Abstract:
Systems, devices and methods for illuminating sites (e.g., surgical sites) are provided. An illumination device (e.g., a surgical site light) includes a body (e.g., a plastic body) with a cross-sectional shape similar to an inward-facing asymmetrical C, and wherein the body is shaped to be placed proximal to a site (e.g., surgical site) and emit light onto the site from a plurality of directions while inhibiting the light from radiating away from the outside of the body.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Application No. 61/578,428, filed Dec. 21, 2011, the contents of which are incorporated by reference in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to devices and methods for illuminating surgical sites, implements and implants. 
     BACKGROUND 
     Providing good light to a surgical site can be problematic. Not only can overhead lights be unwieldy, they can be both a source of glare and of shadows simultaneously, making it difficult to see the surgical site and the video monitors. Head lamps also cast shadows, for example, of a surgeon&#39;s hands or instruments, and are intrinsically heavy (or require cumbersome connections to external light or power sources.) 
     Small lamps and other light-emitting structures are unnecessarily costly and complicated. They typically require bulbs, light-emitting diodes, or fiber-optical elements, as well as a source of power which potentially becomes an electric shock risk to the patient. Not only do they have multiple connections and bulky fixtures that complicate surgery, they can be problematic sources of heat. Also, a light fixture that incorporates elements such as light bulbs into a complex structure requires significant manufacturing costs. 
     Moreover, any light source—whether overhead or localized—can cause glares and reflections that are blinding or distracting. Light that glares off of monitors interferes with the ability of medical staff to monitor a patient&#39;s vital signs and light reflecting from steel or mirrored surfaces and instruments can interfere with a surgeon&#39;s focus. 
     SUMMARY 
     The invention relates to a surgical-site lighting device that connects to an existing light source and illuminates a surgical site from multiple directions without causing glares and reflections. The device is structured so that, when placed near a surgical site with portions of the device extending around opposite sides of the site, light from the source is reflected within the device and emitted onto the site. Moreover, the outer shell of the device provides a substantially opaque shield that prevents the light from causing glares and reflections in the surrounding environment. Since devices of the invention do not need to incorporate light bulbs, optical fibers, or electrical components, they can be manufactured inexpensively, for example, from molded plastic. Thus methods and devices are provided that can be used to provide good light to a surgical site, allowing a surgeon to perform surgery in good view without interference from shadows, structures, glares, heat, and other problems. 
     In certain embodiments, devices of the invention provide a shell with an open C-shaped cross-sectional profile with the open portion of the C facing inwards and downwards. The shell includes a substantially opaque material with an inner reflective surface. Light is received within the shell through an adaptor that couples to a fiber optic light line. The light is both passed through a small slit in the reflector and reflected within the device using a multi-faceted reflector, the inner reflective surface, or both and onto the surgical site while the over-hanging upper portion of the shell shades the surgeon&#39;s eyes and the surrounding environment. 
     In certain aspects, the invention provides a device for lighting a surgical site that includes a connection feature to connect to a light source and receive light into the device and a shell configured to at least partially surround a surgical incision and diffuse the light inwards and downwards. The connection feature may be a fiber optic cable adapter where light is received into the device. The site is illuminated substantially evenly from all sides while the shell shades items outside of and above the device from the light. The shell may have a cross-sectional shape describable as an inward-facing asymmetrical C-like shape. The shell may be shaped such that an upper surface of the shell overhangs a lower surface of the shell. A multi-faceted (e.g., at least two) reflector may be disposed within the device to reflect the light from the source through the device. In certain embodiments, the reflector has a shape like a truncated pyramid and presents four facets angled away from one another. A slit may be provided through the reflector to allow some light to pass directly to the surgical area. 
