Patent Publication Number: US-2023135038-A1

Title: Multi helical broaching punch for osteotomy creation

Description:
BACKGROUND 
     1. Field 
     The present application relates to an osteotomy punch and, more specifically, to a punch having multiple helixes. 
     2. Description of the Related Art 
     The creation of osteotomies is a common step for the insertion and function of many medical devices. Osteotomies may be used as pilot holes or as functional cavities to serve as an anchoring or fixation point, or even a void in which a medical device can reside and function. Traditional punches are osteodilators that create osteotomies by compressing and dilating the bone around the outside of the punch. Traditional punches are designed to reduce the force of insertion by having tapered distal ends and a featureless or smooth outer surface to reduce the friction during insertion because creating osteotomies via compression and dilation requires a large amount of force due to the biomechanical properties of bone that resist compression. 
     BRIEF SUMMARY 
     Traditional approaches to osteotomy punches cause a wide variety of problems. For example, large insertion forces can result in the cracking or fracturing of the bone during insertion, which causes unnecessary damage to the healthy tissue of the patient, increases healing time, and reduces the functional strength of a medical device inserted into the osteotomy. Higher insertion forces also increase the reaction force of the bone onto the punch, which can be seen and felt by the user, as the bone compresses back onto the punch making it very difficult to remove. As a result, users often have to strike the punch in the reverse direction, away from the patient, in order to remove the punch. Reaction forces can also cause the surrounding bone to expand back into the pilot hole when a traditional punch is removed, resulting in an osteotomy with a smaller diameter than the punch. This causes an issue with devices that require a specifically designed pilot hole and the dimensions of the osteotomy affect the functionality of the device. 
     As a result, the inventors recognize that there is a need for an osteotomy punch that relieves these problems by creating osteotomies by broaching instead of osteodilation. In various aspects, the structural designs herein reduce osteotomy insertion forces by slowly and progressively broaching more and more bone material away during insertion, thereby slowly growing the diameter of the osteotomy until it reaches the desired diameter. The various aspects of the structural designs also allow for removal by rotation and unscrewing from the bone which circumvents the reaction force of the bone and allows for easy removal by the user. The various structural aspects are thus more beneficial for the user (medical practitioner) and for the patient because they provide a more efficient means of creating an osteotomy that reduces the insertion force required to make the osteotomy, greatly reduce the chance of bone fracture due to insertion forces, and provide a much easier means of device removal. Embodiments described and illustrated herein work very at creating bone holes by taking small cuts of material to gradually bring the hole to the required size. 
     Furthermore, unlike a conventional drill bit—which cuts rotationally at its tip only while using flutes of the drill bit positioned proximally to the tip to assist with movement of chips created by the cutting away from the tip (per a particular tip configuration as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure)—embodiments of the broaching punches described and illustrated herein are configured to punch and cut through bone axially when in use per a force directed axially in the direction of the distal point of the punch tip. Embodiments of the broaching punch are configured to do so per the broaching features, described and illustrated herein. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
       The present disclosure will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which: 
         FIG.  1    is a side view of a broaching device including a close up view of a broaching tip having helical broaching features. 
         FIG.  2    is a side view of a broaching tip showing the characteristics of the helical edges of the tip. 
         FIG.  3    is a side view of a broaching tip having helical edges that extend in a continuous pitch. 
