Abstract:
The invention is a low cost means to use the patient&#39;s own antibodies against an infectious disease such as a HIV virus infection by surgically shunting the naturally-occurring saliva-borne antibodies into the patient&#39;s bloodstream. To do this, a small incision is made in the central portion of the cheek near an area where the parotid duct and a blood vessel are in close proximity. This area is located using a light source. Then the parotid saliva duct is cut and attached to a vein such that the saliva flows into and mixes with the blood. The portion of the duct leading to the mouth is sealed off, while the portion leading to the salivary gland is temporarily left open. The parotid blood vessel is then cut and a surgical tee is inserted. The parotid duct is attached onto the perpendicular outlet of the surgical tee and the outlet of the parotid duct thereby linking the blood vessel and the parotid salivary duct.

Description:
FIELD OF INVENTION  
         [0001]    The present invention relates generally to a surgical method for the delivery of saliva-borne antibodies produced by the body to the blood stream of the patient for the treatment of blood-borne infectious diseases such as the HIV virus.  
         BACKGROUND OF THE INVENTION  
         [0002]    Since recorded history, mankind has been attacked by infections diseases. The most recent disease to each monumental proportions is AIDS. AIDS was not formally identified as a disease until 1981. The human body has built-in mechanisms to handle the invasion by bacteria and viruses such as the HIV virus which causes AIDS.  
           [0003]    The uniqueness of the HIV virus is that it attacks the immune system itself. Since AIDS was identified, many forms of treatment have been tried. To date, most treatments involve large doses of medication aimed at either attacking the HIV virus or bolstering the body&#39;s immune system. These treatments are, as a general rule, extremely expensive and have only been able to delay, at best, the onset of AIDS. The expense is so high that the chemo treatment&#39;s availability has been limited to the areas that have the highest economic income.  
           [0004]    In rare cases, there has been the incidence of survival of a person infected with the HIV virus who has shown no effects of the disease. One theory that attempts to explain these phenomena is there may have been a mixing of saliva with the blood.  
           [0005]    Guy&#39;s, King&#39;s and St. Thomas&#39; Dental and Medical Schools, London, S. H. Kazmi et al has stated that saliva has demonstrated the ability to inhibit the replication of the HIV-1 in vitro. They quote studies that indicate that the factors that are responsible for the anti-HIV activity in saliva are from the effect of mucins (MG2), secretory leukocyte protease inhibitor (SLPI), cystatins, proline rich proteins, and lactoferrin.  
           [0006]    Sialochemists know a great deal about saliva. It is not only sterile, but it is well recognized that saliva has antimicrobial and antifungal properties. The average person produces 1.5 liters of saliva each day. This amount of saliva produced, of course, varies with several factors. For example, diet, age, AIDS itself, other medical conditions such as diabetes, and whether you are standing, eating, or sitting can each influence the amount produced. Since the HIV virus and other infectious diseases are spreading worldwide, and a naturally-produced substance by the body itself is available to use to attack the deadly virus, it should be used to fight that disease.  
           [0007]    In certain regions of the world today, as much as 35% of the population has been infected with the HIV virus. It is, therefore, necessary to find a means to make the maximum possible use of the body&#39;s own defense mechanisms to battle the HIV virus in a cost-effective way. This is possible with the instant invention.  
         SUMMARY OF THE INVENTION  
         [0008]    The instant invention solves the problem of expense by utilizing the body&#39;s own naturally-produced antibodies to attack the infection directly in the bloodstream.  
           [0009]    A small incision is made in the central portion of the cheek near an area where the parotid duct and a blood vessel are in close proximity. This area is located using a light source. Then the parotid saliva duct is cut and attached to a vein such that the saliva flows into and mixes with the blood. The portion of the duct leading to the mouth is sealed off while the portion leading from the salivary gland is temporarily left open. The parotid blood vessel is then cut and a surgical tee is inserted. The perpendicular outlet of the surgical tee is connected to the outlet of the parotid duct, thereby linking the blood vessel and the parotid saliva supply duct. This allows for the introduction of saliva which carries antibodies directly into the blood stream. Saliva itself assists in the operation in that it has an anti-clotting effect.  
