgical guide pin component to aid in its deployment, as will be described in greater detail later.  
         [0055]    B. The Cannula Instrument  
         [0056]    The second instrument  14  functions as a cannula or guide sheath. The cannula instrument  14  is somewhat larger in diameter than and not as long as the obturator instrument  12 . As shown in FIGS. 1 and 3, the cannula instrument  14  includes an interior lumen  36  that extends from its distal end  24  to its proximal end  22 . The interior lumen  36  is sized to accept the obturator instrument  12 . The size of the interior lumen  36  permits a physician to slide and rotate the cannula instrument  14  relative to the obturator instrument  12 , and vice versa, as will be described in greater detail later.  
         [0057]    The distal end  24  of the cannula instrument  14  presents an end surface  38 . In use, the end surface  38  of the cannula instrument  14  is intended to penetrate soft tissue surrounding the obturator instrument  12 , in response to pushing or twisting forces applied at the proximal end  22 .  
         [0058]    The proximal end  22  carries an enlarged fitting  40 . As best shown in an enlarged view in FIGS. 3 and 4, the fitting  40  tapers from a larger diameter to a smaller diameter in the direction of the proximal end  22 . Like the tapered flange  28  at the proximal end  22  of the obturator instrument  12 , the tapered fitting  40  has an array of circumferentially spaced teeth  42  with intermediate flutes  44 . The tapered fitting  40  of the cannula instrument  14  possesses a larger maximum outer diameter than the maximum outer diameter of the tapered flange  28  of the obturator instrument  12 .  
         [0059]    C. The Drill Bit Instrument  
         [0060]    The third instrument  16  functions as a drill bit. The drill bit instrument  16  has generally the same physical dimensions as the obturator instrument  12 . Like the obturator instrument  12 , the drill bit instrument  16  is intended, in use, to fit for sliding and rotational movement within the interior lumen  36  of the cannula instrument  14 .  
         [0061]    The distal end  24  of the drill bit instrument  16  includes machined cutting edges  46 . In use, the cutting edges  46  are intended to penetrate hard tissue in response to rotation and longitudinal load forces applied at the proximal end  22  of the drill bit instrument  16 .  
         [0062]    The proximal end  22  presents a tapered flange  28 , substantially identical to the flange  28  on the obturator instrument  12 , as FIG. 2 shows in an enlarged view. Like the obturator instrument  12 , the tapered flange  28  changes from a larger diameter to a smaller diameter in the direction of the proximal end  22 . The tapered flange  28  of the drill bit instrument  16  also includes an array of circumferentially spaced teeth  30  with intermediate flutes  32 . The form and orientation of the teeth  30  and flutes  32  on the drill bit instrument  16  correspond to the form and orientation of the teeth  30  and flutes  32  on the obturator instrument  12 .  
         [0063]    II. The Handle  
         [0064]    The handle  18  is made from a molded or cast rigid plastic or metal material. As also shown in FIGS.  5  to  8 , the handle  18  is shaped to be comfortably and securely grasped by a normal human hand (see FIG. 8). The shape and size to accommodate this function can, of course, vary. In the embodiment shown in FIG. 5, the handle  18  is elongated along a main axis  48  to fit comfortably across the palm of the hand. In a representative embodiment, the handle  18  measures about 76 mm in length along the main axis  48 , about 16 mm in width across the main axis  48 , and about 25 mm in height normal to the main axis  48 . These dimensions can, of course, vary to best serve the intended field of use.  
         [0065]    The handle  18  includes a top wall  50 , opposed side walls  52 , and opposed end walls  54 . The junctions  56  of the side walls  52  and end walls  54  with the top wall  50  are preferably rounded according to normal finger joint radii to provide a comfortable gripping area. The side walls  52  and end walls  54  also taper somewhat outward from the top wall  50  (see FIGS. 6 and 8), to enable firm, comfortable grasping between the fingers and thumb, as FIG. 8 shows. The top wall  50  and side walls  52  can be roughened or otherwise textured to provide a secure gripping surfaces. The contours of the handle  18  are also designed to minimize surgical glove tears.  
         [0066]    The handle  18  includes a center post  58 , which is integrally molded to the handle  18  about its geometric center  60  (as FIG. 6 shows). The center post  58  extends downward from the top wall  50  along the geometric center  60  between the side walls  52 . The center post  58  has an exposed end surface  62 , which terminates below the lower edges  64  of the side and end walls  52  and  54 . This gives the handle  18  a general T-shape, when viewed from the side (see FIGS. 6 and 8).  
         [0067]    The underside interior  66  of the handle  18  includes a crossing array of molded stiffening ribs  68  and  70  extending about the center post  58  (as best shown in FIG. 7). Long stiffening ribs  68  extend between the center post  58  and the end walls  54 , along the main axis  48  of the handle  18 . Cross ribs  70  extend across the long ribs  68  between the side walls  52 . The ribs  68  and  70  provide the handle  18  with structural rigidity and strength to transmit, without failure, both longitudinal and torsional load forces.  
