Patent Abstract:
A method and device for controlling the pain of a periodontal ligament injection, and other minor medical and dental procedures. The device desensitizes the tissues utilizing cold, vibration, or both. The method is useful for injections, small biopsies, intraosseous drilling, blood sampling, and so on.

Full Description:
BACKGROUND 
       [0001]    1. Field of Invention 
         [0002]    This invention relates to medicine and dentistry, specifically to desensitization of tissues required in association with traumas. 
         [0003]    2. Description of Prior Art 
         [0004]    In medicine and dentistry, tissues are frequently subjected to traumas, such as periodontal ligament injections, intraosseous injections, general tissue injections, drawing blood, glucose tests, biopsies, lancing abscesses, and so on. Typically the tissues involved are the skin or mucosa epithelial and subepithelial tissues. However, the periosteum, and other tissues may also be involved. 
         [0005]    For the descriptions herein, an instrument causing any trauma is called a sharp, and traumas are called punctures. Sharps include needles, aspirators, scalpels, biopsy punches, biopsy brushes, intraosseous perforators, lancets, and so on. 
         [0006]    There are several methods of desensitizing tissues prior to puncture. These methods include the use of topical chemical anesthetics, Transcutaneous Electrical Nerve Stimulation (TENS), pressure, vibration, cooling, and so on. 
         [0007]    A first method of desensitizing involves applying and removing the desensitizing means from the puncture area immediately prior to the puncture. Examples include the use of DentiPatch (Noven) anesthetic patches, pressing ice or a cold instrument to directly cool the site, and devices of U.S. Pat. Nos. 5,639,238, 5,839,895, 5,873,844 and US Pat Appl 2006/0217636. With anesthetic patches, substantial time is required. With the ice or cold instruments, the method is somewhat awkward. 
         [0008]    A second method of desensitizing involves applying cold, vibration, pressure, or other desensitizing means along one side of the puncturing site immediately prior and during the puncture. Examples include pressing on the tissues with a blunt instrument during the puncture, such as a dental mirror handle or a Pressure Anesthesia Device (U.S. Pat. No. 5,171,225). 
         [0009]    A third method of desensitizing involves applying pressure to tissues substantially surrounding the puncture area immediately prior to and during the puncture. For example, pressure is maintained on the tissues with a Palatal Anesthesia Device (U.S. Pat. No. 5,088,925) while inserting a needle into the central lumen of the device. 
         [0010]    A fourth method of desensitizing involves applying negative pressure to tissues prior and during puncture (U.S. Pat. No. 2,945,496). 
         [0011]    A fifth method involves cooling the puncture area prior to puncturing the tissues. A first cooling method involves directing a vapocoolant aerosol spray onto the puncture area prior to a puncture. An example is Freeze aerosol spray (Hagar Worldwide). To avoid frostbite, only moderately cold vapocoolants may be used when spraying directly onto the tissues. A second cooling method involves applying the cold side of a Peltier electrode to the puncture area prior to a puncture. 
         [0012]    A sixth method involves placing TENS electrodes near the puncture area and applying current during the puncture (U.S. Pat. No. 5,496,363). 
         [0013]    A seventh method of desensitizing involves vibrating the sharp during the puncture (U.S. Pat. Nos. 5,401,242, 5,647,851). For example, a VibraJect (VibraJect LLC) is connected to vibrate a syringe during an injection to activate a pain-gate response (U.S. Pat. No. 6,602,229). 
         [0014]    An eighth method of desensitizing involves vibrating the tissues adjacent to the puncture area (U.S. Pat. Nos. 2,258,857, 3,620,209, 6,231,531, &amp; EP1535572). 
         [0015]    A ninth method of desensitizing involves applying topical anesthetic gels or liquids to the tissue for a substantial time, and puncturing the tissue through the residual anesthetics. 
         [0016]    A tenth method of desensitizing involves stretching the puncture area (US Pat Appl 2006/0211982). 
         [0017]    An eleventh method of desensitizing involves pinching the skin surrounding the puncture area (EP1535572) 
         [0018]    A twelfth method of desensitizing involves applying heat to the puncture area prior and during the puncture (US Pat Appl 2006/0217636). 
         [0019]    A thirteenth method of desensitizing involves applying cold to a puncture area prior and during the puncture with a non-absorbent surface (US Pat Appl 2006/0106363). 
         [0020]    The above tissue desensitization methods suffer from one or more of a number of disadvantages:
       (a) Pain control achieved is slight to moderate   (b) Method requires excessive time   (c) Method is awkward       
 
       SUMMARY OF THE INVENTION 
       [0024]    The invention is a method and device for reducing pain associated with sharps used to puncture tissues, as well as for saving time. 
         [0025]    In a typical embodiment, the device comprises an injector handpiece desensitizing system, similar to the self-contained intraosseous injection systems. The system desensitizes the tissue surface with vibrations and/or cooling, and then injects a medicament with a hollow drill bit, such as a local anesthetic. 
         [0026]    The part of the system that desensitizes the tissues with vibrations and cooling is called the topical press. Cooling and vibrating of tissues are both known to reduce nerve-pain transmission. 
         [0027]    In addition, vibrations can increase the rate of diffusion of a medicament into the tissues. For the purposes of this discussion, it can be assumed that a topical press can vibrate tissues, cool tissues, or both vibrate and cool tissues, unless called a vibrating press or a cooling press. 
         [0028]    In another embodiment, the device comprises a needle device desensitizing system with a connected topical press. In another embodiment, a needle device is used with a topical press that comprises a separate brace for vibrating limbs. 
         [0029]    For use with non-mechanized sharps like syringes and glucose lancets, topical presses are connected to separate instruments. 
       OBJECTS AND ADVANTAGES 
       [0030]    Accordingly, several objects and advantages of my invention and process are to provide pain control for tissue puncture:
       (a) at a high comfort level   (b) without substantial tissue damage   (d) using a simple method   (e) rapidly       
 
         [0035]    Further objects and advantages are to tissue provide pain control of short duration, so that the tissue sensation is normal soon after the procedure. Still further objects and advantages will become apparent from a consideration of the ensuing description and drawings. 
     
