Patent Publication Number: US-2010125172-A1

Title: Surgical pencil providing an illuminated surgical site

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. provisional patent application No. 61/199,299, filed Nov. 14, 2008, the entire disclosure of which is incorporated herein by reference. 
    
    
     BACKGROUND 
     Electrosurgical pencils, or just surgical pencils, have long been used in the medical field for surgical procedures as both a cutting device and a coagulating device. These two uses require two different electric currents with different wave forms. The different electric currents are provided to the electrosurgical pencils generally from an external power source such as an electrosurgical generator. The electrosurgical generator provides electricity in different wave forms and transmits it to the apical end of the electrosurgical pencil that houses a small blade, or other surgical tool, that facilitates the cutting and the coagulating functions. The electricity is transmitted from the tip of the pencil to a ground attached to a patient&#39;s body, thereby eliciting the desired function at the small blade attached to the surgical pencil. 
     The body of a surgical pencil houses a circuit board which is controlled by a switch with appropriate buttons to select and regulate the flow of different electrical wave forms resulting in the desired surgical presentation, e.g. cutting or coagulation. For example, a surgical pencil might have two buttons, one to engage cutting of tissue and the other button for engaging coagulation of tissue. The buttons themselves are either located on the pencil itself in a location that is ergonomic for the surgeon or on foot pedals which the surgeon engages with his/her foot. Both types of button configurations are presently available on the market. Both types of surgical pencils are equally as effective, but their use is dependent on the surgeon&#39;s preference. 
     Despite the success of surgical pencils, there is a need in the art for surgical pencils that have a means for adequately illuminating the surgical site as the tool is being used. Described herein are surgical pencils fulfilling that long felt need in the art. 
     SUMMARY 
     Described herein generally are surgical pencils providing a physician with illumination of a surgical site. There is a long felt need in the art for such devices as visualizing of a target surgical site can be burdensome during delicate and otherwise exhausting surgical procedures. The surgical pencils described herein can be retrofitted with a lighting device, can be manufactured incorporating a lighting device or can be fitted with a preformed lighting device. 
     In one embodiment described herein is a surgical pencil for providing an illuminated surgical site comprising a surgical instrument having a first end, a second end, and elongated structure and a surgical tool associated with the first end; and a removable lighting device associated with the first end of the surgical instrument and operatable by a surgeon having a power button, at least one light and a mating mechanism to connect the removable lighting device to the surgical instrument. 
     In one embodiment, removable lighting device is formed of an elastic polymer or a rigid polymer. In other embodiments, the mating mechanism has a shape that can compliment at least one shape included on the surgical instrument and thereby secure the removable lighting device to the surgical instrument. 
     In another embodiment, the at least one light is a fiber optic lighting element and/or at least one LED light. The light or lights can be provided in a circular arrangement. The removable lighting device can be powered by a built-in battery and/or be disposable. 
     In yet another embodiment, the removable lighting device is reusable with the same surgical instrument or a different surgical instrument. 
     In still other embodiments, the removable lighting device is safe to at least one sterilization technique including, but not limited to gamma irradiation, pressure sterilization and/or steam sterilization. 
     Further, described herein is a lighting device comprising a power button, at least one light, a housing and a mating mechanism to connect the lighting device to a surgical instrument. In one embodiment, the mating mechanism is an expandable housing formed of an elastic polymer. The polymer can be a rubber if elastic or can be a rigid polymer. 
     In still further embodiments, the mating mechanism has a shape that can compliment at least one shape included on the surgical instrument and thereby secures the removable lighting device to the surgical instrument. 
     In some embodiments, the at least one light is a fiber optic lighting element and/or an LED light. The light can be provided in a circular arrangement. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a prospective view of a conventional surgical pencil. 
         FIGS. 2  A-C illustrate an exemplary lighting device. A is a side view, B is a top view and C is a front view. 
         FIGS. 3  A-D illustrate the attachment of the exemplary lighting device from  FIG. 2  onto a surgical pencil. A is a perspective view, B is a bottom view, C is a front view and D is a back view. 
         FIGS. 4  A-D illustrate another exemplary lighting device. A is a side view, B is a back view, C is a front view and D is a top view. 