         [0068]    The handle  18  includes at least one interior cavity or socket  80 / 86  in the center post  58 . The socket  80 / 86  serves to guide the attachment between the handle  18  and at least one of the instruments  12 ,  14 , and  16 . Of course, the number of sockets  80 / 86  can vary. The illustrated embodiment shows two sockets  80  and  86 . In this arrangement, each instrument  12 ,  14 , and  16  in the system  10  can be fitted to the handle  18 .  
         [0069]    Both first and second sockets  80  and  86  open at the end surface  62  of the center post  58 . Both sockets  80  and  86 (see FIG. 6) include interior side walls  76 , which extend into the center post  58 . Both sockets  80  and  86  include interior end walls  78  in the center post  58 , spaced below the top wall  50  of the handle  18 .  
         [0070]    Referring to FIGS. 9 and 10, the interior side wall  76  of the first socket  80  includes an array of circumferentially spaced grooves  82  with intermediate splines  84 . The form and orientation of the grooves  82  and splines  84  are sized to match the form and orientation of the teeth  30  and flutes  32  at the proximal ends  22  of the obturator instrument  12  and the drill bit instrument  16 . The first socket  80  accepts the tapered flange  28  of either the obturator instrument  12  or the drill bit instrument  16 . As FIG. 10 shows, the teeth  30  of the tapered flange  28  mesh in a slip-fit with the grooves  82  of the first socket  80 . The running slip-fit allows longitudinal force to be applied to either instrument  12  or  16  through the handle  18 . The running slip-fit also prevents relative rotation between either instrument  12  or  16  and the first socket  80 , thereby permitting torsional or twisting forces to be applied to either instrument  12  or  16  by the handle  18 , with an increased mechanical advantage.  
         [0071]    Because of its larger size, the tapered fitting  40  of the cannula instrument  14  will not fit inside the first socket  80 . Instead (see FIGS. 11 and 12), the interior side wall  76  of the second socket  86  is sized to accept the tapered fitting  40 . The second socket  86  includes an array of circumferentially spaced grooves  88  with intermediate edges  90 , which, in form and orientation, match the form and orientation of the teeth  42  and flutes  44  on the tapered fitting  40 . The teeth  42  of the tapered fitting  40  mesh in a slip-fit with the grooves  88  of the second socket  86 , as FIG. 12 shows. The running slip-fit allows both longitudinal and torsional forces to be applied to the cannula instrument  14  through the handle, with increased mechanical advantage.  
         [0072]    Because of its smaller size, the tapered flange  28  of either the obturator instrument  12  or the drill bit instrument  16  will fit inside but not mesh with the second socket  86 . The first and second sockets  80  and  86  thereby represent unique attachment sites for different functional instruments.  
         [0073]    Referring to FIGS. 5 and 6, a first passage  92  extends through the top wall  50  of the handle  18 , through the center post  58 , and into the first socket  80 . The passage  92  is generally aligned with the center of the first socket  80  within the cavity  72 . The first passage  92  is sized to pass a conventional surgical guide wire component through the handle  18  and into the lumen  34  of the obturator instrument  12 , when fitted in the first socket  80 . The interior side wall  76  of the first socket  80  is preferably tapered inward toward the first passage  92 , to guide the guide wire through the socket  80  into the first passage  92  without sticking. This arrangement will be described in greater detail later.  
         [0074]    Likewise, a second passage  96  extends through the top wall  50  of the handle  18 , through the center post  58 , and into the second socket  86 . The passage  96  is generally aligned with the center of the second socket  86 . The second passage  96  is sized to pass either the obturator instrument  12  or the drill bit instrument  16  through the handle  18  and into the lumen  36  of the cannula instrument  14 , when fitted in the second socket  86 . This arrangement will also be described in greater detail later.  
         [0075]    III. The Form and Function of the Running Slip-Fit  
         [0076]    The form and function of the running slip-fit between the teeth and flutes  30 / 32  or  42 / 44  on the selected instruments  12 ,  14 , and  16  and the grooves and splines  82 / 84  in the corresponding sockets  80  and  86 , allow the physician to fit the selected instrument  12 ,  14 , or  16  to the handle  18  tactilely, without need of visual tracking or confirmation. At the same time, the form and function of the running slip-fit make possible the reliable transmission, with increased mechanical advantage, of both torsional and longitudinal loads by the handle  18  to the selected instrument  12 ,  14 , or  16 , without undue slippage or wasted motion. Furthermore, the form and function of the running slip-fit permit quick detachment of the selected instrument  12 ,  14 , or  16  from the handle  18 , without sticking or resort to inordinate force.  
         [0077]    In the illustrated and preferred embodiment (see FIG. 13), the form and function of the sockets  80  and  86  are realized by use of three grooves  82  circumferentially spaced by intermediate splines  84 . Each groove  82  comprises an arcuate section  100  that extends between two radial sections  102 . Each spline  84  is defined between the radial sections  102  of two adjacent grooves  82 .  
