HK1249871B - Reducing pain of skin piercing using vibration - Google Patents

Description

Using vibration to reduce the pain of skin punctures

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to the following application:

U.S. patent application 60/661,497, filed September 20, 2004;

U.S. patent application 60/707,754, filed August 12, 2005;

PCT application number PCT/US05/33769, filed September 19, 2005;

U.S. patent application 61/163,945, filed March 27, 2009;

PCT application number PCT/US09/66033, filed November 29, 2009;

PCT application number PCT/US10/28858, filed March 26, 2010;

U.S. patent application 13/179,674, filed July 11, 2011, now U.S. Patent 8,668,664;

U.S. patent application 13/225,782, filed September 6, 2011, now U.S. Patent 8,662,952;

U.S. patent application 13/253,572, filed October 5, 2011;

PCT application number PCT/US12/53744, filed September 5, 2012;

U.S. patent application 61/531,264, filed September 6, 2011;

PCT application number PCT/US12/53943, filed September 6, 2012;

U.S. patent application 61/909,544, filed November 27, 2013;

PCT application number PCT/US14/67587, filed on November 26, 2014;

U.S. patent application 62/155,769, filed May 1, 2015;

U.S. patent application 14/803,535, filed July 20, 2015; and

U.S. patent application 62/208,860, filed August 24, 2015.

The entire contents of the above are hereby incorporated by reference.

Technical Field

The present disclosure relates to a system and method for vibrating a body part to reduce pain during skin puncture, and more particularly, to applying vibration using a handheld tool having a vibrating tip.

Background Art

Procedures for relieving pain when injecting a substance into the body, removing body fluids or tissue, or otherwise piercing the skin include: (a) placing a very cold substance on the patient's skin or muscle at the puncture site; (b) applying a topical treatment to the skin or muscle at the puncture site to temporarily numb the skin or muscle; or (c) rapidly manually massaging the skin or tissue at the injection site while the injection is being made.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present disclosure and the attendant advantages and features will be more readily appreciated by referring to the following detailed description when considered in conjunction with the accompanying drawings, in which:

FIG1 is an exploded view illustrating one embodiment of an apparatus of the present disclosure;

FIG2 is a cross-sectional assembled view of a disposable tip of the present disclosure mounted on a handle sleeve of an instrument;

FIG3 depicts an alternative replaceable tip of the present disclosure including a V-shaped distal end;

FIG4 depicts the tip of FIG3 connected to a device of the present disclosure and applied to a body part of a patient;

FIG5 depicts a front view of the tip of FIG3;

FIG6 depicts a side view of the tip of FIG3;

FIG7 depicts a side view of the tip of FIG3 modified to have an alternative arm inclination angle and showing an alternative non-integral tip with a separable distal end and base;

FIG8 depicts an alternative distal end forming a closed loop;

FIG9 depicts an alternative distal end having arms forming a split loop;

FIG10 shows the distal end of FIG8 being used to apply vibrations to a body part before and during a lancing procedure;

FIG11 is a top perspective view of an alternative replaceable tip of the present invention sized to engage a body part and a tool end;

FIG12 is an exploded view of the tip member of FIG11;

FIG13 is a bottom perspective view of the tip member of FIG11;

FIG14 is a side view of the tip member of FIG11;

FIG15 is a top view of the tip member of FIG11;

FIG16 is a front perspective view of the tip member of FIG11;

FIG17 is a bottom view of the tip member of FIG11;

FIG18 is a perspective view of the tip of FIG11 connected to the remainder of the instrument of the present disclosure;

FIG19 is a perspective view of the apparatus of FIG18 for positioning a prior art lancing device relative to a patient's finger for a treatment procedure in which the apparatus reduces pain during the procedure;

FIG20 is a perspective view of a holder of the present disclosure holding an instrument of the present disclosure;

FIG21 is a side view of the retainer of FIG20 not engaged with a support surface;

FIG22 is a cross-sectional side view of the retainer of FIG20 taken along line A-A of FIG20;

FIG23 is a side view of the holder of FIG20 , wherein the holder has been pressed against a surface to activate the suction cups of the holder and to spring-load the resilient frame of the present disclosure;

FIG24 is a cross-sectional view of the retainer of FIG23 taken along line A-A of FIG20;

25 is a side view of the holder of FIG. 20 with the suction cup engaged with a surface and with the frame applying a pulling force to the suction cup while engaged with the surface; and

FIG. 26 is a cross-sectional view of the retainer of FIG. 25 .