         FIGS. 5  A-C illustrate the attachment of the exemplary lighting device from  FIG. 4  onto a surgical pencil. A is a perspective view, B is a front view and C is an alternate front view. 
         FIGS. 6  A-B illustrate a surgical pencil with at least one lighting device manufactured into the surgical pencil. A is a perspective view and B is a front view. 
     
    
    
     DETAILED DESCRIPTION 
     The present description generally provides surgical pencils which provide a physician with illumination of at least a portion of a surgical site. There is a long felt need in the art for such a device as visualizing a target surgical site or a portion thereof can be burdensome during a delicate and otherwise exhausting surgical procedure. The surgical pencils described herein can be retrofitted with a lighting device, can be manufactured incorporating a lighting device or can be fitted with a preformed lighting device. 
     Referring to  FIG. 1 , a conventional surgical pencil is illustrated. Surgical pencil  100  generally includes first end  102 , second end  104 , and elongated structure  106  and surgical tool  108  associated with first end  102 . Surgical tool  108  can take many forms which are known in the art, but an exemplary tool is a metal tip that is used to seal cuts during surgery. Surgical pencil  100  further includes first button  110  and second button  112  each independently used to cut and cauterize during surgery. In one embodiment, first button  110  can be used to cauterize and second button  112  can be used to cut. The opposite configuration is also possible. Surgical pen  100  also includes cable  114  which provides power to the device&#39;s surgical tool  108 . Alternatively, surgical pencil  100  can include an independent power supply such as a self contained motor or battery. 
     Surgical pencil  100  can be contoured to fit comfortably within a physicians hand during surgery. For example elongated structure  106  can have one or more contours, for example, slope  116  for resting and gripping with one or more fingers. Further, first button  110  and second button  112  are located on elongated structure  106  at places that are easily accessed with one or more fingers during surgery without loss of dexterity and accuracy of surgical pencil  100 . 
     The devices described herein further provide surgical pencil  100  with a lighting device used to illuminate the surgical site for which surgical pencil  100  is being used. The lighting device can be independently powered, for example by an internal battery, or can be powered externally, for example, by the pencil itself. Even further still, the lighting device can be retrofitted onto surgical pencil  100 , can be manufactured into surgical pencil  100  or can be fitted onto a proprietary surgical pencil. 
     One example of a lighting device described herein is illustrated in  FIGS. 2  A-C. Lighting device  200  has substantially cylindrical body  202  with first end  204  and second end  206 . The shape of lighting device  200  can be any shape conceivable in the art, for example, rectangular, triangular, or the like. At least one light  208  is located on first end  204  and projects light waves therefrom. 
     Lighting device  200  has at least one button  210  for controlling light  208 . Button  210  can be any style button that controls the functions of light  208 . For example, a push button can be used to turn light  208  on and off. Alternatively, a twisting button can be used to further control the intensity or focus of light  208 . In one example embodiment, a single button can incorporate both the functions of a push button and twist button. 
     Lighting device  200  further includes at least one attachment mechanism to couple lighting device  200  to surgical pencil  100 . In one example embodiment, the attachment mechanism is slide rail  212  having a leading end  214  and a trailing end  216 . Slide rail can further include at least one locking mechanism, for example, indentations  218 ,  218 ′ to hold lighting device  200  onto surgical pencil  100 . 
       FIGS. 3  A-D illustrate the accompanying mechanism located on surgical pencil  100 . Surgical pencil  100  includes mating mechanism  302  to engage slide rail  212  located on the lighting device  200 . Mating mechanism  302  can be located, for example, on the bottom of surgical pencil  100 . In other embodiments, mating mechanism  302  can be located on the side of surgical pencil  100  or on the top. The location of mating device  302  is dependent on the needs and comfort of the operating surgeon. Slide rail  212  can slide within mating mechanism  302  until leading end  214  abuts stopping point  304 . Mating mechanism  302  includes at least two rails  306  on top of which slide rail  212  can advance until stopping point  304 . Mating mechanism can further include at least one locking mechanism, for example, protrusions  308 ,  308 ′ to hold slide rail  212  within mating mechanism  302 . 
     Alternatively, mating mechanism can be progressively narrower as slide rail  212  is advanced to stopping point  304 . Such an approach will allow friction to hold lighting device  200  on surgical pencil  100 . Other methods of mating lighting devices to surgical pencils can be used, for example, snaps, VELCRO®, glue, bands, locking rings, and the like. However, whichever method is used, lighting device  200  should be secured to surgical pencil  100  in such a manner as to not allow disconnection during a surgical procedure. 
     Another example lighting device is illustrated in  FIG. 4  A-D. Lighting device  400  includes expandable body  402  which is generally circular. At least one light  404  is located on front end  406  on projects light waves therefrom. In one example embodiment, light  404  is a circular light that completely spans the circumference of front end  406 . 
     Lighting device  400  further includes control flap  408  which includes at least one button  410 . Button  410  can be any style button that controls the functions of light  404 . For example, a push button can be used to turn light  404  on and off. Or, a twisting button can be used to further control the intensity or focus of light  404 . Button  410  can be of a similar style to buttons found on a surgical pencil. In one example embodiment, a single button can incorporate both the functions of a push button and twist button. 
     In one example embodiment, lighting device  400  can be formed into the shape of a finger grip. Even further, on some embodiments, a surgeon can instantly custom mold their particular grip into a lighting device or the lighting device can be manufactured having a particular finger grip configuration. Manipulatable hydrogels and other polymers can be used to instantly conform the lighting device to a particular finger grip configuration. Such hydrogels are commonly referred to as “memory gels” in the polymer arts. Further, the lighting device can be configured for right and left hand gripping. 
       FIGS. 5  A-C illustrate how lighting device  400  is mated with surgical pen  100 . Lighting device  400  is made of an expandable material, therefore, before being installed on a surgical pencil, the diameter of expandable body  402  is preferably smaller than the diameter of the surgical pencil. Lighting device  400  is pulled over first end  102  of surgical pencil  100  until it is snug. Expendable body  402  of lighting device  400  allows friction to provide a snug fit around surgical pencil  100 . 
     In one example embodiment, the lighting device  400  is installed onto surgical pencil  100  in such a location that button  410  is situated as a third button on the top of surgical pencil  100 . This location for button  410  allows a surgeon easy access to the functions and features not only of the surgical pencil itself, but also the attached light. 
     Yet another example lighting device is illustrated in  FIGS. 6  A-B. Lighted surgical pencil  600  is a modified version of surgical pencil  100  illustrated in  FIG. 1  that has at least one light  602  manufactured into or as part of a surgical pencil. Surgical pencil  600  has at least one additional button  604  for controlling at least one light  602 . Additional button  604  is located adjacent to first button  110  and second button  112  for ease of use and can be any style button that controls the functions of at least one light  602 . For example, a push button can be used to turn at least one light  602  on and off. Or, a twisting button can be used to further control the intensity or focus of at least one light  602 . 
     In  FIGS. 6  A and B, at least one light  602  is located within housing  606 . Housing  606  is preferably manufactured from similar materials as the surgical pencil itself and is meant to be streamlined so as to not interfere with the use of and grip onto the surgical pencil. 
     The light used herein can be any light that provides sufficient light to adequately illuminate a surgical site. Exemplary lights include fluorescent lights, light emitting diodes (LEDs), xenon lights, fiber optic lights (e.g. light guides) and the like. For example, in one embodiment, lighting device  400  can include a fiber optic light that is situated in a circle spanning the diameter of front end  406  thereof. In another embodiment, multiple LEDs can be situated in a circular pattern around the same circumference. 
     The selection of light can be dependent on the type of lighting device used and the particular surgery. For example, in a disposable lighting device, a lower cost LED light or lights can be ideal. However, in a higher cost reusable precision lighting device, a xenon light or fiber optic light can be ideal. 
     The lighting devices described herein are generally powered by one or more batteries. However, the lighting devices or lights themselves can be powered by the current running through the surgical pencil. For example, illuminated surgical pencil  600  can have at least one light that is powered by the current running through the pencil. If one or more batteries are used, they should be small enough to fit within the body of a lighting device. 
