Abstract:
A marking pen for indicating the proper location of incisions to be made on a patient undergoing surgery is provided. The marking pen includes a handle having a first end and a second end; a wheel comprising a gelatinous ink-soaked polymer rotably attached to the first end of the handle; and a plurality of treads on a periphery of the wheel.

Description:
[0001]     This application is a continuation-in-part of U.S. patent application Ser. No. 10/657,889 filed Sep. 9, 2003, which claims priority to U.S. Provisional Application Ser. No. 60/409,395 filed Sep. 10, 2002, each which is incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     The present invention relates, in general, to a marking pen, more particularly, to a marking pen for use during surgery, so as to guide the surgeon in making a proper incision. The pen may also aid the surgeon in marking where to place sutures, staples, glue or other mechanisms for closing an incision post operatively.  
         [0003]     The use of marking pens in surgery is common. A surgeon will mark lines on a patient&#39;s body so as to know the proper place and length of the incision that will be made during the operation. Such lines can be particularly important in plastic surgery. In such cases, it is extremely important that the incisions be at the proper location, and of the appropriate length. This is often difficult to do during surgery without the aid of markings.  
         [0004]     Typically, a surgeon will use a felt tip pen to mark lines representing the desired incisions. Felt tip pens can drag across the patient&#39;s skin catching some of the skin. The skin that is caught by the pen can bunch up underneath the pen resulting in a jagged or crooked line. Also, felt tip pens, in particular, can “bleed” when they are first placed on a patient&#39;s skin.  
         [0005]     Marking pens of the prior art also have a tendency to dry out. Prior art pens have tried to solve this problem of drying out by providing a surgical marker with a reservoir that feeds a marking portion of the surgical marker. In these pens having reservoirs, the channels leading to the marking portion can become clogged.  
         [0006]     Due to these problems with marking pens, some surgeons rely on other marking techniques. Some doctors dip toothpicks or other similar instruments in ink, and then drag the ink-soaked toothpick across the patient&#39;s skin to form a line. The toothpicks, or other similar marking instruments do not hold a significant amount of ink and must be repeatedly dipped into the ink when the surgeon is drawing a number of lines.  
         [0007]     Accordingly, to overcome these problems, there is a need for a marking pen that enables a surgeon to make a line on the patient&#39;s skin that is not jagged. Additionally, the line can provide configurations that can mark a patient&#39;s skin to aid the doctor in the placement of sutures after the surgery has been performed.  
       SUMMARY OF THE INVENTION  
       [0008]     A method of marking a patient&#39;s skin for surgery includes marking a patient&#39;s skin with ink using a surgical marker without penetrating the patient&#39;s skin. The surgical marker includes a handle and a wheel rotatively attached to the handle. The wheel includes a marking surface for the depositing ink onto the patient&#39;s skin.  
         [0009]     A surgical marker kit includes a sterile handle, a sterile wheel, ink, and a sealed ink container. The handle includes a first end portion and a second end portion. The wheel is configured to attach to the first end portion of the handle. The wheel includes a circumferential marking surface. The wheel is made of a material that selectively retains and dispenses ink. The sealed ink container includes a selectively removable portion to provide access to the ink.  
         [0010]     A surgical marker includes a handle and a wheel rotatively attached to the handle. The wheel includes a first end portion and a second end portion. The wheel rotatively attaches to the first end portion of the handle. The wheel includes a flat or arcuate marking surface disposed at a peripheral edge of the wheel. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  is an exploded view of a surgical marker.  
         [0012]      FIG. 2  is an exploded view of the surgical marker, opposite the view shown in  FIG. 1 .  
         [0013]      FIG. 3  is a perspective view of an alternative embodiment of a surgical marker.  
         [0014]      FIG. 4  is a perspective view of another embodiment of a surgical marker.  
         [0015]      FIG. 5  is a perspective view of a first end portion of the surgical marker of  FIG. 3  showing a first embodiment of a marking wheel attached to the first end portion.  
         [0016]      FIG. 6  is a perspective view of the first end portion of the surgical marker of  FIG. 3  showing a second embodiment of a marking wheel attached to the first end portion.  
         [0017]      FIG. 7  is a drawing of an example of a surgical marker kit. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0018]     It is to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification are simply exemplary embodiments of the inventive concepts. Therefore, specific examples and characteristics relating to the embodiments disclosed herein are not to be considered as limiting.  
