Abstract:
The present invention relates to a carrnulated microfracture kit, apparatus, and method for using the same during a medical treatment. The present kit enables precise and repeated positioning, the regulation and repetition of microfracture force application, and a control of a mosaic bone penetration and other surgical control improvement features. The present invention overcomes the detriments resultant from prior techniques in an apparatus that is readily adaptable to a variety of adaptive orthopedic surgical procedures. Assembled and selectable kits are provided.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims priority to U.S. Provisional Application Ser. No. 60/828,654 filed Oct. 8, 2006, the entire contents of which are herein incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to a cannulated microfracture apparatus and methods for implementing the same. More specifically, the present invention relates to a cannulated delivery apparatus functionally employing a microfracture device and a method for operating the same to augment revascularization. 
         [0004]    2. Description of the Related Art 
         [0005]    Within the broad field of orthopeadic (orthopedic) surgery, various physical techniques and methods have been developed to aid revascularization of arthritic or otherwise damaged or necrotic bone; principally in localities proximate knee, hip, and ankle joints, although there is no limitation to these revascularization regions. 
         [0006]    Previously employed methods included (a) high speed burrs (debridement), (b) sole-use smooth pin members, (c) sole-use microfracture picks, (d) subchondrial drilling, and other methods commonly supported with additional anthroscopic lavage and other processes to rid a joint of resultant loose debris. Each methodology has characteristics now recognized by those of skill in the art as negatives to beneficial patient outcome thereby providing a need for the present invention. 
         [0007]    The employment of debridement burrs, smooth pins, and drilling has fallen out of favor due to the consequential heat necrosis or cell death brought on by in situ heat buildup. 
         [0008]    Due to this difficulty and others, the current favored technique for microfracture employs the use of hand-held and hand-guided picks formed of a solid member with a pointed end. During use, a surgeon places the pick tip through an anthroscopic portal and applies (or attempts to provide) suitably-directed percussive pressure to the end point by simply hitting the back of the pick with a mallet, hammer, or their hand. Unfortunately, due to simple human error the resultant force drives the generally conical tip into the target bone at an angle other than axial to the point itself often damaging the bone and the preferably-reached subchrondral bone, forming one or a plurality of non-uniform holes. Such holes are generally arrayed in an undesirably interfering and irregular or overlapping mosaic fashion based upon the inaccuracy of physical-directed positioning (leading to improper angle, penetration depth, and force use errors). 
         [0009]    In contrast to say drilling, microfracture has substantial advantages beyond the avoidance of heat build up. In addition to the lack of heat necrosis, the pick-tip creates an increased surface area for clot formation while allowing a general structural integrality to remain in the subchrondrial bone. For a broader review of revascularization techniques reference is made to “New Techniques for Cartilage Repair and Replacement by Stone, et al, http://www.stoneclinic.com (visited Jun. 7, 2008), the entire contents of which are herein incorporated by reference. 
         [0010]    It is also to be understood that the existence of conventional laproscopic cannulas are known in the art from U.S. Pat. No. 4,112,932 the entire contents of which are herein incorporated fully by reference. 
         [0011]    Unfortunately, a number of detriments have not been appreciated by the prior art, namely resulting from employing the current microfracture pick techniques. These detriments include:
       (a) The further a user drives the pick into the bone uncontrollably resulting in a wider-than-optimal part of the resultant hole.   (b) Substantially all of the pick angles at the end of each pick-tool shaft do not drive well or cleanly (meaning linearly to a pick-tip-axis with the application of force along a pick-tip axis).   (c) The surgeon is often unable to apply sufficient, regular, or uniform force to drive the pick consistently deeply enough to effect a desired medical outcome—resulting in unsuccessful re-vascularation locations.   (d) A surgeon is unable to reliably and repeatedly reposition the pick relative to the desired bone target following successive uses, thereby resulting in scattered, inaccurate and potentially damaging hole placement and a general difficulty in creating a uniform mosaic pattern for revascularization.       
 
         [0016]    Accordingly, there is a need for an improved cannulated apparatus and method relating to microfracture and revascularization methodologies. 
       SUMMARY OF THE INVENTION 
       [0017]    An aspect of the present invention is to provide an apparatus and method to overcome at least one of the detriments noted above. 
         [0018]    Another aspect of the present invention is to provide a cannulated microfracture kit that allows a regulated application of microfracture force and comprehensive control of microfracture location. 
         [0019]    Another aspect of the present invention is to provide a microfracture kit providing a surgical user with customizable microfracture options readily adapted to a particular skeletal or joint geography and structure. 
         [0020]    Another aspect of the present invention enables a user to finely regulate and controllably vary a microfracture penetration depth, e.g. depth control or penetration control system or means allowing adjustment and control of depth penetration. 
         [0021]    Another aspect of the present invention is to provide a universal microfracture system that readily adapts to personal-use differences in surgical striking techniques. 
         [0022]    Another aspect of the present invention is to provide a positioning and repositioning system and means that readily adapts to alternative angles without varying a depth of penetration. 
         [0023]    Another aspect of the present invention is to provide a non-driving positioning system, allowing a positive positioning point proximate to microfracture location, wherein controlled microfracture into the microfracture location by a trocar does not drive the positioning system, allowing use of more precise and diversely adaptable positioning systems that do not co-operate as a microfracture driving point, e.g. non-driving positioning system. 
         [0024]    Another aspect of the present invention is to provide a non-driving positioning cannulated system slidably separable from a microfracture trocar member, wherein a microfracture driving force driven along the axis of the microfracture trocar does not impact the positioning cannulated system positioning point. 
         [0025]    Another aspect of the present invention is to provide a cannulated microfracture kit that is readily arranged as a pre-packaged system for convenient surgical use, and may optionally allow broken-down kits allowing ready selection by a user of a number of diverse assembly options during a use. 
