Abstract:
An instrument is described for minimizing pain during administration by injection of a liquid, such as, an anesthetic. The instrument includes a main body having a rod mounted freely for vibration and a single use tip removably mounted on the forward end of the main body by a first type of motion and removable by a second and different type of motion. The tip is held on the instrument by an elastic overmold. A vibration unit imparts vibrations to the tip. Demounting of the single use tip will rupture the overmold and render the single use unfit for further use. A method of operating the instrument is described and a single use tip is described.

Description:
RELATED CASES 
       [0001]    The invention is an improvement to the instrument, article and method described in US Published Patent Application 20120029422 published Feb. 2, 2012 the text and drawings of which are here incorporated in their entirety. 
       SUMMARY OF THE INVENTION 
       [0002]    An improved instrument, article and method are provided for minimizing pain during administration by injection of a liquid, such as, an anesthetic. The instrument has a forward end. A rod or lightpipe is mounted freely for vibration projects out of the forward end. The article, a single use tip, is composed of a tip sleeve removably mounted on the forward end of the instrument and a tip member removably mounted on the projecting rod or lightpipe to vibrate a preselected injection site on a human or animal. The tip sleeve and tip member are covered by an elastic overmold that enables the tip member to vibrate freely with respect to the tip sleeve and light from the lightpipe to illuminate the injection site. The overmold of the single use tip is torn during removal of the single use tip from the instrument by a novel structure for the front end and the tip member. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0003]    The above-mentioned features and objects of the present invention will be discussed in terms of the attached figures wherein like reference numerals denote like elements and in which: 
           [0004]      FIG. 1  a perspective view of the instrument with a disposable tip mounted thereon; 
           [0005]      FIG. 2  is an exploded drawing of  FIG. 1  showing an embodiment of the apparatus of the present invention with a disposable tip; 
           [0006]      FIG. 3  shows a perspective view showing the disposable tip member or sleeve; 
           [0007]      FIG. 4  is a perspective view showing the handle tip member or sleeve; 
           [0008]      FIGS. 5 to 10B  show in various rotated views improvements to the handle tip member or sleeve; 
           [0009]      FIGS. 11 to 15  show in various views improvements to the disposable tip; 
           [0010]      FIGS. 16 to 20  show in various views in detail improvements to the disposable tip sleeve of the disposable tip; 
           [0011]      FIGS. 21 to 24  show in various views a disposable tip elastomer or overmold; 
           [0012]      FIGS. 25 to 27  show in various views a disposable tip core. 
       
    
    
     DETAILED DESCRIPTION 
       [0013]    Referring to the drawings, an embodiment of the retractor vibrator is shown generally in  FIG. 1 , designated as  10  for performing the required. An exploded view is shown in  FIG. 2 , in particular, retractor vibrator  10  is a handheld apparatus comprising a main body or handle  12  in the shape of a tube having a battery cover and an end closure that is threaded to screw onto the open end of handle  12  in a complementary fit. This is as described in WO/2010/111611, hereby incorporated by reference in its entirety. Further as described in WO/2010/111611 handle  12  is composed of hard plastic and partially receives a chassis, the uncovered portion of which is covered by a battery cover. Rechargeable batteries, not shown in  FIG. 1 , are located in a battery compartment of the chassis. An induction coil is mounted on the end of chassis and positioned in the battery cover to couple to a charge device in a conventional manner. A motor  24 , not shown, drives eccentrically a cam and is housed in the handle  12 . The cam includes a ball socket whose axis is offset from the motor drive axis by from about 0.010 inches to about 0.025 inches, with an offset of about 0.020 inches being preferred. The vibration induced by the cam and its follower  100  fixed to rod  30  via a fitting at its rear end is transmitted via polycarbonate light rod  30  to polycarbonate tip  50  firmly engaged demountably with rod  30  at its forward end. The vibrations produced at the free ends of the two bifurcated legs  42  of tip  50  will have amplitude of about 0.5 mm (0.020 inches). 
