Abstract:
A disposable, sterile guide constructed of medically-acceptable plastic used for compartmentalizing and therefore protecting the ligament or fascia during three different orthopedic surgical procedures: ECTR, ECuTR, and EPFR. This device reduces the risk of damage to any other part of the surrounding anatomy. The device is disposable and packaged so as to be sterile and therefore readily usable by the surgeon means that it can reduce the risk of infection and is a less expensive alternative to traditional non-disposable, metal instruments that must be sterilized prior to each procedure.

Description:
BACKGROUND 
       [0001]    Endoscopic Carpal Tunnel Release (ECTR), Endoscopic Cupital Tunnel Release (ECuTR), and Endoscopic Plantar Fasciitis Release (EPFR) are three surgical procedures used to relieve symptoms in the hand, elbow, and heel, respectively. During each procedure, the surgeon makes a small incision and inserts a thin tube called an endoscope with a tiny camera attached to it to view the affected area. The surgeon then inserts a cutting instrument through this same, single portal to perform the procedure. The benefit of endoscopic procedures is that they require smaller incisions, leading to the diminution of early post-operative pain, decreasing the amount of recovery time, and expediting patients&#39; return to regular activity. These smaller incisions, however, inherently mean that visualization of the affected area is more restricted as compared to procedures such as Open Carpal Tunnel Release (OCTR), during which one large incision is employed. Throughout the history of endoscopic procedures, surgeons have worked to improve methods of visualization in order to improve safety levels and outcomes. 
         [0002]    Current guides for surgery are usually stainless steel and come in two pieces, which means there are sterility issues between surgeries and also the ever-present risk of the pieces becoming unattached in surgical contexts. This is especially true because current scope pieces engage one another in a friction attachment. 
       SUMMARY OF THE EMBODIMENTS 
       [0003]    The device described herein is a disposable, sterile guide constructed of medically-acceptable plastic used for compartmentalizing and therefore protecting the ligament or fascia during three different orthopedic surgical procedures: ECTR, ECuTR, and EPFR. This device reduces the risk of damage to any other part of the surrounding anatomy. The fact that the device is disposable and packaged so as to be sterile and therefore readily usable by the surgeon means that it can reduce the risk of infection and is a less expensive alternative to traditional non-disposable, metal instruments that must be sterilized before each procedure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0004]      FIG. 1  shows a dilator used to prepare a surgical area for the device. 
           [0005]      FIGS. 2A and 2B  show side and elevation views of the device. 
           [0006]      FIGS. 3A-3D  show an alternate embodiment of the device. 
           [0007]      FIGS. 4A-4C  show a further alternate embodiment of the device. 
           [0008]      FIG. 5  shows another alternate embodiment of the device. 
           [0009]      FIGS. 6A and 6B  show blade and tool variants used with the device. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0010]    The following surgical description may be employed for using the surgical device shown the figures in at least three different surgeries: Endoscopic Carpal Tunnel Release (Hand), Endoscopic Cubital Tunnel Release (Elbow), and Endoscopic Plantar Fasciitis Release (Heel). 
         [0011]    After making an incision, the surgeon may use a dilator  10  ( FIG. 1 ) to dilate the surgical area. The dilator may be about 6 inches long and taper at a broader end  14  to a narrow end  12  from 6 mm to 4 mm. The dilator may include hand grips  16  marked to minimize slipping. 
         [0012]    To make room for the guide device to fit atop and below the targeted ligament or fascia, the surgeon may insert the device  100 ,  300 ,  400  in order to compartmentalize the ligament or fascia. The surgeon may then use the endoscope that has been inserted through a cameral passage or hole to visualize the ligament or fascia area to ensure that there are no other parts of the anatomy, such as nerves or tendons, obstructing the incision path. 
         [0013]    If the incision path is clear, the surgeon can either antegrade cut or retrograde cut the ligament or fascia in a safe environment by inserting the knife through the appropriate slot, because the device or guide has helped the surgeon to compartmentalize the ligament or fascia to be incised, isolating it from other parts of the anatomy that could otherwise be in jeopardy of being inadvertently cut. 
         [0014]    The endoscopic camera and the knife may work independently of each other inside the guide, making it safer for the surgeon to look ahead of the knife when needed. 
         [0015]      FIG. 1  is a drawing of the surgical device  100  for assistance in endoscopic surgical procedures, especially those discussed above but not necessarily limited thereto. 
         [0016]    The surgical device  100  may be 100 mm in length, 8 mm wide, and constructed from ABS plastic. The device  100  may be hollow and cylindrical with 3 mm-thick plastic prongs  110  separated by a 2 mm gap  130 .  FIG. 2  shows one end of the device  100 , which is closed with the exception of three holes: the upper and lower circular holes  140  may be each 2.5 mm in diameter, may be used for the endoscopic camera, and may be located on either side of the 5 mm long slot  150  used for the knife. The location of the upper and lower circular holes  140  on either side of the slot  150  gives the surgeon the ability to use the endoscopic camera to visualize the surgical field more comprehensively from many angles before a cut is made to avoid damaging other portions of the anatomy. 
         [0017]      FIGS. 6A and 6B  show tools like the knife ( 600 ) and wire  605  for use with the device  100 ,  300 , or  400 . In use, a surgeon may grasp the knife  600  or wire  605  by a handle  610  that may include finger cutouts for a thumb  612  and fingers  614 . The tool  600 ,  605  may comprise both a handle portion  610  and working portion  620 . On the knife  600 , the working portion  620  is sized to fit within the slot  150 ,  380  and includes a blade  630  for performing the incisions as the blade moves within the slot  150 ,  380 . 
         [0018]    The wire tool  605  operates similarly to the knife tool  600  except that its working end  620  includes a narrow wire end  635  for removing fine tissue or moving a nerve out of the way of a later incision by the knife tool  600 . The wire end  635  may extend in any direction (upwards towards the viewer as shown in  FIG. 6B  being on alternative) but importantly fits within the knife slot. 
         [0019]    The guide device  100  may include a wedge-shaped protrusion  160  at a terminal end of one (or both) of the prongs  110  that may help in clearing tissue from within the gap  130 . The wedge may be sharp, extend only from the narrow terminal end  115  of the prongs  110  or extend across the width of the prong  110 . 
         [0020]      FIGS. 3A-3E  show an alternate embodiment of the device from  FIG. 2 . As can be seen in  FIG. 3A , the device  300  includes prongs  310  separated by a gap  330  similar to the geometry of  FIGS. 1 and 2 . The device  300 &#39;s prongs  310  have a narrow terminal end  315  opposite a head portion  320  having finger cutouts  340  that in combination help in grasping the device  300 . This head portion  320  helps in device  300  insertion into the patient as well as removal, and also positioning the device  300  during surgery. 
         [0021]    The head portion end face  325  has a tool opening  350  therein. The tool opening  350  passes through the head portion  320  and is in fluid communication with the gap  330 . The tool opening may include a camera opening  360  and a blade slot  380  separated by an open space  370  that allows for a small tool insertion to remove unwanted tissue or other waste from the scope or camera opening. 
         [0022]    The camera opening is for scope insertion, and allows the surgeon to inspect the incision, ensure the area to be incised is clear of nerves, and generally allow the surgeon to see the work to be performed. As can be best seen in  FIG. 4B , the camera may travel within one of the prongs  310  within a camera groove  312  formed along and within each prong  310 . A second groove  314  may also include room for the tools  600 ,  605 . 
         [0023]    The guide device  400  in  FIGS. 4A-C  is similar to the one in  FIGS. 3A-3D  except for finger grooves  490 . These finger grooves  490  extend into the head portion  420  and serve two purposes: First, they act to help a surgeon grasp the guide  400  during insertion, when slipping tools can be a problem. Second the finger grooves  490  help with cooling the device  400  during manufacture, allowing for uniform cooling and thus, decrease defect formation. 
         [0024]      FIG. 5  shows a further alternate design of the device  500 . Within this device, a shelf  565  extends to divide the camera opening halves  560   a,  and  560   b.  This helps support the scope when inserted into the camera openings. 
         [0025]    The device guide described herein may be shipped in sterile packaging to ensure sterility in use, which overcomes the issues with certain steel guides that must be sterilized on each use. Because it is plastic, the device may be discarded after use and easily replaced, thus making it less expensive than a stainless steel tool but also safer. 
         [0026]    In use, the device may encompass the transverse ligament therefore avoiding the challenge of synovium and fat dropping into view when cutting the ligament. This improves visibility because the surgeon isn&#39;t cutting underneath the ligament but encapsulating the ligament and cutting either antegrade or retrograde and seeing the ligament with a top view as well as bottom view while cutting. 
         [0027]    Further, the top and bottom portions of the guide encompasses the ligament and that makes the guide safer for ECTR. 
         [0028]    As shown herein, the guide is as a unitary construction molded in plastic, although it is possible to 3D print the guide as well. Multi-piece construction is possible and may be advantageous in certain contexts. 
         [0029]    The device is also made to accommodate both left and right hand for same procedure by just turning it upside down to always cut on the ulnar safe side of the hand, which is the ulnar side of anatomy. 
         [0030]    While the invention has been described with reference to the embodiments above, a person of ordinary skill in the art would understand that various changes or modifications may be made thereto without departing from the scope of the claims.