     The shell may have an overall shape that allows portions of it to be disposed on distal sides of a surgical site. For example, in various embodiments, looking down on the shell reveals it have a shape approximating a U, O, D, L, V, C, H, Y, or J or a square, diamond, oval, ellipse, rectangle, or other polygon. In certain embodiments, an overall shape of the shell is circular or substantially circular (e.g., oblong or irregular). The shape also allows a surgical instrument to be applied at various angles to the incision/surgical site. 
     In certain aspects, the invention provides a method for illuminating a site of a medical procedure. The method includes receiving light into a shell surrounding a site of a medical procedure and diffusing, by means of the shell, the light inwards and downwards towards the site substantially evenly from all sides while shading items outside of and above the device from the light. In some embodiments, diffusing the light comprises reflecting the light from a reflective surface disposed around a majority of an inside surface of the shell. Light can be received into the shell from any suitable source, such as a fiber optic cable, and reflected off of one or more internal reflectors. 
     In certain aspects, the invention provides a surgical site light having a plastic body with a cross-sectional shape similar to an inward-facing asymmetrical C, wherein the body is shaped to be placed proximal to a surgical site and emit light onto the site from a plurality of directions while inhibiting the light from radiating away from the outside of the plastic body. In some embodiments, the body is spaced away from the site in all directions when in use. 
     In some embodiments, the C-shaped plastic structure forms a circle on itself and is open in the middle. Devices of the invention can be made from plastic or other compatible matter. Materials can be used that are rigid, non-translucent, or both. The non-translucent nature of the device prevents light from reflecting in any direction that would interfere with visual acuity. 
     In certain embodiments, the upper surface a device is wider and overhangs the lower surface to prevent light from interfering with visual acuity and to focus the light in an inferior and center direction onto the procedure site. The inner surface may be covered with a reflective coating, and angled in a manner that further allows light to be focused in a central and inferior direction. Light enters the device via fiber optic cable, which can be connected to a variable output light source. In some embodiments, both the cable and the light source are separate from, and can be coupled to, and uncoupled from, the device. The fiber optic cable can be held in place by the cable adaptor. The adaptor may not only accommodate the cable but also be long enough to cover all metal parts of the cable thus eliminating any contact between any metal parts of the cable and patient. 
     In certain embodiments, once light enters the device it encounters the light reflector. The reflector is pyramidal in shape and covered with a reflective coating. This shape allows for reflectivity around the metalized inner surface of the device. The reflector can include a slit in the middle to allow some passage of light directly into the inner circle. The slit may be large enough to allow for light to pass through, and thereby eliminating shadows at the point of entry, but small enough to allow ample light to be reflected around the remainder of the device. 
     The device can be manufactured to different diameters to allow for different surgical applications. An adhesive strip can be applied to the device (e.g., during the manufacturing process) and the device incorporated into the surgical drape. The device can undergo gamma radiation sterilization as well as ethylene oxide sterilization and thus be used in sterile or non-sterile applications. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A-1E  show a device of the invention. 
         FIGS. 2A-2D  show a multi-faceted reflector according to certain embodiments. 
         FIG. 3  shows a device according to certain embodiments. 
         FIG. 4  shows a section of the device shown in  FIG. 3 . 
         FIG. 5  shows a section of the device shown in  FIG. 3 . 
         FIGS. 6A and 6B  show components of a device according to certain embodiments. 
         FIG. 7  illustrates use of the device according to certain embodiments. 
         FIG. 8A-8D  show a reflector according to certain embodiments. 
         FIG. 9A-9B  illustrate an of arrangement of components in a device of the invention. 
         FIG. 10A-10B  gives a detailed view of an arrangement of components. 
         FIG. 11  is a reproduction of a photo of a device that was made. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention provides methods and devices for illuminating a surgical site. Devices and methods of the invention can be used with any surgical instrument in any surgical procedure that requires illumination. Examples of surgical procedures that may employ devices and methods of the invention include without limit laparoscopic and endoscopic procedures, insertion of anchors and fixation devices, including rods, plates and cables, trochars, injection ports or any procedure benefiting from good illumination. 