         [0014]    During vibration, the light rod  30  is free from all other structure except the cam  26  at its rear end and tip  50  at its forward end so that it can vibrate freely by pivoting about resilient ring  29  (rubber or plastic O-ring) mounted in a groove  14  formed in rod  30  spaced from the forward end of rod  30 . The rod  30  has projections  16  on the rear side of the groove  14  to assist in holding the O-ring  29  in correct position. The forward end of the rod  30  firmly engaged with tip  50 . Also as in the structure described in WO/2010/111611, a PCB board containing electrical and electronic circuitry is mounted on the chassis (not shown). The battery (not shown) is connected via the circuitry to control the motor in the manner described in WO/2010/111611 here incorporated by reference. When the motor is driven, vibration produced by the cam is coupled to polycarbonate light rod  30  via a coupling fitting and cam follower  100 . Alight, preferably an LED, is positioned at the rear end of the rod  30  and powered by the battery and circuitry, as described in WO/2010/111611. 
         [0015]    The forward end of the handle  12  is provided with  4  bolt mountings  32 , see  FIG. 2 . A handle sleeve  34  has a flange  35  at its rear end provided with  4  bolt openings  37  to receive bolts  39  to fix the handle sleeve  34  in position to the handle  12 . A cover annulus  41  is fitted into the handle  12  to close the opening and cover the bolts  39 . The light rod  30  passes through the handle sleeve  34  and projects outwardly from it. The O-ring  29  resiliently engages the inner surface of the handle sleeve  34  near its forward end. The front end of the handle sleeve  34  has a low flange  43  set back from the open front end. 
         [0016]    The handle sleeve  34  receives a single use disposable tip  40  comprised of three components, namely, a forward plastic tip  50  that is firmly but detachably mounted on the end of light rod  30 , a tip sleeve  62  for detachably and rigidly being mounted on handle sleeve  34  and a resilient (rubber or plastic) overmold  52  that covers the plastic tip  50  and holds tip  50  and tip sleeve  62  together in a spaced relationship that enables tip  50  to vibrate freely relative to tip sleeve  62 . 
         [0017]    The components of the disposable tip  40  consist of plastic tip  50  consisting of a cup  51  with its closed end defining a lens  53 . Two curved protrusions or legs  55  extend from the sides of the cup  51  bracketing the lens  53 , extending forwardly and terminating in free ends  57  that are rounded. On its rear facing side, the cup  51  has a cutout  59  and two tongues, tabs or positive ribs  61  that extending rearward, one on each side of the cutout  59 . Diametrically opposite cutout  59  is a small cutout  63 . The rod  30  enters into the cup  51  and firmly and rigidly engages the cup  51  and the forward end of the rod  30  is juxtaposed closely to the lens  53 . 
         [0018]    The tip sleeve  62 , see  FIG. 3 , consists of a tube having at its forward end a ridge  65  and behind it a groove  67 . At its rear end, tip sleeve  62  increases in diameter conically and terminates in a flange  69 . Adjacent its rear end, a rectangular through opening  71  is formed in the shell of the tip sleeve  62 . On the forward side of the opening  71  the inside of the tip sleeve  62  is thickened at  73  to form a flat shelf  75  generally the circumferential width of the opening  71 . On the rear side of the opening  71  the inside of the tip sleeve is thickened to form an inwardly extending plate or rib  77  also generally the circumferential width of the opening  71 . Plate  77  has a v-notch  79  formed at its inmost extent. Reinforcing ribs  78  is on the exterior of the tip sleeve  62  extending from the conical section to the flange  69 . 