         [0026]    The present invention relates to a cannulated microfracture kit, apparatus, and method for using the same during a medical treatment. The present kit enables precise and repeated positioning, the regulation and repetition of microfracture force application, and a control of a mosaic bone penetration array. The present invention overcomes the detriments resultant from prior techniques in an apparatus that is readily adaptable to a variety of surgical procedures to speed patient recovery. 
         [0027]    According to an embodiment of the present invention there is provided a cannulated device having an optional rigid or flexible curved cannulated transfer assembly that enables steady positioning proximate a target surface. 
         [0028]    Another aspect of the present invention is to provide an embodiment wherein a pick end is optionally pointed, employs a helical geometry enabling a threaded bone engagement or simple additional bone penetration, or employs a series of force-regulation rings enabling repeated force use. 
         [0029]    According to another aspect of the present invention, there is provided a microfracture hand tool having a striking surface distal a pick end member. 
         [0030]    According to another aspect of the present invention, there is provided a kit including a depth-of-penetration-stop mechanism enabling a user-surgeon to regulate pick-penetration within a force range, thereby improving a regulation of penetration during use. 
         [0031]    The above, and other aspects, features and advantages of the present invention will become apparent from the following description read in conduction with the accompanying drawings, in which like reference numerals designate the same elements. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0032]      FIG. 1A  is a perspective view of an external articulated joint locating a cannulated microfracture apparatus according to one aspect of the present invention noting a rotational depth control system and off-set co-axial axis set point. 
           [0033]      FIG. 1B  is an exploded view of one aspect of a cannulated microfacture apparatus according to the present invention. 
           [0034]      FIG. 1C  is an exploded partial assembled view of a driving handle of a striker assembly. 
           [0035]      FIG. 1D  is a first positioning view of a cannula pick end penetrating the patient&#39;s skin pocket prior to a striking motion. 
           [0036]      FIG. 1E  is an operative perspective view noting the ease of positioning the axis set depth and angle control relative to a pre-placement positioning. 
           [0037]      FIG. 1F  is an operative perspective view of a pick and cannula having a cone end as in  FIG. 1B . 
           [0038]      FIG. 1G  illustrates adaptive application of angles employing the present positioning system and apparatus (these are noted in exemplary displays in  FIGS. 1I-1L ). 
           [0039]      FIG. 1H  is a perspective view of an exemplary cannula member relative to a first set point position demonstrating the accuracy of multiple angularized repositioning employing the present set point system. 
           [0040]      FIGS. 1I-1L  depict representative mosaics of regularized microfracture penetrations in bone pivoted about a cannula pick tip end, and noting the ability to controllably position microfracture locations in a plurality of non-overlapping, and intentionally overlapping patterns depending upon a required therapeutic determination by a medical professional. 
           [0041]      FIG. 1M  is a first optional striker end of a trocar as viewed in region I in  FIG. 1A  according to the present invention. 
           [0042]      FIG. 1N  is a second optional striker end of a trocar viewed in region II in  FIG. 1B  according to the present invention. 
           [0043]      FIG. 1O  is a third optional striker end of a trocar according to the present invention. 
           [0044]      FIG. 1P  is a fourth optional striker end of a trocar according to the present invention. 
           [0045]      FIG. 1Q  is a fifth optional grinding/cutting/cleaning end of a trocar according to the present invention. 
           [0046]      FIG. 2A  is an exploded view of one aspect of an alternative cannulated microfracture apparatus according to another aspect of the present invention. 
           [0047]      FIG. 2B  is a partial close up view along orientation of section  1 I- 1 I and view III in  FIG. 1G  prior to microfracture and employing the construction of portion V in  FIG. 2A . 
           [0048]      FIG. 2C  is a partial close up view along section  1 I- 1 I in  FIG. 1G  (as shown in  FIG. 2B ) upon initial microfracture. 
           [0049]      FIG. 2D  is a close-up view of the alternative threaded trocar tip end in  FIG. 2C . 
           [0050]      FIG. 2E  is a re-positioned close up view of a microfracture system according to  FIG. 2B , having an angularized displacement along angle A based on a first co-axial set point position, and noting an alternative angle tip construction. 
           [0051]      FIG. 2F  is a re-positioned close up view of a microfracture system placement as in  FIG. 2E , noting an alternative angle with the same set point position. 
           [0052]      FIG. 2G  is a first type of axis set or tip end of a cannula member represented in position in IV in  FIG. 1B . 
           [0053]      FIG. 2H  is a second type of axis set or tip end of a cannula member. 
           [0054]      FIG. 2I  is a third type of axis set or tip end of a cannula member. 
           [0055]      FIG. 2J  is a fourth type of axis set or tip end of a cannula member having a depth-penetration stopping construction. 
           [0056]      FIG. 2K  is a fifth type of axis set or tip end of a cannula member having a multi-step or multi-force depth-penetration stopping construction. 
           [0057]      FIG. 2L  is a sixth type of axis set or tip end of a cannula member having a replaceable and extending replaceable tip-end member. 
           [0058]      FIG. 2M  is a seventh perspective exploded view of a cannulated microfracture apparatus according to another aspect of the present invention having two set pick points on a replaceable and pivotable pick end member. 
           [0059]      FIG. 2N  is an eighth perspective exploded axis set having a dual-point or multi-point replaceable end for threadable-assembly prior to entering a skin opening. 
           [0060]      FIG. 3A  is a ninth perspective view of an axis set or tip end having a smooth annular tip portion and a variable adjustment member, enabling variable positioning by a surgical user by bending and adaptively-positioning the pick-point prior to or after a skin-penetration for enhances surgical freedom. 
           [0061]      FIG. 4A  is a perspective exploded view of a cannulated microfracture apparatus according to another aspect of the present invention. 
           [0062]      FIG. 4B  is a close up view of portion VI in  FIG. 4A  noting an adaptive threaded end of a cannulated trocar device for bone-threading penetration and enhanced security, resistance to unintended displacement, and enhanced bone micro-fracture surface area. 
           [0063]      FIG. 4C  is a partial sectional penetrative view of the apparatus of  FIG. 2A  penetrating bone. 