DETAILED DESCRIPTION

As required, detailed embodiments are disclosed herein; however, it is to be understood that the disclosed embodiments are merely examples, and the systems and methods described below can be implemented in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art to make various uses of the subject matter according to virtually any appropriate detailed structure and function. In addition, the terms and phrases used herein are not intended to be limiting, but rather to provide an understandable conceptual description.

As used herein, the terms "a" or "an" are defined as one or more than one. As used herein, the term "plurality" is defined as two or more than two. As used herein, the term "another" is defined as at least a second or more. As used herein, the terms "including" and "having" are defined as comprising (i.e., open language). As used herein, the term "coupled" is defined as connected, but not necessarily directly and not necessarily mechanically.

The present disclosure reduces pain in patients when injecting, for example, anesthetics, serums, vitamins, vaccines, or other liquids with medical efficacy. The present disclosure 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 patient's skin or muscle. The present disclosure overcomes the cumbersome and time-consuming aspects of the prior art, including providing a more effective effect, often reducing pain to an acceptable level. The present disclosure also reduces pain when, for example, a lancet or hypodermic needle and syringe is used to extract body fluids from a patient.

The present disclosure reduces pain in patients who are being injected with, for example, anesthetics, serums, vitamins, vaccines, or other medically effective fluids. The present disclosure can be easily and inexpensively utilized in medical, veterinary, or dental procedures to almost completely eliminate or substantially eliminate the pain associated with puncturing a patient's skin or muscle for injections. The present disclosure also reduces pain caused by any disturbance of the skin by underlying tissue, such as pain associated with skin punctures associated with removing fluids from the body. Examples include: when removing blood for glucose testing or other blood analysis; during puncture procedures associated with skin treatments, such as for acne or blisters; and for other fluid extractions, such as during phlebotomy, paracentesis, aspiration, or synovial fluid extraction procedures.

The present disclosure provides a disposable tip and handheld device for vibrating a skin or tissue area, which, in one embodiment, has the form of an instrument. Various aspects of the present disclosure are described in the cited applications. In various embodiments, the vibrating end contacts at least two skin or tissue areas, or circular skin or tissue areas, at an injection site or pain contact site, and does so when pain behavior occurs. Pain may be caused by injecting, for example, a liquid anesthetic, serum, vitamin, vaccine, or other medically or dentally effective substance into the skin or tissue at the injection site. Typically, the area of interest for a dentist may be the entire oral mucosal area and the underlying bone, while the area of interest for a physician may be the entire body and the underlying bone. The present disclosure is applicable to both practitioners and may be used on any area of the body. For a dentist, a typical injection procedure may involve injecting lidocaine into the patient's gums or other tissue during a dental procedure.

The method of the present disclosure is to vibrate tissue of a human or animal near a preselected injection site on the human or animal body while injecting a liquid at the preselected injection site through a needle or similar instrument. The vibration can be effective if it is transmitted to a circular or other shaped area of body tissue, which may include bone beneath the skin located on the opposite side of the injection site, particularly the bone on the opposite side of the injection site.

In various embodiments of the present disclosure, reuse of end pieces, such as vibrating tips of instruments, is prevented to avoid cross-contamination between patients. In one embodiment, the tip is destroyed upon removal. In another embodiment, electromagnetic communication is established between an electronic tag on the tip and electronic circuitry within the instrument body. In this way, the tip's use count and validation can be monitored, and activation of the instrument can be disabled if the tip should be replaced after a period of time or a predetermined number of uses, which indicates possible reuse between patients.

The embodiments disclosed herein are tools for relieving pain associated with injections or any other skin puncture. For example, in addition to injections, the present disclosure is applicable to other painful procedures applied to any body tissue, such as cauterization, application of lasers, application of chemicals, or insertion of sutures, clips or staples, or puncturing the skin to extract a body fluid sample. Furthermore, it should be understood that the present disclosure can be used to control the use of any tool tip, whether used in dental, general medical or industrial applications, such as grinder or drill press tool tips or other end effectors.

Referring to Figures 1 and 2, an embodiment of an oscillating tool, generally designated as instrument 10, is shown for performing the functions of the present disclosure, as described below. Specifically, instrument 10 is a handheld device comprising a tubular main frame, body, or handle 12 having a battery cover 14 as an end cap, which is threaded for threaded connection to the open end of handle 12 in a complementary fit. Handle 12 is constructed of a hard plastic or other sufficiently rigid material and partially supports a chassis 22, with the uncovered portion being covered by battery cover 14. One or more rechargeable batteries are located in a battery compartment 16 of chassis 22. An induction coil 18 is mounted on an end of chassis 22 and positioned within battery cover 14 for coupling to a charging device in a conventional manner. An external power source can be connected to instrument 10 via an electrical cord to charge the internal battery, thereby powering the device when the battery is not present, or to power the device when the battery is being charged.

The motor 24 that drives the cam 26 is housed in the handle 12. The cam 26 includes a bore in the form of a ball and socket, the axis of which is offset from the motor drive axis. The vibrations caused by the cam 26 and the follower 100 are transmitted to the polycarbonate tip frame 50 via a polycarbonate light rod 30 and will produce vibrations at the free ends of the two bifurcated legs 42 of the tip frame 50. It will be understood that the polycarbonate can be replaced by any other material having sufficient rigidity and light transmission capabilities. It will also be understood that alternative means of generating vibrations may be provided, including, for example, reciprocating mechanisms, electromechanical actuators and acoustic or other vibration transducers, or other types known or later developed.

During vibration, the light column 30 pivots about a resilient mounting, which in one embodiment is implemented by a resilient O-ring, which at the end of the nozzle 34 can hold the light column 30 relative to the nozzle 34 so that the light column can vibrate freely. A PCB board 20 containing electrical and electronic circuitry 28 is mounted on the chassis 22. A battery is connected via the circuitry 28 to control the motor 24 in the manner described in one or more of the prior applications incorporated herein by reference. When the motor 24 is driven, the vibrations generated by the cam 26 are coupled to the polycarbonate light column 30 via a coupling fitting and a cam follower.

The front end of the handle 12 has an adapter 32 fixed to the base and handle. A nozzle 34 is fixed to the adapter 32. The light column 30 is received in the nozzle 34 and is resiliently coupled to the nozzle at the front end of the light column. The nozzle 34 receives an end piece, which in this embodiment is a disposable tip 40 composed of three parts: a front vibrating tip 50, which is removably and rigidly mounted to the end of the light column 30 to transmit vibrations, wherein the tip 50 has a fork at its front end in various configurations; a tip sleeve 62, which is used to removably and rigidly mount to the nozzle 34; and an overmold 52, which holds the tip 50 and sleeve 62 together and allows the tip 50 to vibrate freely relative to the sleeve 62. As shown in Figure 2, the LED 36 is mounted to the PCB 20 and is configured to transmit light into the light column 30 during vibration of the light column 30.

The cited references detail various embodiments of the instrument 10, including: an electromechanical interlock to prevent excessive reuse of the tip 40; the functionality of the overmold 52 for transmitting vibration and connecting the legs 42; a mechanical connection to cut the overmold 52 during removal of the tip 42 to prevent reuse; a connection between the ball end 100 and the cam 26 for generating vibration; vibration pulsations with varying on/off times; various tip end 42 shapes and configurations; a charging dock and inductive charger for the instrument 10; a toy adapter; a noise generator; application of pressure after puncturing tissue; various angle settings of the tip end 42; light shone between the tip ends 42; a music player incorporated into the instrument 10; and an RFID or near-field tag associated with the tip 40 that communicates with an antenna and processor connected to the handle 12.

Based on the description above and the references cited, it will be apparent to those skilled in the art that the present disclosure can be used in various procedures requiring skin or muscle puncture, scraping, or other potentially painful treatments. Such other procedures include therapeutic vaccinations, including injections for administering medication to a patient, or drawing blood or fluids, among other procedures. Such procedures can be performed anywhere on the body, such as an arm, leg, buttocks, torso, etc.

With reference to Figures 3 to 7, an embodiment of a tip 40B that does not include an overmold 52 is shown, but other embodiments described herein may be used in the applications shown. More particularly, the frame tip or distal tip 50 includes two longitudinally extending arms 81 forming a V-shape. This shape enables any narrow body part - including, for example, tendons, toes, thumbs, muscles, ears, noses, cheeks, tongues or other parts of the mouth, foreheads, or fingers 500 - to be inserted between the arms 81 of the V-shape until contact is made with the opposite side of the body part. In this way, and as can be seen in Figure 4, a single size of the distal tip 50 can accommodate a range of sizes and parts. In addition, distal tips 50 of various sizes and shapes can be provided.

Furthermore, as shown in Figures 6 and 7, arm 81 can be positioned at various angles relative to handle 12. This angle can be selected so that handle 12 can be positioned at a comfortable distance from the body when arm 81 is applied to the body. The angle can also be selected to foster a comfortable posture for the practitioner or patient when holding handle 12, when positioning a specific body part within arm 81. In the embodiment of Figure 6, a 60-degree angle is shown, while in the embodiment of Figure 7, a 45-degree angle is shown. It should be understood that the angle can be selected to facilitate positioning arm 81 in contact with the desired body part, taking into account the relative position of the person holding handle 12 and the manner in which arm 81 and other portions of tip 40 are intended to contact the body part to be numbed. Figure 7 also illustrates that tip 40B can be manufactured as a detachable component, but it should be understood that tip 40B can also be manufactured as an integral part comprising base 44 and tip 50.

As described herein, once distal tip 50 contacts a body part that is expected to experience pain or discomfort, vibration can be initiated and continued. As described herein, the vibration can be at any frequency within a frequency range or along a frequency range, and can be programmed or provided with a specific frequency or frequency range that has been shown to be most effective in alleviating pain associated with puncturing or treating a specific body part and/or a body part with specific characteristics, such as specific characteristics related to skin thickness or sensitivity. As further described herein, the vibration can be pulsed or discontinuous.

Without being bound by any particular theory, the stimulation of nerves near the skin in contact with the vibrating arms 81 reduces nerve conduction associated with pain or discomfort. In this case, the skin between or near the arms 81 can be punctured, scraped, treated with chemicals or medications, or otherwise disturbed in a manner that tends to produce pain or discomfort. The vibrations can be discontinued after a period of time, which is expected to generally substantially eliminate the initial high level of pain or discomfort.

Referring to FIG8 , it can be seen that distal tip 50A is provided with side arms 81A that form a closed loop between arms 81. In this way, an inserted body part, such as finger 500 in FIG10 , can be contacted at multiple points around the site of pain or discomfort. In addition, the loop can be used to maintain contact with the body part to the vibration, which is helpful for patients who are fearful or otherwise prone to movement. As shown in FIG9 , side arms 81A can also be provided with gaps 274 that allow arms 81A to flex to accommodate larger body parts or to provide more resilient contact with body parts on the opposite side.

In FIG10 , the device 10B is shown applied to a finger 500, which is about to be punctured by a lancing needle 510 in order to obtain a blood sample for a therapeutic application, such as blood glucose monitoring. As can be seen, the finger 500 is inserted into the distal tip 50A, although any other tip of the present disclosure that can accommodate a finger may also be used. In this embodiment, the finger 500 is pressed into the narrow portion of the V-shape to increase contact with the distal tip 50A to better transmit the vibrations to the skin of the finger 500. Vibrations are applied to the finger at intervals and frequencies described elsewhere herein and in the cited references, and the discomfort and pain of the punctured finger are reduced, after which the vibrations can be terminated and the finger 500 can be removed from the distal tip 50A.

11-18 , the instrument 10C includes a distal tip 50C configured to cooperate with a skin puncture device. The instrument 10C also includes a nozzle 34 and a tip sleeve or base 44 that operate in the manner shown and described in any embodiment herein, including, for example, those described with respect to instruments 10 and 10A. The distal tip 50C includes a cup 212C that includes positive ribs 61 or any other form of coupling to the nozzle 34 described herein, or that can be otherwise implemented to transmit vibrations to the distal tip 50C. In one embodiment, the distal tip 50C can be provided with a tag 370 and an antenna 302 and associated components as described with respect to the instrument 10A.

The distal tip 50C is provided with a body contact profile 270 that is shaped to accommodate a body part that is to be punctured or otherwise subjected to a potentially painful procedure. In the illustrated embodiment, portion 270 is configured to contact the end of a finger 500 of the patient's hand or the end of a toe of the patient's foot. It should be understood that the present disclosure is not limited to alleviating pain in the fingers, however it should also be understood that the size and dimensions of the contact profile 270 can be configured to engage with any body part. The contact profile 270 is shaped to guide the body part into contact with the tip 50C in a manner that transmits vibrations and to reduce the likelihood of the body part moving during the procedure by contacting the body part along different areas of the body part. The arm 81C extends beyond the contact profile 270 and cooperates with the contact profile to support and guide the body part.

In the embodiment shown, the contact profile 270 is provided in two parts, one part being associated with one of the arms 81C, and each part extending substantially transversely relative to the plane defined by the arms 81C, but the profile 270 can protrude from that plane at any angle that best accommodates the desired body part. The contoured surface 276 forms a curve corresponding to the shape of the end of a person's finger, with the arm 81C thus supporting the pad portion of the fingertip. The contoured surface 276 also has angled surfaces that face each other and serve to center the finger within the tip 50C, with the center of the fingertip's pad thus positioned to be exposed by the space 220C through which the procedure can be performed.

The various surfaces of tip 50C can be formed directly on the integral molded part, or they can be formed on the surface of overmold 52C. In the latter configuration, tip 50C forms an internal support frame that supports overmold 52C and limits its deformation and bending. Overmold 52C can be made of plastic, neoprene, silicone rubber, latex, or any other material that imparts beneficial properties to tip 50C, including any or all of the following: biocompatibility, ease of cleaning, patient comfort, secure, non-slip engagement with body parts, attractive colors, easier molding of complex curved shapes, sealing with nozzle 34, and vibration transmission coupled to nozzle 34. Overmold 52C can include an opening near lens 53C or other opening in cup 61 through which light can be transmitted. However, it should be understood that tip 50C can be molded as a single unitary part from similar materials that provide the same beneficial properties.

In the embodiment shown, arms 81C are separated from each other by gaps 274C, which facilitates the conduction of vibrations along the entire arm 81C, including the contact profile 270. Furthermore, arms 81C are resilient and can bend relatively apart to allow a portion of a body part to pass through and thereby better grip a portion of the body part, directing vibrations into the body part. As described elsewhere herein with respect to other tip arms, arms 81C can be arranged at an angle relative to handle 12.

In one embodiment of the present disclosure, arm 81C and space 220C are sized and dimensioned to engage tools that will be used to perform a patient treatment procedure, such as obtaining a blood sample, as shown in FIG19 . More specifically, in the embodiment of FIG19 , arm 81C is shaped to nearly completely surround and positively position the lancet device 512, which has a tapering, rounded end 520. Thus, arm 81C ensures that the skin area to be punctured is optimally positioned relative to arm 81C, ensuring that vibrations extend around the skin area to be punctured, thereby desirably affecting nerve sensation associated with the punctured area. Without this fit, the skin might be punctured more toward one arm 81C or the other. While this may be effective for many purposes, in certain circumstances, it may be advantageous to ensure that the puncture will be equidistant from both arms and in the center of space 220C, which is accomplished through the fit between arm 81C and the mating end 520 of certain types of lancet devices. It should be understood that the tip 50C can be configured to engage only a body part using the contact profile 270, or only a tool end using the contoured arms 81C, or can be configured to do both, as shown.

In the manner discussed above, the arms 81C can be resiliently bent to allow passage of the mating tool end 520 and thereafter resiliently apply force toward the original position of the arms 81C, thereby gripping the tool end 520 to help maintain the tool's position relative to the body part during use of the tool 512. The tip 50C can also be formed with connected arms 81C as shown in the embodiment of FIG8 and still resiliently grip and mate with an inserted tool end. Alternatively, the arms 81C can be rigid and can be unattached or attached, or formed into a mating relationship with one or more tool ends.

To allow for greater flexibility, to accommodate a wider range of tool sizes that can be inserted between the arms 81C, and/or to facilitate the elastic flexure of the arms 81C, a leading gap 278 can be provided between the base of the arms 81C and the space 220C. The leading gap 278 further provides a lighting path for passing from the light pipe 30 to the work area adjacent to the space 220C.

It should be understood that the cooperative relationship between the arm 81C of the tip 50C and the tool end is not limited to lancing needle devices, and that the cooperative relationship can be formed between the tip 50C and any therapeutic tool currently known or later developed that can be advantageously positioned positively relative to the puncture or potential pain site and the application of vibration from the device 10 or 10A of the present disclosure.

As shown in Figure 19, there is no need for a matching relationship to transmit the therapeutic, pain-relieving benefits of the apparatus 10, 10A of the present disclosure. As shown, for example, alternative puncture needle 510 end shapes can be used, as well as hypodermic syringe 522 or suture 524. Other instrument ends are obvious to the practitioner, and can include, for example, clamps, tweezers, scissors, surgical scalpels or punch biopsy. The therapeutic process can include injecting liquid, for example, when providing medicine or vaccine, or removing fluid, for example, when extracting blood or infection, or for applying light, for example, laser, in dermatological treatment. In addition, the tip 50C of the present disclosure or any tip also can be used in beauty or non-therapeutic process, including, for example, using together with a tattoo needle to form a tattoo, or using together with a laser to remove a tattoo, or using together with a laser to treat skin wrinkles or spots.

20-26 , a mounting base 400 for an instrument 10D of the present disclosure includes a device support 410, a base extension 404, an instrument holder 412, support legs 420, 422, and a suction cup 430. The device holder may be sized and shaped to releasably and securely retain any of the disclosed instruments as described herein or in the cited references.

In FIG. 20 , the instrument 10D further includes an ergonomically shaped handle 12B having a flat profile that facilitates manual grasping to rotate the instrument 10D to the desired optimal angle to bring the tip frame 50 into contact with the treatment site.

The instrument holder 412 is shaped to slidably and releasably retain the handle 12 (generally designated 12/12A/12B) and is formed with a tapered profile that cooperates with the tapered profile of the handle 12 to enable the instrument 10 (generally designated 10/10A/10B/10C/10D) to be inserted to a desired predetermined extent such that a sufficient portion of the handle 12 extends from the holder 412 to enable the handle 12 to be easily grasped and pulled to remove the instrument 10. As an alternative to a tapered fit, the handle 12 can be shaped to contact a surface of the instrument 10 to prevent insertion beyond the desired predetermined extent.

In addition, or as an alternative to the foregoing, the retainer 412 and the handle 12 can be provided with cooperating detents, such as a protrusion 442 on one portion and a recess 444 on the other portion, which engage when the instrument 10 has been fully inserted. In the illustrated embodiment, the protrusion 442 is provided on a resilient arm 446 integrally molded with the retainer 412. The recess 444 is provided within the handle 12, but it should be understood that the recess can be provided within the retainer 412 and the protrusion can be provided on the handle 12. Furthermore, the recess can be provided on the resilient arm 446 and a fixed protrusion can be provided on the handle 12. When the instrument 10 is inserted, the arm 446 flexes to allow the protrusion 442 to be displaced by the handle 12. When the protrusion 442 is aligned with the recess 444, the arm 446 pushes the protrusion 442 into the recess 444. Alignment of the protrusion 442 and the recess 444 can be achieved by a mating surface in the interior surface of the retainer 412 and a corresponding mating exterior surface of the instrument 10, which contacts each other to guide and orient the instrument 10 when the instrument 10 is inserted into the retainer 412.

The retainer 412 includes two opposing arms 414, 416 that can be formed of a resilient material so that the arms 414/416 can bend to achieve engagement and disengagement of the retainer. Alternatively, the resilient arms 414/416 can be formed to define an inner diameter that is smaller than the diameter of the instrument 10 or handle 12 when relaxed, thereby achieving a wedging force when the instrument 10 is inserted, which allows the instrument 10 to be securely maintained between the arms 414/416 when fully inserted.

The holder 412 can also be arranged at an angle relative to the plane defined by the bottoms of the legs 420, 422, which are intended to rest on the surface on which the base 400 is to be mounted. In this way, gravity can be used to maintain the instrument 10 within the holder 412. In the embodiment shown, a 15-degree angle is formed, but any angle can be used, for example, any angle from 10 to 30 degrees, although any angle between zero and ninety degrees (vertical), inclusive, can also be used in accordance with the present disclosure. In one embodiment, the angle can be selected by rotating the holder 412 about a pivot (not shown) that connects the holder 412 to the base extension 404.

The base extension 404 increases the height of the holder 412 above the surface of the mounting device support 400. In this way, when the instrument 10 is in the holder 412, the tip frame 50 does not contact the surface and the handle 12 is spaced from the surface for easy manual grasping.

Legs 420, 422 extend from opposite sides of a lower portion 424 of the base extension 404. While two legs are shown, any number of legs may be provided, such as three, four, or a greater number of legs. However, the legs are advantageously resilient and can be extended to a considerable extent, as will be described in detail with respect to Figures 23 to 26. The formation of independent legs facilitates flexure, however, it should be understood that a cup-like structure may be provided in place of independent legs 420, 422, as long as the desired resiliency and stability, as described below, are provided.

Suction cup 430 is connected to legs 420, 422, or base extension 404, at a closed end forming a peak 432. In the illustrated embodiment, an attachment button 434 is provided on post 450 at peak 432, sized to be inserted through a gap or opening 436 in base extension 404, thereby releasably attaching suction cup 430 to mounting base 400. Suction cup 430 may be attached by other means such as adhesive, removable fasteners, crimping, or any other method. However, advantageously, suction cup 430 can be twisted relative to legs 420, 422, allowing suction cup 430 to move independently to form an optimal angled engagement for maintaining suction or vacuum engagement with a supporting surface. As can be seen in Figures 21 and 22, in an unengaged state, suction cup 430 extends beyond the furthest extent of legs 420, 422. Figure 22 illustrates this state in a cross-section taken along line A-A of Figure 20.

In FIG23 , the mounting base 400 is pressed against the support surface 540 with sufficient force to collapse the suction cup 430 and also bend and collapse the legs 420, 422 so that they contact the surface 540 and bend further to allow additional evacuation of air between the surface 540 and the interior 440 of the suction cup 430. In this way, the legs 420, 422 are spring-loaded or generate a spring potential for stabilizing the mounting base 400, as further explained below. FIG24 illustrates this state in a cross-section taken along line A-A of FIG20 .

25 and 26 , after compressing mounting base 400 to collapse legs 420, 422 and suction cup 430, mounting base 400 can be released, whereby legs 420, 422 resiliently apply a biasing force to push mounting base 400 away from surface 540. If surface 540 is sufficiently smooth and a sealing surface is formed between peripheral contact surfaces 438 of suction cup 430, a vacuum is formed within interior 440 of suction cup 530 when button 434 is pulled away from surface 540. This effect is achieved when the legs resiliently flex to push extension 404 and opening 436 away from surface 540 (not shown in FIGS. 24-26 ). Consequently, a suction force is created that pulls mounting base 400 toward surface 540, and legs 420, 422 continue to push surface 540 away from surface 540, causing base 400 to stabilize relative to surface 540.

Legs 420, 422 are cut away along a portion of outer edge 448 of suction cup 430, exposing the edge of outer edge 448. Accordingly, mounting base 400 can be released by lifting a portion of outer edge 448 off surface 540 to allow air to enter interior 440 and release the vacuum formed therein.

The mounting base 400 can be made of any material, such as metal, wood, plastic, or a composite material. Plastic is advantageous because it can be used in a clinical setting and can be machine washed or wiped with a disinfectant detergent without being damaged. In addition, the plastic can be selected to have inherent elasticity, thereby facilitating the formation of the elastic arms 414, 416, the elastic stop arm 446, and the elastic legs 420, 422. However, other materials can also be used for part or all of the mounting base 400, particularly metals, including, for example, shape memory metal alloys. Non-limiting examples include thermoplastics such as acrylic, ABS, nylon, PLA, polybenzimidazole, polycarbonate, polyethersulfone, polyetheretherketone, polyetherimide, polyethylene, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polyvinyl chloride, and polytetrafluoroethylene.

The suction cup 430 can be made of any of the aforementioned materials that are soft and pliable at room temperature, and also includes thermoplastic elastomers such as styrenic block copolymers (TPE-s), thermoplastic olefins (TPE-o), elastomeric alloys (TPE-v or TPV), thermoplastic polyurethanes (TPU), thermoplastic copolyesters, thermoplastic polyamides, and other materials such as natural or synthetic rubber or silicone-based materials, as understood in the art.

The mounting base 400 can be manufactured using any known method, such as producing the parts as a single piece, as shown, or producing them as parts that can be assembled, for example, by gluing, riveting, heat welding, snapping, or interference fitting. The parts can be produced by extrusion, milling, molding, 3D printing, casting, or any other suitable method. The finish can be applied during the production process, or a coating or paint finish can be applied after production.

Accordingly, the present disclosure provides a mounting base system for countertop or wall mounting of the apparatus of the present disclosure. The mounting base 400 includes an elastomeric suction cup 430 mounted to a semi-rigid mounting base 400. The suction cup has a central post 450 that is connected to the center of the base 400 to form a two-part assembly that provides the suction cup 430 with the ability to flex laterally and the ability to be flattened on the mounting surface.

In use, the user presses the mounting base 400, along with the suction cup 430, firmly downward against the surface 540 to which the base 400 is to be mounted (FIGS. 23 and 24). During this action, the suction cup 430 flattens and displaces the air beneath it, and as the base 400 and suction cup 430 move downward, the flexible legs 420, 422 on the semi-rigid base 400 flex, with the suction cup 430 moving downward via its connection at the center post 450 and button 434 and contacting the tip 432 and the underside of the base extension 404. When the downward pressure is removed and the suction cup fully flattens, there is an inherent upward slack in the suction cup 430, pushing upward onto the center post 450 and tip 432. To limit the upward movement of the suction cup 430, which might otherwise lift the legs 420, 422 from the surface 540, the arms 420, 422 flex and act as springs, simultaneously pressing downward against the workbench surface and pushing upward away from the surface 540 against the button 434. This spring action causes the base 400 to tighten as a whole relative to the mounting surface 540, thereby forming a stable and secure attachment to the mounting surface 540.

All references cited herein are expressly incorporated by reference in their entirety. It will be understood by those skilled in the art that the present disclosure is not limited to the content specifically shown and described above. In addition, unless mentioned to the contrary, it should be noted that all drawings are not to scale. The present disclosure has many different features, and it is contemplated that these features can be used together or separately. Therefore, the present disclosure should not be limited to any specific combination of features or the specific application of the present disclosure. In addition, it should be understood that those skilled in the art will contemplate variations and modifications within the spirit and scope of the present disclosure. Accordingly, all suitable modifications within the scope and spirit of the present disclosure that can be easily implemented by those skilled in the art based on the disclosure set forth herein will be included as additional embodiments of the present disclosure.

Claims (18)

1. A component for reducing pain during skin puncture using vibration, comprising means for vibrating body tissue at a body site, said means comprising: frame; A vibration source that can be activated and connected to the frame; A removable tip, capable of being attached to the frame and having a distal end, when the tip is attached to the frame, is connected to the vibration source, thereby causing the distal end to vibrate when the vibration source is activated, the distal end forming: The arms facing each other define an opening between them. Each arm forms a protrusion extending at an angle to the arm, the protrusion being shaped to fit the body part. The size and dimensions of the arms and protrusions are configured to position and hold the body part near the opening and to transmit vibrations to the body part. The size, dimensions, and position of the arms are configured to surround a portion of the finger pad when the protrusion is positioned against the tip of the finger. It also includes a mounting base for supporting the device on a surface, the mounting base comprising: A suction cup having an open end and a closed end; Support legs, the support legs being connected to the suction cup near the closed end; and A retainer, the retainer being sized to connect to the leg, and the retainer being sized to hold the device when the device is inserted into the retainer. 2. The component of claim 1, wherein the protrusion has an inclined surface corresponding to the curvature at the tip of the finger. 3. The component of claim 1, wherein the arms are separated from each other by a gap extending from the base of the arm to the opening. 4. The component of claim 1, wherein the arms rotate toward each other and are interconnected. 5. The component according to claim 1, wherein the protrusion forms an inclined surface corresponding to the end of the finger. 6. The component of claim 5, wherein the arm forms a surface on which the finger pad can rest when the finger tip is positioned to contact the inclined surface. 7. The component of claim 5, wherein the inclined surface is at least partially formed by an elastically overmolded portion formed on the arm. 8. The component of claim 1, wherein the arm is shaped to surround and mate with a treatment tool inserted into the opening. 9. The component of claim 8, wherein the arm is resiliently connected to the tip and resiliently grips the end of the tool when the arm surrounds and is capable of engaging the treatment tool. 10. The component of claim 9, wherein the size and dimensions of the arm and the protrusion are configured to hold the body part in place while simultaneously grasping the treatment tool. 11. The component of claim 1, further comprising: an electromagnetic tag positioned on the removable tip; and an electromagnetic reader antenna capable of being positioned near the tag when the removable tip is mounted on the frame. 12. The component of claim 1, wherein the body part is a finger. 13. The component of claim 1, wherein the leg is bendable: to allow the suction cup to press against the surface, thereby expelling air from the suction cup; and when the suction cup is not compressed, to allow a force to be applied elastically when the suction cup is in suction contact with the surface, thereby pulling the suction cup in a direction away from the surface. 14. The component of claim 13, wherein the leg is made of elastic plastic. 15. The component of claim 13, wherein the suction cup includes a support post at the closed end, the support post being connected to the leg to enable the suction cup to move relative to the leg. 16. The component of claim 15, further comprising a button connected to the free end of the support column, the button being inserted through an opening in the leg to maintain contact between the suction cup and the leg and to transmit tension from the leg to the suction cup. 17. The component of claim 13, wherein the retainer comprises two opposing flexible arms sized to hold the device between the flexible arms; and wherein, when the mounting base is connected to the surface, the retainer is connected to the leg at a non-orthogonal angle relative to the surface. 18. The component of claim 13, wherein the retainer includes at least one of a resiliently mounted protrusion or opening, the device correspondingly includes another of a mating opening or protrusion, and wherein, when the device is positioned in the retainer, the protrusion and opening matte to maintain a predetermined position of the device in the retainer.