       FIGS. 1A-1E  show a device of the invention.  FIG. 1A  gives a perspective view of device  101  showing shell  103  and connection feature  107 . Reflector  113 ′(or  113 ) can be seen mounted substantially within shell  103 . 
       FIG. 1B  gives a side view of device  101 .  FIG. 1C  gives a bottom view, revealing a portion of reflector  113  and overhang  105  presenting surface  109  in a downward (inferior) direction. 
       FIG. 1D  shows a front view through connection feature  107 , revealing faceted surface  119 ′ of reflector  113 ′.  FIG. 1E  gives a top view of device  101 . 
       FIGS. 2A-2D  show reflector  113  according to certain embodiments. As can be seen, for example, in  FIG. 2A , reflector  113  presents faceted surface (e.g., multi-faceted surface)  119  towards incoming light arriving through connection feature  107 . Due to the fact that surface  119  presents a plurality of surfaces angled away from one another, incoming light is reflected in a plurality of direction into shell  103 . Within shell  103 , the light is reflected and re-reflected throughout the shell while also being reflected out of the shell in an inward and downward direction. While  FIG. 1A , for example, shows shell  103  being substantially circular in overall shape, it will be appreciated that other shapes are possible and can also be adapted to reflect light inwardly and downwardly. For example, any closed curve or polygon may perform as described, as will shapes with a plurality of arms radiating away from reflector  113 , such as a V shape or U shape with reflector  113  and connection feature  107  at a point such as the base of the U or V, alone one of the arms, or at one or both of the tips of the U or the V. 
       FIG. 2B  shows structural features that can be included at the top and bottom of reflector  113  allowing it to be snapped into place, or fitted into, shell  103 . 
       FIG. 2C  illustrates that slit  123  extends completely through reflector  113 . Slit  123  can be provided to allow light to pass directly from the light source to the surgical sight. The aperture area of slit  123  can be varied by design (e.g., from zero to a few cm 2 ) to modulate a ratio of an amount of light penetrating directly through slit  123  to the site to an amount of light reflected via internal surface  109  of shell  103  to the site. Different surgeons or different applications may benefit from one ratio or another according to preferences or circumstances. 
       FIG. 2D  shows the aperture in the back of the housing of reflector  113  for slit  123 . 
       FIG. 3  shows a device  201  according to alternative embodiments. Device  201  as shown in  FIGS. 3-6  is constructed from an upper shell  203  and a base shell  204 . 
       FIG. 4  shows a section of device  201  taken along line G shown in  FIG. 3 . As can be seen in  FIG. 4 , boss  231  holds reflector  113  in place (e.g., according to geometry shown in  FIGS. 9 and 10 ) so that facets  119  are exposed through coupling  107 . 
       FIG. 5  shows a section of device  201  along line H shown in  FIG. 3 . As illustrated here, the arrangement of boss  231  and reflector  113  positions slit  123  to allow light to pass through and illuminate a surgical site. 
       FIGS. 6A  gives a perspective view of upper shell  203  and a base shell  204  of device  201  according to certain embodiments. Not only does manufacturing device  201  according to a two-component design provide an easy to mold and lightweight snap-together assembly, by positioning connection feature  107  and boss  231  on opposed components, the arrangement for assembling the shapes is made visually evident. This allows a user-assembled device to be provided, for example, as two separate components. In some embodiments, upper shell  203  and base shell  204  are packaged and shipped one nested within the other, or as stacks of each separately nested, for compact packaging and shipping. 
       FIG. 6B  illustrates assembly of upper shell  203  and base shell  204 . Upper shell  203  and a base shell  204  can each be fabricated separately, of a suitable material (e.g., plastic). An inside surface of upper shell  203 , base shell  204 , or both can be coated with a reflective material. Components of devices of the invention can be formed of any suitable surgical material such as for example, plastic, surgical stainless steel, resin, glass, foil, fiberboard, other materials known in the art, or combinations thereof. Further suitable materials may include epoxy, titanium or other metals, ceramics, composites, rubbers, or polymers. 