         [0019]     With reference to  FIG. 1 , a surgical marker  110  generally includes a handle  112 , a wheel  114  that attaches to the handle and a nib  116  that also attaches to the handle. The handle  112  in the embodiment depicted in  FIGS. 1 and 2  can be made of any conventional material, such as plastic or stainless steal. Also, the handle  110  can be made of material that can withstand sterilization via gamma radiation. The handle, which can also be referred to as the body, need not include a reservoir for the ink that is eventually deposited on a patient&#39;s skin. The handle  112  includes a first end portion  118  and a second end portion  122 . The handle  110  includes two bends: a first bend  124  and a second bend  126 . The second bend  126  is located nearer the first end portion of  118  of the handle  112  as compared to the first bend  124 . The portion of the handle  110  rearward of the first bend  124 , i.e. towards the second end portion  122 , is aligned generally along a first axis  128 . The portion of the handle  110  forward of the second bend  126  is aligned generally along a second axis  132  that is parallel with the first axis  128 .  
         [0020]     The handle further includes a wheel mount extension  134  that extends forwardly from the first end portion  118  of the handle  110  generally coaxial with the second axis  132 . As more clearly seen  FIG. 2 , the wheel mount extension  134  is polygonal in a cross section taken normal to the second axis  132 . Such a polygonal configuration provides multiple predetermined orientations at which the wheel  114  can attach the handle  112 . The handle  110  also includes a nib extension  136  that extends generally rearwardly from the handle  112  aligned along and coaxial with the first axis  128 . In the depicted embodiment, the nib mounting extension  136  is generally circular in a cross section taken normal to the first axis  128 . Either mounting extension can take alternative configurations.  
         [0021]     Annular ridges  138  are also provided on the handle  112  between the first bend  124  and the second bend  126 . This location is typically where the marking pen is gripped during use. The annular ridges  138  provide for a cleaner gripping surface for the surgeon during the operation. The annular ridges  138  provide less surface area for contaminants to gather on the pen that can make gripping the pen difficult.  
         [0022]     A wheel mount  142  attaches to the handle  112 . In the depicted embodiment, the wheel mount  142  includes a polygonaly shaped opening  144  ( FIG. 1 ) that receives the wheel mount extension  134 . In alternative embodiment, the handle  112  can include the female portion of the connection between the handle and the wheel mount  142  and the wheel mount can include the male portion of the connection. In the depicted embodiment, the opening  144  is a polygonal shape that corresponds to the wheel mount extension  134  and provide for a number of predetermined mounting orientations in which the wheel  114  can mount to the handle  110 . The orientations that the wheel mount  142  can take are fixed about the second axis  132 , which is perpendicular to the axis of rotation for the wheel  114 . The wheel mount  142  also includes tines  146  that are spaced from one another so that the wheel  114  is received between the tines. Openings  148  are provided in each tine  146 . The openings  148  are aligned with one another so that an axle (not shown) is received in the openings to attach the wheel  114  to the wheel mount  142 .  
         [0023]     The wheel  114  in the depicted embodiment is similar and/or can be the same as the wheels that are described below for alternative embodiments of the surgical marker. The wheel  114  includes a plurality of treads  152  that define marking surfaces that will contact the patient&#39;s skin to provide a guideline for an incision that will be made during operation. The wheel also includes a central opening  154  through which the axle is received. The axle is also received in the opening  148  of the wheel mount  142  to attach the wheel  114  to the wheel mount. The wheel  114  in the depicted embodiment is made of an open cell material, for example, HDMP. To produce the wheel  114 , powder material is placed into a form, the powder is then pressed and sintered. Other materials can also be used for the wheel. Since the wheel is not internally fed by a reservoir, the material from which the wheel is made should selectively retain ink to be deposited onto a patient&#39;s skin and selectively deposit that ink upon coming into contact with the skin. The embodiment depicted in  FIGS. 1 and 2 , the wheel  114  includes flat or arcuate marking surfaces that do not penetrate the patient&#39;s skin when marking the skin. Instead ink is deposited on the top layer of the patient&#39;s skin.  
         [0024]     The marking nib  116  connects to the handle  112 . The marking nib  116  in the depicted embodiment includes a circular opening  160  that is configured to receive the nib extension  136  that extends rearwardly from the second end portion  122  of the handle  112 . Alternatively, the marking nib can include a male connection portion that cooperates with a female connection portion of the handle. In the depicted embodiment, the nib  116  can be made of the same or similar material as the wheel  114 . Also, a reservoir can be provided in the handle  112 . Ink can be provided in the reservoir and communicate with a marking end  162  of the nib  116 . A surgeon can mark the starting and ending locations for an incision line using the pointed end  162  of the nib  116 . The nib can either receive ink from a reservoir disposed in the handle  112  or the end  162  of the nib  116  can be deposited in an ink reservoir or contact an ink pad and selectively retain the ink until the ink is deposited on the patient&#39;s skin. The ink for both the wheel  114  and the nip  116  can either by retained by absorption or simply through surface tension that attracts the ink to the respective marking surfaces of the respective wheel  114  and the nip  116 .  
         [0025]     Referring to  FIG. 3 , another embodiment of a surgical marker  10  includes a body  12  having a first end portion  14  and a second end portion  18 . The body  12  can make up at least a portion of a handle of the surgical marker. The body has a generally cylindrical shape and can be made of any conventional material, preferably plastic or stainless steel. Since this surgical marker does not require a reservoir, the body can be solid. A contoured portion  22  is located adjacent the first end portion  14 . The contoured portion  22  can provide a more ergonomic handle for the surgical marker. The second end portion  18  has a tapered end  24  that tapers away from the central portion  16 .  
         [0026]     In the embodiment depicted in  FIG. 3 , a neck  26  attaches to the first end portion  14  of the body. The neck  26  can either be fastened to or an integral with the body  12 . Where the neck  26  is integral with the body  12 , the neck and the body are formed from a single piece. In the depicted embodiment, the neck is cylindrical having two arms,  28  and  30 , that project away from the first end portion  14 . A wheel  32  is rotatively attached between the arms  28 ,  30 . The neck  26  and the arms  28 ,  30  can also be made from a solid piece of plastic, i.e. containing no channels inside. The neck  26  can detach from the body  12  so that the neck and wheel  32  can be discarded and the remainder of the marker can be re-used.  
         [0027]     Referring now to  FIG. 5 , arm  28  includes two tines  34  and  36  and arm  30  includes two tines  38  and  40 . Tines  34  and  36  and arm  28  define an arcuate notch  42  that receives an axle  44  of wheel  32  ( FIG. 1 ). The arm  30  and tines  38  and  40  define an arcuate notch  46  that aligns with the arcuate notch  42 . The arcuate notch  46  also receives the axle  44  of the wheel  32 . The arcuate portions  42 ,  46  are adapted to surround more than half the periphery of the axle  42  of the wheel. Thus, the wheel can lock into the notch when mounted to the neck  26 , yet the wheel can also be detached from the neck after use.  
         [0028]     The wheel  32  includes a plurality of spaced treads  50 . The wheel  32  can be made of a conventional material including an elastomer, a plastic, or other well known material. The wheel in one embodiment is made of a gelatinous ink-soaked polymer. More specifically the wheel comprises a plasticized (approximately 60% ink and approximately 40% resin) felt tip from the medical industry. Such polymers are available from Identity Group, 1480 Gould Drive, Cookeville, Tenn. and the Bacon Felt Co. Other ink-soaked resins could also be used including, but not limited to, polyethylene and polypropylene. The ink-soaked polymer is preferred because it reduces the tendency of the wheel to drag across the patient&#39;s skin, catching some of the skin and causing the skin to “bunch” together. Furthermore, the ink-soaked polymer wheel does not have a tendency to dry out. Also, the ink-soaked polymer wheel eliminates the need for an ink reservoir where channels leading from the reservoir to the wheel may clog. Also, a surgeon using such an ink-soaked polymeric wheel, when marking lines on the patient&#39;s skin, does not need to dip the surgical marker in ink prior to marking the patient&#39;s skin.  
         [0029]     The marking agent or ink used with the wheel can be any conventional marking agent used to mark a patient&#39;s skin. An example of a marking agent is Gentian Violet, however other marking agents can be used.  
         [0030]     The wheel  32  includes treads  50  having marking surfaces  52  disposed at a peripheral edge of each tread. The treads  50  are the shape of a frustum of a prism, however, the treads could take form in a number of different shapes. The marking surfaces  52  are spaced from one another resulting in a dotted line on the patient&#39;s skin when the surgeon makes the mark, however, the marking surfaces need not be spaced from one another when a continuous line is desired. The marking surfaces can be flat, or arcuate to match the radius of the wheel so that as large amount of marking surface as possible contacts the patient&#39;s skin. The marking surface can be square, circular or any other shape. The dots that are made by the wheel on the patient&#39;s skin can be spaced apart from one another the conventional distance at which post-operative sutures are placed, or some multiple thereof, i.e. every third dot a suture or other device to close the incision is placed.  
         [0031]     The axle  44  can be separate from the wheel, or the wheel and axle can be made from one integral unit. As stated before, the axle is received in the arcuate notches  42 ,  46  of the arms  28 ,  30 . The receipt of the axle in the notches allows the wheel to detach from the neck so that the remaining portion of the surgical marker can be re-used.  
         [0032]     With reference to  FIG. 6 , another embodiment of a wheel  60  surgical marker is shown. The wheel  60  is rotatively mounted to the neck  26  between arms  28  and  30  similar to the wheel  32  shown in  FIG. 5 . An axle  62  of the wheel is received in the arms  28  and  30  similar to the wheel  32  in  FIG. 5 . The wheel  60  includes a plurality of treads  64  having markings surfaces  66 . The marking surfaces  60  are cross-shaped having a first portion  68  aligned with a circumference of the wheel and a second portion  72  aligned perpendicular to the circumference of the wheel. The marking surfaces  66  are spaced from one another, similar to the marking surfaces  52  of  FIG. 5 . The marking surface can be flat, rounded to match the radius of the wheel, or other configuration.  
         [0033]     When the surgeon draws the line prior to incision, the first portion  68  of the marking surfaces creates a dotted line to guide the surgeon when making the incision. The second portion  72  of the marking surface creates a hash mark substantially perpendicular to the line formed by the first portion. The hash marks created by the second portion  72  provide a guide to the surgeon when closing the incision. Accordingly, the second portions  72  are spaced apart from one another such that when a line is drawn on patient&#39;s skin, hash marks are formed a distance from one another that is conventional for the spacing of sutures, or some multiple thereof. The radius of the wheel  60  as measured to the marking surface of the tread and the angle measured between two adjacent treads is controlled by the distance at which the doctor will place sutures post-operatively and vice-versa.  
         [0034]     Referring now to  FIG. 4 , another embodiment of a surgical marker  80 . The surgical marker includes a body  82  having a first end portion  84  and a second end portion  86 . The body  82  or handle also includes a contoured portion  88  located in or adjacent the first end portion  84 . A wheel  90 , which is similar to the wheels described above, mounts to the body. The body or handle portion of the surgical marker  80  is very similar in construction to the marker  10  described above, with the exception that the body  82  includes a bend  92  where a neck  94  joins the body at the first end portion  84 . The bend shown in  FIG. 5  is a 30° degree bend; however, other degrees of bend are contemplated by the scope of the invention.  
         [0035]     The bend  92  of the surgical marker  80  allows the surgeon to hold more ergonomically the surgical marker when drawing lines on the patient&#39;s skin. The bend also allows the doctor to grip the marker at an angle one typically holds a pen while writing, yet the neck portion is situated substantially normal to the patient&#39;s skin. This orientation of the wheel can lessen the likelihood of the wheel catching any of the patient&#39;s skin, which can cause unwanted bunching of the skin.  
         [0036]     The surgical markers described above can be provided as part of a kit, see  FIG. 7 , that is sold as a unit. The components of the kit, e.g. the handle  12  (or other handle, for example handle  112 ) and the wheels  32  and  60  and nibs (not shown in  FIG. 7 , see  FIG. 1 ) that attach to the handle, are all sterilized and then packaged. A plurality of wheels, some wheels having different configurations, can also be provided in each kit. Also, a plurality of nibs can be provided in each kit. A sealed container of ink  98  is also provided with each kit. The ink can be soaked into an ink pad that is packaged with a removable lid. An ink reservoir can also be provided in each kit.  
         [0037]     A surgical marker, a method for its use and a kit that includes the marker have been described with reference to depicted embodiments. Modifications and alterations will occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations that come within the scope of the appended claims and the equivalents thereof.