Abstract:
Instrumentation and a method for facilitating surgical tattooing in connection with radiation thereby incorporating a novel ink dispensing instrument having sterile tattoo ink. The dispensing instrument is connectable to a surgical tattoo needle to ensure the delivery of sterile ink during each procedure. Subsequent to demarcation, the instrument and needle may be discarded.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    The present invention relates to a surgical apparatus and method for tattooing a patient for a surgical procedure, and, more particularly to a universal procedure and associated instrumentation for tattooing radiation patients for purposes of identifying target points for repetitive radiation.  
           [0002]    Tattooing in a hospital setting must be sterile. Any injection received in a hospital setting should be as clean as possible to reduce patient harm. Current methods for patient demarcation or tattooing in conjunction with radiation therapy utilize unsterile modalities for applying the ink for the tattoo. In a typical procedure, the ink is provided in a common inkwell which is subject to a number of contaminants during use. Specifically, the inkwell becomes contaminated once it is opened. Thereafter, the repetitive insertion of tattooing needles/syringes on multiple patients introduces additional contaminants which, may additionally increase the potential for transmission of infectious diseases between subsequent patients.  
         SUMMARY OF THE INVENTION  
         [0003]    Accordingly, the present invention is directed to a new standard procedure or protocol, and associated instrumentation, for applying a surgical tattoo. In a preferred embodiment, a method for surgically tattooing a patient, comprises the steps of providing a sealed ink dispensing instrument having sterilized tattoo ink therein and defining a port for dispensing said tattoo ink, dispensing the tattoo ink from the port of the ink cartridge, directing the tattoo ink with respect to predetermined body tissue of a patient to mark the body tissue and disposing the ink cartridge after use on the patient. The ink dispensing instrument may have a deformable ink cartridge with the tattoo ink therein whereby the step of dispensing includes deforming the ink cartridge to dispense the tattoo ink under pressure. A needle may be connected to the ink cartridge adjacent the port such that the tattoo ink is passed through a lumen in the needle to mark the predetermined body tissue.  
           [0004]    A surgical ink dispensing instrument for facilitating surgical tattooing of a patient is also disclosed. The dispensing instrument includes an ink cartridge defining an internal chamber, and having a port in communication with the internal chamber and sterile tattoo ink disposed within the internal chamber of the ink cartridge. The ink cartridge may be substantially flexible to permit the operator to deform the ink cartridge to expel the tattoo ink through the port. An end cap is removably mounted to the ink cartridge about the port to substantially enclose the port. The ink cartridge may define a generally elongated portion for engagement by the user.  
           [0005]    The method and instrumentation of the present invention ensures the use of sterile tattoo ink in each tattooing procedure thereby overcoming disadvantages of current practices used for surgical tattooing.  
       
    
    
     BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0006]    Preferred embodiments of the present invention will be better understood with reference to the drawings wherein:  
         [0007]    FIGS.  1 - 2  are frontal and rear perspective views of an ink dispensing instrument for use in accordance with the principals of the present invention;  
         [0008]    [0008]FIG. 3 is a perspective view with parts separate of the dispensing instrument of FIG. 1;  
         [0009]    [0009]FIG. 4 is a cross-sectional view of the dispensing instrument;  
         [0010]    [0010]FIG. 5 is a perspective view of an alternate embodiment of the ink dispensing instrument of FIG. 1;  
         [0011]    [0011]FIG. 6 is a cross-sectional view of the dispensing instrument of FIG. 5;  
         [0012]    [0012]FIG. 7 is a side cross-sectional view of the dispensing instrument;  
         [0013]    [0013]FIG. 8 is a perspective view of another alternate embodiment of the ink dispensing instrument of FIG. 1;  
         [0014]    [0014]FIG. 9 is a cross-sectional view of the dispensing instrument of FIG. 8;  
         [0015]    [0015]FIG. 10 is a perspective view with parts separated of the dispensing instrument;  
         [0016]    [0016]FIG. 11 is a side cross-sectional view of the dispensing instrument; and,  
         [0017]    [0017]FIG. 12 is a flow chart illustrating the preferred procedure for applying a surgical tattoo with the instrumentation.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0018]    The preferred embodiment of the method and instrumentation disclosed herein are discussed in conjunction with a surgical tattooing procedure for radiation therapy. It is envisioned, however, that the invention may be applicable to a variety of procedures including, non-surgical tattooing procedures.  
