System for pain reduction during skin puncture and breakable tip therefor

The invention relates to refinement of an object and device used in medical and dental procedures, in particular to improve the device in the form of a retractor vibrator and an item in the form of a disposable tip for reducing or minimizing pain during tissue or skin piercing operations, e.g. , in particular, an anesthetic, by injection into the gums, skin or other tissue of the patient.

BACKGROUND OF THE INVENTION [0002] As described in prior patent applications, in the art, to reduce pain when injecting a fluid, for example an anesthetic, serum, vitamins, vaccine, and other effective medical or dental fluids, the normal procedure includes (a) applying a very cold material to the skin or body of the patient at the injection site, (b) applying topical treatment to the skin or body at the injection site that causes temporary numbness of the skin or body, or (c) dynamic manual massaging of the skin or tissue at the injection site, injecting. Although these procedures have a certain effect, they are cumbersome, require time to do them or bring limited effects and do not reduce the pain at the desired level.

SUMMARY OF THE INVENTION [0003] The scope of the invention is defined in the appended claims.

[0004] It is a general object of the present invention to provide improved solutions for the inventions described in previous patent applications, in particular regarding a retractor vibrator and the described disposable or disposable tip. Thanks to the improvements described and reported to

In the present document, it will be possible to overcome further difficulties in injecting the anesthetic, serum, vitamins, vaccines, or other effective medical or dental fluids. In particular, it is an object of the present invention to provide an improved device and a previously described object that can be easily and inexpensively used during medical, veterinary or dental treatments to almost completely or substantially eliminate the pain associated with injection when piercing the skin or body of a patient.

Within the scope of the objectives of the present invention, the present invention includes an improved object in the form of a disposable tip and an improved hand tool, in a preferred embodiment of a retractor vibrator, for vibrating the area of ​​the skin or tissue, and preferably at least two areas of the skin or tissue or on a circular area of ​​skin or tissue, directly at the injection site and simultaneously with needle injection of a liquid, for example, anesthetic, serum, vitamins, vaccine, or other effective medical or dental fluids, into the skin or tissue at the injection site, into a more effective and hygienic way. The area of ​​interest of the dentist is the entire area of ​​the mucosa in the mouth and deeper bones, while the area of ​​interest in the case of medical doctors is the whole body and located deeper bones.

[0006] Accordingly, it is an object of the invention to provide an improved pain minimizing device when injecting a liquid, e.g. an anesthetic, comprising a main body, a removable disposable tip (novel item), fixed on the main body in a unique manner to prevent for re-use of the tip and vibrating assembly fixed in the main body, which, when actuated, causes the tip to vibrate in a unique and innovative way. The tip is subjected to vibrations and has a free end characterized by a fork to form two spaced apart projections defining a spacing therebetween, the distal projections being able to be placed in the vicinity.

The selected injection site on the human or animal body and tissue at said pre-selected injection site is vibrated during injection and then vibrations are continued to massage the tissue and to distribute the injected fluid in the tissue and prevent tissue expansion and swelling. tissue. Preferably, the following vibrations are made at a greater pressure on the tissue exerted by the person performing the injection in order to better massage. The following vibrations are most effective if the pressure exerted is enough to hear the bone beneath the tissue. A dentist who is an expert in the field is able to sense whether, while exerting pressure on tissue, e.g. gums, its device that touches the gums is well applied or is effectively based on the underlying bone. After sensing contact with the tissue or bone, the pressure is maintained for 1 to 90 seconds. The area at the injection site is illuminated by the instrument in a unique way. In addition, a better performance is achieved by pulsatile vibrations according to a favorable cycle, e.g. when switched on for about 1 second and off for about 1/10 of a second.

[0007] As a further refinement, the object in the form of a disposable tip comprises a tip sleeve made of hard plastic, such as polycarbonate to be fixed on the front of the instrument by means of a releasable connection, e.g. a bayonet type, and a forked tip element, also made of a hard material wherein said parts are held together in a slightly remote position by a casing of a rubber or thermoplastic elastomer having a predetermined value in a hardness test. The fork tip element has a plastic goblet formed in its base, which is attached to the vibrated optical fiber that protrudes from the front of the device. A lens formed at the end of the socket distributes light from the optical fiber to the injection site. The teeth in the fork tip element extend forward and bend downwards at an angle of approximately 55 degrees. The self-sealing ring keeps the fiber optic in the middle position in the front part

The device can also be used to freely vibrate the optical fiber.