     Reflective surface  109  on the inside of shell  103  can be provided by any suitable means. In some embodiments, reflective surface  109  includes a coating of a reflective material, such as a metallic material. In some embodiments, surface  109  includes foil disposed within shell  103 . Surface  109  may include a mirror, for example, a glass, crystal, or plastic minor, that is curved and disposed within shell  103 . 
       FIG. 7  illustrates use of the device according to certain embodiments. Sterile surgical sheet  301  may be placed over a site for an incision. Sheet  301  may have hole  305  for surgery. Device  101  may be located under sheet  301  and connected to light source  317  via fiber optic cable  309 . 
     Device  101  includes connection feature  107  which can include an adaptor to couple to fiber optic cable (e.g., fiber optic light line)  309  from light source  317 . The light source may include glass fiber optic cables, plastic fiber optic cables or any other suitable means for transmitting and emitting light. Light source  317  may be any suitable device for producing light such as, for example, a halogen or incandescent light box or other light source readily available in most hospital settings. Suitable light sources are available from Welch Allyn Inc. (Skaneateles Falls, N.Y.) The light source may have any suitable power level. 
     In certain embodiment, light source  317  is a the XLS-300 High-Powered 300 W xenon light source from Olympus Corporation (Shinjuku, Tokyo, JP). Any other suitable light source capable of producing light that is transmitted via the light transmitters, such as fiber optic cables, may also be used. Light sources and optic cables are discussed in U.S. Pat. Nos. 5,850,496 and 5,115,126 and surgical illumination generally is discussed in U.S. Pat. Nos. 5,785,648; 6,616,603; 7,150,714; and 5,353,786, the contents of each of which are incorporated by reference. 
     Providing device  101  with circular or other open-format morphology of shell  103  allows a surgeon to work freely in the area surrounded by device  101 . In some embodiments, an outer diameter of device  101  between about 2 inches and about 10 inches. In certain embodiments, an outer diameter of device  101  is between 4 and 8 inches, or about 5 to about 7 inches. Moreover, device  101  is spaced away from the incision or any surgical instruments. Surgical light is discussed in U.S. Pat. Nos. 7,909,761; 5,488,696; and 4,605,990, the contents of each of which are incorporated by reference in their entirety. 
     In some embodiments, device  101  is provided with an adhesive, such as a peel-and-stick adhesive on one surface. Removing the peel-off backing allows sheet  301  to be fixed into place on device  101 . In certain embodiments, a device  101  is provided with a sheet  301  attached, for example, with an adhesive. 
     While reflector  113  is discussed herein having a pyramidal aspect, other embodiments are within the scope of the invention. In some embodiments, reflector  113  has two facets. Facets of reflector  113  may be flat, curved, or irregular. 
       FIG. 8A  gives a perspective view of a reflector  131  according to certain embodiments. As can be seen, for example, in side view in  FIG. 8B  or front view in  FIG. 8C , reflector  131  may have a substantially convex curved face  135  and operate to provide the benefits of the invention. 
       FIG. 8D  shows a top view of reflector  131 , illustrating the outer housing—which may be Plastic—and face  135 . This assemblage can be assembled into device  101 . Preferably, reflector  113 , reflector  131 , or the like is assembled into device  101  opposed to connection feature  107  according to a geometry that reflects light throughout the device. 
       FIG. 9A-9B  illustrate a geometry of arrangement of components within device  101 . Reflector  127 , which may have the illustrated morphology or any other morphology described herein or useful for illumination, is opposed to connection feature  107 . 
       FIG. 10A-10B  show a spatial relationship between reflector  127  and connection feature  107 . In some embodiments, connection feature  107  has a substantially cylindrical portion defining an axis. The axis of feature  107  may extend into a surface of the reflector. However, in certain embodiments, for example where slit  123  is present, the axis of feature  107  does not intersect the reflector at all but, rather, pass by or through it (e.g., through slit  123 ). 