    
     
       DRAWING FIGURES 
         [0036]    In the drawings, closely related figures have the same number, but different alphabetic suffixes. 
           [0037]      FIG. 1  is a perspective view of a drill injector with a slotted topical press-head detail. 
           [0038]      FIG. 2  is a perspective view of a drill injector bit. 
           [0039]      FIG. 3  is a cutaway view of a drill injector and topical press. 
           [0040]      FIGS. 4A to 4E  show embodiments of a topical presses. 
           [0041]      FIG. 4A  is a perspective view of a disc press. 
           [0042]      FIG. 4B  is a perspective view of a segmented topical press. 
           [0043]      FIG. 4C  is a cross-section view of a sharp cap. 
           [0044]      FIG. 4D  is a cross-section detail of a sharp cap lock. 
           [0045]      FIG. 4E  is a perspective view of a sharp tip press. 
           [0046]      FIGS. 5A to 5E  show embodiments of topical press covers. 
           [0047]      FIG. 5A  is a top view of a slotted cover for a slotted press. 
           [0048]      FIG. 5B  is a top view of a full cover for covering a receiver press. 
           [0049]      FIG. 5C  is a perspective view of a slot pad for covering the tissue side of a slotted press. 
           [0050]      FIG. 5D  is a perspective view of a full pad for covering the tissue side of a receiver press. 
           [0051]      FIG. 5E  is a perspective view of a lumen pad for covering the tissue side of a receiver press. 
           [0052]      FIG. 5F  is a perspective view of a bandage cover for covering a topical press. 
           [0053]      FIG. 6  is a cross-sectional view of an injection device. 
           [0054]      FIGS. 7A and 7B  show embodiments of a brace press. 
           [0055]      FIG. 7A  is a perspective view of a brace press. 
           [0056]      FIG. 7B  is a perspective view of a segmented brace press. 
           [0057]      FIGS. 8A to 8C  show handheld topical presses. 
           [0058]      FIG. 8A  is a perspective view of a massager press. 
           [0059]      FIG. 8B  is a perspective view of a hand instrument topical press with a vibrator 
           [0060]      FIG. 8C  is a perspective view of a hand instrument topical press. 
       
    
    
     REFERENCE NUMERALS IN DRAWINGS 
       [0061]      
         [0000]    
       
         
               
               
               
               
             
           
               
                   
               
             
             
               
                 10 
                 sharp 
                 12 
                 injector 
               
               
                 14 
                 handpiece 
                 16 
                 slot 
               
               
                 18 
                 actuator 
                 20 
                 bit 
               
               
                 22 
                 flutes 
                 24 
                 shank 
               
               
                 26 
                 groove 
                 28 
                 flat 
               
               
                 30 
                 tube 
                 32 
                 bore 
               
               
                 34 
                 orifice 
                 36 
                 shoulder 
               
               
                 38 
                 disc 
                 40 
                 receiver 
               
               
                 42 
                 segment press 
                 44 
                 cap 
               
               
                 46 
                 absorbent 
                 48 
                 barrel 
               
               
                 50 
                 first position lock 
                 52 
                 third position lock 
               
               
                 54 
                 male lock ring 
                 56 
                 tip press 
               
               
                 58 
                 slot cover 
                 60 
                 full cover 
               
               
                 62 
                 slot pad 
                 64 
                 adhesive 
               
               
                 66 
                 full pad 
                 68 
                 lumen pad 
               
               
                 70 
                 bandage 
                 72 
                 spot 
               
               
                 74 
                 stack 
                 76 
                 backing 
               
               
                 78 
                 needle device 
                 80 
                 brace 
               
               
                 82 
                 access 
                 84 
                 anchor 
               
               
                 86 
                 segment brace 
                 88 
                 massager 
               
               
                 90 
                 handle 
               
               
                   
               
             
          
         
       
     