         FIG.  4    is a side view of a broaching tip having helical edges that extend in a variable pitch. 
         FIG.  5 A  is a side view of a broaching tip having helical edges that extend cylindrically and in a taper. 
         FIG.  5 B  is a side perspective view of the broaching tip of  FIG.  5 A . 
         FIG.  5 C  is an opposite side view of the broaching tip of  FIG.  5 A . 
         FIG.  6 A  is an end view of a broaching tip having two edges. 
         FIG.  6 B  is an end view of a broaching tip having three edges. 
         FIG.  6 C  is an end view of a broaching tip having four edges. 
         FIG.  7    is a side view of a broaching tip having a threaded portion. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to the drawings, wherein like numerals refer to like parts throughout, there is seen in  FIG.  1    a broaching punch  10  for creating osteotomies. Punch  10  includes a tip  12  having helical broaching features  14  extending along the outer surface  16  of a main body  18  of tip  12  from an intermediate and proximal portion thereof to a distal point  19  of punch  10 . As seen in  FIG.  2   , helical broaching features  14  are formed by a cutting edge  22  extending outwardly from and around body  18  and characterized by a predetermined angle  24 , height or depth  26 , spacing or pitch  28 , and arrangement  30  of various dimensional combinations, as described herein. 
     The pitch/spacing  28  of helical broaching features  14  can be constant over the length of body portion  18 , as seen in  FIGS.  2 - 3    (showing a 3 helix (lead) and a majority constant pitch of, e.g.,  0 . 240 ″, or the pitch/spacing  28  of helical broaching features  14  may be variable, as seen in  FIG.  4   . An example of an acceptable pitch can be one that allows the punch to be removed with minimal turns while still providing an effective cutting edge for easy insertion. As such, a variable pitch can be preferred in certain circumstances to provide a fast-cutting transition up a taper portion of the tip  12  while still having a fast removal rate by transitioning to a larger pitch as shown in  FIGS.  4 - 5    (as further discussed below with respect to ease of removal in view of particular pitch and number of helixes). The broaching punch tip  12  shown in  FIG.  4   , for example, has a sharp angled tip with relatively small pitch/spacing  28  (which is a portion of the tip  12  configured to punch and cut into bone until it reaches to the point where the angle as measured from the central longitudinal axis levels off and approaches zero degrees). The angling of the tip  12  then levels off (becomes substantially parallel to the central longitudinal axis at a position proximal to the more sharply angled distal portion) right at or before the pitch/spacing  28  of helical broaching features  14  get relatively longer. The leveling off of the angle and lengthening of the pitches allows for easier and faster removal. 
     Referring to  FIG.  5 A , the external geometry of the outer surface formed by broaching features  14  can have portions or surfaces that are parallel  30 , portions or surfaces that are tapered  32 , or combinations thereof. Turning to  FIG.  5 B , a side perspective view of the broaching punch tip  12  of  FIG.  5 A  is shown. Each broaching feature  14  includes a root at the respective proximal edge  14 - 1 , a cutting edge  22  at its respective distal edge  14 - 2 , and a broaching feature body  14  extending therebetween. The cutting edge  22  of each broaching feature  14  extends above (or further away from the central longitudinal axis as compared to) the root/proximal edge  14 - 1  of its and/or the broaching feature  14  immediately in front of it. Stated differently, in order for the cutting edge  22  to be most effective, it is preferable for the dimensions for angle  24 , depth  26  and spacing  28  be configured so that the diameter of cutting edge  22  is larger than the diameter of a proximal edge of the root  14 - 1  as shown. 
     As described and illustrated herein, a broaching feature&#39;s pitch  28 , height or depth  26 , and angle  24  (as highlighted in  FIG.  2   , for example) can be used to define each broaching feature  14  (which may be the same or different from surrounding broaching features  14 ). These three parameters characterize a triangle and as such, establish a domain of potential values where each parameter can meet a mathematical definition outlined in the following Eq. 1. 
     