[0008] As a further object of the invention, it is possible to design an improved apparatus as described above in which the removable tip comprises a surface acting as a retractor, a control switch for activating / deactivating the vibrating unit can be provided on the main body. Furthermore, the tip may include an element that interacts with the improved device in such a way that when placed on the improved device, the element actuates a switch or contacts to enable the improved instrument. When the tip is removed as a result of the necessary handling, the rubber or thermoplastic elastomer casing is so torn that reuse of the tip is impossible. As in the previous device, the improved instrument may include a music player in the main body for playing music through the loudspeaker. In addition, the main body may comprise rechargeable batteries as a source of voltage for driving the vibrating unit. In addition, a source of light is provided on the main body facing the space defined between the spaced projections to illuminate the punctured area and provide better visibility.

[0009] Furthermore, a method is described comprising the steps of vibrating a human or animal tissue in a unique manner by which vibration remains effective near a selected injection site while injecting a fluid with a needle or like device at a pre-selected injection site, and then vibrating continues at greater pressure to massage the injection site and to distribute the injected fluid in the surrounding tissue.

[0010] The aims of the invention are achieved by a pain minimizing device when injecting a fluid, e.g. an anesthetic, comprising a main body having a front end, a light-sending rod or fiber optically mounted loosely in said vibrating body and protruding from said front end, a tip comprising a tip sleeve mounted removably at the front end

This element has a front bifurcation defining a pre-selected injection site on a human or animal body that is removably attached to an optical fiber. The tip sleeve and tooth tip element are covered and held together by a flexible sheath, while allowing light from the rod to be illuminated with the light of the injection point, the vibrating assembly being fixed in the main body and connected to said illuminating rod such that after commissioning it transmits vibration through said rod. illuminating said tooth tip element. The apparatus may include means for controlling the activation and deactivation of the vibrating assembly during the cycle of operation; the duty cycle may include switching on for about 1 second and switching off for about 1/10 of a second. The tip element with teeth may comprise at least one surface that acts as a retractor. The tip sleeve and the main body may include interacting elements to prevent the tip being used again. A music player can be placed in the main body to play music through the loudspeaker. The illuminating rod is preferably made of polycarbonate and the illuminating rod is held by the O-ring at the front end to ensure free vibration. A music player can be placed in the main body to play music through the loudspeaker. The illuminating rod is preferably made of polycarbonate and the illuminating rod is held by the O-ring at the front end to ensure free vibration. A music player can be placed in the main body to play music through the loudspeaker. The illuminating rod is preferably made of polycarbonate and the illuminating rod is held by the O-ring at the front end to ensure free vibration.

The object of the invention is further implemented by providing a pain minimizing device when injecting a fluid, e.g. an anesthetic, comprising a main body having a front end, a lighting rod attached to said body extending towards said front end, a disposable tip containing a tip sleeve attached removably at the front end of said main body and a tooth tip element having a front fork defining a space surrounding a selected injection site on a human or animal body that is removably mounted on the illuminating rod, said tip sleeve and tooth tip element being covered and held together by a flexible casing, allowing simultaneous illumination with the light mentioned above

A vibrating assembly mounted in the main body and connected to said illuminating rod such that after actuation it transmits vibrating to said tooth tip element via said illuminating rod, said tip and main body having elements cooperating with each other in such that when the tip is placed on said main body, its image automatically prevents the life of said tip from being repeated. The device may include means for controlling the activation and deactivation of the vibrating unit during an operating cycle, which is preferably set to a duty cycle including on for about 1 second and off for about 1/10 of a second. The tip element with teeth may comprise at least one surface that acts as a retractor.

[0012] The method may comprise the steps of vibrating the human or animal tissue nearby, at or around the selected injection site, while illuminating the injection and fluid injection site with a needle or the like at the pre-selected injection site, vibrating pulsing. The pulsing is preferably switched on for about 1 second and off for about 1/10 of a second.