           [0064]      FIG. 4D  is a partial penetrative view of the apparatus of  FIG. 2A  penetrating bone following the action of  FIG. 2C . 
           [0065]      FIG. 5A  is a cannulated microfracture kit for rapid use assembly view noting selectably-contained kit elements of varying types and lengths. 
           [0066]      FIG. 5B  is a close up view of a first threaded trocar end in view IX in  FIG. 5A . 
           [0067]      FIG. 5C  is a close up view of a threaded trocar end in view X in  FIG. 5A  having a larger diameter than  FIG. 5B . 
           [0068]      FIG. 5D  is a larger close up view of a threaded trocar end in view XI in  FIG. 5A  having a larger diameter than  FIG. 5C . 
           [0069]      FIG. 5E  is a side view of a first threaded pilot hole produced in a bone member, using for example the threaded trocar in view IX in  FIG. 5B . 
           [0070]      FIG. 5F  is a side view of the formation of a larger threaded hole employing a first-produced threaded hole in  FIG. 5E  as a guide and larger diameter trocar from view XI in  FIG. 5A . 
           [0071]      FIG. 6A  is another cannulated microfracture kit assembly view noting alternative contained elements. 
           [0072]      FIG. 6B  is a trocar tip end in view XII of  FIG. 6A  for inserting a biological aid such as a growth media, a growth media containing membrane, or cement on a designated bone site. 
           [0073]      FIG. 6C  is a cross sectional view of  FIG. 6B  along line  6 C- 6 C. 
           [0074]      FIG. 6D  is an alternative multi-micro pin trocar tip end aspect of the present invention having multiple pick points. 
           [0075]      FIG. 6E  is an alternative trocar shall construction as seen in view XIII in  FIG. 6A . 
           [0076]      FIG. 6F  is an alternative spiral trocar shaft construction as seen in view XIV in  FIG. 6A  having a common outer diameter 
           [0077]      FIG. 6G  is an alternative spiral trocar shaft construction a seen in view XV in  FIG. 6A  having an external thread spiral to aid debris removal. 
           [0078]      FIG. 7A  is a cannulated microfracture kit assembly view noting an alternative aspect of the present invention supporting a multi-strike function without repositioning employing multi-strike trocars. 
           [0079]      FIG. 7B  is a cross sectional view along line  7 C- 7 C in  FIG. 7A . 
           [0080]      FIG. 7C  is a cross sectional view along line  7 D- 7 D in  FIG. 7A . 
           [0081]      FIG. 7D  is a close up view of an operative end of a single trocar and multi-opening cannula in  FIG. 7A  during use with a fluid flow noting impact. 
           [0082]      FIG. 7E  is a close up view of an operative end of a dual trocar use from the inventive aspect of  FIG. 7A  showing the second trocar penetration use during continued fluid flow. 
           [0083]      FIG. 8A  an exploded cannulated microfracture kit assembly view noting alternative guide construction features according to another aspect of the present invention where the guiding slide is external. 
           [0084]      FIG. 8B  is an assembled view of the kit assembly of  FIG. 8A . 
           [0085]      FIG. 8C  is a cross sectional view along line  8 C- 8 C in  FIG. 8B . 
           [0086]      FIG. 8D  is a close up view of the assembly in  FIG. 8A  positioned for a first microfracture use. 
           [0087]      FIG. 8E  is another exploded view of a cannulated microfracture kit assembly similar to that in  FIG. 8A , having multi-trocar adaptation and an alternative guide assembly with rounded penetration snout. 
           [0088]      FIG. 8F  is an assembled view of the kit assembling of  FIG. 8F . 
           [0089]      FIG. 8G  is a cross sectional view along line  8 G- 8 G in  FIG. 8F . 
           [0090]      FIG. 8H  is a close up view of the assembly in  FIG. 8E  positioned for a first multi-microfracture use. 
           [0091]      FIG. 9A  is an optional microfracture kit assembly containing selectable length items and variable striking and support heads. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0092]    Reference will now be made in detail to several embodiments of the invention that are illustrated in the accompanying drawings. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps. The drawings are in simplified form and are not to precise scale. For purposes of convenience and clarity only, directional terms, such as top, bottom, up, down, over, above, and below may be used with respect to the drawings. These and similar directional terms should not be construed to limit the scope of the invention in any manner. The words “connect,” “couple,” and similar terms with their inflectional morphemes do not necessarily denote direct and immediate connections, but also include connections through mediate elements or devices. 
         [0093]    Referring now to  FIGS. 1A-1C , a first and second cannulated microfracture system  1000 ,  1001  each include respectively a trocar  300 ,  301  having respective contact tip ends  600 ,  601  on proximal ends thereof (shown here as preferably co-axially located but this is not required), a threadably adjustable striker system  500  having a threadably-adjustable striker member  501  on a distal end thereof and a handle member or grip/striking assembly  800 . 
         [0094]    Strikers  500  include a striker or striking end thereof  501 , a receiving hole  502  ( FIG. 1C ) for an optional pin member  803  having a securing detent ball  804 , as shown for accepting a striker grip assembly  800  having optional T-handle ends  801  and Tri-handle ends  802  to aid hand control and twisting or shifting during use. 
         [0095]    A cannula  200 ,  203  includes an axis set or pick end  400  on a proximal end and a sheath end  700  on a distal end thereof. Pick end member  400  includes, in this embodiment, and a single pick point  401 . Sheath end  700  includes optional ports  201 ,  201  adaptive to threadably accept a Luer Lock Tip device (an example is produced by Terumo Medical Corp, Elkton, Md.  21921 ) (not shown), or optionally a fluid flow member  1  and vacuum member  2 , or any other common surgical supply/suction or aid system used conventionally during orthopedic surgery. A representative physical joint is shown to aid contextural understanding, here employing a knee joint of a leg  9  having hinged bones  10 ,  13  and imaged with a conventional imaging or scope unit  3  penetrating a flesh or skin layer  11 . 