       
         
           
             
               Tan 
               ( 
               
                 angle 
                 ⁢ 
                     
                 24 
               
               ) 
             
             = 
             
               
                 height 
                 ⁢ 
                     
                 26 
               
               
                 pitch 
                 ⁢ 
                     
                 28 
               
             
           
         
       
     
     An example range of these geometries used for the creation of bone (pilot) holes for the placement and securement of bone anchors, for example, can be 0.025″ to 1.3″ for broach pitch  28 , 0.007″ to 0.200″ for broach height 26, and 3° to 90° for broach angle  24 . 
     Additional angles associated with embodiments of the broaching punch  10  can include at least two or more angles associated with the tip  12 , as shown in  FIG.  5 C . Angle  1  is associated with the distal point  19 , Angle  2  is associated with the portion of the tip  12  where there is a change in the angle of the tip body after the distal point  19  (moving in the proximal direction along the tip from the distal point  19 ), and Angle  3  (if there is another angle of the tip  12 ) is associated with the portion of the tip  12  where there is a change in the angle of the tip body after the portion with Angle  2  (moving in the proximal direction along the tip from the portion of the tip body with Angle  2 ). The value of Angle  1  can depend on the bone quality and broaching performance required to create a particular pilot hole. For example, in a scenario where the bone is challenging (e.g., dense cortical bone), Angle  1  can have a value from 15° to 45°, Angle  2  can range from greater than 0° to 20° and Angle  3  can be non-existent or range from greater than 0° to 45°. In a scenario where the bone is softer (e.g., cancellous bone), Angle  1  can range from 40° to 180°, Angle  2  can range from −10° to 30°, and Angle  3  can be non-existent or range from greater than 0° to 45°. 
     Example lengths of tips  12  can be about 1.0 to 2.0″, and example diameters to the cutting edge  22  of a broaching feature  14  can range from about 0.01″ to 0.50″ 
     Referring to  FIG.  6 A through  6 C , helical broaching features  14  (which can terminate into a smooth cone with a sharp awl at the distal end) may comprise multiple helixes formed by multiple independent helical edges  22 , such as two edges  22  as seen in  FIG.  6 A , three edges  22  as seen in  FIG.  6 B , or four edges  22  as seen in  FIG.  6 C . Using a helical broach allows the broach to be easily removed by unscrewing the broach after axial forced creation of the hole. This is particularly helpful in relatively deep broached holes. To maintain small cuts but allow for faster and easier removal of the broach, additional helixes can be added (as shown  FIGS.  6 A-C ). 
     Examples of the effect of varying the pitch and number of helixes (which can be tuned based on a number of variables including use/purpose, type of substrate/bone, size of bone, location of bone, etc.) will now be briefly described. A broaching tip with a single helix having a 0.08″ pitch would take about 12.5 turns to extract from a 1″ deep broached hole. In comparison, a broaching tip with three helixes having a 0.24″ pitch would take about 4.1 turns to extract from a 1″ deep broached hole. A variable pitched broaching tip example can be used, for example, for harder bone. Such a tip can include a pitch that changes from a small (0.08″ pitch) to a larger 0.24″ pitch over the distance of desired hole depth. This would provide a relatively gradual change leading up to a desired diameter then a greater pitch to achieve faster removal (see, e.g.,  FIG.  4   ). 
     Referring to  FIG.  7   , another aspect of punch  10  include broaching features  14 , as described herein, in a first portion  40  of main body  18  and thread tapping features  50  in a second portion  52  of main body. In this aspect, helical broaching features  14  are used in combination with a tapping feature such that threading can be tapped into an osteotomy as it is created. Conventionally, a tapped osteotomy requires a traditional punch and then a separate tap to create the desired threads in the osteotomy. Using two devices slows down the procedure, as the number of instruments needed is doubled, and the additional time required is especially compounded in situations where several osteotomies are needed to complete a procedure. Additionally, when used arthroscopically, the user must go back down the cannula with the tap to find the pilot hole created by the traditional punch. Often, the surface of the bone is obstructed from view by soft tissue and finding the pilot hole under the scope is difficult. These short comings of conventional devices are avoided by having first portion  40  of main body  18  with broaching features  14  and thread tapping features  50  in a second portion  52  of main body  18  that can be used to form threads in the hole formed by broaching features  14 . 
     In use, broaching punch  10  is driven into predetermined location of the bone so that helical broaching features  14  form an osteotomy. If punch includes tapping features  50 , then tapping features  50  may be used to form a tapped osteotomy. The first portion  40  with the broaching features  14  can be punched into bone, and the second portion  52  with the tapping features  50  can be twisted into the bone hole formed by the first portion  40 . Users thus only need one device, thereby speeding up the procedure by removing the need to use two devices, relieving the hassle of finding a pilot hole with a tap, and ensuring that any threads also cut into the osteotomy are aligned with the pilot hole. Users will thus cause less damage to patients and greatly reduce the chances of accidental bone fracture. Users will also be able to create more accurate, higher quality osteotomies for medical device insertion and functionality while avoiding any difficulties in removing the device from the patient. 
     While several inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used (e.g., the parameters of the bone hole desired to be formed, and the type of bone in which the bone hole will be formed). Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein (per a review of this disclosure). It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; inventive embodiments may be practiced otherwise than as specifically described and claimed. 
     Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about” and “substantially” are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value. Here and throughout the specification and claims, range limitations may be combined and/or interchanged; such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise. 
     The recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. Further, ranges provide are examples only, and other values are contemplated herein and can depend on potential use of the embodiments described and illustrated herein (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). 
     No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosed embodiments. 
     It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed embodiments without departing from the spirit and scope of the same. There is no intention to limit the scope of the disclosure to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the disclosure.