Abstract:
A device and method for treating a tick bite or other skin wound that may have been exposed to pathogens employs a syringe filled with antipathogen solution whereby the solution is applied under mild pressure directly to the wound site. The device employs spreader/retractor arms to open the wound for better access of the solution into the wound. The method of using the device to cleanse and disinfect a wound is described.

Description:
This application hereby claims the benefit of U.S. Provisional Applications No. 61/832,531 filed Jun. 7, 2013, No. 61/857,234 filed Jul. 22, 2013, and No. 61/878,530 filed Sep. 16, 2013. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     Diseases resulting from tick bites are becoming epidemic. Deer tick bites, in particular, have been implicated in the spread of Lyme disease, and efficient methods of dealing with the bites are disclosed. Prompt removal of the tick and treatment with a bactericide may help prevent subsequent infections. 
     2. Description of Problem and Prior Art 
     Ticks are known to carry and transmit several diseases including Rocky Mountain Spotted Fever and Lyme disease. The prevalence of these tick borne diseases, particularly Lyme disease, has recently reached epidemic proportions in parts of the United States. It has been determined that it takes time after the initial tick bite for the pathogen to transfer from a tick into and through skin. Accordingly, prompt removal of a tick after it is noticed provides a first line of defense against infection. 
     Removal of a tick without causing it to inject the pathogen turns out to be very difficult. Recommendations of various sources regarding the necessity and removal of ticks are summarized in Appendix “A”. The information emphasizes that during the difficult removal process, the individual should not damage, irritate, agitate, puncture, crush, squeeze or break the tick. If one or more of these unfortunate occurrences should happen, the pathogen in the saliva glands in the forward portion or further back in the body of the tick can be expelled deep into the wound. Doctors state that it is extremely difficult to remove an imbedded tick, particularly a very small deer tick, without causing one or more of the above listed items to occur. This is the case since ticks have a barbed hypostome that anchors the tick in the skin. With just a washing of the general area, it is clearly very difficult to kill the pathogen in the depth of a bite wound in which a tick has also deposited salivary cement on walls of the wound. The pathogen bonds to the tick&#39;s saliva protein (known as SALP 15 protein) as a cloaking device As a result, a very large number of people may now have Lyme disease or other tick borne diseases because they only used soap and water or alcohol to wash off the general area of the bite. 
     An approach is needed that will kill the pathogen deep in the wound and quickly separate the SALP 15 protein and pathogen from the wound and immediate area. In the case of Lyme disease, for example, because the deer tick does not expel the pathogen for many hours after it has embedded and then many times expels on removal, such an approach provides the opportunity to kill pathogens at the wound site before they get into the blood circulatory system. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  shows a partially exploded view of the interceptor. 
         FIG. 2  shows the interceptor as it is moved towards the skin surface. 
         FIG. 3  shows the nozzle of the interceptor firmly pressed against the skin over a wound, the spreader arms engaging and tensioning the skin around the wound, and the splash shield engaging the surface of the skin. 
         FIG. 4  shows an alternative embodiment of the spreader and delivery assembly incorporating a luer lock fitting. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Definitions 
     In the following description of the invention, DISTAL refers to the end of the device or its parts that will be closest to the site of application against skin during use. 
     In the following description of the invention, ANTERIOR refers to the end of the device or its parts that will be furthest from the site of application against skin during use. 
     Description: 
     The present invention provides an interceptor device and method by which pathogens deposited by tick wound or other types of small wounds may be killed or significantly reduced in number before having an opportunity to enter the blood stream. 
     In the figures like numbers denote the same part. With reference to the Figures, the interceptor device  1  of the invention comprises of a flushing needleless syringe  2  with plunger  3  which has an elongated dispensing conical tip  4 . A splash shield  5  has an inner diameter  6  larger than the outer diameter  27  of syringe  2  so that syringe  2  may pass into splash shield  5 . Once assembled, splash shield  5  surrounds the discharge conical tip  4  of syringe  2 . The distal end  7  of shield  5  is transparent so that the areas of contact of the device with the skin can be observed. End  7  may have guide rings  8 . Shield  5  has a retaining ring  9  located near its distal end  7 . Retaining ring  9  has a centrally located circular opening  10 . 
     A spreading and delivery assembly  13  attaches to conical tip  4 . Spreading and delivery assembly  13  consists in part of two concentrically mounted tubes  14  and  15 . The outside diameter of tube  14  approximates the interior diameter of tube  15 . Tube  14  extends beyond the distal end of tube  15  and forms a discharge port or nozzle  16 . The anterior end of tube  14  extends beyond the anterior end of tube  15  then through opening  10  of retaining ring  9  of shield  5  and couples the spreading and delivery assembly  13  by compressively mounting at  22  onto conical tip  4  of syringe  2 . The exterior of tube  15  fixedly engages the opening  10  in retaining ring  9 . 