       DESCRIPTION 
     FIGS.  1  to  8   
       [0062]    According to one aspect, the invention provides methods for puncturing tissues with a sharp. 
         [0063]    A first tissue puncture method for injecting medicament into the periodontal ligament of a tooth comprises the steps of puncturing the tissues by drilling into the ligament with a drill bit having a central bore, injecting medicament through the bore and into the ligament, and removing the bit from the ligament. 
         [0064]    It is preferred that a vibrating and/or cooling topical press desensitizes the tissues prior to an initial puncture. The topical press vibrations are generally in a frequency range of 2 Hz to 200 Hz, but the preferred frequency is between 25 Hz and 45 Hz. The topical press may be cooled by exposure to cold liquids, gasses, or solids, such as cold air in a freezer, refrigerated beads, water cooled to +0.5° C., propylene glycol cooled below 0° C., CO 2  ice, aerosolized CO 2  ice crystals, refrigerants, vapocoolant aerosols, and so on. Suitable vapocoolants have a boiling point between +15° C. and −100° C., with preferred boiling points between +5° C. and −30° C., such as 1,1,1,2-tetrafluoroethane, dichlorotetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,3,3,3-hexafluoropropane, vapocoolant blends, and so on. 
         [0065]    It is preferred that medicament is pumped through the bore while the bit is drilling into the ligament to substantially prevent clogging of the bore with debris. 
         [0066]    A second tissue puncture method comprises the steps of supporting a sharp with respect to a topical press, vibrating and/or cooling a tissue puncture area with a topical press, or cover thereof, puncturing the tissues with a sharp at a puncture point within the vibrating and/or cooled puncture area, and withdrawing the sharp from the puncture point. 
         [0067]    A third tissue puncture method comprises the steps of supporting a sharp with respect to a topical press, the topical press having a receiving surface having an opening therethrough for passage of the sharp, directly vibrating and/or cooling a tissue puncture point with the topical press or cover thereof, puncturing the vibrating and/or cooling tissues at the puncture point with a sharp, and withdrawing the sharp from the tissues. 
         [0068]    A fourth tissue puncture method comprises the steps of supporting a sharp with respect to a topical press surface or cover thereof, directly vibrating and/or cooling a tissue puncture point with the topical press or cover thereof, puncturing the topical press surface or cover thereof, puncturing the vibrating and/or cooling tissue puncture point with a sharp, and withdrawing the sharp from the tissues. 
         [0069]    A fifth tissue puncture method comprises the steps of directly vibrating and/or cooling a tissue puncture point, puncturing the vibrating and/or cooling the tissue puncture point with a sharp, and withdrawing the sharp from the tissues. 
         [0070]    A sixth tissue puncture method comprises the steps of vibrating a tissue area which substantially encompasses a puncture point, puncturing the vibrating tissue area at the puncture point with a sharp, and withdrawing the sharp from the puncture point. 
         [0071]    A seventh tissue puncture method comprises the steps of cooling a tissue area which substantially encompasses a puncture point utilizing an coolant-absorbent surface, puncturing the cooling puncture point with a sharp, and withdrawing the sharp from the puncture point. 
         [0072]    A eighth tissue puncture method comprises the steps of cooling a tissue puncture area with a cold topical press or cover thereof, inserting a sharp into and through the topical press and into the cooling tissues of the puncture area, and withdrawing the sharp from the tissues. 
         [0073]    For the purposes of this discussion, in general, a sharp used to puncture the tissues is called a sharp  10 , including needles, intra-osseous anesthesia drills, lancets, and so on. 
         [0074]    According to another aspect of the invention, there is provided a sharp for injecting the periodontal ligament of a tooth, injector  12 , as shown in  FIG. 1 . Injector  12  is a type of sharp  10 . Injector  12  is shown connected to a motorized injector handpiece, handpiece  14 , of the type shown in US Pat Appl 2006/0106363. A type of topical press, slot  16 , is shown connected to handpiece  14  for desensitizing the tissues for injector  12 . Slot  16  is a disc-shaped topical press configured with a slot open to the perimeter. 
         [0075]    It is preferred that slot  16  is supported with respect to handpiece  14  by a resiliency means. The resiliency means applies pressure on slot  16  away from handpiece  14  and over a limited distance. An example of a resiliency means is a spring, and elastic part, and so on. As such, after slot  16  contacts a puncture area, handpiece  14  may advance toward the tissues by compressing the resiliency means. 
         [0076]    Also shown is a cooling and/or vibrating means, actuator  18  for cooling and/or vibrating any topical press, such as slot  16 . For handpiece  14 , it is preferred that actuator  18  is an offset-weight vibrator with linkage to the handpiece  14  motor. However, actuator  18  may have a dedicated motor and power source. It is preferred that actuator  18  is located in the proximity of the topical press. However, actuator  18  may be located in proximity to the motor, or other locations. 
         [0077]    In the preferred embodiment of injector  12 , the distal portion of injector  12  comprises a bit, bit  20 , for penetrating into the ligament, as shown in  FIG. 2 . The surface of bit  20  is substantially covered with spiraling serrations, flutes  22 . Bit  20  is tapered from a sharp point at the distal tip to the widest point proximal to a cylindrical shank, shank  24 . Toward the proximal end of shank  24  is a groove, groove  26 , and a drive facet, flat  28 , for engaging the drive mechanism of handpiece  14 . On the proximal end of shank  24  is a hollow tube, tube  30 , for connecting to a medicament source. Tube  30  has a central bore, bore  32 . Bore  32  extends continuously from the proximal tip of tube  30  through shank  24 , and through at least a portion of bit  20 . An orifice, orifice  34 , communicates from the surface of bit  20  to bore  32 . 