           [0010]    The subject matter of the present invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. However, both the organization and method of operation, together with further advantages and objects thereof, may best be understood by reference to the following description taken in connection with accompanying drawings wherein like reference characters refer to like elements. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    [0011]FIG. 1 is an interior to the surface tissue side view of the human face illustrating the relative location of the parotid saliva duct an the parotid vein further illustrating the relative position of the ears, eyes, and lips to the target surgical location.  
         [0012]    [0012]FIG. 2 is an isometric view of the light wand illustrating the probe and probe tip.  
         [0013]    [0013]FIG. 3 is a side view of the human face illustrating the relative location of the parotid saliva duct opening into the oral cavity and further illustrating the relative position of the ears, eyes, and lips to saliva duct opening.  
         [0014]    [0014]FIG. 4 is a side view of the human face illustrating the relative location of the incision relative to the ears, eyes, and lips.  
         [0015]    [0015]FIG. 5 is an isometric view of the surgical tee.  
         [0016]    [0016]FIG. 6 is an isometric view showing the relative view of the points of insertion of the surgical tee into the parotid saliva duct and the parotid venal plexuses vein.  
         [0017]    [0017]FIG. 7 is a cross-sectional view of the serrated edge surgical tee embodiment along lines  7 - 7 .  
         [0018]    [0018]FIG. 8 is an isometric view of the “cut and glue” embodiment.  
         [0019]    [0019]FIG. 9 is an isometric view of the puncture surgical tee embodiment.  
         [0020]    [0020]FIG. 10 is a cross sectional view of an insertion plug embodiment of the surgical tee along lines  10 - 10 . 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0021]    Now referring to FIG. 1., the instant invention is a surgical method for the introduction of naturally-occurring saliva antibodies (not shown) directly into the bloodstream of the patient  1  by surgically directing the saliva flow  2  from a parotid saliva gland  3  into the blood  4  flowing in a selected parotid venal plexuses vein  5 . There is a wide range of embodiments for the instant invention. Specifically, there are two principal embodiments for the location of the surgery, and several involving the type of surgical tee used.  
         [0022]    The preferred embodiment is surgery to the outside surface of the face of the patient  1  using a surgical tee (not shown). Now referring to FIG. 2, the preferred method in either embodiment is to locate the area of the incision  23  using a light wand  9  or a strong source of hand held light such as a flashlight (not shown).  
         [0023]    Now referring to FIG. 2 and FIG. 3, the tip  11  of the probe  13  of the light wand is inserted into the parotid duct opening  15  up to the insertion point  17  indicated on the probe. Light from the probe  13  is visible on the surface of the face or on the interior surface of the cheek (not shown). Surgery follows the following steps:  
         [0024]    Step  1 : Preoperative Procedures  
         [0025]    The use of surgery to treat conditions internal to the tissue of the face is extremely well known in the art. The same preoperative procedures should be used as precedes any facial surgery. Consideration should be given to sterility of the operating form and the patient&#39;s  1  condition prior to the surgery. Unique to AIDS, due to the high concentration and occurrence in the undeveloped economic areas, is the need to perform this surgery in rural or even non-hygienic arenas. Following standard pre-surgical chemo-prophylactic treatment is always in order, but is not relevant to the instant invention.  
         [0026]    Step  2 : Locating the Surgical Area  
         [0027]    Still referring to FIG. 2 and FIG. 3, the ideal location to perform the surgery on the face of the patient  1  should be located. To do this, the top  11  of the probe  13  of the light wand  9  is inserted into the opening  15  of the parotid saliva duct  19  up to the point  17  indicated on the probe  13  that is indicated by the patient&#39;s parameters.  