     The anterior ends  17  of several stiff but flexible spreader arms  18  are captured and firmly held in place at  19  between the outer surface of tube  14  and the inner surface of tube  15  at the distal end of tube  15 . Spreader arms  18  extend distally below the distal ends of tubes  14  and  15  and further consist of spring coils  20  located approximately about half the length of the spreader arms  18 . The distal ends of spreader arms  18  are rounded to form contact surfaces  21 . When mounted to conical tip  4 , the spreader and delivery assembly  13  extends the distal end of tube  14  and spreader arms  18  below the distal end  7  of splash shield  5 . A fill tube  28  having an interior diameter slightly greater that the exterior diameter of tube  14  may be temporarily placed onto nozzle  16 . A wound or a tick bite is schematically shown at  23  on the skin surface  24 . 
     The interceptor device of this invention is intended to be used with an appropriate antipathogen or antimicrobial. Exemplary antipathogens for use against tick borne pathogens include alcohol and possibly chlorhexidine. 
     Method of Use: 
     The following steps outline the general overall procedure for proper use of the interceptor device. 
     1) Before attempting to remove a tick, prepare the interceptor. The syringe  2  may be filled by placing the spreading and delivery assembly  13  sufficiently below the surface of an antipathogen solution so that withdrawal of the syringe plunger  3  draws antipathogen solution up into the syringe. Alternatively, a filling tube  28  may be placed onto nozzle  16  through which to draw antipathogen solution into the syringe. Set the interceptor aside. 
     2) After finding the tick which is embedded in the skin (or other applicable shallow insect bite wounds), using a pen or similar device mark the wound location with a small circle (about ¼″ in diameter). This allows better visualization of the bite and more accurate centering. Since the tick can expel pathogen for the first time during removal, be careful to remove the tick as described at The Centers for Disease Control web site. 
     3) Disinfect the wound area with rubbing alcohol or other antipathogen recommended for use on Lyme disease pathogens 
     4) Immediately move the interceptor  1  slowly towards the wound  23  in skin surface  24  as shown in  FIG. 2  centering nozzle  16  as well as possible on wound  23 . The interceptor should be applied substantially perpendicularly to skin surface  24  so that all the spreader arms  18  contact the skin at the same time. As the contact surfaces  21  of the spreader arms  18  engage the skin, they simultaneously apply pressure to tighten the skin in the immediate area of the wound in a direction outward from the wound center. The coils  20  in spreader arms  18  permit flexible movement of the spreader arms as contact with the skin is made. Continue moving the interceptor until nozzle  16  contacts and is pressed firmly against the skin around wound  23  and the splash shield  5  contacts the skin surface as shown in  FIG. 3 . 
     5) Thoroughly flush the wound multiple times by advancing the syringe piston  3  to force the alcohol or other antipathogen solution into and around the wound. Splash shield  5  protects the user from direct spray. For each flush, keep nozzle  16  pressed against the skin  24  and maintain the solution pressure generated by the syringe on the wound for several seconds in a constant manner. It is suggested that a minimum of three flushes be used with a duration of at least 5 seconds each. 
     6) After the last flush, leave nozzle  16  in contact with skin  24  and partially withdraw syringe piston  3  to apply suction to the wound to evacuate the contaminated fluids in the wound. 
     7) Empty the syringe by following standard household procedures for infectious liquids. 
     8) Attach the fill tube  28  to nozzle  16  and fill syringe  2  with clorhexidine by withdrawing the syringe plunger  3 . Follow previous instructions for steps 4 through 6 above, but do not evacuate after the last flush. 
     9) Dispose of all leftover liquids, devices and materials in a safe manner for contaminated products. Disinfect your hands, gloves and equipment before and after the procedure. 
     Special Note: The treatment procedure outlined above should be done immediately (preferably 10 to 15 sec.) after the tick is removed. Every second counts to keep the pathogen out of the blood circulatory system and possibly prevent primary and secondary infections as well. A deer tick usually does not expel the pathogen ( Borrelia spirochete ) until after the tick has been embedded for several hours (refer to the CDC website); that is why it is critical to routinely examine the skin for tick attachments. Once the pathogen has entered the blood stream, the interceptor will no longer be useful to prevent or disinfect for tick borne disease. It is recommended that a doctor be seen immediately after use of the interceptor for follow up treatment. 
     As the interceptor is applied to the wound area, the ends  21  of spreader arms  18  contact the skin  24  first and then spread outwards from wound  23  pulling the skin around wound  23  slightly taut thereby tightening or retracting the skin away from the wound. In the figures of this patent document, three such spreader arms  18  are shown. However, in alternative embodiments a greater or lesser number of spreader arms  18  may be used. The important feature is that the spreader arms result in forming and positioning the wound opening to permit more efficient irrigation and better accessibility. At the same time, this tightening in a direction away from the center of the wound allows small cracks and crevices to open in the skin in the immediate area of the wound within the splash guard perimeter so that the antipathogen solution can enter. Using an antipathogen such as chlorhexidine in the last flush leaves some of the fluid in the wound and surrounding area to possibly continue killing any residual pathogens. 
     Using the interceptor as described not only treats just the wound opening but also the entire area within the splash guard area which experiences the highest count of pathogens. This specific process aids to continually, over a period of time, kill pathogens that can gradually escape from tubular mouthparts of the tick that often break off in the wound and are not immediately retrieved during the tick removal process. Sometimes these deeply imbedded mouthparts are never retrieved. 
     Preferably, the distal end  7  of the splash shield  5  is transparent so the user can see the wound and guide the interceptor to exactly center nozzle  16  on wound  23  in order to topically flush, irrigate and evacuate the wound. Guide rings  8  help the user to visualize the placement of the nozzle  16  onto wound  23 . The splash guard  5  may be stored in a refrigerator to cool its distal end  7  that makes contact with the skin. Use of a cool splash guard may cool the skin in the immediate area of the wound to slow blood circulation in the immediate exposed capillaries to help contain the pathogen. This may contribute to a higher kill count of infection. 
     In an alternative embodiment shown in  FIG. 4 , the spreader and delivery assembly  13  has a female luer lock  25  fastened at the anterior end of tube  14 . The female luer lock  25  engages the male luer lock  26  of syringes that terminate with a male luer fitting thus permitting the spreader and delivery assembly  13  to be attached to and used with such syringes. Additionally, in yet another alternative embodiment, the nozzle  16  may be generally oval shaped in order to better approximate the shape of a wound. 
     The interceptor and method of the present invention provides a more thorough accessibility to the disease carrying organisms hidden in the hypostome salivary cement and the protein enhanced residuals that line the walls and the base of the wound. In the case of tick borne diseases like Lyme disease and Rocky Mountain spotted fever, these residuals add to the difficulty of making direct contact with the organisms. Use of the interceptor and the method may be applicable to other shallow insect wounds like spider bites as well as other small wounds not necessarily resulting from an insect bite. Alcohol in general has the capability to break down, denature and dilute proteins. In addition, the use of the interceptor and method of this invention could have a very significant impact on secondary infections. 
     Use of the interceptor is an alternative to traditional topical washing methods. The spreader arms and the nozzle of the interceptor are intended to overcome the natural inclination of the wound to close against the hypostome and protein salivary cement that impedes penetration of the antipathogen by increasing access of the antipathogen solution to the wound base and surrounding pores and crevices. 
     Those skilled in the art will appreciate that various modifications and alterations may be made to the device and method described in this patent document and such are considered to fall within the scope of this disclosure and appended claims. 
     APPENDIX “A” 
     The following are brief synopses of sources of tick related information: 
     Los Angeles County West Vector and Vector-Borne Disease Control 
     Do not twist or jerk the tick; this may cause mouthparts to break off and remain in the skin. Remove these with tweezers or infections may occur. Also, do not squeeze, crush or puncture the body of the tick. Its fluids (saliva, hemolymph, gut contents) may contain infectious organisms. Do not handle the tick with bare hands because infectious agents may enter through mucous membranes or breaks in the skin. 
     U.S. Army Center for Health 
     Ticks secrete a cement-like substance during feeding, securing the mouthpart (hypostome) to your wound wall, adding to removal difficulty. Do not squeeze, crush or agitate the tick because this may force infectious body fluids through the mouthparts into the wound. A secondary infection can occur. 
     Harvard Medical School 
     Improper removal methods can cause the tick to deposit more of its disease carrying secretions into the wound which increases the risk of infection. Try not to crush or squeeze the tick during the removal process. The tick deposits salivary cement into the wound. 
     Patient Information (Sources: Linden Hu, M.D., Allen C. Steere, M.D., Jennifer Mitty, M.D.) 
     Improper removal may cause the tick to act as a syringe, thereby injecting bodily fluids in the wound. Do not squeeze, crush or puncture the tick as the body fluids may contain infectious organisms. 
     Lymedisease.org 
     Broken off mouthparts can cause secondary infections so it is best to try to remove them. Do not squeeze or crush the body of the tick; this may force infected body fluids through the mouthparts into the wound. Do not agitate the tick by removal with liquids or heat. 
     MedicineNet.com (Source: William C. Shiel Jr., M.D. FACP, FACR) 
     Wear gloves; don&#39;t spread pathogens from the tick. Breaking of the tick increases the chance of infection. Crushing of the tick may release pathogens. Improper removal can cause the tick to release fluids into the wound, increasing the chances of transmitting disease. If the mouthparts and head remain in the wound, have them removed by a doctor. 
     Patient Information: Beyond the Basics (Sources: Linden Hu, M.D., Jennifer Mitty, M.D., MPH, Allen C. Steere, M.D.) 
     Improper removal may cause the tick to behave like a syringe, injecting into the wound. Do not squeeze, crush or puncture the body of the tick, since its body fluids may contain infectious organisms. 
     Managing Lyme Disease, 16 th  Edition, October, 2008, Page 36 (Patient Instructions) 
     Remove the tick; then apply antiseptic. Do not irritate them with heat or chemicals or grasp the body, as this may cause the tick to inject germs. Prophylactic antibiotic treatment is highly recommended if the tick was improperly removed. If the tick&#39;s contents made contact with the wound from the tick being squeezed, an infection could occur. 
     Centers for Disease Control 
     Use a set of fine-tipped tweezers to remove the tick. Don&#39;t twist or jerk the tick; this can cause mouthparts to break off. If this happens remove the mouthparts with tweezers. Thoroughly clean the bite area and your hands with rubbing alcohol.