         [0078]    The sockets  80  and  86  of the handle  18  can possess different sizes and arcuate relationships, smaller or larger, according to the intended use. For example, posterolateral access to a vertebral body is made using instruments having a larger dimension than instruments used to accomplish a transpedicular access. The sockets  80  and  86  on the handle  18  will therefore be sized differently, depending upon the dimensions of the mating instruments. Practicality and functionality dictate the minimum and maximum dimensions. The size and circumferential spacing of the sockets  80  and  86 , as well as the overall dimensions of the handle  18  itself, are selected based upon desired performance, manufacturing, and ease of use criteria.  
         [0079]    In an exemplary construction to be used with instruments for making a posterolateral access, in the first socket  80 , the arcuate sections  100  of the grooves  82  lay at a diameter of about 5.2 mm and the splines  84  lay at a diameter of about 3.3 mm, measured from the center  94  of the first socket  80 . In the second socket  86 , the arcuate sections  100  of the grooves  82  lay along a diameter of about 12.8 mm and the splines  84  lay along a diameter of about 8.1 mm, measured from the center  98  of the second socket  86 . In this exemplary embodiment, the first passage  92  has a diameter of about 1.8 mm, and the second passage  96  has a diameter of about 6.5 mm. In this exemplary embodiment, the center post  58  has a major diameter of about 22.8 mm and a minor diameter of about 15.8 mm. The center  94  of the first socket  80  is spaced inward along the main axis  48  from one side of the center post  58  by about 17 mm, while the center  98  of the second socket  86  is spaced inward along the main axis  48  from the same side by about 7.6 mm.  
         [0080]    In an exemplary construction to be used with instruments for making a transpedicular access, in the first socket  80 , the arcuate sections  100  of the grooves  82  lay at a diameter of about 3.0 mm and the splines  84  lay at a diameter of about 1.9 mm, measured from the center  94  of the first socket  80 . In the second socket  86 , the arcuate sections  100  of the grooves  82  lay along a diameter of about 7.4 mm and the splines  84  lay along a diameter of about 4.7 mm, measured from the center  98  of the second socket  86 . In this exemplary embodiment, the first passage  92  has a diameter of about 1.0 mm, and the second passage  96  has a diameter of about 3.7 mm. In this exemplary embodiment, the center post  58  has a major diameter of about 22.8 mm and a minor diameter of about 15.8 mm. The center  94  of the first socket  80  is spaced inward along the main axis  48  from one side of the center post  58  by about 17.0 mm, while the center  98  of the second socket  86  is spaced inward along the main axis  48  from the same side by about 7.6 mm.  
         [0081]    As shown, the arcuate section  100  of each groove  82  extends over an equal arc GA of about 30°, and the grooves  82  are equally spaced apart by an arc SA of about 90°. In this arrangement, the splines  84  are circumferentially spaced apart by an equal arc EA of about 120°.  
         [0082]    In addition, in the illustrated embodiment, each spline  84  is rounded or filleted facing into the socket  80 / 86  to facilitate molding and manufacture. In an exemplary embodiment, the splines  84  in the first socket  80  are filleted at a radius of about 0.3 mm, and the splines  84  in the second socket  86  are filleted at a radius of about 0.6 mm.  
         [0083]    The form and orientation of the teeth and flutes  30 / 32  and  42 / 44  on the mating instrument  12 ,  16 , or  18  are selected to match the form and orientation of the grooves and splines  82 / 84  of the appropriate socket  80 / 86 . The teeth and flutes  30 / 32  and  42 / 44  have as their respective maximum outer diameters a dimension that is about 12% less than the maximum interior diameter of the mating groove and spline  82 / 84 , thereby providing a running slip fit, RC  8 .  
         [0084]    The form and function of the running slip-fit are also influenced by the relative size of the sockets  80 / 86 . Tactile placement is enhanced by maximizing the difference in socket size, so that fitting the wrong instrument in the wrong socket is eliminated. This, in turn, dictates the design of the mating instruments  12 ,  14 , and  16 . The difference in socket sizes dictates the difference in sizes of the taper flanges  28  and fittings  40  on the various instruments  12 ,  14 , and  16 .  
         [0085]    The form and function are also affected by the relative orientation of the first and second sockets  80 / 86  in the center post  58 . In the illustrated and preferred embodiment, the first and second sockets  80  and  86  are placed in close side-by-side relationship along the main axis  48  of the handle  18 . A groove  82  of the first socket  80  is oriented with a spline  84  of the second socket  86 , or vice versa, to minimize the spacing between the two sockets  80  and  86 , while maintaining structural integrity.  