         [0078]    It is preferred that bore  32  ends at orifice  34  a given distance from the distal tip of bit  20  so that bit  20  has a solid core in the tip portion to reduce the risk of fracture. However, bore  32  may extend to the distal tip of bit  20 . It is preferred that bit  20  is comprised of nickel-titanium alloy, and has a taper between 0.02 and 0.04. However, bit  20  can be of greater or lesser taper, and may be comprised of other materials. 
         [0079]    It is preferred that a non-fluted area of enlarged diameter, shoulder  36 , is located at the junction of shank  24  and bit  20 . In use, bit  20  penetrates the tissue to the level of shoulder  36 , and shoulder  36  presses against the gingiva to provide a fluid seal against backpressure leakage of injected medicament from the ligament puncture. 
         [0080]    It is preferred that the medicament is onboard handpiece  14 . However, the medicament may be located remotely from handpiece  14 . It is preferred that medicament is pumped by handpiece  14  by an automatic pump mechanism. However, a manual pump may be used. 
         [0081]      FIG. 3  shows a slot  16  desensitizing the tissues and an injector  12  penetrated into the periodontal ligament of a tooth. Shoulder  36  is shown pressing into the tissues to form a seal to fluid backpressure. An actuator  18  is connected to handpiece  14 . The connection of slot  16  to handpiece  14  has slidingly permitted handpiece  14  to move closer to slot  16  as injector  12  penetrates the ligament. 
         [0082]      FIGS. 4A to 4F  shows embodiments of the topical press. In general, a topical press comprises at least a structural surface, called a tissue surface, configured to contact the surface of the tissues, wherein the topical press may be vibrated and/or cooled while in contact with the tissues to desensitize the tissues. 
         [0083]    The topical press may comprise a single unitary press, or may comprise multiple segments. The preferred overall geometrical shape of a topical press varies with the application, such as straight segments, curved segments, a disc, a slotted disc, and so on. 
         [0084]    It is preferred that the topical press tissue surface is smooth and convex. However the tissue surface may be substantially flat, concave, irregular, corrugated, porous, fibrous, and so on. It is preferred that the topical press is comprised of stainless steel. However, the topical press may be comprised of other metals, plastic, composites, ceramic, elastomers, wood, absorbent material, fibrous material, fibrous material at least partly impregnated with a hardener, fibrous material on a hard backing material, any combination of a fibrous material and another material, and so on. 
         [0085]      FIG. 4A  shows a disc-shaped topical press, disc  38 , having an open passage, receiver  40 , to receive the entry of a sharp  10  into the tissues beyond. In  FIG. 4A , receiver  40  is funnel-shaped. 
         [0086]      FIG. 4B  shows a segmented topical press, segment press  42 , comprised of adjacent segments for contacting the tissues. It is preferred that the segment press  42  segments have a simple connection to actuator  18 . However, the segment press  42  segments may be connected to actuator  18  by a tunable vibratory phase means. As such, the vibrations of either segment may be tuned to be in or out of phase relative to the other segment to influence tissue desensitization. 
         [0087]      FIG. 4C  shows a topical press configured as a cap for a sharp  10 , cap  44 . Sharp  10  is able to pass through the distal end of cap  44  to puncture the tissues. The distal end of cap  44  is penetrable by sharp  10 , such as by sharp  10  penetrating a thin area of cap  44 , by penetrating a fibrous area of cap  44 , by penetrating a porous area of cap  44 , by entering a pre-existing minimally-sized receiver  40  in cap  44 , by pushing open a small flap, and so on. 
         [0088]    It is preferred that at least the exterior surface of the distal end of cap  44  is comprised of an absorbent material, absorbent  46 , which is absorbent of coolants, such as a gauze, felt, other fibrous materials, porous materials, and so on. 
         [0089]    For a cap  44  associated with a syringe, it is preferred that the syringe barrel, barrel  48 , is stored in a first position with respect to cap  44 . Barrel  48  may telescope into cap  44 , thereby causing sharp  10  to penetrate the tip of cap  44 , extend distally from cap  44 , and thereby penetrate the tissues to a second position. Barrel  48  may be telescopically withdrawn from cap  44 , thereby withdrawing sharp  10  from the tissues and retracting sharp  10  entirely into cap  44 , and cap  44  locks into barrel  48  in a sharp-retracted third position. With cap  44  locked into barrel  48 , sharp  10  cannot be moved distally again. However, cap  44  may be elastically compressible between an advancing barrel  48  and the tissues, and elastically reboundable as the barrel  48  withdraws so as to cover sharp  10 , and so on. 
         [0090]    It is preferred that cap  44  remain in contact with the tissues until after sharp  10  is entirely withdrawn into cap  44 . As such, the procedure can be completed without sharp  10  being exposed to the user or the patient. In addition, cap  44  facilitates containment of bodily fluids, such as droplets that may be released as sharp  10  withdraws from the tissues. 
         [0091]    It is preferred that cap  44  has a locking mechanism with barrel  48 , first position lock  50 , and third position lock  52 . A male lock component, male lock ring  54 , is at the distal end of barrel  48 . First position lock  50  is a female locking portion that permits male lock ring  54  to release and slide toward distal end of cap  44 , such that sharp  10  protrudes through cap  44  and into the tissues at the second position for barrel  48 . When the barrel is retracted and moving in a proximal direction, male lock ring  54  slides past first position lock  50 , and expands into third position lock  52 . The inclined plane of female third position lock  52  mates with the plane of male lock ring  54 , preventing the release of male lock ring  54  either proximally or distally. Cap  44  is shown releasably locked with the first position lock  50  engaged with barrel  48 . 
         [0092]      FIG. 4D  shows a cap  44  after retracting sharp  10  through receiver  40  and into cap  44 . Cap  44  has slid over first position lock  50 , and is non-releasably locked with barrel  48  in third position lock  52 . The inclined plane of female third position lock  52  mates with male lock ring  54 , preventing the release of male lock ring  54  either proximally or distally. Absorbent  46  shows at the end of cap  44 . 
         [0093]      FIG. 4E  shows a topical press configured for connecting to the tip of a sharp  10 , a tip press  56 . The receiver  40  of tip press  56  is configured to securely connect to the sharp  10  tip, such as by having a cylindrical configuration with a lumen of specified diameter, an elongated cylindrical lumen where the cylinder protrudes substantially above the surface, or a similar lumen. Tip press  56  may also comprise a protective cover for sharp  10 . Absorbent  46  covers the distal end of tip press  56 . 
         [0094]    It is preferred that tip press  56  provides a degree of resistance to sharp  10  penetration. As such, when sharp  10  is pushed toward the tissues, tip press  56  is first pressed onto the tissue surface prior to sharp  10  pushing through tip press  56  and into the tissues. Configurations of receiver  40  which provide penetration resistance include a lumen of a specific diameter, a lumen with a diameter constriction, a cone with a central lumen, a cone having visualization slits in the side that are open to a central lumen, an area of receiver  40  that is sufficiently thin to be penetrable by a sharp  10 , and so on. For a tip press  56  with a penetrable thin area, an open lumen is not formed until after the sharp  10  penetrates receiver  40  to form a lumen. 
         [0095]    For some applications, it is preferred that at least a portion of the topical press is covered by a cover.  FIGS. 5A to 5D  show preferred covers for the topical press. It is preferred that covers are comprised of an absorptive, fibrous material. However, the cover may be comprised of plastic, metal, or composites, and so on, and may be arranged in strands, sheets, mesh, foil, fabric, and so on. 
         [0096]    A cover fitted to cover slot  16 , slot cover  58 , is shown in  FIG. 5A . Slot cover  58  facilitates visualization of the sharp  10 , and permits removal of the topical press from the mouth prior to removal of the sharp  10 . 
         [0097]      FIG. 5B  shows a full cover, full cover  60 , for covering a topical press, such as disc  38 . It is preferred that full cover  60  has no central lumen. However, full cover  60  may have a lumen that aligns with receiver  40  of disc  38 , or a lumen may be made by the user before or after placement on disc  38 . Full cover  60  may also be used to cover slot  16  to combine advantages of both. As such, full cover  60  may be used to vibrate and/or cool a puncture point, yet slot  16  can be withdrawn from sharp  10  by sliding out of full cover  60  while full cover  60  remains punctured by sharp  10 . 
         [0098]      FIG. 5C  shows a cover configured to cover only the tissue side of slot  16 , slot pad  62 . Slot pad  62  is comprised of absorbent materials such as woven material, felts, fibrous material, porous materials, mesh, and so on. Slot pad  62  facilitates visualization of the sharp  10 , and permits removal of slot  16  from the puncture area at anytime. It is preferred that slot pad  62  is connected to slot  16  by an adhesive coating, adhesive  64 . However, slot pad  62  may connect with molded snaps that grasp the edges of the slot or the outer perimeter of slot  16 , and so on. 
         [0099]    A cover which covers only the tissue side of disc  38 , full pad  66 , is shown in  FIG. 5D . Full pad  66  is comprised of absorbent materials that permit penetration of a sharp  10  through full pad  66  and into the tissues, such as woven material, felt, fibrous material, foil, sheets, mesh, and so on. It is preferred that full pad  66  is connected to segment press  42  by adhesive  64 . However, full pad  66  may connect with molded snaps that grasp the edges of the receiver  40  lumen or the outer perimeter of segment press  42 , and so on. Full pad  66  may also simultaneously connect to the separate bars of segment press  42 . 
         [0100]      FIG. 5E  shows a pad with a central lumen, lumen pad  68 , connected to disc  38 . The central lumen of lumen pad  68  may be aligned with receiver  40  when connected to disc  38 . It is preferred that lumen pad  68  is connected to disc  38  by adhesive  64 . However, lumen pad  68  may connect with molded snaps that grasp the edges of the lumen or the outer perimeter of disc  38 , and so on. 
         [0101]      FIG. 5F  shows a topical press cover designed to remain over an extraoral puncture area after withdrawal of sharp  10 , bandage  70 . Bandage  70  has a first side and a second side, wherein the first side contacts the tissues, called the tissue side, and the second side is away from the tissues, called the top side. A substantial portion of the tissue side is coated with adhesive  64  to facilitate adhesion to the tissues prior, during, and after the puncture. 
         [0102]    It is preferred that bandage  70  has at least one adhesive-coated area on the top side, spot  72 , so as to facilitate adhesion of a bandage  70  to the topical press. It is further preferred that a multiplicity of spots  72  are spaced along the top side perimeter. When a bandage  70  having adhesive  64  and spots  72  are adhered to the topical press is pressed into contact with the tissues, the topical press is thereby transferred to the tissue and adhered to the tissue. 
         [0103]    The topical press vibrates the tissues with a higher efficiency than substantially planar vibrators. As the topical press depresses the tissue surface, it nests into the tissue due to a relatively small footprint, thereby engaging the tissue. The topical press vibrations therefore push, pull and massage the tissue, rather than simply sliding or rapping on the surface. 
         [0104]    When bandage  70  adheres the topical press to the tissues, the vibration efficiency is further enhanced. Adhered bandage  70  adhesively connects the topical press to the tissues, such that the topical press connectedly vibrates the tissues. Further, when bandage  70  physically contacts the tissue over the actual puncture point, the puncture point is vibrated directly, in addition to vibrating the tissue area surrounding the puncture point. 