         [0096]    Focusing now on alternative microfracture system  1001  and trocar  301  in  FIG. 1B  (but also shown in  FIG. 1A ) a threaded region  4  optionally surrounds an outer region proximate striker or striking end  500 . It is to be understood, that striker  500  is threadably mounted on threaded region  4  of trocar  301  (and  300 ), and is adjustable lengthwise along the trocar&#39;s axial length by rotation in either direction G, a surgically desirable distance M, so as to adjust a penetration distance resultant from an applied force F, upon contact with sheath end  700 , as will be discussed. 
         [0097]    During use a contact end of striker  500  impacts an impact region of each respective sheath end  700  which, being pre-positioned by a user on the bone, stops the forward motion of the  300  trocar and hence penetration of the bone at a desired depth. As a consequence, it will be recognized that the present system provides one form of adjustable and selectable depth adjustment means for controlling and pre-determining a microfracture depth for patient safety by simply user-adjusting the length of the trocars  300 ,  301  received within striker  500  via threadable adjustment. As a consequence, those of skill in the art will recognize that an effective length of a trocar, measured between striking end  501  and tip ends  600 ,  601  may be readily adjusted by manual manipulation. 
         [0098]    During an operative use, it is envisioned that a surgeon will position systems  1000 ,  1001  in contact with a bone requiring microfracture treatment and will initially strike either striker end  501  of striker  500  or, upon assembly with kit  800 , the rear end of handle assembly  800  depending upon personal choice. In either assembly condition, force F is transmitted axially along a length of trocars  300 ,  301  to tips  600 ,  601  for contacting bone. 
         [0099]    As a benefit of the present depth control or depth adjustment system being connected with the respective trocars, it will be recognized that the depth adjustment system will additionally operate when striker  500  is assembled with handle assembly  800  thereby providing a user maximum freedom of choice in a fast-paced surgical environment. As an optional technique, following initial operation of axial Force F, a user may grip handle assembly  800  for simple removal, rotation (clock-wise or counter clockwise), prying, repositioning, or otherwise manipulate systems  1000 ,  1001  in a substantially inelastic manner to achieve a beneficial surgical result. 
         [0100]    Referring now to  FIGS. 1D through 1F , a possible series of method steps for the present systems is provided. As noted in  FIG. 1D , a cannula  202  is provided with a sheath end  700  (not shown) on a proximate end and an adaptive pick point or axis set  409  as discussed above. 
         [0101]    In  FIG. 1E , a cut in a skin layer  11  allows a surgical approach to bone surface  10 . As shown, pick point  409  on canula  202  first enters the cut and is urged through skin layer  11  creating a small skin pocket  11 A above the surface of bone  10 . As is shown, smooth bullet end  250  is adaptively used to on end  400  so as to ease entry through elastomeric skin  11  to allow cannula  200  to position tip end  409  on bone  10 . As should be recognized from the images, skin is elastomeric and provides a sealing contact with the external surface of cannula  202 . 
         [0102]    Referring now specifically to  FIGS. 1E and 1F , it is readily apparent that cannula  202  may be easily positioned, and repositioned reliably relative to the bone-pick point connection within open region  11 A, so as to prohibit cannula  202  from slipping relative to bone  10  prior to a microfracture use. A particular advantage, but not a requirement, of this construction, is that a user may rapidly reposition cannula  202  (as will be discussed) for causing microfractures without having to guess at a location, because a pick-point location is a controlled reference position. The bone-pick point connection with  409  remains as a secure and intentionally-movable reference point that allows a surgeon to rapidly create the microfractures required for revascularization. 
         [0103]    Referring now to  FIGS. 1G and 1H , it is envisioned that either microfracture system  1000 ,  1001  may be positioned on a respective axis CL set or prick point apparatus  400  on an outer surface of a bone member  10 , and rotated or pivoted as desired about a plurality of angles (as shown) in order to enable positioning highly-accurate microfractures to promote bone health and biological revascularization in a manner noted in the orthopedic literature by those of skill in the art. 
         [0104]    As will be similarly appreciated in  FIG. 1H , angularized motion along a common plane may also be achieved relative to the pick-point position on bone  10 , while either conducting microfracture treatment or when flushing with a fluid  1 ,  1 A, as shown. 
         [0105]    Referring now to  FIGS. 1I through 1L , a surface of bone  10  is noted centered on an initial pick point location  15 , or on a plurality of initial pick point locations  15 , as shown. Employing the process noted in  FIGS. 1G ,  1 H, as well as lift-and-reposition methods, it should be readily apparent to those of skill in the surgical arts, that regularly spaced microfracture locations  16  may be uniformly spaced at a common depth by employing the present system, and may similarly be placed at related positions by simply manipulating, rotating, and tipping, cannula  200  relative to an initial insertion direction about point  15 . In this way it must be appreciated that a plurality of depth-controlled and position-controlled microfractures may be created on a bone surface, allowing ready avoidance of diseased or damaged bone. For example, as show in  FIG. 1I , a simple ring may be created, or as in  FIG. 1J , a single or series of arcs may be created, or optionally combinations thereof without departing from the scope and spirit of the present invention. 
         [0106]    Referring now to  FIGS. 1M-1Q , a plurality of alternative trocar tip ends and constructions are provided. As noted earlier, a smooth trocar  300  may include, for example a single trocar smooth end  600 , and may obviously include differing trocar diameters (for example 1.2 mm, 2.0 mm, 2.5 mm, 3.0 mm and upwardly to, any user desired diameter) without departing from the teachings herein. It is envisioned that for a common fixed trocar similar to  300  a minimum diameter will be approximately 18 gauge for structural strength reasons to withstand impact, but as will be discussed later adaptive constructions provide opportunities for smaller or micro-tips having even smaller diameters without departing from the scope and spirit of the present invention. 
         [0107]    Alternatively, trocar  301  is shown with a tip end  601  having outwardly projecting rings or threads, optionally leaving a smooth cone tip (as shown) or having a threaded cone tip (See  FIG. 2D  and tip end  605 ). In  FIG. 10 , a trocar  302  may include a tip end  601 ′ having an alternative slant angle or slant tip feature  602  having optional angles at for examples, 5, 10, 15, or 20 degrees from the axis or more depending upon a surgeons or manufacturer&#39;s desire. 
         [0108]    In  FIG. 1Q , a trocar  303  is shown having a hollow tip end  603  ringed with optional saw teeth for bone cutting or optional abrading teeth members for mechanical debraiding at low speed using, for example T-handle system  800  earlier discussed. 
         [0109]    In  FIG. 1P , a trocar  304  includes (optionally) a dual end having an outward threaded profile  304 A with an inner core region  304 B with an annular cutting ring member (as shown) and a forwardly projecting narrow pin member or needle trocar portion  305 . 
         [0110]    Referring now to  FIG. 2A , a third cannulated microfracture system  1001 ′ includes a trocar  300 ′ having respective contact tip ends  601 ′ on a proximal end thereof (shown here as preferably co-axially located but this is not required), threadably adjustable striker system  500  has a threadably-adjustable striker member  501  on a distal end thereof and a handle member or grip/striking assembly  800 , similar to the discussion in  FIGS. 1A ,  1 B. 
         [0111]    A cannula  200 ′ includes an axis set or pick end  400 ′ on a proximal end and a sheath end  700  on a distal end thereof. Pick end member  400 ′ includes, in this embodiment, and a single pick point  400 ″. Sheath end  700  includes optional ports  201 ,  201  adaptive to threadably accept a Luer Lock Tip device (an example is produced by Terumo Medical Corp, Elkton, Md.  21921 ) (not shown), or optionally a fluid flow member  1  and vacuum member  2 , or any other common surgical supply/suction or aid system used conventionally during orthopedic surgery. 
         [0112]    Referring to  FIG. 2B  a close-up view of the embodiment of  FIG. 2A  is positioned accordingly to the method noted in  FIGS. 1D-1F  with skin  11  snugly about an outer surface of cannula  300 ′ for sealing with pick end  400 ′ having a single pick  400 ″, securely positioning the proximal end of canula  200 ′. In this assembly, a user may readily vary the positioning and depth control of trocar  300 ′, in the manner noted above by varying the threaded position or set position of striker  500  along threaded region  4 . As will be appreciated, where solely strilcing is desired, it is possible to remove pin  803  from handle set  800  to expose the striking surface, which may be in any suitable form for preferred striking without departing from the scope and spirit of the present invention. 
         [0113]    Referring now to  FIGS. 2C through 2F , a trocar  300 ′ sliding within cannula  200 ′ is positioned relative to point  400 ″ and force applied thereby allowing point set  601  to penetrate the bone causing a first microfracture. Referring now to  FIG. 2D , it is alternatively noted, that a trocar tip end  605  having a threaded end may be both driven without twisting and threaded/screwed into bone  10 , depending upon user preference. 
         [0114]    In  FIGS. 2E-2F , it is illustrated that pick point  401 ′ on cannula  200 ′ allows a user to pivot system  1001 ′ an optional angle A, A′ relative to an initial pick point position CL on bone  10  so as to allow a user to control a direction of microfracture relative to an initial centerline CL. 
         [0115]    In  FIGS. 2G through 2M  generally, a wide variety of set point geometries are possible without departing from the scope of the present invention, each understandable by one of skill in the art based upon the disclosure herein and the supporting images. It will be noted, that while many pock points may be shown as removable and selectable, fixably securing these differing geometries is within the scope of the present invention. 
         [0116]    Referring now to  FIG. 32G , cannula  200 ′ is provided with a wide variety of tips, including axis set point geometry  400 ′ having a single long pick point  407  removably joinable with set geometry  400 ′ by means of threads  407 A. In  FIGS. 2H and 2I  it will be understood by those of skill in the art that long pick point  407  may additionally include depth stop mechanisms such as an annular ring  401 B or a series of outwardly bulging members  401 C each respectively serving as a stress concentrator and stress raiser when urged into a bone surface so as to minimize or prohibit unintended bone penetration beyond a desired depth. Similarly, the pick points in  FIG. 2G-2I  are threadably joined to set point geometry  400  as an optional feature of the invention although fixable connections may be preferred by manufacturers. 
         [0117]    Referring now to cannula  200 ′ which includes a set point geometry  400 ′ now joined with a bull nose pick point  402 , providing a high-contact angle with bone so as to minimize detrimental bone penetration without significant pressure. Due to the wide contact angle (greater than say 90 degrees) or any of the other adaptations herein, a user may gain the benefit of a pick point without the negatives of unintended bone penetration. 
         [0118]    Referring now to  FIG. 2K , an alternative stepped pick point  403  is secured to cannula  200 , either removably or fixably, depending upon manufacturer need. As noted above, stepped pick point  403  provides a series of wider diameters growing from an initial cone-shaped pint, so that for example, at a first force amount F, the first cone-shaped point penetrates the bone, but requires a doubling of the first force (F 2 ) to push past the next step, and so forth. As a consequence, a user may readily appreciate that some bone is brittle or damaged and may only require a light contact to positionably secure the end of cannula  200  to a bone location. 
         [0119]    Referring now to  FIG. 2L , a similarly adaptive end  404  is provided on cannula  200 ′ so as to allow tip end  404  to project away from the end of cannula  200 ′ for a distant securing location and thereby allow a greater range of positioning for revascularization. 
         [0120]    Referring similarly now to  FIG. 2M , similarly to the embodiment noted in  FIG. 2L , a tip end  405  of cannula  200 ′ includes both a lateral extension member and two projecting pick points, as shown (see  FIG. 2L  for dual points). As a consequence of the present design, a user may “rock” cannula  200 ′ between the two points of a two-pointed version of  405  to gain additional freedom of use. 
         [0121]    Referring now to  FIG. 2N , a cannula has a replacement end system  201  threadably joining an annular dual pick member  406  threadably fixed to end system  201  on cannula  200  so as to bring the benefit of both a system to allow replacement of cannula tip ends but also the benefit of “rocking” or shifting cannula  200  between either point so as to move it&#39;s position a repeatable and reliably predictable distance from a first location. 