         [0086]    The close, side-by-side orientation of different size sockets  80  and  86 , coupled with the form and orientation of each socket  80  and  86 , allows for quick tactile recognition of the proper socket  80 / 86  on the handle  18  and quick tactile alignment of the mating tapered flanges  28  or tapered fittings  40  on the instrument  12 ,  14 , and  16  in the identified socket  80  or  86 . The filleted splines  84  allows for slip-fit engagement against the matching tapered flanges  28  or fittings  40  on the attached instrument  12 ,  14 , or  16 . The filleted splines  84  also allow ease of disengagement of the instrument  12 ,  14 , and  16  from the handle  18 , without sticking. The form and orientation of the tapered flanges  28  or fittings  40  also allow the application of torsional loads by the handle  18  about the axis of the attached instrument  12 ,  14 , or  16 , while the handle  18  applies a longitudinal load along the axis of the attached instrument  12 ,  14 , or  16 .  
         [0087]    IV. Kit for Packaging the System  
         [0088]    As shown in FIG. 14, a kit  104  is provided for storing the one or more functional instruments  12 ,  14 , and  16  in association with the handle  18  prior to use. The kit  104  also includes other components  106  and  108 , which are intended to be used in association with the instruments  12 ,  14 , and  16  and handle  18 . For example, the kit  104  shown in FIG. 14 includes a guide pin component  106  and a catheter component  108 , which carries a diagnostic or therapeutic element  110  for deployment in the targeted interior body region. Though not shown in FIG. 14, the kit  104  can also include a conventional spinal needle assembly  152 , which will be described in greater detail later.  
         [0089]    The kit  104  can take various forms. In the illustrated embodiment, the kit  104  comprises a sterile, wrapped assembly.  
         [0090]    In this assembly (see FIG. 15 also), the kit  104  includes an interior tray  112  made, e.g., from die cut cardboard, plastic sheet, or thermo-formed plastic material. The tray  112  includes spaced apart tabs  114 , which hold the handle  18 , instruments  12 ,  14 , and  16 , and components  106  and  108  in a secure position during sterilization and storage prior to use.  
         [0091]    Preferably, the tray  112  presents the handle  18 , instruments  12 ,  14 , and  16 , and components  106  and  108  in an ordered, organized layout, which is arranged to aid the physician in carrying out the intended procedure. For example, the layout of the tray  112  can present the instruments  12 ,  14 , and  16  and components  106  and  108  in top-to-bottom order, according to sequence of intended use. For example, in a typical bone access procedure (as will be demonstrated in greater detail later), the guide pin component  106  is deployed first, followed by the obturator instrument  12 , then the cannula instrument  14 , then the drill bit instrument  16 , and lastly the catheter component  108 . Accordingly, the tray  112  packages these instruments and components in a top-to-bottom order, with the guide pin component  106  topmost, the obturator instrument  12  next, the cannula instrument  14  next, the drill bit instrument  16  next, and the catheter component lowermost  108 . When a spinal needle assembly  152  is included in the kit  104 , the spinal needle assembly  152  is mounted above the guide pin component  106 .  
         [0092]    In this layout, the handle  18  is packaged to the side of the instruments  12 ,  14 , and  16 . The tray  112  can include written labels  116  identifying the handle  18  and each instrument and component contained in the kit  104 .  
         [0093]    When packaged as a sterile assembly, the kit  104  includes an inner wrap  118 , which is peripherally sealed by heat or the like, to enclose the tray  112  from contact with the outside environment. One end of the inner wrap includes a conventional peal-away seal  120 , to provide quick access to the tray  112  at the instant of use, which preferably occurs in a sterile environment, such as within an operating room.  
         [0094]    When packaged as a sterile assembly, the kit  104  also includes an outer wrap  122 , which is also peripherally sealed by heat or the like, to enclosed the inner wrap. One end of the outer wrap  122  includes a conventional peal-away seal  124 , to provide access to the inner wrap  118  and its contents. The outer wrap  122  can be removed from the inner wrap  118  in anticipation of imminent use, without compromising sterility of the handle  18 , instruments  12 ,  14 , and  16 , and components  106  and  108  themselves.  
         [0095]    Each inner and outer wrap  118  and  122  includes a peripherally sealed top sheet  126  and bottom sheet  128  (see FIG. 15). In the illustrated embodiment, the top sheet  126  is made of transparent plastic film, like polyethylene or MYLAR™ material, to allow visual identification of the contents of the kit  104 . The bottom sheet  128  is made from a material that is permeable to ETO sterilization gas, e.g., TYVEK™ plastic material (available from DuPont).  
         [0096]    The kit  104  also preferably includes in the tray  112  directions  130  for using the handle  18 , the instruments  12 ,  14 , and  16 , and the components  106  and  108  to carry out a desired procedure. An exemplary procedure which the directions can describe will be explained later.  