         [0028]    The tip  11  of the probe  13  of the light wand  5  should be inserted far enough to illuminate the parotid saliva gland area  21 . The parotid saliva duct  19  is specifically located with respect to veins in the immediate area and can be located by the light produced by the light wand probe  13  shining in the tissue of the face area of the cheek  21  once the skin is incised to the proximate depth of the parotid saliva duct  19 .  
         [0029]    The age and size of the patient should be considered. The diameter of the light wand probe  13  can be adjusted to the size of the expected parotid duct  5  of the patient. Children will have a parotid ducts  5  typically from {fraction (1/10)} to ½ millimeters in diameter. Adults will have parotid ducts  5  typically from ½ to 1½ millimeters in diameter.  
         [0030]    Now referring to FIG. 5, while the exact location of the incision  23  will vary somewhat in its exact location, the general location will be just anterior to the duct opening  15  and can be predicted without use of the light wand to a reasonable degree of accuracy.  
         [0031]    The instant invention can be utilized without the light wand  9  in the event that it would become necessary. However, use of the light wand  9  can aid in reducing the size of the necessary incision  23  and the degree of skill required by the surgeon or skilled medical personnel, which is a highly desirable factor to the patient.  
         [0032]    The light wand  9  is the most accurate known means to find the best location for the surgical incision. However, a flashlight (not shown) placed inside the mouth will in some cases be enough to locate the venal plexuses vein  5  and the parotid saliva duct  19 .  
         [0033]    Surgery can be performed either inter or intra-orally. The preferred embodiment is surgery to the exterior of the face  7 . Interoral surgery will eliminate visible scarring, but creates other problems. Surgery inside the oral cavity is less sterile and more restricted in access. An additional disadvantage is that the interoral incision must pass through a muscle layer and has a greater probability of complications.  
         [0034]    Step  3 : Local Anesthesia  
         [0035]    Now referring to FIG. 4, the area of the incision  23  should be anaesthetized. This is typically done by using standard dental techniques using a 30 gage short needle and a cartridge of dental anesthetic in an aspirating dental syringe, injected at or anterior into the parotid duct  19 . Use of anesthetic is well known in the art.  
         [0036]    Step  4 : Sterilization of Surgical Area  
         [0037]    Still referring to FIG. 4, the area of the incision  23  should typically be sterilized using an iodine swab and is also well known in the art. Now referring to FIG. 5, the surgical tee  25  should also be sterilized prior to introduction into the patient  1 . The surgical tee has a first end  33 , second end  35 , and a perpendicular end  27 .  
         [0038]    Step  5 : Opening of Surgical Area  
         [0039]    Referring to FIG. 4, the surgical area  21  should typically be opened with a #2 scalpel blade to create the incision  23 . The incision  23  should be through the full thickness of the skin and carefully dissected posterior to any blood vessels, down into the parotid gland saliva duct  19 , illuminated by the light wand  9 . Now referring to FIG. 6, the parotid saliva duct  19  is then separated from the surrounding tissue with blunt dissection thereby forming a distal end  19   a  and a proximal end  19   b.    
         [0040]    Step  6 : Removal of the Light Wand  
         [0041]    The light wand  9  can be removed at this point, or it can be left in to assist the surgeon in identifying the parotid saliva duct  19  which is clear. Care is typically required in locating the parotid saliva duct  19 . For most surgeries, it would be helpful to leave the light wand  5  in place at this step in the procedure. A strong internal light source, not shown, can be used to further illuminate the surgical area.  
         [0042]    Step  7 : Selection of Vein  
         [0043]    Still referring to FIG. 6, within the surgical area  21  in an area exposed by the incision  23 , a parotid venal plexuses vein  5  should be selected and isolated by blunt dissection in the area anterior to the incision  23 . The portion of the parotid plexuses vein  5  should be one that is in close proximity to the parotid saliva duct  19 . Severing the parotid venal plexuses vein  5  creates a first vein end  6   a  and a second vein end  6   b.  The first vein end  6   b  having a first vein opening an the second vein end  6   c  having a second vein opening  6   d.    