         [0122]    As will be noted from studying  FIG. 3A , an alternative tip end construction is provided for cannula  200  with features that ease use in certain circumstances. As shown, a curved or smoothly rounded end  250  or bullet end  250  is provided for easing through flesh layer  11  upon initial insertion. Similarly a flexible pick point  409  shaped as a thin-finger projecting proximate rounded end  250 . 
         [0123]    As shown pick point member  409 ′ may be constructed at a variety of positions and of a variety of shapable materials (such as memory metal, or plastically deformable metal), within a kit for example, and replacably or fixably mounted on the end of cannula  200  in a threaded or other manner similar to that noted in  FIG. 2N . Here, a first angle for pick point member  409  provides a greater spacing  252 Y from a cannula axis  284 , but is correspondingly closer at length  252 X. Similarly, where pick point member  409  is positioned closer to centerline  284 , the tip end projects further at length  253 X but provides a correspondingly narrower extension at length  253 Y. As will be understood from those of skill in the art having viewed  FIG. 3A , a wide variety of cannula axis sets or pick points may be adaptively employed for patient benefit without departing from the scope and spirit of the present invention. 
         [0124]    As a further modification of the present discussion, it is proposed that pick point member  409  may be alternatively constructed from a memory-metal—namely a metallurgical allow that is responsive to a thermal inducement to change it&#39;s position relative to an initial shifted position. As a consequence, the present disclosure suggests the use of a memory metal for constructing point member  409  thereby allowing a user to merely bend point member  409  into closer alignment with axial center  284  at a “room temperature” of less than approximately 85° F. to allow easier insertion through an opening in the skin. It is further suggested that upon entry of the body at approximately 98° F., the temperature change will cause point member  409  to return to its original position allowing convenient insertion and use. 
         [0125]    Referring now to  FIGS. 4A through 4D , an alternative revascularization assembly, system, or kit  1002  is provided with cannula  200 ′ having an adaptive axis set or end  400 ′ with a prick or point  401 ′ as discussed above, although any of the alternatively disclosed axis set ends or pick points may be employed without departing from the scope and spirit of the present invention. An adaptive trocar  304 ′ includes a continuous threaded outer band  304 A′ and a formed cutting ring  304 B′ on a proximal end and a striker  510  on a distal end thereof as shown and discussed earlier. As noted, the depth adjustment system is similarly provided herein, as shown. Trocar  304 ′ is particularly formed with a hollow channel, in a manner similar to cannula  200 ′, so as to allow optional insertion of a further extending needle trocar  305  having a striking end  511  there through. While striking end  511 , has a threadably adjustable and positionable member  511 A and respective adjustment threads  4  the operation will be similarly recognized as similar to adjusting the earlier adjustable penetration trocar by those of skill in the art. 
         [0126]    As shown particularly in  FIGS. 4B and 4D , during use, a physician or surgeon may position first trocar  304 ′ through cannula  200 ′ and either drive or twist and screw end  304 A′ into bone  10  below flesh layer  11 . Thereafter, first trocar  304 ′ may be removed for repositioning to promote revascularization or alternatively left in place. However, in yet a further alternative, where the physician determines sufficient penetration has not yet been achieved, needle trocar  305  may be inserted into second cannula/trocar member  304 ′ and thereby further penetrate bone  10  (see  FIG. 4D ). Similarly in the alternative as determined by a qualified user, system  1002  may be operated with only cannula  200 ′ and needle trocar  305  (without trocar  304 ′) so as to allow substantial operating space between an outer perimeter of needle trocar  305  and the inner surface of cannula  200  so as to allow rapid flush/vacuum/debris removal cycles via ports  201 ,  201  or for other medical purposes as are readily apparent to those of skill in the art. 
         [0127]    As can be visualized herein, element  304 ′ serves both as a cannula and as a trocar depending upon a user&#39;s desire and patient desires. Similarly, the above-discussed depth or drive stop system is readily adapted employing threads  4  so as to allow adjustment of striker heads  510 ,  511  relative to their respective distal contact ends. In the present embodiment in  FIG. 4A , it should be understood by those of skill in the art that two depth or drive stop systems are provided on respective trocar  304 ′ and  305 . As will be further appreciated the shape of striker heads  501 ,  511  is not controlling, and alternative shaped striker head constructions may be employed without departing from the scope of the present invention. For example, a triangular or rectangular or rectilinear shaped striking head may be employed. 
         [0128]    Referring now to  FIG. 5A , where a system, kit or set  1003  of alternatively formed items is provided in a packaging member  20  having a readily removable cover top  21 . It is envisioned, that system  1003  may be readily pre-packaged in a sterile environment before being transported to a use arena, whereupon a user may simply peel-off layer  21 , which may be formed from an opaque, transparent, or translucent materials as desired by a user. Layer  21  may containing identifiable instructions or other images or words on an outer surface thereof. 
         [0129]    While any cannula noted herein may be readily so packaged,  FIG. 5A  illustrates the enclosure of cannula  200 , as well as three alternative style trocar members, respectively  306 ,  307 , and  308  having respective striking ends  503 ,  504 , and  506 , as will be discussed in detail. As will be apparent to one of skill in the art, kit or system  1003  may be pre-assembled for convenience and include any of the elements discussed herein. Similarly, it will be recognized that tray  20  for kit or system  1003  may be easily resized or re-organized according to a user&#39;s need without escaping the scope of the present invention disclosed herein. Thus for example, two cannulas may be provided with eight trocars and rotation head assembly  800  without departing from the spirit and scope of the present invention. 
         [0130]    Referring now to  FIGS. 5B ,  5 C, and  5 D differing tip ends  605 ,  606 , and  607  are provided on respective trocars  306 ,  607 , and  308  as noted. Tip ends  605 ,  607 , and  607  vary by outer diameters respectively Q, R, and Z. Similarly, it will be noted that tip end  605  is a threaded end, while tip end  606  is a narrow ring end, and tip end  607  is a wide ring tip end. 