         [0097]    When packaged as a sterile assembly, the-directions  130  can include the statement “For Single Patient Use Only” (or comparable language) to affirmatively caution against reuse of the contents of the kit  104 . The directions  130  also preferably affirmatively instruct against resterilization of the handle  18 , instruments  12 ,  14 , and  16 , or components  106  and  108  and also instructs the physician or user to dispose of the entire contents of the kit  104  upon use in accordance with applicable biological waste procedures.  
         [0098]    The presence of the handle  18 , instruments  12 ,  14 , and  16 , and components  106  and  108  packaged in the sterile kit  104  verifies to the physician or user that the contents are sterile and have not been subjected to prior use. The physician or user is thereby assured that the handle  18 , instruments  12 ,  14 , and  16 , and components  106  and  108  meet established performance and sterility specifications.  
         [0099]    It should be appreciated that the instruments and components contained in the kit  104  can be packaged into several, smaller functional kits. For example, a tool kit can package a spinal needle assembly, a guide pin component, an obturator instrument, a cannula instrument, and a drill bit instrument, together with the handle. A separate catheter kit can package the catheter component. Another separate cement kit can package a cement nozzle and tamp. FIGS. 14 and 15 illustrate one of many different possible embodiments.  
         [0100]    V. Illustrative Use of the System  
         [0101]    The following describes use of the handle  18 , instruments  12 ,  14 , and  16 , and components  106  and  108  shown in FIG. 14 packaged in the kit  104  in the context of treating bones. This is because these items can be advantageously used for this purpose. Still, it should be appreciated that the handle  18  is not limited to use in the treatment of bones. The handle  18  can be used in association with virtually any hand-held instrument intended to contact tissue to perform a diagnostic or therapeutic function.  
         [0102]    The handle  18 , instruments  12 ,  14 , and  16 , and components  106  and  108  will described with regard to the treatment of human vertebra. It should be appreciated, however, their use is not limited to human vertebrae. The handle  18  can be used in association with hand-held instruments in the treatment of diverse human or animal bone types.  
         [0103]    A typical vertebra  130  (see FIGS. 16 and 17) includes a vertebral body  132 , which extends on the anterior (i.e., front or chest) side of the vertebra  130 . The vertebral body  132  has the shape of an oval disk. The vertebral body  132  includes an exterior formed from compact cortical bone  136 . The cortical bone  136  encloses an interior volume  138  of reticulated cancellous, or spongy, bone  140  (also called medullary bone or trabecular bone).  
         [0104]    The spinal cord  142  passes through the spinal canal of the vertebra  132 . The vertebral arch  144  surrounds the spinal canal  142 . The pedicles  146  of the vertebral arch adjoin the vertebral body  134 . The spinous process  148  extends from the posterior of the vertebral arch  144 , as do the left and right transverse processes  150 .  
         [0105]    Referring first to FIG. 18, in a typical procedure, a patient lies on an operating table, while the physician introduces a conventional spinal needle assembly  152  into soft tissue (designated S in the drawings) in the patient&#39;s back. The patient can lie facedown on the table, or on either side, or at an oblique angle, depending upon the physician&#39;s preference. Indeed, the procedure can be performed through an open anterior procedure or an endoscopic anterior procedure.  
         [0106]    The spinal needle assembly  152  comprises a stylet  154  slidably housed within a stylus  156 . The assembly  152  typically has, for example, about an  18  gauge diameter. Other gauge diameters can and will be used to accommodate appropriate guide pins.  
         [0107]    Under radiologic or CT monitoring, the physician advances the assembly  152  through soft tissue S down to and into the targeted vertebra  132 , as FIG. 18 shows. The physician will typically administer a local anesthetic, for example, lidocaine, through assembly  152 . In some cases, the physician may prefer other forms of anesthesia.  
         [0108]    The physician directs the spinal needle assembly  152  to penetrate the cortical bone  136  and the cancellous bone  140  of the targeted vertebra  132 . Preferably the depth of penetration is about 60% to 95% of the vertebral body  134 .  
         [0109]    [0109]FIG. 18 shows gaining access to cancellous bone  140  through the pedicle  146 , which is called transpedicular access. However, posterolateral access, through the side of the vertebral body  134  may be indicated, based upon the objectives of the treatment or for other reasons based upon the preference of the physician.  
         [0110]    Referring now to FIG. 19, after positioning the spinal needle assembly  152  in cancellous bone, the physician holds the stylus  156  and withdraws the stylet  154 . It is at this time, or slightly before, that the outer and inner wraps  118  and  122  of the kit  104  can be removed, exposing the components carried on the tray  112  for use.  
         [0111]    The physician first acquires the guide pin component  106  from the tray  112 . As FIG. 20 shows, while still holding the stylus  156 , the physician slides the guide pin component  106  through the stylus  156  and into the cancellous bone  140 . As FIG. 21 shows, the physician now removes the stylus  156 , leaving the guide pin component  106  deployed within the cancellous bone  140 .  