         [0044]    Now referring again to FIG. 5, enough area around the parotid venal plexuses vein  5  should be clear enough to enable the insertion of a surgical tee  25  or other connection means between the parotid venal plexuses vein  5  and the parotid saliva duct  19 .  
         [0045]    Step  8 : Severing of the Parotid Saliva Duct  
         [0046]    If not already removed, the light wand  9  should be removed at this point. The parotid saliva duct  19  is severed at this time using a suture scissors (not shown) forming a distal end  19   a  and a proximal end  19   b.  The point of severing the parotid duct should be as far anterior as possible.  
         [0047]    Step  9 : Insert Connector into Parotid Duct  
         [0048]    Now referring to FIG. 5 and FIG. 6, in the preferred embodiment, the next step is to insert the third tee end  27  of the tee  25  into the proximal end  19   a  of the parotid saliva duct  19  and occlude the distal end  19   b  of the parotid saliva duct  19  using standard surgical procedures such as cauterization, suturing, clamping, or cyanoacrylate type adhesive. The method of occluding is not relevant to the instant invention.  
         [0049]    Step  10 : Sever Selected Vein  
         [0050]    Still referring to FIG. 6, double clamp the vein lateral to and before severing ends  6   a  and  6   b  of the selected parotid plexuses vein  5 . Sever the parotid plexuses vein  5  between the clamps forming the first vein opening  6   c  and the second vein opening  6   d.    
         [0051]    Step  11 : Connection of Vein and Parotid Duct  
         [0052]    Insert the first tee end  33  and the second tee end  35  of the tee into the severed ends of the plexus vein at  6   c  and  6   d.  Next, secure the ends of the vein to the surgical tee  25  using standard surgical procedures such as suturing, clamping, or cyanoacrylate adhesive. At this point, the saliva produced by the parotid saliva gland  3  can enter into the blood flowing through the parotid plexus vein  5 .  
         [0053]    It should be noted that it is not material to the invention whether the duct connections or the vein connections are made first.  
         [0054]    Step  12 : Close Incision  
         [0055]    The final step in the surgical procedure is to remove the clamps and check for leakage of fluids from either the vein  5  or duct  19  connections. Once no leakage is confirmed, then the incision is closed with sutures such as 000 silk or absorbable sutures which are well known in the art.  
         [0056]    Step  13 : Post Operative Procedure  
         [0057]    Any opening of the human body requires postoperative care. This is well known in the art and is not relevant to the instant invention. Typically, the sutures should be removed in five to seven days. Any signs of infection should be treated by medically-trained personnel.  
       ALTERNATIVE MEANS OF DUCT-VEIN CONNECTIONS  
       [0058]    The preferred embodiment described above is the preferred means to connect the parotid venal plexus vein  5  to the parotid saliva duct  19 . However, other embodiments are possible. One such embodiment is the use of sewing the exposed ends of vessels and duct together in the common method that is well known in the art.  
         [0059]    Use of Serrated Surgical Tee  
         [0060]    Now referring to FIG. 7, another embodiment is the use of a serrated surgical tee  25  whose outer surfaces are covered with serrated edges that are sloping toward the surgical tee&#39;s  25  center area. These edges will facilitate the holding of the ends of the parotid venal plexus vein onto the serrated surgical tee  25 . Depending upon what is needed, any of the surgical tee ends  27 , 33 , 35  can be serrated or unserrated. Once inserted, the sewing or gluing should still be used.  
         [0061]    Cut and Glue Method  
         [0062]    Now referring to FIG. 8, yet another embodiment of the instant invention is using sewing or glue without a surgical tee  25 . The parotid venal plexus vein  5  is incised creating a vein opening  81  to the approximate diameter of the parotid saliva duct  19 , and the proximal end  19   a  is inserted into the vein opening  81 . The distal end  19   a  of the parotid saliva duct  19  is then fixed into the parotid venal plexus vein  5  using sewing or glue or any other commonly-used procedure that is known in the art.  