[0013] The object of the invention with respect to the device comprises providing a disposable tip used with a device that includes a vibrating optical fiber assembly (transparent or translucent rod that transmits light) that is vibrated by a vibrating unit, an optical fiber extending from the front end of the instrument. a tip comprising a tip sleeve to be removably attached to the front end of the device and a tip element with teeth for removably mounting on a protruding optical fiber. The tip element with the teeth has a front bifurcation defining the selected injection site on the human or animal body. The tip sleeve and the tip element with teeth are covered and held together by a flexible casing, which allows the tip element to vibrate freely with the teeth relative to the tip sleeve, and light from the optical fiber illuminates the injection site. The disposable tip, i.e. the tip sleeve and the tip element with the teeth are from

The annular gap between them is covered with a sheath. The tooth tip element includes a bell and integrally formed pair of longitudinally extending teeth with a tooth covering having a wider portion to provide at least one surface for retraction and grooves on the underside to collect saliva and ensure that the disposable tip will not be reused . At least one longitudinal groove may be formed in the wider part of the sheath. In addition, the casing at the ends of the teeth is preferably bulbous. The front end of the end sleeve preferably defines an alternating groove and the rib and the sheath fills the groove and includes the rib.

BRIEF DESCRIPTION OF THE DRAWINGS [0014] The aforementioned features and objects of the present invention will be discussed with reference to the attached figures, wherein the same reference numerals designate the same elements in which:

Fig. 1 is a perspective view of an innovative device with a disposable tip attached thereto;

Fig. 2 is a drawing illustrating an embodiment of a deployed device according to the present invention with a disposable tip;

Fig. 3 is an exploded view of how a removable or disposable tip is attached at the end of the device;

Fig. 4 is an exploded view from another perspective showing the main elements of the device;

Fig. 5 is an exploded view through a collet sleeve, a tip sleeve and a plastic tip of the device;

Fig. 6 shows a section through the rear part of the assembly shown in Fig. 7 showing the position of the illuminating rod in the device;

Fig. 7 is a view of the unit in section of the disposable tip mounted on the sleeve of the handle of the device;

Figure 8 is a perspective view showing the tip sleeve;

Figure 9 is a perspective view showing the grip sleeve;

EP 2 753 393 B1

Fig. 10 is an exploded view in perspective showing the attachment of the tip to the sleeve of the device.

Fig. 11 is a similar exploded perspective view showing the tip just before being fastened on the device sleeve.

Fig. 12 is a perspective view of the assembly showing the terminal mounted on the device sleeve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0015] With reference to Figs. 1 to 12, an embodiment of the improved retractor vibrator fulfilling the functions of the present invention, as explained below, is shown generally in Fig. 1 denoted by No. 10. The views are shown in Fig. 2 -5. In particular, the retractor vibrator 10 is a hand-held device comprising a main body or a tubular shaped holder 12 having a battery cover and a end closure that is threaded so that it can be screwed onto the open end of the handle 12 in a complementary manner. This is described in document WO / 2010/111611. Furthermore, as described in document WO / 2010/111611, the holder 12 is made of hard plastic and partially accommodates a mounting base, the uncoated portion of which is covered by the battery cover. The battery cells, not shown in Fig. 1, are located in the battery chamber of the mounting base. The induction coil is mounted at the end of the mounting base and is placed in the battery cover in such a way as to connect to the charging device in a conventional manner. A motor 24 schematically illustrated in the model of Fig. 7 drives the eccentric cam 26 in the model eccentrically and is located in the holder 12. The cam 26 includes a ball seat whose axis is offset from the motor drive axis by from about 0.010 inch to about 0.025 inch, the offset being about 0.020 inches is preferred.

At the free ends of the two forked legs 42 of the tip 50, they reach an amplitude of about 0.5 mm (0.020 inches). During vibrating, the illuminating rod 30 does not touch any other elements except the cam 26 at its rear end and the tip 50 at its front end, so that it can vibrate freely by rotating around the elastic ring 29 (a rubber or plastic self-sealing ring) placed in the a groove 14 formed in a rod 30 spaced from the front end of the rod 30. The rod 30 has projections 16 on the back side of the groove 14 to better retain the O-ring 29 in position. The front end of the rod 30 is permanently connected to the tip 50. Also in the construction described in WO / 2010/111611, on the mounting base (not shown) there is a PCB containing electrical and electronic circuits. The battery (not shown) is connected through the circuit to control the motor as described in WO / 2010/111611. When the motor 24 is driven, the vibrations induced by the cam 26 are transmitted to the polycarbonate illuminating rod 30 by a coupling and cam follower 100. A light 36, preferably LED, is located at the rear end of the rod 30 and is powered by a battery and circuit as described in WO / 2010/111611.