         [0112]    The physician next acquires the obturator instrument  12  and the handle  18  from the tray  112 . As FIG. 22 shows, the physician slides the obturator instrument  12  over the guide pin component  106 , distal end first. The physician slides the guide pin component  106  through the first passage  92  and the first socket  80  of the handle  18 . As previously described, the interior side wall  76  of the first socket  80  is preferably tapered inward to guide the guide wire into the first passage  92  without sticking. The physician slides the handle  18  along the guide pin component  106  toward the tapered flange  28  of the obturator instrument  12 , until achieving a running slip-fit between the first socket  80  and the tapered flange  28 , in the manner previously described. The obturator instrument  12  is now ready for use.  
         [0113]    As FIG. 22 shows, the physician makes a small incision(designated I in FIG. 22) in the patient&#39;s back. The physician twists the handle  18  while applying longitudinal force to the handle  18 . In response, the tapered surface  26  of the obturator instrument  12  rotates and penetrates soft tissue through the incision I. The physician may also gently tap the handle  18 , or otherwise apply appropriate additional longitudinal force to the handle  18 , to advance the obturator instrument  12  through the soft tissue S along the guide pin component  106  down to the entry pedicle  146 . The physician can also tap the handle  18  with an appropriate striking tool to advance the sharpened surface  26  of the obturator instrument  12  into the pedicle  146  to secure its position, as FIG. 23 shows.  
         [0114]    The physician next slides the handle  18  along the guide pin component  106  away from the obturator instrument  12  to disengage the tapered flange  28  from the first socket  80 . The physician then proceeds to slide the handle  18  completely off the guide pin component  106 . The physician acquires the cannula instrument  14  from the tray  112 .  
         [0115]    As FIG. 24 shows, the physician slides the cannula instrument  14  over the guide pin component  106 , distal end first, and, further, over the obturator instrument  12 , until contact between the end surface  38  and tissue occurs. The physician now slides the guide pin component  106  through the second passage  96  and second socket  86  of the handle  18 . The physician slides the handle  18  toward the tapered fitting  40  of the cannula instrument  14  until a running slip-fit occurs between the second socket  86  and the tapered fitting  40 , as previously described. The cannula instrument  14  is now ready for use.  
         [0116]    As Fig. F shows, the physician applies appropriate twisting and longitudinal forces to the handle  18 , to rotate and advance the cannula instrument  14  through soft tissue along the obturator instrument  12 . As FIG. 25 shows, when the end surface  38  of the cannula instrument  14  contacts cortical bone  136 , the physician appropriately taps the handle with a striking tool to advance the end surface  38  into the pedicle  146  to secure its position.  
         [0117]    As FIG. 26 shows, the physician now withdraws the obturator instrument  12 , sliding it off the guide pin component  106 , to leave the guide pin component  106  and the cannula instrument  14  in place, as FIG. 27 shows. The physician slides the handle  18  along the guide pin component  106  away from the cannula instrument  14  to disengage the tapered fitting  40  from the second socket  86 . The physician then slides the handle  18  completely off the guide pin component  106 . The physician now acquires the drill bit instrument  16  from the tray  112 .  
         [0118]    The physician slides the drill bit instrument  16  over the guide pin component  106 , distal end first, through the cannula instrument  14  until contact with the bone tissue occurs. The physician next leads the guide pin component  106  through the first passage  92  and first socket  80  of the handle  18 . As previously described, the preferred taper of the first socket  80  guides the guide wire through the socket  80  into the first passage  92  without sticking. As FIG. 28 shows, the physician slides the handle  18  along the guide pin component  106  toward the tapered flange  28  of the drill bit instrument  16 , until a running slip-fit occurs between the first socket  80  and the tapered flange  28 , as previously described. The drill bit instrument  16  is now ready for use.  
         [0119]    As FIG. 29 shows, under X-ray control (or using another external visualizing system), the physician applies appropriate twisting and longitudinal forces to the handle  18 , to rotate and advance the cutting edge  46  of the drill bit instrument  16  to open a passage  158  through the bone tissue and completely into the cancellous bone  140 . The drilled passage  158  preferable extends no more than 95% across the vertebral body  134 .  
         [0120]    The physician now slides the handle  18  along the guide pin component  106  away from the drill bit instrument  16  to disengage the tapered flange  28  from the first socket  80 . The physician, further, slides the handle  18  completely off the guide pin component  106 .  
         [0121]    The physician can now remove the drill bit instrument  16  and the guide pin component  106 , leaving only the cannula instrument  14  in place, as FIGS. 30 and 31 show. The passage  158  made by the drill bit instrument  16  remains. Access to the cancellous bone  140  has been accomplished.  
         [0122]    The physician can now acquire the catheter component  108  from the tray  112 . The physician can advance a diagnostic or therapeutic element  110  carried by the catheter component  108  through the cannula instrument  14  and passage  158  into the interior volume  138  of the vertebral body  134 .  