         [0019]    Overmold  52  is hollow and the forward portion has two longitudinally extending arms  81  that fit over the longitudinally extending legs  55 . The free ends of the arms terminate in an enlarged end bulbous portion  82 . The overmold  52  is composed of rubber or a thermoplastic elastomer having a durometer of preferably about 40 A but may vary from about 30 A to about 50 A. Portion  91  of the overmold fits over the cup  51  and has a hole  83  that fits around the lens  53  to let the light shine through. The two arms  81  have a series of transversely extending, longitudinally spaced grooves  85  on the underside, defined by projecting filaments, to trap saliva so reuse of the disposable tip will not be attempted. The two arms  81  of the overmold  52  can be smooth or have many filaments in the form of ribs as shown, or an array of projecting filaments of any shape, projecting off of the surface of the overmold arms  81 , providing a greater stimulation to the tissue while in use. An intermediate portion  87  is enlarged transversely on both arms  81  of the overmold  52  to collectively form a retractor surface  89  to help press away or retract tissue. Rear portion  92  of the overmold  52  has a reduced thinned section  93  that at the rear is integral with a terminal section  95  complementary in configuration to the forward end of the tip sleeve  62  to fit over the ridge  65  and behind it in the groove  67  to anchor the overmold  52  to the tip sleeve  62  and holds it spaced from the tip  50 . 
         [0020]    The handle sleeve  34 , as shown in  FIG. 4  is a longitudinally extending tube and has at its forward end, a circumferential radially inward flange  101  that terminates spaced from either side of a tapered protrusion or tooth  103  extending axially or longitudinally forward level with the forward end of the sleeve  34 , to define recesses  154 . The tooth  103  extends slightly into the sleeve  34  forming a rear shoulder  152 . Circumferential flange  101  formed at the forward end of the handle sleeve  34  serves as a constraint on the forward side to hold the O-ring  29 . O-Ring  29  also passes behind and bears on shoulder  152  of tooth  103  and thus, is constrained on the forward side also by the tooth  103 . These elements together hold the light rod  30  on the forward side in position within the forward end of handle sleeve  34 . On the rear side, projection  16  on the light rod is constrained by arcuate radially inwardly projections  150 . Also recesses  154  are formed on either side of the tooth  103  between the terminating ends of the circumferential flange  101  and the tooth  103 . Recesses  154  are about 1-2 mm deep. As noted, only the O-ring  29  engages the inner surrounding surface of handle tip  34 . The rod  30  with the O-ring  29  acting as a pivot is otherwise completely free to vibrate. 
         [0021]    The handle sleeve  34  at its rear end is of larger diameter with a transition conical section  111  between the front end and rear end. The rear end terminates in flange  35  having bolt opening  37 . Spaced forward of the flange  35  is a surface portion  127  of the conical section  111  that is of fixed diameter. An arcuate ridge  113  is formed that extends circumferentially from a point  125  of larger diameter than portion  127  circumferentially for about 60 to 90 degrees and terminates at point  121 . Ridge  113  is narrowed by cutout  115  on its right side as viewed in  FIG. 4  and has a dip  117  to enable a bolt to pass through to a bolt opening  37 . The ridge  113  defines a groove  119  on its rear side, due to surface  127  having a fixed diameter and a low rib  123  extends longitudinally in groove  119  to the rear of cutout  115 . 
         [0022]    Each of tip sleeve  62 , handle sleeve  34  and handle  12  have indicia to show how the parts line up. Handle  12  has an arrowhead  131  pointing forward on its front end aligned with the control button  132  to turn the power on and off. Handle sleeve  34  has an arrowhead  133  pointing forward just behind the flange  35 . The disposable tip  40  has an arrowhead  135  on tip sleeve  62  pointing rearward so that when the disposable tip  40  is pushed longitudinally onto the handle sleeve, the tooth  103  will be inserted or protrude into the cutout  59  of the plastic tip  50 , but with clearance from both the plastic tip  50  and light rod  30  so that vibration of tip  50  by light rod  30  is not interfered with in any way. Also, the rear ends of positive ribs  61  will be received and positioned in recesses  154  in the handle sleeve  34 , but with clearance from the handle sleeve  34  and tooth  103  so that tip  50  vibration is not interfered with in any way. The positive ribs  61  of tip  50  and recesses  154  of handle sleeve  34  are complementary and the clearance between them is at least about 0.5 mm. 