[0016] The front end of the handle 12 is provided with 4 cavity attachments 32 per pin, see Fig. 2. The handle sleeve 34 has a collar 35 at its rear end provided with 4 bolt holes 37 which receive pins 39 to attach the sleeve 34 to the handle. in a concealed position in the handle 12. The covering ring 41 is attached to the handle 12 to close the opening and cover the pins 39. The illuminating rod 30 passes through the sleeve 34 of the handle and protrudes outwards from it. The self-sealing ring 29 connects elastically to the inner surface of the holder sleeve 34 at its forward end. The front end of the holder sleeve 34 has a low collar 43 located at the rear of the open front end.

[0017] The sleeve 34 of the holder adopts a disposable tip 40, See Fig. 1012, comprising three elements, i.e. a front plastic tip 50 that is permanently but removably attached at the end.

2, the end sleeve 62 is removably and rigidly fixed to the sleeve 34 of the holder and a resilient (rubber or plastic) cover 52 that covers the plastic tip 50 and holds the tip 50 together and the bushing together. 62 the distal tip allowing free vibration of the tip 50 with respect to the tip sleeve 62.

[0018] Each of the components of the disposable tip 40 will now be described in more detail. The plastic tip 50 includes a bell 51 with its closed end defining a lens 53. Two curved protrusions or legs 55 extend from the sides of the cup 51 surrounding the lens 53, and extend to the front where they terminate in free ends 57 that are rounded. On the back side of the cup 51 there is a cut-out 59 and two projections, tabs or protruding ribs 61 that extend backward, one on each side of the notch 59. A small cut-out 63 is provided opposite the cut-out 59. The rod 30 is placed in the hub 51 and is permanently and rigidly connected to the calyx 51, and the front end of the rod 30 is placed near the lens 53.

The tip sleeve 62, see Fig. 8, is formed from a tube having an edge 65 at its front end and a groove 67 at its front end. At the rear end, the diameter of the tip sleeve 62 increases conically and the sleeve is completed with a collar 69. At the rear end finally, a rectangular hole 71 is formed in the cover of the tip sleeve 62. At the front of the hole 71, the interior of the tip sleeve 62 is thickened at place 73 to form a flat shelf 75 with a circumferentially wide opening 71. At the rear of the hole 71, the inside of the tip sleeve is thickened to form a plate 77 extending midway, substantially also about the perimeter width of the hole 71 Plate 77 has a v-shaped indentation 79 formed in the innermost location. The reinforcing ribs 78 are on the outer side of the tip sleeve 62, extending from the conical portion to the flange 69.

[0020] The sheath 52 is hollow and the front part has longitudinally extending arms 81 that are applied to the longitudinally extending legs 55. The free ends of the arms are terminated by an enlarged end bulbous portion 82. The sheath 52 is made of rubber or thermoplastic

The elastomer achieves a value of 40A in the hardness test, although it may also contain between about 30A and about 50A. The sheath portion 91 is applied to the hub 51 and has an opening 83 that surrounds the lens 53 to allow light illumination. The two arms 81 have a series of longitudinally extending longitudinally extending grooves 85 on the underside defined by protruding fibers in which saliva accumulates thus preventing an attempt to reuse the disposable tip. The two shoulders 81 of the sheath 52 may be smooth or may have multiple rib fibers as shown in Fig. 7, or a series of protruding fibers of any shape protruding from the skin surfaces 81 of the sheath, providing greater tissue stimulation during use. The intermediate portion 87 is enlarged transversally on both arms 81 of the sheath 52 to co-form the surface of the retractor 89 to pull or retract the tissue. The rear portion 92 of the sheath 52 has a reduced thinner portion 93 that forms rearward with the end portion 95 which in structure corresponds to the front end of the tip sleeve 62 for application to the edge 65 and behind it to the groove 67 to connect the sheath 52 to the sleeve. 62 the tip and keep it away from the tip 50.

[0021] The holder sleeve 34, as shown in Figs. 1, 2, 4, 5, 7, 9 and 10-12, is a longitudinally extending tube and has at its front end a circumferential, radially inwardly directed flange 101 which is terminated at a distance from both sides of the truncated protrusion or tooth 103 extending axially or longitudinally forward past the front end of the sleeve 34, defining recesses 154, see in particular Figs. 10-12. The tooth 103 extends slightly into the sleeve 34 to form a rear projection 152. The circumferential flange 101 formed at the front end of the grip sleeve 34 serves as a limitation on the front side to maintain the self-sealing ring 29. The self-sealing ring 29 also passes back and abuts on the tooth protrusion 152. 103, and therefore, is limited on the front side also by tooth 103. said elements hold together the illuminating rod 30 on the front side in a position at the front end of the holder sleeve 34. On the back side, projection 16 on the illuminating rod is limited by arcuate

The radius and central projections 150, one of which is visible in Figs. 10 to 12. As can also be seen in FIG. 10 to 12, the cavities 154 are formed on both sides of the tooth 103 between the ends of the circumferential flange 101 and the tooth 103. The cavities 154 are about 1-2 mm deep. As mentioned, only the self-sealing ring 29 connects to the inner surrounding surface of the tip 34 of the holder. A rod 30 with a self-sealing ring 29 acting as a rod can completely vibrate freely.

[0022] The holder sleeve 34 at its rear end has a larger diameter with an intermediate conical portion 111 between the front end and the rear end. The rear end is terminated by a flange 35 having a bolt opening 37. At the front, at a distance from the flange 35, there is a surface portion 127 on the conical portion 111 that has a defined diameter. The arcuate edge 113 is formed in such a way that it extends circumferentially from the region 125 with a larger diameter than the portion 127 circumferentially at about 60 to 90 degrees and terminates at the location 121. The edge 113 is tapered through the notch 115 on the right side, as seen in FIG. Fig. 9 and has a recess 117 to allow passage of the pin through the opening 37 on the pin. The edge 113 defines a groove 119 located at the rear,

[0023] Each of the end sleeves 62, the grip sleeve 34 and the holder 12 has an indicator showing how to align the parts. The handle 12 has a forward arrow 131 pointing at its front end aligned with a control button 132 for switching the power on and off. The sleeve 34 of the handle has an arrow 133 pointing to the front immediately after the flange 35. The disposable tip 40 has an arrow 135 on the rear end sleeve 62, such that when the disposable tip 40 is pushed longitudinally to the grip sleeve, the tooth 103 is inserted or pushed to the handle. notches 59 in the plastic tip 50, however, with respect to both the plastic and illumination terminal 30 of the rod 30 so that the vibrating tip 50 through the illuminating rod 30 is not disturbed in

There is no way. Also, the rear ends of the protruding ribs 61 will be positioned and positioned in recesses 154 in the grip sleeve 34, but with a distance from the sleeve 34 of the handle and the tooth 103, in such a way that the vibrating tip 50 is not disturbed in any way. The protruding ribs 61 in the end 50 and the cavity 154 in the holder sleeve 34 are complementary and the distance between them is at least 0.5 mm. See in particular Figs. 10-12.

[0024] When the disposable tip 40 is pushed into the holder sleeve 34 in the linear longitudinal direction, the thickened region 73 that forms the flat shelf 75 causes the tab 77 to extend toward the center of the plate 113 at the cut-out 115 and further into the groove 119, whereupon the flat shelf 75 falls to the surface 127, the rectangular opening 71 includes the edge 113 at the cut-out 115 and the plate 77 falls on the rib 123, with the v-shaped groove 93 connecting to the rib 123. At this point, the rod 30 is placed and fixed in the hub 51 of the tip 50 in the disposable tip 40, which is closed on the sleeve 34 of the holder and can not be pulled axially. A tooth 103 at the front end of the holder sleeve 34 is positioned and fixed in the recess 59 with a sufficient clearance around at least about 0.5 mm. in this way, that no vibrations occur in the vibration range. In addition, the rear ends of the protruding ribs 61 on both sides of the notch 59 are inserted into the cavities 154 at a suitable depth to provide a secondary connection to the handle sleeve 34 if any relative rotation occurs with respect to the sleeve 34 and the tip 50. Both tooth 103 and rear ends the protruding ribs 61 serve to retain the sleeve 34 of the handle and the tip 50 from relative rotation. The tooth 103 and the protruding ribs 61 will, in such a case, be placed side by side in the same radial coaxial cylinder with the longitudinal axis of the device, the handle sleeve 34 and the cutout and the tabs 61 of the calyx 50. the rear ends of the protruding ribs 61 on both sides of the notch 59 are inserted into cavities 154 at a suitable depth to provide a secondary connection to the handle sleeve 34 in case of any relative rotation relative to the sleeve 34 and the tip 50. Both the tooth 103 and the rear ends of the protruding ribs 61 serve to stop the sleeve 34 of the handle and the tip 50 from relative rotation. The tooth 103 and the protruding ribs 61 will, in such a case, be placed side by side in the same radial coaxial cylinder with the longitudinal axis of the device, the handle sleeve 34 and the cutout and the tabs 61 of the calyx 50. the rear ends of the protruding ribs 61 on both sides of the notch 59 are inserted into cavities 154 at a suitable depth to provide a secondary connection to the handle sleeve 34 in case of any relative rotation relative to the sleeve 34 and the tip 50. Both the tooth 103 and the rear ends of the protruding ribs 61 serve to stop the sleeve 34 of the handle and the tip 50 from relative rotation. The tooth 103 and the protruding ribs 61 will, in such a case, be placed side by side in the same radial coaxial cylinder with the longitudinal axis of the device, the handle sleeve 34 and the cutout and the tabs 61 of the calyx 50. Both the tooth 103 and the rear ends of the protruding ribs 61 serve to retain the sleeve 34 of the handle and the tip 50 from relative rotation. The tooth 103 and the protruding ribs 61 will, in such a case, be placed side by side in the same radial coaxial cylinder with the longitudinal axis of the device, the handle sleeve 34 and the cutout and the tabs 61 of the calyx 50. Both the tooth 103 and the rear ends of the protruding ribs 61 serve to retain the sleeve 34 of the handle and the tip 50 from relative rotation. The tooth 103 and the protruding ribs 61 will, in such a case, be placed side by side in the same radial coaxial cylinder with the longitudinal axis of the device, the handle sleeve 34 and the cutout and the tabs 61 of the calyx 50.

[0025] In order to remove the disposable tip 40 from the grip sleeve 34, it is necessary to rotate the tip sleeve 62 relative to the grip sleeve 34 from the gripping point 125 towards the end point 121 until the plate 77 reaches this point 121, and the disposable tip 40 can be removed.

EP 2 753 393 B1 removed by longitudinal pulling forward. However, during the relative rotational movement between the tip sleeve 62 and the holder sleeve 34, the plastic tip 50 will quickly connect to the tooth 103, or through the side walls of the notches 59 either tabs or protruding ribs 61 or both, and then the tip 50 is stopped motionlessly. it is prevented from rotating. The tip sleeve 62 can still be rotated relative to the sleeve 34 of the handle so that it can remainremoved, and during this operation, when the tip sleeve 62 is rotated, a torsional force is generated which is transmitted to the sheath 52, and the elastic limit value of the sheath 52 in the thinned portion 93 is quickly exceeded and the sheath is seriously rubbed or torn away by the thinned portion 93 in the applied sheath 52 at about 60 to 90 degrees or more, effectively eliminating its usability and / or reusability. The rear end of the protruding ribs 61 of the tip 50 being in the cavities 154 is assisted in the event of any failure of the tooth 103 to keep the tip 50 stationary while disassembling the disposable tip 40 from the sleeve 34.

[0026] As described, the attachment member 31 attached to the end of the illuminating rod 30 comprises a protruding rod with a ball end 100 as a cam follower moving behind the movement of the cam 26 to transfer the vibrating motion of the cam 26 to the illuminating rod 30. The end of the illuminating rod 30 is aligned with LED 36 bulb as described above. Although a continuous pulsing can be used, it has been found that the sequence of pulsating vibrations is more effective. A pulsing sequence that assumes switching on for about one second and off for about one-tenth of a second is sufficient to give a pulsating vibration without the risk of stopping the vibration of the tip to zero. In this way, the device or device pulsates about every second, causing re-stimulation of the nerve endings in the area, and in fact the brain never