         [0123]    The diagnostic or therapeutic element  110  of the catheter component  108  can be configured to perform various functions. For example, the distal element  110  can comprise a biopsy instrument, to obtain samples of cancellous bone. Alternatively, the distal element  110  can be a stylet to introduce a medication or the like into cancellous bone. Still alternatively (as shown in the illustrated embodiment), the distal element  110  can comprise an expandable body to compact cancellous bone  140  and form a cavity in the vertebral body  134 , in the manner disclosed in U.S. Pat. Nos. 4,969,888 and 5,108,404, which are incorporated herein by reference. Upon compaction of cancellous bone, the distal element  110  can also include a nozzle to inject a flowable bone cement material into the formed cavity.  
         [0124]    VI. Alternative Handle Configurations  
         [0125]    As before explained, the shape of the handle  18  can vary. FIGS.  5  to  8  show a handle  18  with a generally T-shaped configuration.  
         [0126]    A. Round Handle  
         [0127]    FIGS.  32  to  34  show a representative alternative embodiment, in which a handle  218  has a general round configuration, made from a molded rigid plastic or metal material. The round handle  218  is also shaped to be comfortably and securely grasped by a normal human hand. In a representative embodiment, the handle  218  measures about 38 mm in diameter.  
         [0128]    The handle  218  includes a top wall  160  and a peripheral side wall  162 . The junction of the side wall  162  with the top wall  160  is preferably rounded to provide a comfortable grip. In addition, the side wall  162  includes a series of circumferentially spaced scallops  164  to assist the transmission of turning forces. In the illustrated embodiment, seven equally spaced scallops  164  are present to provide an appropriate turning resolution. The scallops  164  are each curved inwardly to comfortable accommodate the dimension of a thumb (e.g., with a radius of curvature of about 9 mm to 10 mm). The top wall  160  and the side wall  162  can be roughened or otherwise textured to enhance the over grip.  
         [0129]    In the illustrated embodiment, the top wall  160  includes circumferentially spaced voids  166  aligned with each scallop  164 . The voids  166  reduce the overall weight of the handle  218  and are arranged to provide optimal balance for the handle  218 .  
         [0130]    Like the T-shaped handle  18 , the round handle  218  includes a center post  168 , which is integrally molded to the walls  160  and  162  about the geometric center  170  of the handle  218 . The center post  168  extends downward from the top wall  160  along the geometric center  170  between the side wall  162 . The center post has an exposed end surface  172 , which terminates below the lower edge  176  of the side wall  162 . In an exemplary embodiment, the center post  168  has an outside diameter of about 22.8 mm, which is about the same outside diameter as the center post  58  of the T-shaped handle  18 .  
         [0131]    The round handle  218  likewise includes the first and second sockets  80  and  86  to enable attachment of the various instruments, in the same manner as previously described. The sockets  80  and  86  include arrays of grooves  82  circumferentially spaced by splines  84 . The form, orientation, and size of the grooves  82  and splines  84  can be same as already described and shown in FIG. 13 to match the form and orientation of the teeth and flutes  30 / 32  and  42 / 44  at the proximal ends of the obturator instrument  12  and the drill bit instrument  14  (in the first socket  80 ) and the cannula instrument  12  (in the second socket  86 ). The tapered flanges  28  and fitting  40  thereby mesh in a running slip-fit in the appropriate first and second sockets  80  and  86 .  
         [0132]    As explained with respect to the T-shaped handle  18 , the comparable running slip-fit that the round handle  218  provides, allows both longitudinal and twisting forces to be applied to the attached instrument  12 ,  14 , and  16  through the handle  218 . The different sizes of the first and second sockets  80  and  86  on the round handle  218  likewise represent the same sort of unique attachment sites for the different functional instruments, as previously explained for the T-shaped handle  18 .  
         [0133]    Like the T-shaped handle  18 , first and second passages  92  and  96  extend through the top wall  160  of the round handle  218  and into the first and second sockets  80  and  86 , respectively. The first passage  92  is sized to pass a conventional surgical guide wire through the handle  218  and into the lumen of the obturator instrument  12  or drill bit instrument  165  fitted in the first socket  80 . The second passage  96  is sized to pass either the obturator instrument  12  or the drill bit instrument  16  through the handle  218  and through the lumen  36  of the cannula instrument  14  fitted in the second socket  86 .  
         [0134]    B. Anvil Handle  
         [0135]    FIGS.  35  to  38  show another alternative embodiment of a handle  318 , which embodies features of the invention. In this embodiment, the handle  318  is characterized by an elliptical “anvil” shape.  
         [0136]    The elliptical handle  318  has a top wall  176  and a side wall  178  made from a molded rigid plastic or metal material. The handle  318  is dimensioned to be grasped between the forefinger and the thumb, with the top wall  176  facing upward, as FIG. 35 shows. The shape and orientation, when held by the physician, are intended to facilitate the application of greater tapping or striking forces, to advance an attached instrument  12 / 14 / 16  through denser or harder tissue, such as skeleton bone.  