         [0023]    As the disposable tip  40  is being pushed onto the handle sleeve  34  in a linear longitudinal direction, the thickened area at  73  that forms a flat shelf  75  causes the inwardly extending plate  77  to ride over the ridge  113  at cutout  115  and go behind into the groove  119 , whereupon the flat shelf  75  drops down onto the surface  127 , the rectangular through opening  71  straddles the ridge  113  at the cutout  115  and the plate  77  drops onto the rib  123  with the v-notch  93  engaging the rib  123 . At this point, the rod  30  is received in and positioned in the cup  51  of the tip  50  of the disposable tip  40 , which is latched onto the handle sleeve  34  and cannot be pulled off axially. The tooth  103  at the forward end of handle sleeve  34  is received in and positioned in the cutout  59  with suitable clearance all-around of at least about 0.5 mm so that there is not any interference respecting vibration. Also, the rear ends of the positive ribs  61  on either side of the cutout  59  are received in the recesses  154  to a sufficient depth to enable back-up engagement with the handle sleeve  34  in the event there is any relative rotary motion with respect to the handle sleeve  34  and the tip  50 . Both the tooth  103  and the rear ends of the positive ribs  61  serve to hold the handle sleeve  34  and the tip  50  from relatively rotating. The tooth  103  and the positive ribs  61  will, at this time, be juxtaposed in the same radial cylinder coaxial with the longitudinal axis of the instrument, the handle sleeve  34  and the cutout and the tabs  61  of cup  50 . 
         [0024]    To remove the disposable tip  40  from the handle sleeve  34 , it is necessary for the tip sleeve  62  to be rotated relative to the handle sleeve  34  from adjacent point  125  toward the terminal point  121  until the plate  77  clears this point  121 , at which time, the disposable tip  40  can be removed by longitudinally puffing forward. However, during the relative rotary motion between the tip sleeve  62  and handle sleeve  34 , the plastic tip  50  will quickly engage the tooth  103 , either by the side was of the cutout  59  or the tabs or positive ribs  61  or both and the tip  50  will then be held stationary and prevented from rotating. The tip sleeve  62  will still be rotatable relative to the handle sleeve  34  so it can be removed, and in this process as the tip sleeve  62  is rotated, a torsion force will develop and be imparted to the overmold  52  and the elastic limit of the overmold  52  at the thinned section  93  will quickly be exceeded and the overmold will experience a severe tearing or shredding of the thinned section  93  of overmold  52  over about 60 to 90 degrees or more destroying effectively its utility and/or its ability to be reused. The rear end of the positive ribs  61  of tip  50  being in the recesses  154  is a back-up in case of any failure of the tooth  103  to hold the tip  50  stationary during demounting of the disposable tip  40  from the sleeve  34 . The rear ends of the positive ribs  61  being positioned in recesses  154  will also prevent any rotation of tip  50  relative to handle sleeve  34  during the demounting of disposable tip  40  and thereby insure the tearing or shredding of the thinned section  93  of overmold  52 . 
         [0025]    As described, the fitting member  31  attached to the end of the light rod  30  includes a projecting stub with ball end  100  as a cam follower for contacting and following the cam  26  to impart the vibratory motion of the cam  26  to the light rod  30 . The end of the light rod  30  is in alignment with the LED  36  as previously described. Although continuous pulsing can be used, it has been discovered that a pulsed vibration sequence is more effective. A pulsed sequence of about one second on and then about a tenth of a second off, is sufficient to pulse the vibration without allowing the vibration of the tip to ever drop down to zero. In this manner, the device or instrument pulses about every second, re-stimulating the nerves in the area, and apparently the brain never gets used to it, so the vibrations remain effective. To this end the electronics controlling the pulsing is modified to include the necessary means for pulsing and obtaining the desired on/off duty cycle as noted. The motor is energized using 110 volt AC (50-300 Hz frequency). The frequency can vary from about 50 Hz to about 300 Hz with about 140 Hz to 160 Hz being preferred. The vibration at the free ends of the prongs or forks  42  can vary from about 0.1 mm to about 1.0 mm with the preferred range being 0.65 mm to 1.0 mm. The duty cycle is about 1.05 seconds with on pulsing of about 1 sec. and off of about 0.05 sec. The vibration amplitude may vary from about 0.1 mm to about 1.0 mm, with the preferred range being from about 0.65 mm to about 1.0 mm. 