         [0131]    Referring now to  FIGS. 5E and 5F , it is envisioned that trocar  306  having threaded tip end  605  is threaded into bone  10  provided a threaded cavity as a form of pilot hole for later use. Trocar  306  is thereafter reverse threaded out of the pilot hole allowing entry of trocar  307  having tip end  606 . As a result of the prior-created threaded pilot hole, trocar  307  ready follows the same path in bone  10  and similarly expands the opening to aid surgical healing. As a consequence, while any operative manner may be employed from the related embodiments, the present embodiment provides a possible pre-assembled kit structure for use in a critical surgical environment. 
         [0132]    Referring now to  FIG. 6A , an alternatively adapted kit or system  1004  is provided having a tray  20 A with a peel-away cover  21 A operating similarly in the manner noted above. As was earlier the case, cannula  200  having a tip end is provided as a representative example but those of skill in the art will readily recognize that alternatively constructed cannula and selectable tip ends as discussed herein may be substituted without departing from the scope and spirit of the present invention. 
         [0133]    As further alternatives to the above-noted trocar constructions, a plurality of differently constructed trocars  309 ,  610 ,  311 , and  312  are providing having respective striker ends  506 ,  507 ,  508 , and  509  opposing respective contact ends  608 ,  610 ,  611  and  612 , as will be discussed. 
         [0134]    Referring now to  FIGS. 6B and 6C , trocar end  608  is provided with an outer shaft, in this case having transverse external channels  309 A formed about an outer periphery to allow transport of fluid  1  and removal of the same and debris during use. 
         [0135]    A concave region or cup  608 A surrounds a spiked tip end or pin  608 B that provides a supportive contact member for transporting a biological material  608 C, such as growth medium to a desired location. As a consequence, it is envisioned that the present embodiment operates as a transport system for enabling accurate positioning of growth medium within a previously prepared microfracture location. An alternative construction of this system, an adapted micro-pin end  609  contains a plurality of extending tiny-sized pin members thereby allowing a user to pack bone growth medium or another treatment medium or a treatment transport medium such as a dissolvable sponge about tiny pins on micro pin ends  609 . As will be readily understood by those of skill in the art, when employing the trocar end embodiments in  FIGS. 6B and 6D , a microfracture is preferably made by an earlier-applied trocar, which is then removed from cannula  200  and replaced with trocar  309  carrying bone growth or vascular growth medium. 
         [0136]    Referring now to  FIGS. 6E ,  6 F, and  6 G, adaptive trocar tip ends are discussed for aid during microfracture operations. As noted in  FIG. 6E , tip end  611 , and in this case the shaft of trocar  310 , contains a helical channel  611 A about an outer periphery to aid in transport. An alternative construction noted in  FIG. 6F  provides for a multi-flute design for tip  610 , providing opposing flutes  610 A,  610 A for similar reasons to those noted above. Finally, as noted in  FIG. 6G , an outer spiral member  612 A on tip  612 , provides two transport channels  612 B,  612 C. In each of the examples noted above a mechanism and design to aid in fluid flow and removal of debris mechanism is provided so that those of skill in the art may recognize that the present system is readily adapted to changing surgical requirements. It is envisioned, that a surgical user may now select with precision a trocar tip end for a particular surgical need without departing from the scope of the present discussion. 
         [0137]    Referring now to  FIGS. 7A through 7E , a kit, system, or assembly  1005 , contains as desired, a cannula  205  having a pick set of pick point  409  for example. At least one micro-diameter trocar  313  is provided with a striker end  512  and a micro tip end  613 . Cannula  205  contains an internal division chamber  207  containing a plurality of passages  207 A, inter connected by internal connections  207 A′ (for inter-passage fluid flow) for slidably receiving and guiding one or more micro-diameter trocars  313  as required. It is similarly envisioned, that via ports  201 , fluid flow  1  and suction  2  may readily fill, for example two of three passages  207 A so as to flush debris from bone  10 . As is depicted, after cannula  205  is positioned with pick point  409  in a desired location, a user may employ sufficient trocars  313  to microfracture the bone surface in a desired manner. Where more than one micro-diameter trocar  313  is employed, threadably adjustable striker ends  512  may be shaped as, for example, a triangle/pie-shape, to thereby allow the use of all three micro-diameter trocars  313 . As will be obvious to those of skill in the art, the present construction allows the generation of precise, and secure micro-fractures without the need to insert multiple cannulas in a local. 
         [0138]    Referring now to  FIGS. 8A through 8D , an alternative system, kit, or assembly  1006  is provided and employs a re-designed open-channel cannula member  209  having an off-set guiding handle  27  on a first end, and pick point  409  on the distal end thereof for positioning. A smoothly sloped end  409 B operates to guide insertion through a skin opening. A trocar  314  is provided having a striker end  513  adjustable via a strike adjustment feature  4 , discussed earlier. A bottom key  26  member projects from one side of trocar  314  and is slidably guided in a corresponding key channel  25  in cannula  209 . In this manner, cannula  209  remains operative as a slidable guide for striking bone  10  with a tip end  600  to generate bone debris  611 . 
         [0139]    It operating system, kit, or assembly  1006  those of skill in the art will recognize the detail that striker end  513  is threadably adjustable via threads  4  along a length direction of trocar  314 , while striker end  513  is of a sufficiently large diameter to contact an end of key channel  25  proximate handle  27  so as to thereby prevent further penetration, the sum construction being recognizable as depth control or penetration limitation system. 
         [0140]    Referring now to  FIGS. 8E through 8H , another alternative system, kit, or assembly  1010  is provided and employs a re-designed open channel cannula  209 A having pick point  409  at a proximate end and handle  27  at a distal end. A combination trocar/cannula  240  is provided having a guiding key  26  for slidably engaging a guiding channel  25 , as shown. 