         [0137]    In an exemplary embodiment, the top wall  176  has a length dimension along it major axis  180  of about 57.2 mm and a length dimension along its minor axis  182  of about 50.8 mm. In the exemplary embodiment, the side wall  178  extends below the top wall  176  for a distance of about 11.3 mm.  
         [0138]    The side wall  178  is chamfered inward, to present concave front and rear gripping surfaces  184  and  186 , which are spaced apart along the major axis  180 . In the illustrated embodiment, the radius of chamfer for the front surface  184  is intended to match the joint radius of the forefinger. The radius of the chamfer for the rear surface  186  is intended to match the joint radius of the thumb. Preferably, both the forward and rearward surfaces  184  and  186  are knurled or roughed to enhance the physician&#39;s grip.  
         [0139]    As FIG. 35 shows, the inward chamfer of the side wall  178  shelters the physicians&#39;s hand from the top wall  176 , on which the striking forces are applied. The top wall  176  is also preferably bowed upward, to present a raised striking surface, which further distances the physician&#39;s hand from the point of impact of the striking instrument.  
         [0140]    A portion of the rear gripping surface  186  is cut away to form two interior sockets  188  and  190 . The sockets  188  and  190  are axially oriented. The second socket  190  possesses an interior dimension, which is larger than the interior dimension of the first socket  188 .  
         [0141]    The form and size of the first interior dimension of the first socket  188  is intended to receive the proximal end  22  of either the obturator instrument  12  or the drill bit instrument  16 , but not the cannula instrument  14 , in a releasable interference snap-fit. In this arrangement, the proximal end of the instrument  12  and  16  can include a tapered flange  28 , as already described, but need not. The releasable snap-fit stabilizes the instrument  12  or  16  in the first socket  188  for the application of a striking force on the top wall  176 .  
         [0142]    In like fashion, the form and size of the second interior dimension of the second socket  190  is intended to receive the proximal end  22  of the cannula instrument  14 , but not the obturator instrument  12  or the drill bit instrument  16 , in a releasable interference snap-fit. In this arrangement, the proximal end  22  of the cannula instrument  14  can include a tapered fitting  40 , as already described, but need not. The releasable snap-fit stabilizes the cannula instrument  14  in the second socket  190  for the application of a striking force on the top wall  176 .  
         [0143]    Since the first and second sockets  188  and  190  extend through the handle  318 , the handle  318  will accommodate the passage of a guide pin component  106  and the like through any instrument attached to the handle  318 . For the same reason, the handle  318  will also accommodate the passage of smaller diameter instrument within a larger diameter instrument held by the handle  318 .  
         [0144]    The form and orientation of the sockets  188  and  190  in the elliptical handle  318  also permit the physician, using only tactile sensing, to insert the selected instrument into the desired socket  188  or  190  and remove the attached instrument from the socket  188  or  190 , without need of visual intervention.  
         [0145]    It should be appreciated that the sockets  80  and  86  shown in the T-shaped handle  18  in a side-by-side arrangement (see FIGS.  5  to  8 ), can, in an alternative embodiment, be stacked one above the other in the manner shown for the anvil handle  318  in FIG. 36. In this arrangement, the smaller first socket  80  is stacked concentrically above the larger second socket  86 . The passage  92  extends along the center axis of the sockets  80  and  86 , opening into the first socket  80  and thereby serving both sockets  80  and  86 . This alternative construction allows central placement of all the instruments carried by the handle.  
         [0146]    All preceding embodiments show the handle as possessing female attachment components (i.e., the sockets) to receive male handle attachment sites (i.e., the fittings) on the instruments. Of course, this arrangement can be reversed and still provide all the benefits of the invention. That is, as shown in FIG. 39, a handle  400  can carry male handle attachment sites  402  and  404  that mate in the desired running slip fit fashion with female attachment components  406 ,  408 , and  410  carried by the instruments  412 ,  414 , and  416 , respectively. In FIG. 39, attachment site  402  uniquely mates with the attachment components  406  and  410 , while attachment site  404  uniquely mates with attachment component  408 . Alternatively, the handle  400  can carry one male attachment site and one female attachment component, and one instrument can likewise carry a male attachment site, while another instrument can carry a female attachment component. It should be fully appreciated that many attachment site/component combinations on the instruments and handle are possible. Regardless of the particular combination selected, the use of the handle  400  in association with the instruments  412 ,  414 , and  416  is identical to that previously described in the context of other embodiments.  
         [0147]    The foregoing description demonstrates the applicability of a handle made according to the invention for use in association with a wide assortment of different instruments or tools, and for use both inside and outside the medical field. The handle provides error-free coupling to different instruments or tools, and, further, uniquely allows coupling to one instrument or tool which has nested within it another instrument or tool. The shape and size of the handle can also vary significantly, limited only by the practicalities surrounding hand-held use and manipulation.  
         [0148]    The features of the invention are set forth in the following claims.