Abstract:
A surgical illumination device and method of using includes a mounting platform attachable to a surgical device and light conducting fibers attached to the platform.

Description:
[0001]     This Application claims the benefit of Provisional Patent Application 60/655,153 filed Feb. 22, 2005 and is herein incorporated by reference in its entirety. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The invention relates to a surgical illumination device for lighting an exposed area during medical or surgical treatment. The device is separately attachable to a variety of surgical or medical devices.  
       BACKGROUND  
       [0003]     Medical treatment often requires a surgeon to create an incision in a patient to access the anatomical site requiring treatment. Any incision results in some amount of trauma to the patient, including pain, potential infection, healing time and dysfunction. A smaller incision generally reduces trauma and is thus a goal of all surgical treatment. In order to most effectively access the interior of a patient, retractor systems have been developed which allow a physician sufficient anatomical access while minimizing patient trauma through a smaller incision. A system developed and sold by Omni-Tract Surgical, Inc., a division of Minnesota Scientific, Inc., St. Paul, Minn. achieves this goal by providing a surgical retractor system which is mounted to an operating table and inserted into a minimal incision and then able to be firmly locked into any configuration required by the physician throughout the duration of the procedure (see U.S. Pat. Nos. 5,400,772, 5,727,899, 5,899,627 and 6,042,541, all of which are hereby incorporated by reference). Thus, a minimal incision is created which still allows the physician ample room to be able to perform the procedure. A problem that exists with operating through a minimal incision, however, is providing sufficient illumination to enable the physician to see what he/she is doing. In traditional surgical technique, a larger incision allowed the use of distantly mounted, relatively powerful lights to illuminate the exposed interior of the patient&#39;s body. The recent advent of minimal sized incisions, however, creates the need for another way to illuminate the treatment site.  
         [0004]     Illuminated surgical retractors are known in the art. Lumitex®, Inc., Strongsville, Ohio has developed an illuminated panel made of sandwiched, woven optical fibers that can be attached to the flat blade of a traditional surgical retractor by adhesive wings. The panel is connected to a high intensity light source via an optical fiber and provides light to the interior of an exposed surgical treatment site. Because a woven optical fiber panel lighting system requires hand labor to manufacture, such a lighting system is expensive to manufacture. The Lumitex® retractor, as well as other lighted retractors, are also specific to certain retractor designs and not readily usable on varying sizes and retractor types. Further, these retractors take up a great deal of space in the wound, thus requiring larger incisions and making the surgeon&#39;s job more difficult. Finally, these light types are not readily moved from retractor to retractor after initial placement. What is clearly needed, therefore, is a surgical illumination device that is inexpensive and easily adaptable to a wide variety of surgical and medical instruments.  
       SUMMARY  
       [0005]     In one aspect, the invention comprises a device for securing light conducting fibers to a surgical retractor blade. The device includes a mounting platform attachable to a surgical device and means for attaching least one light conducting fiber to the mounting platform.  
         [0006]     In another aspect, the platform is a clip defining a first end and a second end, the first and second ends almost meeting each other to form a gap which when moved apart exert a force toward each other.  
         [0007]     In yet another aspect, the platform is a pad defining a first major surface and a second major surface.  
         [0008]     In an alternative aspect, the invention comprises a surgical illumination device, including amounting platform attachable to a surgical device and at least one light conducting fiber attached to the platform.  
         [0009]     In a further aspect, the platform is a clip defining a first end and a second end, the first and second ends almost meeting each other to form a gap which when moved apart exert an amount of force toward each other.  
         [0010]     In another aspect, the platform is a pad defining a first major surface and a second major surface.  
         [0011]     In still another aspect, the invention comprises an illumination device having a mounting platform attachable to a surgical device. At least one light conducting fiber is attached to the mounting platform and a light source is in light communication with the at least one light conducting fiber to conduct light energy through the at least one light conducting fiber.  
         [0012]     In an additional aspect, the invention comprises a method of using a surgical illumination device, comprising the steps of: (a) providing a mounting platform attachable to a surgical device, the platform having at least one light conducting fiber attached to it; (b) attaching the mounting platform to a surgical device; (c) connecting the at least one light conducting fiber to a light source; (d) locating the surgical device, attached mounting platform and at least one light conducting fiber at a patient&#39;s medical treatment site; and (e) energizing the light source, thereby illuminating the medical treatment site. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]      FIG. 1  shows a plan view of an embodiment of the invention having light conducting fibers attached to a clip which attaches to a surgical retractor blade.  
         [0014]      FIG. 2  shows a cross-section of the light conducting fiber bundle taken between the points  2 - 2  as shown in  FIG. 1 .  
         [0015]      FIG. 3  shows a perspective view of a clip in a stressed configuration with light conducting fibers attached, which is attached to a retractor blade.  
         [0016]      FIG. 3A  shows an end view of the clip shown in  FIG. 3  in the unstressed configuration, without light conducting fibers attached.  
         [0017]      FIG. 3B  shows an end view of the clip shown in  FIG. 3  in the unstressed configuration, with light conducting fibers attached.  
         [0018]      FIG. 4  shows a perspective view of an alternative embodiment of the invention having light conducting fibers attached to a pad having an adhesive surface for attachment to a surgical retractor blade.  
         [0019]      FIG. 4A  shows an end view of an embodiment of a pad having the light conducting fibers directly attached to a first major surface of the pad by means of an adhesive.  
         [0020]      FIG. 4B  shows an end view of the pad shown in  FIG. 4  having an adhesive attachment layer with light conducting fibers attached to the retaining channels.  
         [0021]      FIG. 5A  shows an end view of an embodiment of a clip in the unstressed configuration, without any light conducting fibers attached.  
         [0022]      FIG. 5B  shows the clip shown in  FIG. 5A  in the unstressed configuration with light conducting fibers attached to the first major surface of the clip by means of an adhesive.  
         [0023]      FIG. 6  shows a clip having light conducting fibers attached, which is attached to the blade of a surgical retractor during a surgical procedure. 
     
    
     DETAILED DESCRIPTION  
       [0000]     Definitions  
         [0024]     “Pull Force” refers to an amount of force required to remove a first object from a second object to which the first object is attached.  
       NOMENCLATURE  
       [0000]    
       
           200  Surgical Illumination Device  
           202  Light Source  
           203  Connector  
           204  Light Conducting Fiber Bundle  
           205  Light Conducting Fiber  
           206  Retractor Blade  
           207  Sheath  
           208  Clip  
           209  First End of Clip  
           210  Retaining Channel  
           211  Second End of Clip  
           213  Gap  
           215  First Major Surface  
           300  Surgical Illumination Device  
           302  Light Source  
           304  First Major Surface  
           305  Adhesive  
           306  Second Major Surface  
           308  Pad  
           310  Pressure Sensitive Adhesive  
           400  Surgical Illumination Device  
           407  Adhesive  
           408  Clip  
           409  First End of Clip  
           411  Second End of Clip  
           413  Gap  
           415  First Major Surface  
           600  Surgical Illumination Device  
           602  First Major Surface  
           604  Second Major Surface  
           606  Retaining Channel  
           608  Pad  
           610  Pressure Sensitive Adhesive  
           1000  Leg 
 
 Construction 
 
       
     
         [0059]      FIG. 1  shows a plan view of an embodiment of the surgical illumination device  200  of the present invention. In this embodiment, the invention comprises a clip  208 , best shown in  FIGS. 3, 3A ,  3 B which is formed to fold upon itself so that a first end  209  and second end  211  almost meet to form a gap  213 . In another embodiment (not shown), the first end (not shown) and second end (not shown) do meet when the clip (not shown) is not attached to a surgical instrument. Whether or not the first and second ends of the clip  208  meet is not critical to the functioning of the invention. Before the clip  208  is slid over an edge of a surgical retractor blade  206  as shown in  FIGS. 3 and 6 , or other medical or surgical instrument (not shown), the clip  208  is formed so the gap  213  defines a distance which is less than the width of the retractor blade  206 . In the embodiment (not shown) where the first end (not shown) and second end (not shown) actually contact each other, the width of the retractor blade  206  is less important as the gap  213 , by definition, defines a lesser distance than the width of the retractor blade  206 . In both embodiments, upon installing the clip  208  onto a surgical instrument, the first  209  and second ends  211  of the clip  208  are forced apart, which exerts an amount of force sufficient to securely attach the clip  208  to the retractor blade  206  during a surgical procedure. Most retractor blades  206  have a thickness between 0.048 inches and 0.105 inches. The average pull force required to securely attach the clip  208  to a 0.05 gage retractor blade  206  is approximately 1.67 pounds but may vary according to specific requirements between approximately 1.54 and 1.86 pounds. The average pull force required to securely attach the clip  208  to a 0.105 gage retractor blade  206  is approximately 4.64 pounds but may vary according to specific requirements between approximately 4.40 and 4.60 pounds. The clip  208  and attached light conducting fibers  205  are thus adjustably movable according to the desires of the physician. It is also contemplated by and therefore within the scope of the invention to add a coating (not shown) or textured inner surface (not shown) or altered inner surface geometry (not shown) to the contacting surfaces of the clip (not shown), which increases the holding ability of the clip without increasing the exerted force.  
         [0060]     The clip  208  is preferably made of a medically and biologically compatible plastic such as Lustran® ABS plastic, made by Lanxess Engineering Plastics and can be machined, extruded or injection molded. Alternative materials could also be used such as stainless steel or nitinol, however, plastic materials are preferred due to low cost and high performance.  
         [0061]     In the embodiment shown in  FIGS. 1, 3 ,  3 A,  3 B, and  6 , the clip  208  defines a first major surface  215  into which at least one retaining channel  210  at least partly extends across the first major surface  215 . The retaining channel  210  is preferably a partial circle cut or molded into the first major surface  215  having the majority of the circle below the first major surface  215 , thus allowing the light conducting fiber  205  to be popped in and out of the retaining channel as required.  
         [0062]     The clip  208  has attached to it at least one and preferably a plurality of light conducting fibers  205  which are attached to and in light communication with a light source  202 . Light conducting fibers  205 , commonly known as “fiber optics” are made of polymethyl methacrylate. The light source is a well known xenon type such as manufactured by Wolf, CUDA, Karl Stortz, Wehmerlite and Olympus. Light intensity can be adjusted at the light source  202  as required by the physician.  
         [0063]      FIG. 3  shows a perspective view of an embodiment of the surgical illumination device  200  of the present invention. In this embodiment a retractor blade  206  is provided which can be attached to a table mounted retractor system (not shown) or may alternatively be hand held by a technician (not shown). As shown in cross section in  FIG. 3   a , the clip  208  is configured to be quickly attachable to the retractor blade  206  by means of a friction or compression fit. It should be mentioned that it is contemplated to configure the device  200  to be attachable to any medical device, thus the invention is not limited to use with surgical retractors.  
         [0064]     Attached to the clip  208  is at least one light conducting fiber  205  which is in light communication with a light source  202 . The light conducting fiber has core of polymethyl methacrylate and is clad with a fluorinated polymer; light conducting fibers  205  are well known in the art and are sold by Moritex, Inc., Tokyo, Japan. As shown in  FIGS. 1 and 2 , a light conducting fiber bundle  204  may be used instead of a single light conducting fiber  205  and comprises a plurality of light conducting fibers  205  encased in a sheath  207 . The sheath  207  is made of a material such as 85 Shore PVC, such as Lynn Part Number LVD-165 made by Lynn Plastics Corp., in a diameter of approximately 0.135 inches when encasing three light conducting fibers  205 . Different numbers or diameters of light conducting fibers  205  will, of course, require a different sized sheath  207 . A standard snap fit connector  203  terminates the light conducting fiber bundle  204  or single light conducting fiber  205  and is configured to plug into the light source  202 . An advantage of using a clip  208  mounted system is that it can quickly and easily be moved on the medical device as individual procedures may require.  
         [0065]      FIGS. 4 and 4 B show a perspective view of yet another embodiment of the surgical illumination device  600  of the present invention. As shown in cross section in  FIG. 4B , a pad  608  is configured to be quickly attachable to the surgical device by means of a pressure sensitive adhesive  610  affixed to a second major surface  604 . Attached to the pad  608  is at least one and preferably a plurality of light conducting fibers  205  which are in light communication with a light source (not shown for this embodiment, but similar to the light source  202  as discussed herein).  
         [0066]     The pad  608  is provided with at least one retaining channel  606  which extends at least partly across a first major surface  602 . The at least one retaining channel  606  is preferably a partial circle cut or molded into the pad  608 , having the majority of the circle below the first major surface  602 . The retaining channel  606  opens through the first major surface  602 , thus allowing the light conducting fiber  205  to be popped in and out of the retaining channel  606  as required. While a flat pad  608  is shown in  FIGS. 4 and 4 B, additional embodiments including curved (not shown), compound (not shown), complex (not shown) or having a surface specifically configured to conform to a particular surgical instrument (not shown) are also contemplated by and therefore within the scope of the invention. The pad  608  can be made of a wide variety of plastic, metallic or composite materials as required and machined, extruded or injection molded.  
         [0067]      FIG. 4A  shows an alternative embodiment of the surgical illumination device  300 . A pad  308  is configured to be quickly attachable to a surgical device (not shown) by means of pressure sensitive adhesive  310  attached to the second major surface  306 . Attached to the first major surface  304  of the pad  308  is at least one light conducting fiber  205  which is in light communication with a light source (not shown). The light conducting fiber  205  is attached to the pad  308  by means of an adhesive  305  such as Bayer Lustran ABS. Additional methods of attachment such as magnetic (not shown) are also contemplated by and therefore within the scope of the invention.  
         [0068]     While a flat pad  608  is shown in  FIG. 4A , additional embodiments including curved (not shown), compound (not shown), complex (not shown) or having a surface specifically configured to conform to a particular surgical instrument (not shown) are contemplated by and therefore within the scope of the invention.  
         [0069]      FIGS. 5A and 5B  show yet another embodiment of the surgical illumination device  400 . In this embodiment, a clip  408  is provided which is similar to the clip  208  shown in  FIGS. 1, 3 ,  3 A,  3 B and  6 . In this embodiment, the invention comprises a clip  408  which is formed to fold upon itself so that a first end  409  and second end  411  almost meet to form a gap  413 . In another embodiment (not shown), the first end (not shown) and second end (not shown) do meet when the clip (not shown) is not attached to a surgical instrument. Whether or not the first  409  and second ends  411  of the clip  408  meet is not critical to the functioning of the invention. Before the clip  408  is slid over an edge of the blade (not shown) of a surgical retractor or other surgical or medical instrument, the clip  408  is formed so the gap  413  defines a distance which is less than the width of the retractor blade (not shown). In the embodiment (not shown) where the first end (not shown) and second end (not shown) actually contact each other, the width of the retractor blade is less important. In both embodiments, upon mounting the clip  408  onto a surgical instrument, the first  409  and second ends  411  of the clip  408  are forced apart so as to exert an amount of force sufficient to securely attach the clip  408  to the retractor blade (not shown) during a surgical procedure. Most retractor blades (not shown for this embodiment) have a thickness between 0.048 inches and 0.105 inches. The average pull force required to securely attach the clip  408  to a 0.05 gage retractor blade is approximately 1.67 pounds but may vary according to specific requirements between approximately 1.54 and 1.86 pounds. The average pull force required to securely attach the clip  408  to a 0.105 gage retractor blade is approximately 4.64 pounds but may vary according to specific requirements between approximately 4.40 and 4.60 pounds. The clip  408  and attached light conducting fibers  205  are thus adjustably movable according to the desires of the physician. It is also contemplated by and therefore within the scope of the invention to add a coating (not shown) or textured (not shown) or altered inner surface geometry (not shown) to the contacting surfaces of the clip (not shown), which would increase the holding ability of the clip without increasing the exerted force.  
         [0070]     The clip  408  is preferably made of a medically and biologically compatible plastic such as Bayer Lustran ABS, made by Lanxess Engineering Plastics Corp. and can be extruded or injection molded. Alternative materials could also be used such as stainless steel or nitinol.  
         [0071]     As shown in cross section in  FIGS. 5A and 5B , the clip  408  is configured to be quickly attachable to a retractor blade (not shown) by means of a friction or compression fit. It should be mentioned that it is contemplated to attach the device  400  to any medical device, thus the invention is not limited to being used with surgical retractors only. Attached to the clip  408  is at least one light conducting fiber  205  which is in light communication with a light source (not shown for this embodiment, but similar to light source  202  as discussed above). As shown in  FIG. 5B , at least one light conducting fiber  205  is attached to the pad  308  by means of a pressure sentisitve adhesive  305 . It should be mentioned that although not shown, magnetic means of attachment are also contemplated by and therefore within the scope of the invention.  
         [0072]     As shown in  FIG. 2 a  plurality of light conducting fibers within a bundle  204  can be encased in a sheath  207 . The sheath  207  is made of 85 Shore PVC in a diameter of approximately 0.135 inches when encasing three light conducting fibers  205 . Different numbers or diameters of light conducting fibers  205  will, of course, required a different sized sheath  207 . A standard snap fit connector  203  terminates the light conducting fiber bundle  204  and is configured to plug into the light source  202 . An advantage of using a clip  208  mounted system is that it can quickly and easily be moved on the medical device as individual procedures may require.  
         [0000]     Use  
         [0073]     Using the present invention first requires the physician and staff to prepare the patient for a medical procedure, typically surgery, followed by creating an incision proximal and convenient to the underlying area to be treated. Next, a clip  208 ,  408  having light conducting fibers  205  attached or pad  308 ,  608  having light conducting fibers  205  attached is attached to the retractor blade  206  or other surgical or medical instrument (not shown). Following this, the retractor blade  206  or other surgical or medical instrument (not shown) inserted into the incision to provide access for the physician to conduct the intended procedure. Next the retractor system is locked in place mechanically or held in place by technicians through the duration of the procedure. The light source  202  is turned on, which results in light energy flowing through the light conducting fibers  205  and exiting via the “open” end to provide illumination inside the incised area of the patient&#39;s body, shown as a leg  1000  for purposes of illustration but not intended to be limited to any particular anatomical region. Following completion of the procedure, the light source  202  is turned off, the retractor blade  206  or other surgical or medical instrument (not shown) is unlocked where necessary and removed or just removed and the incision closed using well known techniques.