     Devices and methods of the invention provide significant advantages over prior systems for providing illumination during a surgical procedure. The device minimizes the requirement of cumbersome cables, headlights, overhead fixtures, and power sources, while allowing direction of light to an ideal location. Device  101  does not compromise or reduce the working area, as it is spaced away from the incision, and provides superior illumination of the procedure site without inducing glare or affecting the surgeon&#39;s visual acuity Devices and methods of the invention help people see a surgical field when overhead operating room lights need to be dimmed or turned off. The surgical site is illuminated without creating a glare on the monitor screen or in a person&#39;s eyes, creating a more efficient and safer environment for surgeons, operating room staff and patients. 
     Devices and methods of the invention improve efficiency or flow of surgical procedures by avoiding the need to repeatedly adjust overhead lights and thereby eliminate the need for the people&#39;s eyes to accommodate to different lighting conditions; increase the visibility of ports while changing instruments; eliminate the questionable practice of removing camera or light from inside patient&#39;s abdomen or pelvis to illuminate a surgical site; enhance visualization of the surgical field when preparing and inserting mesh and other implants; improve visualization of sharps on the surgical field reducing the risk of accidental punctures to staff; reduce the risk of injury to surgical assistants and OR staff by improving ability to monitor robotic arm movement during surgery; allow for estimation of blood loss around surgical ports; allow staff to maintain correct count of surgical instruments, sponges and sharps on the field as well as employed as a teaching device allowing students to see location of such ports/trochars/devices without turning on overhead lights. 
       FIG. 11  is a reproduction of a photo of a device that was made. Devices and methods of the invention are inexpensive to manufacture, and work in conjunction with existing operating room equipment and technology. Additional applications include invasive radiology, various imaging modalities and enhancing teaching techniques. 
     In certain alternative embodiments, devices and methods of the invention incorporate multiple structures to provide light both above and below the incision site. Dual-device structures are provided, for example, for use with single incision laparoscopic surgery procedures (SILS). Such procedures may employ an SILS port. See, e.g., U.S. Pub. 2012/0130186; U.S. Pub. 2012/0022333; U.S. Pub. 2011/0021877; and U.S. Pub. 2010/0249523, the contents of each of which are incorporated by reference in their entirety. 
     Two of device  101  that are permanently attached one on top of the other form multi-structure device of according to one alternative embodiment. The light port lies at the junction of the two light rings and is anchored in place during the manufacturing process to the upper lip of the lower ring. This forms a seal that prevents the escape of gasses from the body cavity during the laparoscopic procedure. The shell  103  of each device  101  is constructed from non-translucent material (e.g., plastic) and has a reflective inner surface  109 . 
     In certain embodiments, the upper one of device  101  has two light adaptors. The first adaptor is in a longitudinal plane as above. The second light adaptor is oriented in a vertical plane and is used to provide light to the lower light ring. A direct connection between upper and lower devices  101  is aligned and forms a channel to allow light from the second adaptor to pass through the upper device  101  to the lower device  101 . The light then encounters the light reflector, which will reflect light around the lower light device  101 . Light is then directed by the reflective surface in an inferior direction thereby illuminating the body cavity and the in vivo surgical site. An inflatable seal located on the outer diameter of the upper device  101  may be provided to prevent gasses from escaping the body cavity. Single-incision procedures are discussed in U.S. Pub. 2012/0116362 and U.S. Pub. 2008/0064931, the contents of which are incorporated by reference. 
     Devices of the invention can be sterilized by means known in the art. 
     As used herein, the word “or” means “and or or”, sometimes seen or referred to as “and/or”, unless indicated otherwise. 
     Incorporation by Reference 
     References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes. 
     Equivalents 
     Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.