         [0141]    An end of trocar/cannula  240  distant a striking member  241  is a smoothly sloped entry zone  242 , provided to ease passage through skin layer  11 , and if necessary, serve as a bone-contact microfracture end. In a manner noted above, an inner portion of trocar/cannula  240  contains passages  243  for containing one or more micro-trocars  350 . As was noted early, threaded range  4  allows for pivotable adjustment of strike end  241  relative to an overall length, so that upon contacting an end of channel  25 , the end of handle member  241  functions as a depth stop control means. Of course, micro-trocars  350  may be similarly inserted via contact end  241  so as to create controllable micro-fractures in bone  10 . 
         [0142]    In view of treatment systems  1006  and  1010 , the present invention envisions the use of cannulas  209 ,  209 A in combination with other surgical tools, as long as each adaptive surgical tool may be slidably adapted for use along the channel so as to enter skin layer  11  smoothly and controllably without guessing. This adaptation may be of critical importance where additional surgical requirements urge the inclusion of imaging tools, sampling tools, and other testing tools all benefiting from the security provided by set or pick points  409  and the guidance provided by the above-described channel-slide construction. 
         [0143]    Referring now to  FIG. 9A , an assembly kit system  1011  is provided with a carrying tray  630 , a supportive foam inner member  620  and a peel-back cover  640  that is hermetically sealed to enclose kit  1011  between manufacture and use. 
         [0144]    As noted, inner member  620  contains a plurality of pocket recesses  620 A shaped to securely receive and stabilize respective items of the kit. 
         [0145]    Within the recesses in inner member  620  are contained a break-down or substitutable series of components related to those described above, as will be discussed. As shown are a cannula sleeve member  200  having a threaded connection end  284  for threadably engaging a sheath end  700  having corresponding female receiving threads  286  at an end thereof and respective ports  201 . In combination, cannula member  200  and sheath end  700  form the cannula element noted above; however the present kit also provides replacement cannula ends  283 ,  282 , and  281  each having different respective lengths. For example, the present kit may contain cannulas having a lengths of 6, 8, 10, and 12 inches, although alternative lengths are readily envisioned without departing from the scope and spirit of the present invention. Each replacement cannula  280 ,  281 ,  282 , and  283  may be readily selected according to a user&#39;s preference or surgical need, and each may contain a threadably removable set point constructed in a manner noted above. Similarly, a plurality of trocars  363 ,  362 ,  361 , and  360  having corresponding lengths of 6, 8, 19, and 12 inches are provided, each with a respective threaded ends  290  that threadably engage striker head assemblies  801  to provide length adjustment. 
         [0146]    As will be apparent to those of skill in the art having reviewed the disclosure herein, the length adjustment means allows adjustment of a penetration depth between a maximum and minimum of an adjustment range. For example, a user needing a penetration depth of ½ inch may select a 6-inch length cannula assembly and a 6-length trocar assembly, and loosen the striking end ½ inch so as to allow a user to drive the same to the desired depth. 
         [0147]    In view of the alternative constructs discussed above, it is proposed that those of skill in the art of surgical instrument design will readily recognize the ready adaptation to need the present system provides. 
         [0148]    Alternatives to the present include, but are not limited to the alternatives noted below. For trocars ( 300  series elements) a wide variety was noted, including those of fixed lengths, and selectable lengths having diameters of, for example 1.2 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm etc and down as small as approximately an 18 gauge needle. A wide series of trocar tips was also provided, and these include various smooth ends, threaded ends, helical ends, micro-prong ends, fixed angles, flat ended trocars (for packing bone growth medium); and concave tip ends for transporting and placing bone growth medium. 
         [0149]    A wide variety of sheaths for the cannulas was also noted, and included variants to accept a lure-lock device, vacuum application, and fluid flows as well as other items such as imaging systems. Cannulas similarly are provided with a wide range of constructions, from tubular, to multi-exit constructions, to adaptive dove-tail type slot and groove constructions that will allow ready tool insertion into a skin opening. Similarly axis set points were proved in wide variations from those with short and long prick ends, curved prick ends, angularized “hockey-stick” type ends, depth stop ends, memory metal pick ends, dual tip ends, replacement tip ends, and wide angle ends among others. 
         [0150]    Similarly, it will be recognized that the present invention teaches adaptation to reach surgical solutions. For example, cannulas  209 ,  209 A do not include a sheath member  700  as noted in the opening discussion so that the present system teaches the need for ready adaptation for surgical success without requiring strict adherence to the depicted embodiments. 
         [0151]    Also provided were a variety of assistive tools such as handle attachments to a striking end for hand-twisting and removal, ready kit packaging for transport and secure storage, and provision of a wider made-to-request system requirement so that a user may construct the systems herein at a desired length from a grouping of differently shaped parts (See for example  FIG. 9A ). 
         [0152]    Additionally, it should be understood herein, that the use of the phrase trocar shall be interpreted broadly to cover generally sharp ended surgical instruments employed for applying force to a human-body element, without inferring outside limitations requiring the penetration of skin or use with flexible cannulas. Similarly, it will be understood herein, that the use of the phrase cannula or canula (both are correct spellings historically used), sheath or guide rail or guide shall be interpreted very broadly to mean a surgical device that guides, supports, aims, or is otherwise used with a trocar as described herein, without any outside limitation. Thus for example, cannula  200  ( FIG. 1A ) shall be understood to represent the same instrument as guiding cannula  209  ( FIG. 8A ) despite their differing appearance and construction. 
         [0153]    In the claims, means- or step-plus-function clauses are intended to cover the structures described or suggested herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, for example, although a nail, a screw, and a bolt may not be structural equivalents in that a nail relies on friction between a wooden part and a cylindrical surface, a screw&#39;s helical surface positively engages the wooden part, and a bolt&#39;s head and nut compress opposite sides of a wooden part, in the environment of fastening wooden parts, a nail, a screw, and a bolt may be readily understood by those skilled in the art as equivalent structures. 
         [0154]    Having described at least one of the preferred embodiments of the present invention with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various changes, modifications, and adaptations may be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims.