Systems and methods for pain relief during skin penetration and breakable tips thereforCROSS-REFERENCE TO RELATED APPLICATIONS
The present application and invention described herein claims the benefit of priority from US patent application No.13/253,572 filed 5/10/2011 and US patent application No.13/225,782 filed 6/9/2011. US patent application No.13/253,572 is a partial continuation of US patent application No.13/225,782, US patent application No.13/225,782 is a partial continuation of PCT application No. PCT/US2010/028858 filed on day 26 3/2010, PCT application No. PCT/US2010/028858 is a partial continuation of PCT application No. PCT/US2009/066033 filed on day 29 11/2009 in 2009, which PCT application No. PCT/US2009/066033 claims priority to US provisional patent application No.61/163,945 filed on day 27 3/2009 in 2009. The present application and invention described herein also relates to commonly owned US patent No.7,981,071 issued on 19/7/2011, which US patent No.7,981,071 is a US national phase application of PCT application No. PCT/US2005/033769 filed on 19/9/2005, which claims priority from US provisional patent application No.60/707,754 filed on 12/8/2005 and US provisional patent application No.60/611,497 filed on 20/9/2004. Each of the above-identified applications is incorporated herein by reference in its entirety.
Technical Field
The present application relates to improvements in methods, articles and devices used in medical and dental procedures, and in particular to a method and a device in the form of a retracting vibrator and an article in the form of a disposable tip for reducing or minimizing pain during tissue or skin penetration procedures, such as administering a medicament by injecting a liquid, such as and in particular an anesthetic, into the gums, skin or other tissue of a patient.
Background
As described in the prior applications, in the prior art, when injecting liquids, such as anesthetics, serum, vitamins, vaccines, or other liquids of medical or dental efficacy, the normal procedure for alleviating pain is either (a) placing a very cold material against the patient's skin or muscle at the injection site, (b) applying a topical treatment to the skin or muscle at the injection site, temporarily numbing the skin or muscle, or (c) rapidly massaging the skin or tissue at the injection site with the hand while performing the injection. While these procedures have some effectiveness, they are either cumbersome, require some time to complete or have limited effectiveness and do not slow the pain to a satisfactory level. The invention described in the previous application provides a unique and novel apparatus and method for alleviating pain during skin piercing procedures, particularly those involving dentistry.
Disclosure of Invention
It is a general object of the present invention to provide improvements to the inventions described in the previous applications, particularly with respect to the described retracting vibrators and single use or disposable tips. Other deficiencies in the injection of anesthetics, serum, vitamins, vaccines or other liquids of medical or dental efficacy are overcome by the use of the improvements described and claimed herein. In particular, it is an object of the present invention to provide improvements to the previously described devices, articles and methods which can be easily and inexpensively used during medical, veterinary or dental procedures to almost completely or substantially eliminate the pain associated with injections when puncturing the skin or muscle of a patient.
Consistent with the objects of the invention, the invention comprises an improved method, an improved article in the form of a disposable tip, and an improved handheld device, preferably in the form of a retracting vibrator, for vibrating an area of skin or tissue, preferably at least two areas of skin or tissue or a circular area of skin or tissue, immediately adjacent to an injection site in a more efficient and hygienic manner, simultaneously with injecting a liquid, such as an anesthetic, serum, vitamin, vaccine or other liquid of medical or dental efficacy, through a needle to the skin or tissue at the injection site. The areas of interest to the dentist are the entire oral mucosal area and underlying bone, while the areas of interest to the doctor are the entire body and underlying bone. During a dental procedure, this typical injection procedure may involve injecting lidocaine into the patient's gums or other tissue.
It is therefore an object of the present invention to provide an improved apparatus for minimizing pain during administration of a medicament by injection of a liquid such as an anesthetic, the apparatus comprising a main body, a single use detachable tip (novel article) cantilever-mounted on the main body in a unique manner to prevent reuse of the tip, and a vibration unit mounted in the main body which, when activated, causes the tip to vibrate in a unique and novel manner. The tip vibrates and has a free end characterized by a bifurcation to form two spaced projections defining a space therebetween, whereby the spaced projections can be placed adjacent a predetermined injection site of a human or animal and tissue at the predetermined injection site vibrates when an injection is performed, and then the vibration is continued to massage the tissue to disperse the injected fluid into the tissue and prevent tissue bulking and swelling of the tissue. Preferably, the subsequent vibration is performed by applying a greater pressure to the tissue by the injecting person to achieve a better massage. This subsequent vibration is most effective if the applied pressure is sufficient to sound the bone beneath the tissue. The average dentist in the field can feel when he applies pressure to the tissue, such as the gingiva, and his instruments effectively touch the gingiva and well touch or hit the underlying bone. The pressure is maintained for 1 to 90 seconds when tissue or bone contact is sensed. The area of the injection site is illuminated in a unique way by the instrument. Further, improved performance is obtained by pulsing the vibration according to a preferred duty cycle of about one second on and about one tenth of a second off.
As a further refinement, the article in the form of a single use or disposable tip comprises a tip sleeve made of a rigid plastic such as polycarbonate for mounting on the front of the instrument by a detachable connection such as a bayonet, and a forked tip member also made of a rigid plastic, the parts of which are held together in slightly spaced relation by an envelope of rubber or thermoplastic elastomer of a predetermined hardness. The forked tip member has a plastic cup formed in its base that mounts on a vibrating light pipe that protrudes from the front of the instrument. A lens formed in the end of the cup projects light from the light pipe onto the injection point. The tines of the forked tip member extend forward and are bent downward at an angle of approximately 55 degrees. An O-ring keeps the light pipe centered in the front of the instrument while allowing the light pipe to vibrate freely.
As a further object of the invention, an improved apparatus as described above can be arranged: wherein the removable tip comprises a surface that acts as a retractor and a control switch can be provided on the body for on-off control of the vibration unit. In addition, the tip can include an element that cooperates with the modified instrument such that when placed on the modified instrument, the element activates a switch or contact to open the modified instrument. When the tip is removed by the necessary operation, the envelope of rubber or thermoplastic elastomer is torn completely, making the reuse of the tip impossible. As in the previous apparatus, the improved apparatus can include a music player in the main body for playing music through a speaker. In addition, the main body can include a rechargeable battery as a power source to drive the vibration unit. Further, a light source is provided on the main body, directed at the space defined between the spaced projections to illuminate the area being injected, providing better visibility.
Furthermore, another object of the present invention includes a method comprising the steps of: while injecting fluid through a needle or like instrument at a preset injection site, the tissue of the human or animal is vibrated in a unique manner that keeps the vibration powerful and effective, and then greater pressure is applied to continue the vibration to massage the injection site to disperse the injected fluid and distribute it into the surrounding tissue.
The object of the invention is achieved by an apparatus for minimizing pain during administration of a medicament by injection of a liquid such as an anesthetic, comprising a body having a front end, a light transmitting tube or lightpipe mounted in said body for free vibration and protruding from said front end, and a tip consisting of a tip sleeve removably mounted on the front end of said body and a forked tip member having a front fork defining a predetermined injection point on a human or animal removably mounted on the lightpipe. The tip sleeve and the forked tip member are covered and held together by an elastic envelope while enabling the light of the polish rod to illuminate the injection site, and a vibration unit is installed in the main body and coupled to the polish rod such that, when activated, vibrations are transmitted to the forked tip member via the polish rod. The apparatus can include means for controlling the vibration unit for an On-Off duty cycle; the duty cycle can include about 1 second on and about 1/10 seconds off. The forked tip member may include at least one surface that functions as a retractor. The tip sleeve and the body can include members that cooperate with each other to prevent reuse of the tip. A music player may be included in the main body for playing music through the speaker. The polish rod is preferably made of polycarbonate and is held at the front end by an O-ring so as to vibrate freely.
The object of the present invention is further achieved by providing an apparatus for minimizing pain during administration of a drug by injection of a liquid such as an anesthetic, comprising a body having a front end, a polished rod mounted in said body extending towards said front end, a single-use disposable tip consisting of a tip sleeve removably mounted on the front end of said body, and a forked tip member having a front fork removably mounted on the polished rod defining a space holding a predetermined injection point on a human or animal, said tip sleeve and forked tip member being covered and held together by an elastic envelope while enabling light from said polished rod to illuminate the injection point, and a vibration unit mounted in the body and coupled to said polished rod, such that when activated, vibrations are transmitted to the forked tip member via the lightbar, the tip and body having elements that co-act with each other such that once the tip is placed on the body, its removal automatically prevents reuse of the tip. The apparatus can comprise means for controlling the vibration unit for an On-Off duty cycle, which is preferably set to a duty cycle of about 1 second On and about 1/10 seconds. The forked tip member may include at least one surface that functions as a retractor.
As regards the method, the object of the invention may comprise the following steps: vibrating tissue of a human or animal in close proximity to, adjacent to and supporting a preset injection site while illuminating the injection site and injecting a liquid at the preset injection site by means of a needle or the like, wherein the vibration is pulsating. The pulse is preferably on for about 1 second and off for about 1/10 seconds.
With respect to the article, objects of the present invention include providing a single use disposable tip for an instrument comprising a vibratory unit and a lightpipe (transparent or translucent rod transmitting light) vibrated by the vibratory unit, the lightpipe protruding from a front end of the instrument, the tip comprising a tip sleeve for removably mounting on the front end of the instrument and a forked tip member for removably mounting on the protruding lightpipe. The forked tip member has a front prong that defines a predetermined injection site on the human or animal. The tip sleeve and forked tip member are covered and held together by a resilient envelope, enabling the forked tip member to vibrate freely relative to the tip sleeve and light from the lightpipe to illuminate the injection site. The single use disposable tip, i.e., the tip sleeve and the forked tip member, are spaced apart and the annular space therebetween is covered with an envelope. The forked tip member includes a cup and a pair of integrally formed longitudinally extending prongs, the envelope of which has a wider portion to provide at least one distraction surface and an underside groove to collect saliva to ensure that the disposable tip is not reused. At least one longitudinal groove may be formed in the wider portion of the envelope. Further, the envelope at the tip of the fork is preferably bulbous. The forward end of the tip sleeve preferably defines an alternative groove and rib and the envelope fills the groove and is secured in the rib.
Drawings
The above features and objects of the present invention will be discussed in relation to the accompanying drawings, in which like reference numerals refer to like elements and in which:
FIG. 1 is a perspective view of the novel instrument with a disposable tip mounted thereon;
FIG. 2 is an exploded view showing an embodiment of the device of the present invention having a disposable tip;
FIG. 3 shows in exploded view how a removable or disposable tip is mounted on the tip of the instrument;
fig. 4 shows the main components of the instrument in a different perspective view in an exploded view;
FIG. 5 shows in exploded view, in cross-section, the handle sleeve, tip sleeve and plastic tip of the instrument;
FIG. 6 shows the rear of the assembled view of FIG. 7 in section, showing the position of the polished rod of the instrument;
FIG. 7 shows an assembled view in cross-section of the disposable tip mounted on the handle sleeve of the instrument;
FIG. 8 is a perspective view showing the tip sleeve;
FIG. 9 is a perspective view showing a handle sleeve;
FIG. 10 shows the tip mounted to the instrument sleeve in an exploded perspective view;
FIG. 11 is a similar exploded perspective view showing the tip just prior to mounting on the instrument sleeve;
FIG. 12 is an assembled view showing the tip mounted on the instrument sleeve in perspective. Detailed Description
Referring to fig. 1 through 12, an embodiment of an improved retracting vibrator for performing the functions of the present invention is shown generally at 10 in fig. 1 and will be described hereinafter. In fig. 2-5, exploded views are shown. Specifically, the retracting vibrator 10 is a hand-held device that includes a tubular body or handle 12, the body or handle 12 having a battery cover and an end cap that is threaded onto the open end of the handle 12 with a complementary fit. This is described, for example, in WO/2010/111611, which is fully incorporated herein by reference. In addition, the handle 12 is made of a rigid plastic and partially receives a housing (chassis), and an uncovered portion of the handle 12 is covered by a battery cover, as described in WO/2010/111611. A rechargeable battery, not shown in fig. 1, is located in the battery compartment of the housing. The induction coil is mounted at the end of the housing and positioned in the battery cover to be coupled to the charging device in a conventional manner. A motor 24, shown schematically in phantom in figure 7, eccentrically drives a cam 26, shown in phantom, and is housed in the handle 12. The cam 26 comprises a ball seat having an axis that is offset from the motor drive axis by from about 0.010 inches to about 0.025 inches, preferably by about 0.020 inches. The vibrations induced by the cam 26 and the follower 100 are transmitted via the polycarbonate polish rod 30 to the polycarbonate tip 50, which polycarbonate tip 50 is firmly engaged at its front end with the rod 30, and which follower 100 is fixed at its rear end to the rod 30 via the fitting 31, see fig. 6 and in particular the cross-section of fig. 7. The vibrations generated at the free ends of the two legs 42 of the tip 50 have an amplitude of about 0.5mm (0.020 inches). During vibration, the polished rod 30 is independent of all other structures except the cam 26 at its rear end and the tip 50 at its front end, so that it can vibrate freely by pivoting about an elastic ring 29 (rubber or plastic O-ring) mounted in a groove 14 formed in the rod 30, spaced from the front end of the rod 30. The stem 30 has a projection 16 on the rear side of the groove 14 to help hold the O-ring in place. The forward end of the rod 30 is firmly engaged with the tip 50. Also, as in the structure described in WO/2010/111611, a PCB board containing electrical and electronic circuits is mounted on a chassis (not shown). A battery (not shown) is connected via this circuit to control the motor in the manner described in WO/2010/111611 incorporated herein by reference. When the motor 24 is driven, the vibration generated by the cam 26 is coupled to the polished rod 30 via the coupling fitting and the cam follower 100. A light 36, preferably an LED, is located at the rear end of the wand 30 and is powered by a battery and circuitry, as described in WO/2010/111611.
The front end of the handle 12 is provided with four embedded bolt seats 32, see fig. 2. The handle sleeve 34 has a flange 35 at its rear end, the flange 35 being provided with four bolt openings for receiving bolts 39, the bolts 39 being used to secure the handle sleeve 34 to the handle 12 in a recessed position. A cover ring 41 is fitted to the handle 12 to close the opening and cover the bolt 39. The polish rod 30 passes through and protrudes outward from the handle sleeve 34. The O-ring 29 resiliently engages the inner surface of the handle sleeve 34 near the forward end of the handle sleeve 34. The front end of the handle sleeve 34 has a lower flange 43 disposed rearwardly from the open front end.
Handle sleeve 34 receives a single use disposable tip 40, see fig. 10-12, which tip 40 includes three components, namely a forward plastic tip 50, a tip sleeve 62, and an elastomeric (rubber or plastic) envelope 52, the tip 50 being securely but removably mounted on the end of polished rod 30, the tip sleeve 62 being adapted to be removably and rigidly mounted on handle sleeve 34, and the envelope 52 covering plastic tip 50 and holding tip 50 and tip sleeve 62 together in spaced relation, which enables tip 50 to vibrate freely relative to tip sleeve 62.
Each of the components of the disposable tip 40 will now be described in more detail. The plastic tip 50 consists of a cup 51, the closed end of the cup 51 defining a lens 53. Two curved projections or legs 55 extend from the sides of cup 51 that support lens 53, extend forwardly and terminate in a rounded free end 57. On its rearward side, the cup 51 has a cutout 59 and two tongues, tabs or male ribs 61, the two ribs 61 extending rearward, each rib being located on one side of the cutout 59. Diametrically opposed cuts 59 are small cuts 63. The rod 30 enters the cup 51 and is firmly and rigidly engaged with the cup 51, while the front end of the rod 30 is closely juxtaposed with the lens 53.
Referring to fig. 8, the tip sleeve 62 is constructed of a tube having a ridge 65 at its forward end and a groove 67 behind the ridge 65. At the rearward end of tip sleeve 62, the diameter of tip sleeve 62 conically increases and terminates at a flange 69. Adjacent the rearward end of tip sleeve 62, a rectangular through hole 71 is formed in the housing of tip sleeve 62. On the front side of the opening 71, the inside of the tip sleeve 62 is thickened at 73 to form a flat shelf 75 of approximately 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 77 of the same general circumferential width of the opening 71. The plate 77 is formed with a V-groove 79 on its innermost side. The strengthening ribs 78 are located on the exterior of the tip sleeve 62 and extend from the conical portion to the flange 69.
The envelope 52 is hollow and has two longitudinally extending arms 81 at the front, the arms 81 being fitted over the longitudinally extending legs 55. The free ends of the arms terminate in enlarged distal bulbous portions 82. The envelope 52 is constructed of rubber or a thermoplastic elastomer, preferably about 40A, but can vary in hardness from about 30A to 50A. The portion 91 of the envelope fits over the cup 51 and has a hole 83, the hole 83 fitting around the lens 53 to allow light to pass through. The two arms 81 have on the underside a series of transversely extending, longitudinally spaced grooves 85, said grooves 85 being defined by projecting filaments for collecting saliva, so that no attempt will be made to reuse the disposable tip. The two arms 81 of the envelope 52 can be smooth or have a number of filaments in the form of ribs as shown in figure 7, or an array of filaments of any shape protruding from the surface of the envelope arms 81, to provide greater stimulation of the tissue in use. The intermediate portion 87 is enlarged laterally on both arms 81 of the envelope 52 to collectively form a distraction face 89 to assist in compressing or distracting tissue. The posterior portion of the envelope 52 has a tapered portion 93, the portion 93 being integral posteriorly with an end portion 95, the end portion 95 being complementary in configuration to the anterior end of the tip sleeve 62 to fit over the ridge 65 and behind the ridge 65 into the groove 67 to secure the envelope 52 to the tip sleeve 62 and maintain it spaced from the tip 50.
As shown in fig. 1, 2, 4, 5,7, 9 and 10-12, the handle sleeve 34 is a longitudinally extending tube and has a circumferentially radially inward flange 101 at its forward end, the flange 101 terminating spaced to either side of a tapered projection or tooth 103, the tooth 103 extending axially or longitudinally forward flush with the forward end of the sleeve 34 to define a notch 154, see particularly fig. 10-12. The teeth 103 extend slightly into the sleeve 34 to form a rear shoulder 152. A circumferential flange 101 formed at the forward end of the handle sleeve 34 serves as a restraint to hold the O-ring 29 on the forward side. O-ring 29 also passes behind shoulder 152 of tooth 103 and bears on this shoulder 152 and is thus also restrained on the front side by tooth 103. These elements together hold the polish rod 30 in place in the forward end of the handle sleeve 34 on the forward side. On the rear side, the protrusions 16 on the polished rod are bounded by arcuate radially inward protrusions 150, one of which protrusions 150 is visible in fig. 10-12. It is further seen in fig. 10-12 that notches 154 are formed on either side of the tooth 103, between the terminating end of the circumferential flange 101 and the tooth 103. The recess 154 is approximately 1-2mm deep. As noted, only the O-ring 29 engages the inner circumferential surface of the handle tip 34. The rod 30 is otherwise completely free from vibration with the O-ring 29 as a pivot.
The handle sleeve 34 has a larger diameter at its rear end than the transition conical portion 111 between the front and rear ends. The rear end terminates in a flange 35 having bolt openings 37. Spaced forwardly from the flange 35 is a fixed diameter surface portion 127 of the conical portion 111. Arcuate ridge 113 is formed extending circumferentially approximately 60 to 90 degrees from a point 125 of greater diameter than portion 127 and terminating at point 121. The ridge 113 narrows as shown in fig. 9 due to its right-hand cutout 115 and has an arcuate slot 117 to enable a bolt to pass through the bolt opening 37. Since the surface 127 has a fixed diameter, the ridge 113 defines a groove 119 on its rear side, and the low rib 123 extends longitudinally in the groove 119 to the rear of the cut-out 115.
Each of the tip sleeve 62, handle sleeve 34 and handle 12 has indicia to show how the components are aligned. The handle 12 has a forwardly directed arrow 131 at its forward end, the arrow 131 being aligned with a control button 132 for turning the power on and off. The handle sleeve 34 has a forwardly directed arrow 133 behind the flange 35. Disposable tip 40 has a rearwardly directed arrow 135 on tip sleeve 62 so that when disposable tip 40 is pushed longitudinally onto the handle sleeve, teeth 103 will insert or protrude into cut-outs 59 of plastic tip 50, but have clearance from plastic tip 50 and polished rod 30 so that vibration of tip 50 is never affected by polished rod 30. Furthermore, the rear end of the male rib 61 will be received and positioned in the recess 154 of the handle sleeve 34 but with clearance from the handle sleeve 34 and the teeth 103 so that the vibration of the tip 50 is never affected. The male ribs 61 of the tip 50 and the notches 154 of the handle sleeve 34 are complementary and have a gap of at least about 0.5mm therebetween, see particularly fig. 10-12.
As the disposable tip 40 is pushed in a linear longitudinal direction onto the handle sleeve 34, the thickening at 73 that forms the flat shelf 75 causes the inwardly extending plate 77 to pass over the ridge 113 at the cut-out 115 and back into the recess 119, at which point the flat shelf 75 falls onto the surface 127, the rectangular through hole 71 crosses the ridge 113 at the cut-out 115, and the plate 77 falls onto the rib 123, with the V-groove 93 engaging the rib 123. At this point, the rod 30 is received and positioned in the cup 51 of the tip 50 of the disposable tip 40, the disposable tip 40 being locked to the handle sleeve 34 and cannot be pushed axially away. The teeth 103 at the forward end of the handle sleeve 34 are received and positioned in the cutouts 59 with a suitable clearance of at least about 0.5mm from the surroundings so that there is no vibration related disturbance. In addition, the rear ends of the male ribs 61 on either side of the notch 59 are received in the recesses 154 to a sufficient depth to enable ready engagement with the handle sleeve 34 with any relative rotational movement with respect to the handle sleeve 34 and tip 50. The teeth 103 and the rear end of the male rib 61 serve to retain the handle sleeve 34 and tip 50 from relative rotation. At this point, the teeth 103 and male ribs 61 will be juxtaposed in the same radial cylinder coaxial with the longitudinal axis of the instrument, handle sleeve 34 and the cut-out and projection 61 of the cup 50.
To remove the disposable tip 40 from the handle sleeve 34, the tip sleeve 62 must be rotated relative to the handle sleeve 34 from the proximal point 125 toward the termination point 121 until the plate 77 passes this point 121, at which time the disposable tip 40 can be removed by pushing longitudinally forward. However, during relative rotational movement of the tip sleeve 62 and the handle sleeve 34, the plastic tip 50 will quickly engage the teeth 103, either through the side walls of the cutout 59 or the projections or the male ribs 61 or both, and then the tip 50 will remain fixed and prevented from rotating. Tip hub 62 will still rotate relative to handle hub 34 so it can be removed and in the process, as tip hub 62 rotates, a torque will be created and applied to envelope 52 and will quickly exceed the elastic limit of envelope 52 at thinned portion 93, while thinned portion 93 of envelope 52 will undergo severe tearing or shredding beyond about 60 to 90 degrees or more, effectively destroying its ability to be used and/or reused. The rear end of the male rib 61 of the tip 50 in the recess 154 is a backup in the event of any failure of the tooth 103 to hold the tip 50 stationary during removal of the disposable tip 40 from the sleeve 34. The rear end of the male rib 61 located in the notch 154 will also prevent any rotation of the tip 50 relative to the handle sleeve 34 during removal of the disposable tip 40 and thereby ensure tearing or shredding of the thinned portion 93 of the envelope 52.
As described, the fitting member 31 attached to the end of the polished rod 30 includes a protruding stub having a ball end 100, the ball end 100 serving as a cam follower for contacting the cam 26 and moving with the cam 26 to apply the vibration of the cam 26 to the polished rod 30. The end of the light rod 30 is aligned with the LED36 as previously described. Although continuous pulses can be used, pulse vibration sequences have been found to be more effective. A pulse sequence of about one second on and then about one tenth of a second off is sufficient to pulse the vibration without causing the vibration of the tip to drop to zero. In this way, the device or instrument pulses about every second, re-stimulating the nerves in the area, and it is clear that the brain is never accustomed to it, so the vibrations remain effective. To this end, the electronics controlling the pulses are modified to include the necessary means for generating the pulses and obtaining the desired On/Off duty cycle as described. The motor is powered using 110 volts alternating current (50-300 Hz frequency). The frequency can vary from about 50Hz to about 300Hz, and preferably about 140Hz to 160 Hz. The vibrational energy at the free end of the jaw or prong 42 can vary from about 0.1mm to about 1.0mm, with a preferred range being from 0.65mm to 1.0 mm. The duty cycle is about 1.05 seconds with the pulse on for about 1 second and off for about 0.05 second. The amplitude may vary from about 0.1mm to about 1.0mm, with a preferred range being from about 0.65mm to about 1.0 mm.
The novel instrument exhibits enhanced amplitude and taps the contacted tissue, causing the vibrational stimulus to penetrate deeper into the dental patient's oral mucosa or into the skin of the medical patient, thereby stimulating sensory nerve endings located deep in the tissue, producing action potentials that burst sensory information to the brain via the myelinated a-beta afferent nerve fiber axes.
In addition, the vibrations are emitted a full 360 degrees around the disposable tip 40, primarily from three locations of the tip, namely from each free end of the downwardly bent arms, and from the paddle or retractor 87. Also when abutting the lips or cheeks or bones, the connection with the tip sleeve 62 will sometimes irritate the lips or cheeks or bones. The enhanced vibration is not limited to the region at the tip of the downward bent arm. Alternative free tip shapes are shown in WO/2010/111611 which is incorporated herein by reference.
As previously described in WO/2010/111611, a plastic sleeve or wrap can be placed around the instrument during use to protect its sterility and avoid contamination. The plastic sleeve or wrap has a hole punched into it so that it can fit over the handle sleeve 34 and the disposable tip 40 can be mounted to the handle sleeve 34 as described. To this end, the flange of the rear of the disposable tip 40 is spaced slightly from the front of the instrument to provide a slot to accommodate a plastic sleeve or wrap intermediate the instrument and the tip.
If the device or instrument is to be used for medical applications, that is, to be used on a part of the body other than the mouth, the disposable tip 40 will bend upward, 180 degrees opposite the dental application described above, and the legs or other tip member shape of the tip member 50 can be covered or uncovered by the envelope 260 bridging and holding together the cup of the tip member and the ribbed end of the tip sleeve 62.
From the above description, it should be apparent to those skilled in the art that the present invention can be used in a variety of procedures requiring skin or muscle penetration. These other procedures include, for example, vaccination, injection, etc. to administer medication to a patient. These skin pricking procedures can be performed on any part of the body such as the arms, legs, buttocks, torso, etc.
The method of the invention comprises vibrating tissue of a human or animal adjacent a predetermined injection site while injecting a liquid at the predetermined injection site on the human or animal body by means of an instrument such as a needle. Vibration is most effective if transmitted to the cylindrical volume of tissue and the injection site, particularly the underlying bone on the opposite side of or around the injection site. Furthermore, a noise generator is preferably mounted in the body of the instrument, so that the vibration is achieved by noise, which will provide distraction. In the most preferred embodiment of the method, a pulsed vibration sequence is used. A pulse sequence of one second on and then 0.05 second off is sufficient to pulse the vibration without ever dropping the vibration of the tip to zero. In this way, the device or instrument pulses about every second, re-stimulating the nerves in the area, and it is clear that the brain is never accustomed to it, so the vibrations remain effective.
The tip vibrates and has a free end characterized by a shape to induce vibrations in tissue and underlying bone, whereby the free end can be placed adjacent to a preset injection point of a human or animal and the tissue and underlying bone at said preset injection point vibrate when the injection is performed. Vibration continues even after the injection has been completed to massage the tissue to disperse the injected fluid into the tissue and prevent tissue bulking and swelling of the tissue, which is the source of pain.
Preferably, the subsequent vibration is performed by applying a greater pressure to the tissue by the injecting person to achieve a better massage. This subsequent vibration can be more effective in certain areas of the mouth if the applied pressure is sufficient to sound the bone beneath the tissue. The average dentist in the field can feel when he applies pressure to the tissue, such as the gingiva, and his instruments effectively touch and well touch or strike the underlying bone. When this bone contact is felt, the pressure is maintained for at least 1 to about 90 seconds or until no further tissue expansion is observed.
Although the invention has been shown and described herein in what is conceived to be the most practical and preferred embodiment, it is recognized that alterations, modifications, variations, and changes may be made to the invention without departing from the intended scope of the invention, as set forth in the appended claims.