         [0019]    The following discussion includes a description of the instrumentation utilized in applying a surgical tattoo followed by a description of the preferred method or protocol utilizing the instrumentation  
         [0020]    Referring now to the drawings wherein like reference numerals identify similar like elements throughout the several views, FIGS.  1 - 4  illustrate a preferred ink dispensing instrument in accordance with the present invention. Tattoo ink dispensing instrument  10  includes essentially three elements, namely, ink cartridge  12 , leading cap  14  and trailing cap  16 . Ink cartridge  12  defines internal cavity  18  which accommodates the sterile ink. Ink cartridge  12  has a generally frustoconical outer shape or configuration with an enlarged trailing end  20  which gradually tapers to a smaller leading end  22 . Leading end  22  defines a narrowed distribution port  24  which has an internal lumen  26  communicating with the internal cavity  18  of ink cartridge  12 .  
         [0021]    Trailing end  20  of ink cartridge  12  includes a circumferential collar  28  to which trailing cap  16  is mounted. In the preferred embodiment, trailing cap  16  includes a transverse outer wall  30  which is joined to circumferential collar  28  of ink cartridge by conventional means, including for example adhesives, cements, snap fit threaded means. In the preferred embodiment, trailing cap  16  is joined to the ink cartridge  12  through an ultrasonic welding technique. Trailing cap  16  preferably defines internal circumferential stop  32  which is received within the trailing end  20  of the ink cartridge in sealing engagement therewith.  
         [0022]    Trailing end cap  16  defines an elongated length which facilitates functioning of the trailing end cap  16  as a handle. Preferably, in use the operator holds end cap  16  in a manner similar to that of a writing implement thus providing ease of control and a degree of familiarity to the operator.  
         [0023]    Leading cap  14  is placed on ink cartridge  12  prior to loading of the ink and preferably includes an internal stop  34  which is received within the lumen  26  of the port  24  to fluidly seal the port  24  at this end. Leading cap  14  further defines an internal circumferential wall  36  which is mounted about the port  24  and preferably dimensioned so as to frictionally engage the port  24  to thereby retain the end cap  14  on the ink cartridge during assembly and shipping.  
         [0024]    As best depicted in FIG. 4, the tattoo ink  38  (represented as  - - -  ) filled within ink cartridge  12  is and is FD&amp;C approved sterile tattoo ink which is the only ink permitted for human skin tattooing. Various colors are contemplated.  
         [0025]    The components of the instrument  10  are preferably fabricated from a suitable polymeric material by known injection molding techniques. Ink cartridge  12  may have some rigidity to minimize deformation thereof whereby the tattoo ink is gravity fed through distribution port  24 . Alternatively, ink cartridge  12  may be flexible to be squeezed in a manner to force the tattoo ink through distribution port  24 . Trailing end cap  16  is preferably rigid.  
         [0026]    The preferred dimensions of the instrument are as follows:  
         [0027]    l 1 —length of trailing end cap: 2-3 inches, preferably about 2.5 inches  
         [0028]    l 2 —length of cartridge: 1.5-2.1 inches, preferably about 1.8 inches  
         [0029]    d 1 —diameter of trailing end cap: 0.250-0.450 inches, preferably about 0.350 inches.  
         [0030]    In a preferred method of manufacture, leading cap  14  is mounted to ink cartridge  12  and the ink cartridge  12  is filled with sterile FD&amp;C approved tattoo ink. Thereafter, trailing cap  16  is then mounted to ink cartridge  12  and sealed through the ultrasonic well joint. Thus the entire device is hermetically sealed, sterile and filled with the appropriate FD&amp;C approved tattoo ink. This device can be prepackaged and shipped and delivered to the end user.  