     The lighting devices themselves have bodies or casings made of non-conductive materials such as polymers. Exemplary polymers include, but are not limited to polyurethanes, silicones, polyesters such as polyolefins, polyisobutylene and ethylene-alphaolefin copolymers; acrylic polymers and copolymers, ethylene-co-vinylacetate, polybutylmethacrylate, vinyl halide polymers and copolymers, such as polyvinyl chloride; polyvinyl ethers, such as polyvinyl methyl ether; polyvinylidene halides, such as polyvinylidene fluoride and polyvinylidene chloride; polyacrylonitrile, polyvinyl ketones; polyvinyl aromatics, such as polystyrene, polyvinyl esters, such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins, such as ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers; polyamides, such as Nylon 66 and polycaprolactam; alkyd resins; polycarbonates; polyoxymethylenes; polyimides; polyethers; epoxy resins, polyurethanes; rayon; rayon-triacetate; cellulose, cellulose acetate, cellulose butyrate; cellulose acetate butyrate; cellophane; cellulose nitrate; cellulose propionate; cellulose ethers; carboxymethyl cellulose; synthetic and natural rubbers such as polysiloxanes, latex, polymerized isoprene, bromo isobutylene isoprene, chloro isobutylene isoprene, polychloroprene, chlorosulphonated polyethylene, ethylene propylene, ethylene propylene diene monomer, fluoro silicone, hydrogenated nitrile butadiene, polyisoprene, isobutylene isoprene butyl, methyl vinyl silicone, acrylonitrile butadiene, acrylonitrile butadiene carboxy monomer, styrene butadiene, epichlorodydrin; and combinations thereof. 
     The polymer or combination of polymers chosen to form the bodies or casings of the lighting devices must be rigid enough to hold a particular configuration and perform its intended function. In some example embodiments, the polymer used is a thermal set rigid plastic. In other embodiments, the polymer is a flexible nylon or rubber polymer. For example, a lighting device as illustrated in  FIGS. 4 and 5  can be formed of a flexible rubber or nylon polymer that has a shape memory that can stretch and return to its original un-stretched form after use. 
     One or more lens is used in conjunction with the lighting devices described herein to focus the light onto the surgical tissue or tissues of interest. The lenses can be made of plastics or glass or may be formed of a transparent polymer used to make the housing. The lenses can be made to provide a particular local length to the light. For example, curvature of the inner or outer surface of the lens, thickness of the lens, refractive index of the lens and the like can be used to provide a particular focal length. An exemplary focal length of the light is generally from the lens to the tip of the cutting device. Such a focal length can be adjusted, however, using a button or a dial to move the lens closer or farther from the light. An exemplary focal length is about 3.0 cm, or about 4.0 cm or about 5.0 cm. In one exemplary embodiment, the focal length is about 4.5 cm. 
     The lighting devices, in one embodiment, can be reusable. In such a case, the lighting devices are washable and sterilizable using conventional sterilization techniques. For example, the lighting devices must be sealed sufficiently to allow multiple washings with a detergent or alcohol based cleaner without damaging the device. Further, for example, the devices can be sterilized using gamma irradiation techniques. 
     In other example embodiments, the lighting devices are disposable. Such single use devices are generally used for a single surgical procedure and then discarded in an appropriate manner consistent with health regulations. Even if a lighting device is disposable, the surgical pencil used does not have to be disposable. For example, a non-disposable surgical pencil can be used with many disposable lighting devices. 
     The lighting devices described herein generally emit light in the visible range to aid a surgeon in a surgical procedure by illuminating the target surgical site. However, in addition to illuminating the target surgical site, the lighting devices can further include a laser light source to provide guidance to a surgeon by providing a line indicating where the incision is likely to end up. Such a laser light can indicate to a surgeon where exactly a cut using the surgical pencil is likely to proceed. This laser light source can be useful in avoiding delicate tissues. 
     Other specific visible wavelengths of light can be used. For example, if fluorescent surgical markings are used to indicate cuts to be made on a target tissue, a conventional “black light” can be used in the lighting devices described herein to highlight the surgical markings. 
     Even further still, in some embodiments, the lighting devices can include a microchip that wirelessly communicates with virtual surgical devices. For example, virtual surgery techniques provide computer generated surgical markings which can be followed by a surgeon on one or more displays. With a microchip as described, virtual surgical device systems can track the location of the surgical pen relative to the surgical markings and depict that location on a screen with one or more virtual markings. Such an embodiment can aid a surgeon for example in a microsurgery. 