It gets used to this feeling, thanks to which the vibration remains effective. To this end, the electronics controlling the pulsing have been modified to include the necessary means to pulsate and obtain the desired on / off cycle, as discussed earlier. The motor is driven by AC 110 volts (frequency 50-300 Hz). The frequency may range from about 50 Hz to about 300 Hz, with a range of about 140 Hz to 160 Hz being preferred. Vibrations at the free ends of the teeth or bifurcations 42 may range 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 pulsing on for about 1 second. and turned off for about 0.05 sec. The vibration amplitude may range from about 0.1 mm to about 1.0 mm,

The inventive device is characterized by an increased amplitude and reduces the tissue contacting it, causing a deeper penetration of the vibratory stimulation in the oral mucosa in the dental patient or in the patient's other medical specialties, thus stimulating the nerve receptors that are deeply located in the tissue, causing sensory information to be sent to the brain via the fast-conducting A-beta nerve fibers covered by the myelin sheath.

[0028] Furthermore, the vibration is spread within full 360 degrees around the disposable tip 40, mainly from three locations on the tip, i.e. from each of the free ends curved down the shoulders, and from the blade or retractor portion 87. In addition, contact with the tip sleeve 62 stimulates the mouth or cheek or bone as it rests upon them. Increased vibration is not limited to the area at the curved ends of the lower arms. Alternative free tips of the tip are provided in document WO / 2010/111611.

[0029] As described previously in document WO / 2010/111611, a plastic sleeve or sheath may be placed around the device to ensure its sterility and to avoid contamination during use. The plastic sleeve or sheath has a hole cut out in it

EP 2 753 393 B1 is attached to the sleeve 34 of the holder, and the disposable tip 40 can be attached to the sleeve 34 of the holder as described. For this purpose, the collar at the back of the disposable tip 40 is spaced slightly from the surface of the device to provide a gap in which a plastic sleeve or sheath is placed between the device and the tip.

If the device or device is to be used for medical purposes, i.e. for a part of the body other than the lips, the disposable tip 40 is curved upward, 180 degrees away from the use in the dentistry described above, and the leg of the device 50 the ends, or other shape of the tip element, may be covered or uncoated with a sheath 260 connecting and holding the hub together in the tip element and the ribbed end in the tip sleeve 62.

[0031] As will be appreciated by those skilled in the art, from the foregoing description, the present invention can be used in a variety of treatments requiring skin or body puncture. Such other treatments may include, for example, vaccinations, injections, administration of medicine, etc. Such skin punctures can be made on any part of the body, e.g. on the shoulder, legs, buttocks, trunk, etc.

[0032] The method consists in subjecting the human or animal tissue to vibrate near a selected injection site on the human or animal body, while injecting the liquid with a needle or the like at the pre-selected injection site. Vibration is most effective if it is transferred to the cylindrical volume of the tissue and to the bones below the injection site, and partly to the opposite sides or around the injection site. Furthermore, preferably, the noise generator is located in the main body of the device such that the vibration is accompanied by a noise that provides distraction. The method uses a pulsing vibration sequence. A pulsing sequence is activated for about one second and then turned off for about 0.05 seconds, it was enough to obtain a pulsating vibration without the risk of stopping the vibration of the tip to zero. In this way, the device or device pulsates every second, causing re-stimulation of nerve endings in a given area, and

In fact, the brain never gets used to this sensation, thanks to which vibrations remain effective.

[0033] The tip is vibrated and has a free end with a characteristic shape to induce vibration in the tissue and underlying bone, the free end being positioned near the pre-selected injection site on the human or animal body resulting in the tissue being found below the bone in said pre-selected injection site are vibrated when the injection is performed. Vibrations are continued even after the injection is completed in order to massage the tissue and to distribute the injected fluid in the tissue and prevent tissue expansion and swelling of the tissue, which is a source of pain.

[0034] Preferably, the following vibrations are made at a greater pressure on the tissue exerted by the person performing the injection in order to perform a better massage. The following vibrations may be more effective in some areas of the mouth if the pressure exerted is sufficient to hear the bone underneath the tissue. A dentist who is skilled in the art is able to sense whether, when applying pressure to tissue, e.g. gums, his or her gum device is well applied or if the device is effectively resting on the underlying bone. After sensing such contact with the bone, the pressure is maintained for at least 1 to about 90 seconds until tissue expansion subsides.

[0035] Although the present invention has been described and described herein as the most practical and preferred embodiments, it should be understood that variations, modifications, adaptations and variations of the device are possible without departing from the scope of the invention as defined in the appended claims.

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