         [0105]    It is preferred that bandages  38  are supplied in a convenience stack, stack  74 , also shown in  FIG. 5F . To mount a bandage  70  onto a topical press, the topical press is pressed onto spots  72  of the top bandage  70  of stack  74 . Spots  72  adhere to the topical press, and bandage  70  is thereby pulled away from stack  74  when the topical press is withdrawn. 
         [0106]    It is preferred that adhesive  64  is removably covered with an adhesion-resistant backing, backing  76 . Backing  76  minimizes adhesion between individual bandages  70  in stack  74 . Backing  76  therefore increases the likelihood that bandage  70  will pull away from stack  74  when the topical press is withdrawn. Backing  76  is removed immediately prior to puncturing the tissues, thereby exposing adhesive  64 . However, adhesion between individual bandages  70  in stack  74  may be minimized without backing  76 , such as by providing a bandage  70  having an adhesion-resistant top side similar to backing  76 . 
         [0107]    As such, bandages  70  have a multiplicity of functions. Bandages  70  form a contamination barrier between the tissues and the topical press, facilitate vibrating the tissues at a puncture area, enhance tissue vibration pain-gate effect, wipe body fluids from the withdrawing sharp  10 , and can remain as a dressing over the puncture area. 
         [0108]    Bandages  70  may be connected to the topical press by means other than spots  72 , such as by utilizing vacuum ports in the topical press, spikes to impale bandage  70 , tiny barbs to engage small pores on the top side of bandage  70 , a spring-clip, and so on. 
         [0109]    When full cover  60 , full pad  66 , or bandages  70 , cover a topical press, they physically contact the tissue at the actual puncture point. As such, when vibrated and/or cooled, full cover  60 , full pad  66 , or bandages  70 , directly vibrate and/or cool the tissues of the puncture point, in addition to vibrating the tissues of the surrounding puncture area. 
         [0110]      FIG. 6  shows a mechanized injector, needle device  78 . After a user activates a switch or triggering mechanism, needle device  78  moves a needle sharp  10  from a first retracted position to a second tissue-penetrating position, injects a medicament through needle sharp  10 , and returns needle sharp  10  to a third retracted position. The third position may coincide with the first position. Examples of similar mechanized puncture devices include automatic syringes, automatic glucose lancets, and so on, as shown in US Pat Appl 2002/0082522, and U.S. Pat. Nos. 6,454,743, 6,099,503, and 5,035,704. 
         [0111]      FIGS. 7A and 7B  show topical presses which are useful with mechanized puncture devices, such as needle device  78 , but are also useful with traditional manual syringes, manual glucose lancets, and so on. 
         [0112]      FIG. 7A  shows a topical press for contacting a bodily surface, brace  80 , having an open access for sharps, access  82 , and a connected actuator  18 . It is preferred that brace  80  is configured to fit closely against a limb, such as an arm, leg, fingertip, and so on, such that the limb nests into brace  80 . It is preferred that brace  80  has a detachable connection, anchor  84 , to a stable object, such as a chair, wall, pole, tree, and so on. It is further preferred that the position of brace  80  is adjustable in at least one dimension, such as by moving it along anchor  84 , by sliding, ratcheting, clipping, and so on. 
         [0113]      FIG. 7B  shows another embodiment of a brace press, segment brace  86 , connected to actuator  18  and anchor  84 . Segment brace  86  is similar to brace  80 , but is a set of two separate braces. 
         [0114]    Sharp  10  has access to the tissues in the variable area between the brace segments. It is preferred that actuator  18  is capable of vibrating the brace segments in or out of phase with respect to one another, such as by incorporating dedicated actuators  18 . 
         [0115]      FIGS. 8A to 8C  show handheld topical presses. 
         [0116]      FIG. 8A  shows a handheld vibrating topical press, massager  88  for use with manually operated sharps  10 , such traditional syringes, lancets, and so on. Massager  88  is connected to a handle, handle  90 , and an actuator  18 . Actuator  18  vibrates and/or cools massager  88 . It is preferred that massager  88 , as well as handle  90 , and actuator  18  have a coordinated appearance resembling a child&#39;s toy, so as to reduce children&#39;s fear. The toy shown in  FIG. 8A  shows a slot  16  configured as an animal&#39;s paws. 
         [0117]    For intraoral use, smaller topical presses are required.  FIG. 8B  shows a topical press with an actuator  18  connected to handle  90 , for vibrating and/or cooling intraoral tissues. It is preferred that actuator  18  is nondetachably connected to handle  90 . However actuator  18  may be detachably connected to handle  90 . 
         [0118]    A coolant actuator  18  is comprised of a refrigeration system. An example of a coolant actuator  18  comprises a contained vapocoolant, an intake valve, a release valve, and a tubing to full pad  66  on disc  38 , wherein opening the valve releases vapocoolant onto full pad  66 , thereby cooling full pad  66 . However, a coolant actuator  18  may comprise a small refrigeration compressor and fan system, or intake and release valves for externally supplied liquid or gas coolants from a remote refrigeration system, and so on. 
         [0119]      FIG. 8C  shows an intraoral topical press hand instrument having a handle  90  connected to disc  38 . 
         [0120]    It is preferred that the opposite end of handle  90  is connected to an instrument that is different than disc  38 , such as a mouth mirror. However, handle  90  may be connected to a second disc  38 , such as a disc  38  set at an angle different from a first disc  38 , or any other instrument. 
         [0121]    From the description above, a number of advantages of the topical press become evident:
       (a) The topical press is able to substantially reduce tissue sensitivity to control pain   (a) It is simple to use   (b) The topical press is time efficient   (c) The topical press can decrease patient apprehension       
 
       OPERATION 
     FIGS.  1 - 8   
       [0126]    By using the topical press of the invention, it is now possible, surprisingly, to achieve substantial reduction in puncture discomfort within seconds. 
         [0127]    The process offers the advantage that the user can now puncture the tissues simply and economically. 
         [0128]    In a further embodiment of the invention, there are multiple applications of the method for desensitizing the tissues with a topical press and puncturing with a sharp  10 . 
       EXAMPLE 1 
       [0129]    For a periodontal ligament injection, a user selects a handpiece  14  having an injector  12  and a slot  16  with an absorbent surface, as shown in  FIG. 1 . A local anesthetic cartridge is loaded into the medicament chamber. Actuator  18  is turned on to vibrate slot  16 . A refrigerant is applied to the surface of slot  16 . A few seconds are allowed to elapse until the slot  16  surface appears frosty. 
         [0130]    Slot  16  is inserted into the gingival sulcus of a tooth and pressed against the tissue puncture area by partly compressing the resiliency means of handpiece  14 . Handpiece  14  rotates injector  12 , and anesthetic is pumped from the anesthetic cartridge, into tube  30 , into bore, and flowing out orifice  34 . By further compressing the resiliency means, handpiece  14  is advanced toward the tissues until rotating injector  12  punctures the tissues. 
         [0131]    Anesthetic is pumped under pressure from orifice  34  and into the ligament space as injector  12  penetrates the ligament. The anesthetic flow anesthetizes the tissues and prevents debris from entering into orifice  34 . Anesthetic continues to flow as injector  12  advances into the ligament. Injector  12  tends to seal the tissue hole created by the advancing injector  12 , thereby creating a backpressure of anesthetic. The backpressure causes the anesthetic to flow distally from orifice  34  toward the distal tip of injector  12 , and into the ligament. 
         [0132]    Injector  12  is advanced until shoulder  36  seats into the sulcus, as shown in  FIG. 3 . Shoulder  36  further seals the puncture hole to fluid backpressure, and facilitates diffusion of anesthetic toward the tooth apex. A sufficient volume of anesthetic is pumped into the ligament so as to diffuse through the cortical plate, into the medullary bone, and to the apex of the tooth. Injector  12  is counter-rotated out of the puncture site. Handpiece  14  is removed from the area. 
       EXAMPLE 2 
       [0133]    For an injection, a user selects a needle device  78  having an actuator  18 , as shown in  FIG. 6 . 
         [0134]    Needle device  78  has a segment press  42 , as shown in  FIG. 4B . A disposable syringe having a needle sharp  10  is preloaded with a medicament is placed in needle device  78 . Needle device  78  is oriented perpendicularly over a skin puncture area and segment press  42  is pressed into contact with the skin. 
         [0135]    Needle device  78  is turned on. Actuator  18  begins to vibrate segment press  42 , and segment press  42  vibrates the skin of the puncture area. Sharp  10  is moved toward the skin, and penetrates the vibrating tissue injection site between the vibrating segments of segment press  42  to a preset depth. Needle device  78  injects the medicament. After the injection is complete, sharp  10  is withdrawn from the tissues and actuator  18  turns off. Needle device  78  is lifted from the skin. 
       EXAMPLE 3 
       [0136]    For an injection, a user selects a needle device  78  and a segmented brace  86  topical press. Actuator  18  is connected to both segments. Segmented brace  86  and needle device  78  are connected to a chair utilizing anchor  84 , as shown in  FIG. 7B . 
         [0137]    A disposable syringe with a needle sharp  10  is preloaded with a medicament and placed in needle device  78 . The patient is seated in the chair with shoulder bared. The position of segmented brace  86  is adjusted to the patient&#39;s height by sliding segmented brace  86  along anchor  84 . The patient&#39;s shoulder is nested into of segmented brace  86 . 
         [0138]    Actuator  18  and needle device  78  are turned on. Actuator  18  vibrates the two segments of segmented brace  86 , which vibrates the skin of the puncture area. Needle device  78  moves sharp  10  toward the shoulder. Sharp  10  penetrates the vibrating puncture point between the vibrating segments of segmented brace  86  to a preset depth. Needle device  78  injects the medicament. 
         [0139]    After the injection is complete, sharp  10  is withdrawn from the tissues and actuator  18  turns off. 
       EXAMPLE 4 
       [0140]    For an injection, a user selects a needle device  78  having an actuator  18 , and a disc  38 , as shown in  FIG. 4A . A syringe with a needle sharp  10  is preloaded with a medicament and placed in needle device  78 . The user presses needle device  78  perpendicularly onto adhesive spots  72  of a bandage  70  at the top of stack  74 , as shown in  FIG. 5F , such that spots  72  adhere to disc  38 . As the user withdraws needle device  78  from stack  74 , adhered spots  72  lifts the top bandage  70  with its backing  76  away from stack  74 . As such, bandage  70  covers disc  38 , thereby preventing direct contact of disc  38  with the skin during use. Backing  76  is removed from adhesive  64  of bandage  70 , exposing adhesive  64 . 
         [0141]    Needle device  78  is oriented perpendicularly to the surface of the skin. Needle device  78  is pressed onto the skin so that disc  38  contacts the skin with bandage  70  interposed. Adhesive  64  adheres bandage  70  to the skin. 
         [0142]    Needle device  78  is turned on. Actuator  18  begins to vibrate disc  38  and bandage  70 , which in turn vibrates the skin and the puncture area. Sharp  10  moves toward the skin, penetrating bandage  70  and the vibrating tissue at the puncture point. Needle device  78  injects the medicament. 
         [0143]    Actuator  18  turns off, the needle is withdrawn from the tissues, through bandage  70 , through disc  38 , and up into needle device  78 . Needle device  78  is lifted from the skin. As needle device  78  is lifted from the skin, the adhesion of bandage  70  to the skin is greater than the adhesion of spots  72  to disc  38 . Therefore bandage  70  pulls away from disc  38 , and remains adhered to the skin. 
       EXAMPLE 5 
       [0144]    For an injection, a user selects a needle device  78  having an actuator  18 , a preloaded syringe, and a cap  44 , as shown in  FIG. 4C . An absorbent surface of cap  44  is sprayed with a refrigerant. Needle device  78  is oriented perpendicularly over a tissues puncture area and cap  44  is pressed into contact with the tissues. 
         [0145]    Needle device  78  is turned on. Actuator  18  vibrates cap  44 , and cap  44  vibrates the tissues of the puncture area. The refrigerant spray cools the tissue. Needle device  78  releases first position lock  50  by pushing the syringe barrel and the sharp  10  needle telescopically into cap  44 . Sharp  10  penetrates the distal end of cap  44  and punctures the tissues to a preset depth at the second position. Needle device  78  stabilizes the barrel at the second position, and pushes the syringe plunger until the medicament is injected. 
         [0146]    Needle device  78  telescopically withdraws the barrel from cap  44 , and withdraws sharp  10  from the tissues until sharp  10  is retracted entirely into cap  44 . As sharp  10  is fully retracted, the male component of the lock slides over first position lock  50 , and expands into third position lock  52 , thereby locking cap  44  into the barrel in the sharp-retracted position. Cap  44  cannot be moved distally again, as shown in  FIG. 4D . Actuator  18  turns off. Needle device  78  is lifted from the tissues. 
       EXAMPLE 6 
       [0147]    A user selects a tip press  56  having a tissue side covered with absorbent fibers, as shown in  FIG. 4E . A sharp  10  is inserted into receiver  40  of tip press  56  until it encounters a thin sheet occluding the lumen, whereupon the insertion is halted. Sharp  10  does not protrude from the tissue side of tip press  56 . A vapocoolant is sprayed onto the absorbent tissue side of tip press  56 . After a few seconds the absorbent side appears frosty. Frosty tip press  56  is carried on sharp  10  to the puncture site, and is held against the tissues for a few seconds to cool the tissues. Sharp  10  is pushed through the thin occluding sheet, emerges from tip press  56 , and punctures the tissues. The procedure is completed, such as an injection, and then sharp  10  and tip press  56  are removed from the tissues. 
       EXAMPLE 7 
       [0148]    User selects a topical press massager  88  with the outer appearance of a puppy with front paws extended forward, as shown in  FIG. 8A . Actuator  18  is turned on to vibrate primarily the front paws. The vibrating front paws are placed on the skin of a child to desensitize the skin with vibrations. The appearance of massager  88  partly allays the child&#39;s fears. A sharp  10  is used to puncture the skin, such as a manual syringe, and is removed. 
       EXAMPLE 8 
       [0149]    A topical press hand instrument having a disc  38  on a first end and a mirror on a second end is frequently used by a user as a mouth mirror, as shown in  FIG. 8C . Prior to a palatal injection, an adhesive full pad  66  is removed from a backing paper and adhered to the tissue side of a disc  38 , as shown in  FIG. 5D . A vapocoolant is sprayed onto full pad  66 . After a few seconds, the surface of full pad  66  appears frosty. Full pad  66  is firmly held against the tissues for a few seconds to cool the tissues, thereby reducing tissue sensitivity. A sharp  10  needle is inserted through receiver  40 , through full pad  66 , and into the tissues. A few drops of local anesthetic are deposited. The topical press is lifted from the tissues by sliding disc  38  with full pad  66  up the sharp  10  needle shaft toward the hub. After depositing additional local anesthesia, the user removes the sharp  10  needle and the topical press from the mouth. 
       EXAMPLE 9 
       [0150]    A user selects a topical press hand instrument having a slot  16 . A slot cover  58  is stretched snugly over slot  16 , as shown in  FIG. 5A . A vapocoolant is sprayed onto slot cover  58 . After a few seconds, the surface of slot cover  58  appears frosty. Slot  16  with frosty slot cover  58  is firmly held against the tissues for a few seconds to cool the tissues. A sharp  10  is inserted through slot  16  and into the tissues. After a few seconds, the user pulls slot  16  away from the inserted sharp  10 , and withdraws the topical press from the mouth. After the procedure, sharp  10  is removed from the tissues, and from the mouth. 
       EXAMPLE 10 
       [0151]    A topical press having a metal disc  38 , as shown in  FIG. 8B , is stored on a frozen block, such as ice. The cold topical press and frozen block are removed from the freezer and placed within reach of the user. The user turns on vibrating actuator  18 , and firmly holds the cold disc  38  against an oral puncture area to simultaneously cool and vibrate the tissues. A sharp  10  penetrates the tissues through receiver  40 . Sharp  10  is removed from the tissues. Sharp  10  and the topical press are removed from the mouth. 
       SUMMARY, RAMIFICATIONS AND SCOPE 
       [0152]    Accordingly, the reader will see that the topical press of this invention is able to substantially control pain associated with minor tissue trauma and punctures. Furthermore, the topical press and method have the additional advantages in that it permits pain control in just a few seconds. 
         [0153]    Although the description above contains many specificities, these should not be construed as limiting the scope of the invention and process, but as merely providing illustrations of some of the presently preferred embodiments of this invention. 
         [0154]    For a first example, needle device  78  is shown with needle sharps  10 . However, it can be adapted for use with other sharps  10 . 
         [0155]    For a second example, handpiece  14  can be improved to include a computerized medicament pump, battery power, a vibrator for injector  12 , an onboard coolant system for the topical press, and so on. 
         [0156]    Thus the scope of the invention should be determined by the appended claims and their legal equivalents, rather than by the examples given.

Technology Classification (CPC): 0