     The microchip can also be associated with a gyroscope. The gyroscope can provide the microchip with information about the surgical pencil&#39;s orientation. Based on this information, the microchip can control the focus and direction of light emitted from a lighting device. For example, lighting device  200  can include a microchip and gyroscope. In such an embodiment, light  208  can be directed by a microchip. So, if a surgeon moves the pencil in a particular direction, the gyroscope detects that change in direction, the microchip translates that directional change and the direction and focus of at least one light is changed to accommodate for this directional change. This gyroscopic system can aid a surgeon by keeping the light focused and steady despite small changes in angular movement by the surgeon&#39;s hand. In other words, the light remains stabilized despite small movements of the hand. 
     The lighting devices and illuminated surgical pencil devices described herein provide specific advantages for patient and physician comfort as well as to a surgeon&#39;s stamina by illuminating the surgical site locally from the surgical pencil itself. One advantage, if desired, is allowing the surgery to take place under ambient or low ambient light conditions without sacrificing complete and accurate visualization of a target surgical field or a portion thereof. These capacities can be ideal for a surgeon and surgical team used to working long hours under bright lights that generate intense heat in order to visualize the target surgical area and that can result in previously unavoidable surgeon discomfort and fatigue. Additionally, it is not uncommon for a surgeon to be wearing several layers of clothing along with surgical barriers, including gloves, face barriers, goggles, hats, and overcoats, to name a few, during a given surgical procedure, further contributing to the discomfort and fatigue normally associated with hot and bright surgical working environments. 
     Compounding matters, the complexity of contemporary operating rooms has increased over the years as a result of the extra equipment, fixtures, associated power cords and the like required for ever more complicated surgeries. Such situations are not conducive to comfortable, non-fatiguing surgical environments. The ease of use and ambient lighting requirements of the presently described lighting devices and illuminated surgical pencil devices can address and overcome these issues. 
     As an additional benefit directly from the present lighting devices and illuminated surgical pencil devices, the ambient or low ambient lighting conditions that now can be utilized without sacrificing visualization and control also reduce reflected glare and high contrast shadows in the surgical environment that, in the past, could confuse or possibly even overwhelm the vision of the surgeon. Previously, a related visual limitation in surgery was that a surgeon commonly required surgical team members or students to position themselves out of certain areas in order to reduce shadows that they might cast on the target surgical site. This resulted in limiting their view of the surgery. The present lighting devices addresses this problem by reducing shadows and increasing visibility, especially of the target site by providing light directly to the surgical site from the surgical pencil itself. 
     Similarly, it is not uncommon for a surgeon to look away from a target surgical site in order to change or to move equipment, to take a mental break, or to communicate with a surgical team or students. Upon looking back onto the traditional target surgical site, the surgeon would have to wait briefly to allow his eyes to adjust to the high intensity lighting, causing delays in the procedure. The present lighting devices and illuminated surgical pencil devices eliminate this problem under normal or low ambient light conditions while still providing effective surgical reference indicia. 
     Even further still, the use of the present lighting devices and illuminated surgical pencil devices allows a surgical team to position themselves in the most appropriate location for the surgery, not necessarily where the high intensity light and resulting shadows dictate. Moreover, the present lighting devices and illuminated surgical pencil devices provide an ideal environment for students to observe a procedure in comfortable ambient to low ambient light conditions without the associated fatigue. 
     The use of ambient or low ambient light in medical or surgical processes and the resulting reduced heat and complexity in the operating room also adds to the comfort of a surgical patient and enhances the compliance of the patient with the needs of the surgeon. Patient comfort during a surgical procedure is very important, especially when the patient is under local anesthesia and is conscious. It is not uncommon for bright lights to be focused on at least a portion of a patient, typically on the target surgical site. Such lighting systems can get hot and make a patient uncomfortable. Patients who are uncomfortable commonly are more on edge, squirm and/or twitch, or are tense. These are not ideal situations for a patient undergoing surgery. The present lighting device&#39;s ability to adequately illuminate a surgical site without the need to direct high intensity lighting during use can simplify and shorten a medical procedure, provide enhanced patient comfort and compliance, and improve the medical procedure&#39;s outcome; all while providing the surgeon with enhanced visual control of the process. 
     Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. 
     The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. 
     Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. 
     Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. 
     Specific example embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Example embodiments of the invention so claimed are inherently or expressly described and enabled herein. 
     In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.