         [0031]    The ink dispensing instruments of the afore-described embodiments are intended for use in conjunction with a tattoo needle  38  depicted in FIG. 3 which may be secured to the device through any number of known conventional means. For example, the needle  38  can be mounted about the distal port and connected therewith with threaded means (shown in phantom) on the needle  38  as internal threads  39  which threadably engage corresponding threads (not shown) of cartridge  12 , a bayonet coupling, a frictional engagement, etc. Alternatively, the needle is not required and the ink from the ink cartridge can be dispensed onto a needle point which is subsequently applied to the skin of the patient for tattooing.  
         [0032]    FIGS.  5 - 7  illustrate an alternate embodiment of the dispensing instrument of FIG. 1. In this embodiment, the trailing cap is eliminated. Ink cartridge  12  has an elongated portion or handle  40  adjacent its trailing end and integrally forward therewith during injection molding. The handle includes recessed grooves  42  (best depicted in FIG. 6) which accommodate the fingers of the user. The elongated portion on handle  40  enables the operator to hold the instrument in a manner similar to using a pencil or pen. This provides the user with a familiar feel that enhances control when applying the tattoo. This instrument defines a length ranging from 4.00-4.50 inches, preferably about 4.25 inches.  
         [0033]    FIGS,  8 - 11  illustrate another embodiment of the present invention. The device in these figures is substantially similar to the prior embodiment and includes an ink cartridge  60  defining a generally bulbous shape which is rounded at its proximal end. The distal end of the ink cartridge  60  includes a distal port  62  and has a end cap  64  which is mounted to the distal port in the manner discussed above. The ink cartridge  60  may comprise two components, namely, the ink base cartridge  66  and a nozzle  68  which defines the distal port  62  and is ultrasonically welded to the base  66  to connect the two components. The bulbous ink cartridge  60  facilitates holding of the instrument between the index and middle finger, and the thumb and provides a greater area to facilitate squeezing or deformation of the ink cartridge to expel the sterile tattoo ink.  
         [0034]    Surgical Tattooing Protocol  
         [0035]    The preferred surgical tattooing protocol with the instrumentation will now be discussed with reference to the flow chart of FIG. 12. In step  100 , the prepackaged ink dispensing instrument is provided and opened by tattooing personnel. A sterilized tattooing needle  38  is mounted to ink cartridge  16  as discussed hereinabove. Alternatively, if desired, a mounted tattooing needle is not utilized. The needle is then introduced to the skin of the patient. With reference to steps  200 ,  300 , the ink cartridge is dispensed (step  200 ) or squeezed (or if gravity fed no squeezing is required) to deliver the ink through distal port into the needle and then directed (step  300 ) into the skin of the patient. After use, the needle and ink cartridge are discarded (step  400 ). In an alternate arrangement, a tattooing needle is not mounted to the ink cartridge, but, is introduced within the skin. Thereafter, the tattoo ink is applied to the outer surface of the needle to travel along the needle into the tissue.  
         [0036]    It is contemplated that the dispensing instrument of the present invention will be individually wrapped in a sterile packet attached and boxed. The packets will be attached to each other and an operator would pull off one packet at a time when needed. See, e.g., the dispensing system disclosed in U.S. Pat. Nos. 5,358,140 and 5,282,349, the contents of each being incorporated herein by reference. The novel instruments will be used for safe and sterile application of permanent tattoo dots on skin for purposes of identifying points of interest. The predominant use would be on radiation patients although other uses are envisioned as well.  
         [0037]    The present apparatus will lower medical wastes in department. In accordance with the present invention, the instrument is preloaded with permanent or semi-permanent ink dye. The preloaded instrument would be used to penetrate the skin at predetermined locations and thereafter activated to deliver the ink dye to appropriately tattoo the patient for, e.g., successive radiation treatments. After use, the instrument would be disposed although it is envisioned that the syringe could be sterilized for subsequent use(s).  
         [0038]    The present invention thus contemplates the aforediscussed surgical tattooing apparatus and a method for tattooing a patient utilizing the apparatus. The system assures that sterile tattoo ink is used for each individual patient.  
         [0039]    While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the invention