         [0063]    Insertion Tee Embodiment  
         [0064]    Now referring to FIG. 9 and FIG. 10, the insertion tee embodiment is illustrated. The insertion tee  91  has three parts: the plunger  93 , the serrated screw attachment  95 , and the lance  97 , having a penetrating tip  97  which has a sharp tip  99 . To use the insertion tee  91 , the plunger  93  is inserted into the serrated screw attachment  95  to the point of full insertion. When the plunger  93  is fully inserted, a sharp tip  99  will protrude from the vessel end  101  of the insertion tee  91 . The medical personnel performing the procedure will push the sharp tip  99  into parotid venal plexus vein  5 .  
         [0065]    Once the parotid venal plexus vein  5  is punctured, the serrated screw attachment  95  will be rotated until the flange  103  rests snugly against the parotid venal plexus vein  5  surface. The preferred method in use of the insertion tee  91  is to use threading  105  as in a common wood or metal screw, to made the flange  103  fit snugly again the venal plexus vein  5 . The threading  105  of the serrated screw attachment  95  will affix the insertion tee  91  into the parotid venal plexus vein  5  up to the point of the flange  103 .  
         [0066]    Once in place, the serrated tee  25  can be placed into the blunt dissected end of the parotid duct  19   a  and sealed in place using standard surgical procedures. The serrated edges  107  of the serrated screw attachment facilitates sealing the parotid duct  5  to the surgical tee  25 .  
         [0067]    Other Tee Embodiments Possible  
         [0068]    Additionally, other embodiments are possible such as the use of different materials. Whatever materials that are used must be biocompatable and not cause blood clotting. Expected composition of surgical tees includes plastics, ceramics, and metals such as stainless steel or titanium embodiments.  
       LIGHT WAND CONSTRUCTION  
       [0069]    Now referring to FIG. 2, the light wand  9  needs to be readily portable and capable of being held in the hand of the medical personnel utilizing the instant invention. The light wand body  20  of the light wand  9  should contain a power source such as batteries. The production of light from a hand held power source is similar to that of a common flashlight or fiber optic light and is well known in the art.  
         [0070]    Out of the forward end  22  of the light wand body  20 , a probe  13  will extend approximately the length of distance from the forward end  22  of the light wand body  20  when held near the mouth, approximately three to five centimeters beyond the expected location of the parotid duct opening  15 . The probe should be constructed of light conductive material such as fiber-optic materials. The tip of the probe  11  should be rounded and tapered to allow for easy insertion of the probe and to allow for naturally-occurring variances in parotid duct size. Also, from the insertion point  17  to the tip  11  could be frosted so that light leaves the frosted area  19  well as the tip  11 .  
         [0071]    In the more isolated areas, commonly-used luminescent materials such as phosphorous latent plastic can be used as a probe  11  instead of a power-generated light source. Proper care should be taken to ensure sterility and non-contamination of the patient  1 .  
       SALIVA PRODUCTION REQUIREMENTS  
       [0072]    Obviously, for the instant invention to work, there must be adequate saliva production. The production of saliva depends upon many factors. For example, AIDS itself inhibits the production of saliva. Other medical conditions such as diabetes, other diseases and advanced age can reduce the amount of saliva that is produced by the patient  1 . Also, the maximum amount of saliva is produced when the patient is sitting or eating.  
         [0073]    AIDS limits the amount of saliva produced in the later stages. Therefore, the earlier the instant invention is used once AIDS is detected, the more benefit it should be expected to be. Consequently, in the later stages of AIDS, conventional medication should be used to stabilize the patient prior to the surgery being conducted.  
       OTHER EMBODIMENTS POSSIBLE  
       [0074]    While several embodiments of the present invention have been shown and described, it will be apparent to those skilled in the art that many changes and modifications may be made without departing from the invention in its broader aspects.