         [0026]    The instrument exhibits enhanced amplitude and percusses the tissue contacted, causing a deeper penetration of the vibratory stimulus into the oral mucosa of a dental patient, or into the skin of a medical patient, thereby stimulating the sensory nerve receptors, which are located deep within the tissue, creating action potentials which send sensory information to the brain via myelinated A-beta afferent nerve fiber axons. 
         [0027]    Also, vibration is sent out in a full 360 degrees around the disposable tip  40 , mainly, from three places off of the tip, namely, from each free end of the curved downwardly arms, as well as, from the paddle or retractor portion  87 . Also the joint with tip sleeve  62  at times will stimulate the lip or cheek or bone when resting against it. The enhanced vibration is not limited to just the area at the ends of the curved downward arms. Alternative tip free end shapes are shown in WO/2010/111611, incorporated herein by reference. 
         [0028]    The improvement to the above structure involves the handle forward tip member or sleeve  34  and the disposable tip member of sleeve  62 . The same reference numbers are given to the same parts in  FIGS. 8 to 27 . The handle forward tip member or sleeve  34  is constructed similarly to the prior design at it end that engages the disposable tip core. At its end mounted to the main body  12 , the outer surface is differently profiled. The ramp  111  is present and a projecting rib  300  is formed circumferentially extending for a short distance terminating at one end  302  in a short section angled forward toward the tip core  50 . Rib  300  is positioned on sleeve  34  diametrically opposite the tooth  103 , in the opposite position to where it was in the prior instrument. A circumferentially extending space is defined behind the rib  300  bordered axially spaced by a shoulder  304  that also runs circumferentially. As shown in the clockwise direction in the drawing, the shoulder  304  defines a stop  306  whereas in the counterclockwise direction it defines a curving  308  forward toward the tip core  50 . 
         [0029]    The disposable tip member or sleeve  62  is modified to define an elongated circumferentially extending slot  320  that extends circumferentially more than the rib  300 . The slot  320  is on the underside opposite the indicia printed on the top side of tip  40 . A depending rib  322  is circumferentially defined inside the sleeve  62  that borders from one end to the other end of the slot  320  adjacent the end of sleeve  62  that is remote form the tip core  50 . A shelf  324  is formed leading to the slot  320 . 
         [0030]    When the disposable tip  40  is mounted on the handle forward tip member or sleeve  34 , the tip sleeve  62  is pressed axially straight on the handle tip member. The slot  320  partially aligning with the rib  322  will pass over the rib  300  so that the depending rib  322  is positioned in the circumferential space against the shoulder  304 . Any attempt to rotate the tip sleeve  62  to the left as shown in  FIG. 11  will result in the end of rib  322  striking the stop  306 . When the tip sleeve  62  is to be removed, it will be rotated to the right as shown in  FIG. 11  whereupon the other end of the rib  322  will follow the shoulder  304  and due to the curving  308  will be pushed off the sleeve  34 . To this end the angled section at end  302  enables clearance for the rib  322  so the disposable tip  40  can be pulled off the handle forward tip member or sleeve  34 . The rotation of the disposable tip will cause tearing of the overmold to render the disposable tip  40  unfit for further use. 
         [0031]    All references cited herein are expressly incorporated by reference in their entirety. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. There are many different features to the present invention and it is contemplated that these features may be used together or separately. Thus, the invention should not be limited to any particular combination of features or to a particular application of the invention. Further, it should be understood that variations and modifications within the spirit and scope of the invention might occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention.