WO2013036625A1

WO2013036625A1 - Modifications to vibrating instrument for reducing pain during skin-puncturing procedures and methods for use of the modified vibrating instrument

Info

Publication number: WO2013036625A1
Application number: PCT/US2012/053943
Authority: WO
Inventors: Steven Goldberg; Michael Goldberg
Original assignee: Bing Innovations, Llc
Priority date: 2011-09-06
Filing date: 2012-09-06
Publication date: 2013-03-14

Abstract

The invention provides modifications which improve the function of a vibrating instrument and methods for using the improved vibrating instrument. The vibrating instrument is for reducing pain during skin-puncturing procedures or injections and operates by vibrating tissue surrounding the area of the skin puncture or injection. The modifications include a coolant structure for a vibrating tip of the instrument and a sterile, single-use bag for covering at least a portion of the instrument such that use of the instrument can be prolonged or maximized. The sterile, single-use bag may additionally include a compartment for the coolant structure.

Description

MODIFICATIONS TO VIBRATING INSTRUMENT FOR REDUCING PAIN DURING SKIN-PUNCTURING PROCEDURES AND METHODS FOR USE OF THE

MODIFIED VIBRATING INSTRUMENT

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Provisional Patent Application No. 61/531,264, filed on September 6, 201 1, the content of which is hereby incorporated by reference in its entirety.

This application is related to U.S. Patent Application No. 13/253,572 filed October 5,

201 1; U.S. Patent Application No. 13/225,782 filed September 6, 2011 ; and PCT

International Patent Application No. PCT/US2010/028858, filed in March 26, 2010. These applications are hereby incorporated by reference in their entirety. The information incorporated is as much a part of the instant application as filed as if the text was repeated in the application, and should be treated (the incorporated information) as part of the text of the application as filed.

FIELD OF THE INVENTION

The invention generally concerns pain management, particularly an instrument and method for reducing pain during skin-puncturing procedures by vibrating tissue surrounding the area of skin puncturing, and most particularly modifications for improving function of the instrument such as a coolant structure for the vibrating tip of the instrument and a sterile, single-use bag for covering at least a portion of the instrument. BACKGROUND

Fear of dental procedures involving injections and/or hypodermic needles is extremely common. As a result, a high percentage of people do not visit a dentist on a regular basis. Anticipation of pain resulting from an injection often drives the fear. This is not unfounded since injections are rarely painless.

A variety of liquids can be injected in dental or other medical applications, such as anesthetics, analgesics, serum, vitamins, vaccines, and other efficacious liquids. These injections are often necessary for optimum health. Thus, attention has been given to the problem of pain.

Standard procedures for reduction of pain when injecting a liquid include: placement of cold material to tissue at the injection site, such as a cooling spray; application of a topical treatment to the tissue at the injection site, such as an anesthetic to temporarily numb the tissue; and rapid, manual massage of tissue at the injection site simultaneously with administration of the injection. Although these procedures have some advantages, they can lengthen the injection process (i.e. waiting for tissue to become numb); they can be cumbersome (i.e. require additional tools and/or materials); or they can have limited effect (i.e. pain is not reduced to a satisfactory level).

Therefore, alternative methods for reducing the pain accompanying injections are desirable. To this end, the instant invention encompasses a handheld instrument for vibration of tissue at an injection site. The instrument vibrates tissue simultaneously with

administration of the injection. The instant invention particularly provides modifications for improving function of the instrument such as a coolant structure for the vibrating tip of the instrument and a sterile, single-use bag for covering at least a portion of the instrument.

Without being bound by theory, it is thought that the effectiveness of vibrations for reducing and/or blocking pain results from "gate control." See Kendra Cherry, What is Gate Control Theory?" accessed from the About.com (Psychology) website on August 29, 2012. For example, nerve endings sense the vibrational stimuli first and "close the gate" to transmission of the feelings of pain.

SUMMARY OF THE INVENTION

The instant invention provides highly effective instruments and methods for pain management during skin-puncturing procedures or injections. Injections are often necessary for optimal health and are an essential component of most dental, medical, and veterinary applications. During an injection, the instrument functions by vibrating the tissue surrounding the area of skin puncturing. The soothing, pulsed vibrations completely eliminate or substantially minimize the pain and discomfort accompanying an injection. The instrument is economical, versatile and suitable for use with both human and animal patients.

Considering that the inventors have described the instrument in previous applications, the instant invention particularly concerns modifications (to the instrument) that improve the function of the instrument. Such modifications include a coolant structure for the vibrating tip of the instrument (i.e. a tip with a hollow interior for holding coolant) and a sterile, single-use bag for covering at least a portion of the instrument to maximize use of the instrument.

Covering the instrument or the tip of the instrument with a bag does not attenuate vibrations or otherwise adversely affect vibration. The coolant is either included in the tip, which is hollow for this purpose, or included in a compartment built into the sterile, single-use bag. The coolant is applied to cool tissue at the injection site and/or surrounding the injection site. One, non-limiting example of a coolant is a eutectic gel.

The invention also includes methods for administrating injections using instruments modified with the described coolant structures and/or the sterile, single-use bags.

The invention further includes methods for reducing or eliminating pain associated with injections by using instruments modified with the described coolant structures and/or the sterile, single-use bags in injection procedures.

Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings, wherein are set forth, by way of illustration and example, certain embodiments of this invention. The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention may be obtained by references to the accompanying drawings when considered in conjunction with the subsequent detailed description. All figures of the drawings are schematic and are for illustration purposes only. The embodiments illustrated in the drawings are intended only to exemplify the invention and should not be construed as limiting the invention to the illustrated embodiments.

FIG. 1 A shows an embodiment of a sterile, single-use bag for covering a vibrating instrument.

FIG. IB shows an embodiment of a vibrating instrument which may be covered by the bag of FIG. 1A.

FIG. 2 shows the instrument of FIG. IB covered with the bag of FIG. 1A.

FIG. 3 shows a cross-sectional view of the instrument of FIG. 2.

FIG. 4A shows an embodiment of a sterile, single-use bag for covering a tip of a vibrating instrument.

FIG. 4B shows an embodiment of a vibrating instrument having a tip which may be covered by the bag of FIG. 4A.

FIG. 5 shows the instrument of FIG. 4B covered with the bag of FIG. 4A.

FIG. 6 shows a cross-sectional view of the instrument of FIG.5.

FIG. 7 shows a cross-sectional view of another embodiment of an instrument that can be used with the sterile, single-use bags of FIGS. 1A and 4A. FIG. 8A shows a perspective view of an instrument having a disposable tip in which a free end of the tip member is configured as a full or complete ring.

FIG. 8B is a top view of the instrument of FIG. 8A.

FIG. 8C is a side view of the instrument of FIG. 8A.

FIG. 8D illustrates administration of an injection using the instrument of FIG. 8A.

FIG. 9 shows a perspective view of an instrument similar to that shown in FIG. 8A with the exception of size. The tip member ring is smaller than that of the instrument shown in FIG. 8A.

FIG. 10 shows a perspective view of the instrument of FIG. 8A including a lightpipe having a colored fiber optic LED light and a tip member ring made of a translucent material.

FIG. 11 A shows a perspective view of an instrument having a disposable tip in which a free end of the tip member is configured as a split or broken ring.

FIG. 1 IB is a top view of the instrument of FIG.1 1 A.

FIG. 11C is a side view of the instrument of FIG. 1 1A.

FIG. 1 ID illustrates administration of an injection using the instrument of FIG. 11A.

FIGS. 12A-12E show exploded views illustrating the assembly of the instrument of FIG. 11A. FIG. 12A shows a top piece of the two-piece tip member. FIG. 12B shows a bottom piece of the two-piece tip member. FIG. 12C shows the lap joint for connecting the top piece to the bottom piece of the tip member. FIG. 12D shows the tip sleeve for connecting to the assembled tip member. FIG. 12E shows a cap for covering an opening in the top piece of the tip member (FIG. 12A).

FIG. 13 A shows an exploded view illustrating the connection of the tip member and the tip sleeve of the instrument of FIGS. 12A, 12B, and 12D.

FIG. 13B shows a linearized view of the lap joint of FIG. 12C.

FIG. 14 shows a portion of a commercialized embodiment of an instrument in which the tip shown in FIGS. 12A, 12B, 12D, and 13A is connected to a handle.

FIG. 15 shows an exploded view of the tip of the instrument shown in FIG. 14.

FIG. 16A shows a perspective view of an instrument having a disposable tip in which a free end of the tip member is configured as a bifurcation having non-angled, thick projections.

FIG. 16B is a top view of the instrument of FIG.16A.

FIG. 16C is a side view of the instrument of FIG. 16A.

FIG. 16D illustrates administration of an injection using the instrument of FIG. 16A. FIG. 17A shows a top view of an instrument having a disposable tip in which a free end of the tip member is configured as a bifurcation having angled, thick projections.

FIG. 17B is a side view of the instrument of FIG. 17A.

FIG. 17C shows a single-use, sterile bag including a coolant compartment. This bag is for covering the tip of the instrument in FIG. 17A.

FIG. 17D also shows a single-use, sterile bag including a coolant compartment. This bag is for covering the entire instrument in FIG. 17 A.

FIG. 17E illustrates administration of an injection using the instrument of FIG. 17A covered by the bag of FIG. 17D.

FIG. 18A shows a perspective view of an instrument having a disposable tip in which a free end of the tip member is configured as a bifurcation having non-angled, thin projections.

FIG. 18B is a top view of the instrument of FIG.18A.

FIG. 18C is a side view of the instrument of FIG. 18A.

FIG. 18D illustrates administration of an injection using the instrument of FIG. 18A.

FIG. 19A shows a perspective view of an instrument having a disposable tip in which a free end of the tip member is configured as a tripod having three projections.

FIG. 19B is a top view of the instrument of FIG.19 A.

FIG. 19C is a side view of the instrument of FIG. 19A.

FIG. 19D illustrates administration of an injection using the instrument of FIG. 19A.

FIG. 20A shows a perspective view of an instrument having a disposable tip in which a free end of the tip member is configured as a bifurcation having rotatable projections.

FIG. 20B is a top view of the instrument of FIG.20A.

FIG. 20C is a side view of the instrument of FIG. 20A.

FIG. 20D illustrates administration of an injection using the instrument of FIG. 20A.

DETAILED DESCRIPTION OF THE INVENTION

For the purpose of promoting an understanding of the principles of the invention, reference will now be made to embodiments illustrated herein and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modification in the described instruments, disposable tips, sterile bags, coolant structures, methods, procedures, and any further application of the principles of the invention as described herein, are contemplated as would normally occur to one skilled in the art to which the invention relates. FIGS. 1A-3 exemplify an embodiment of a sterile, single-use bag 10« and an instrument 100 covered with the bag.

FIG. 1A offers a perspective view of a sterile, single-use bag 10« for covering vibrating instrument 100. Bag 10« is made of a flexible, thin, translucent plastic material 1 and is shaped according to shape of the instrument it is designed to cover. Bag 10« provides a temporary sterile covering for an instrument during use. The sterile, bag covering prolongs or maximizes the use of the tip of the instrument while allowing the user to remain in compliance with infection-control protocols and avoiding patient cross contamination. Bag 10« has a forward, front portion 3a and an open, rear portion 3b. Bag 10« can be pulled tighter around the instrument through the use of an elastic drawstring 2 located at an end of rear portion 3b. Bag 10« is disposable.

FIG. IB offers a perspective view of an instrument 100 that can be covered with bag 10«. Instrument 100 includes an elongated tubular member or handle 8 having a forward end 8« and a rear end 8b and a single-use disposable tip 20. A lightpipe 29 (FIG. 12D) is cantilever mounted in the elongated, tubular body 8 and projects from the forward end 8«. The tip 20 is mounted on lightpipe 29. A vibration unit, driven a battery and motor (not shown), is mounted in elongated, tubular body 8 and coupled to lightpipe 29. In use, lightpipe 29 transmits vibrations from the vibration unit to tip 20. Tip 20 includes two portions, a tip member 20« coupled to a tip sleeve 206 via an overmold 4. Tip portions, 20« and 206, are made of a hard plastic, such as polycarbonate, and overmold 4 is elastic and made of a rubber material or a thermoplastic elastomer (TPE) such as Santoprene®

(trademark originally registered by Monsanto Company and currently owned by Exxon Mobil of Irving, Texas). Tip sleeve 206 includes a front end 20c connected with overmold 4 and a rear end 20/ connected with elongated, tubular member (handle) 8. Tip member 20« has a rear end 20d connected with overmold 4 and free, front end 20c. Free end 20c has a pre-selected shape (i.e. shape is selected prior to beginning an injection procedure) and can take a variety of configurations depending upon the characteristics of the tissue with which it is to be used. In FIG. IB, free end 20c takes the form of a bifurcation 6 forming two downwardly curving, spaced projections, bifurcations, or prongs 6a and 6b defining a space between them. The two projections 6a and 6b are the contact points with the tissue (points of vibration) and bracket the pre-selected injection site. A lens 5 shines light from lightpipe 29 to illuminate and more clearly define the injection site. Each of the projections 6a and 6b can also include a plurality of ridges 7 on a bottom surface. Ridges 7 promote interaction with the tissue and may produce greater nerve stimulation. Operation of the instrument 100 is controlled by master switch 9 activated by button 11. Any of the instruments described herein can also include a music player in the main body for playing music or attachable toy accessories for children.

A compartment 33 can be included inside front portion 3a (FIG. 17D). Compartment 33 holds a coolant, such as a non-toxic eutectic coolant gel, and is positioned under or to the sides of the vibrating tip member 20« forming a sealed, gel-filled cushion or block. The coolant reduces temperature (i.e. cools) tissue at the injection site and cooperates with the vibrations of the tip to reduce pain upon administration of an injection. Thus, addition of gel- filled compartment 33 improves the desired function of the instrument 100. For clinical application, the coolant gel is either stored in a refrigerator or frozen prior to placement in the bag or tip at the time of injection. The coolant is disposable in the same manner as the single- use bags and/or tips.

FIG. 2 shows instrument 100 covered entirely by sterile, single-use bag 10«. FIG. 3 shows a cross sectional view. When a user grips instrument 100, bag 10« will collapse around the instrument 100. The open, rear portion of the bag 36 can be left free or open to hang down and/or drape loosely over the instrument 100. Alternatively, bag 10« can be provided with drawstring 2 to pull the bag 10« closed or semi-closed tighter around instrument 100. When covering instrument 100, the front portion 3a of bag 10« has a close "glove fit" around tip member 20« and the open, rear portion 3b has a loose fit around tip sleeve 206 and the elongated, tubular member (handle) 8. The glove fit of front portion 3a can be achieved by pulling and/or adjusting drawstring 2. The front portion 3a conforms to the shape 12« of projections 6a and 6b. The glove-like fit does not cause attenuation of the vibrations of the projections 6a and 6b, and thus, the function of instrument 100 is not altered. The loose fit of open, rear portion 3b enables easy covering of instrument 100. The loose fit is exemplified at 126.

FIGS. 4A-6 exemplify another embodiment of a sterile, single-use bag 106 and a tip 20 of an instrument 100 covered with the bag.

FIG. 4A offers a perspective view of a sterile, single-use bag 106 for covering tip 20 of vibrating instrument 100. While bags 10« and 106 are similar, the smaller size of bag 106 differentiates it from bag 10«. Bag 106 is shorter and covers only the tip 20 rather than the whole length of instrument 100. Use of bag 106 is advantageous to a user wearing sterile gloves because the gloves render covering handle (elongated, tubular member) 8

unnecessary. Bag 106 is made of a flexible, thin, translucent plastic material 1 and is shaped according to shape of the tip it is designed to cover. Bag 106 provides a temporary sterile covering for a tip during use. A sterile, bag covering prolongs the use of the tip of the instrument while allowing the user to remain in compliance with infection-control protocols and avoiding patient cross contamination. Bag 106 has a forward, front portion 13« and an open, rear portion 136. Bag 106 can be pulled tighter around the tip 20 through the use of an elastic drawstring 2 located at an end of rear portion 13b. Bag 106 is disposable. As with bag 10«, a compartment 33, containing coolant, can be configured to fit bag 106.

FIG. 4B offers a perspective view of an instrument 100 having a tip 20 that can be covered by bag 106. Although this instrument is identical to the instrument of FIG. IB, instrument 100 is shown again in FIG. 4B to clarify how bag 106 is structured to fit tip 20.

FIG. 5 shows instrument 100 having a tip 20 covered entirely by bag 106. FIG. 6 shows a cross sectional view. Bag 106 is attached to the elongated, tubular member (handle) 8 by hooks 43 which extend from each side of the forward end 8« of handle 8 (FIG. 6). The open, rear portion of the bag 136 can be left free or alternatively, bag 106 can be provided with drawstring 2 to pull the bag 106 closed or semi-closed tighter around forward end 8« of handle 8. When covering tip 20, the front portion 13« of bag 106 has a close "glove fit" around tip member 20« and the open, rear portion 136 has a loose fit around tip sleeve 206. The glove fit of front portion 13« can be achieved by pulling and/or adjusting drawstring 2. The front portion 13« conforms to the shape 14« of projections 6a and 66. The glove-like fit does not cause attenuation of the vibrations of the projections 6a and 66, and thus, the function of instrument 100 is not altered. The loose fit of open, rear portion 136 enables easy covering of tip 20. The loose fit is exemplified at 146.

Another embodiment of a vibrating instrument that can be improved by the modifications of the invention is shown in FIG. 7. Instrument 101 includes an elongated tubular member or handle 8 having a forward end 8« and a rear end 86 and a non-disposable tip 15. There is no tip sleeve. A lightpipe 29 is cantilever mounted in the elongated, tubular body 8 and projects from the forward end 8«. Tip 15 is connected with nose 17 at the forward end 8« via flanges 16. A vibration member, driven a battery and motor (not shown), is mounted in elongated, tubular body 8 and coupled to lightpipe 29. In use, lightpipe 29 transmits vibrations from the vibration member to tip 15. An overmold 4a couples tip 15 to lightpipe 29. Overmold 4a enables tip 15 to vibrate freely relative to instrument 101. Tip 15 is made of a hard plastic, such as polycarbonate, and overmold 4a is elastic and made of a rubber material or a thermoplastic elastomer (TPE) such as Santoprene® (trademark originally registered by Monsanto Company and currently owned by Exxon Mobil of Irving, Texas). Instrument 101 can be used with either sterile, single-use bags 10« and 106. Single- use bag 106 can be attached to the elongated, tubular member (handle) 8 by hooks 43 which extend from each side of the forward end 8« of handle 8.

The coolant structure of the invention is additionally contemplated as applicable to previously-described single-use, disposable tips. The tip generally includes at least two portions, a tip member and a tip sleeve, spaced apart with the annular space between covered by an overmold to connect member and sleeve. The free end of the tip member is the only portion of the instrument directly in contact with tissue during vibration to ensure efficient transmission of vibrations. In one embodiment, tissue contact is at a pair of contact points spaced about ¼ of an inch apart. The tip is non-rotary and rigidly mounted to the handle of an instrument such as that shown in FIGS. IB and 4B. The tip portions (tip member and tip sleeve) are fabricated to have hollow interior spaces to accommodate the coolant structure.

Since the tip member is in contact with tissue it is important that the tip member include coolant such that the coolant can also contact the tissue.

The tip member has a variety of shapes and configurations. The shape or

configuration of the tip member is selected prior to the beginning of an injection procedure and is most commonly selected based upon the characteristics of the tissue receiving the injection. The liquid to be injected may have some influence on the shape or configuration selected.

A configuration selected for dental procedures is the curved bifurcation as shown in FIG. IB. In this configuration, free end 20c takes the form of a bifurcation 6 forming two downwardly curving projections or prongs 6a and 6b.

Medical applications have different circumstances and thus medical tips have a variety of configurations as shown in FIGS. 8-20. In cosmetic procedures, such as in an injection of Botox® Cosmetic (Allergan of Irvine, CA) or other fillers, the area of tissue requiring cooling is greater than that in a dental procedure. The hollow portions of the tip should be broader and thicker in order to hold a greater volume of coolant for the increased area of cooling. Each projection spreads out and has a greater cross section to create additional space to hold coolant.

The shape of each projection can vary from flat to curving. Downward curving is less important for medical applications than for dental applications. Projections should spread out to the sides for greater surface area and there should be a narrower space (compared to dental bifurcated tip) in between any bifurcation or enclosure created. The space between can range from about 1/16^th of an inch to about 1 inch. Further, bifurcation isn't an absolute requirement; the tip can be a flat single paddle or a closed circle. Projections or paddles can be flat or cylindrical or a projection can be flat on one side and cylindrical on the other side or cylindrical at 360°.

Different configurations may require increased vibration and amplitude for the tip. In this case, the size of the motor is increased and voltage supplied to the motor is increased. A larger motor can drive a heavier tip with greater contact on tissue.

Multiple configurations of the hollow tip are exemplified in the figures. All of these tips are capable of being filled with a coolant, such as a eutectic gel. Configurations shown include full ring, split ring, two projections (bifurcated), three projections (tripod), angled projections, and single projection or paddle.

Configuration is a consideration because the topography of tissue at some injection sites can be complex; i.e. the face and/or bridge of the nose. The selection of the tip is important, from a visibility standpoint, such that the injection site and the results of the injection site are not obscured. Also, for any particular application, the operator should have a comfortable hand position and the paddle, ring, or projections of the tip should be angled appropriately from the handle and not straight out.

Since shifting the center of mass of the tip will affect vibration, for example, unbalanced fluid in the tip could cause the tip shape to vibrate differently, it is important that the coolant is maintained without substantial unbalancing movement. At the same time, the coolant will expand when absorbing heat from contact with the tissue, so it is important that expansion capability be included in the design of the tips.

An instrument 100 (FIGS. IB and 4B) fitted with a tip 18 in the configuration of full or complete ring is shown in FIG. 8A. The full ring is an unbroken circle. A top view is shown in FIG. 8B and a side view in FIG. 8C. Tip sleeve 186 is mounted to handle 8 at one end and connected with tip member 18« at the other end via overmold 4. A full ring tip member can be formed from a single piece or from multiple pieces. In FIG. 8A, tip member 18« is in the form of a two piece clamshell-like ring that tapers toward the center. The tapering enables access to an injection site from all angles. The ring inner diameter X is about 3/8^th of an inch and the ring outer diameter Y is about 7/8^th of an inch. The two pieces of ring tip member 18, top piece 18c and bottom piece 18< , can be connected by a lap joint 28 (FIG. 12C, FIG. 13B) to form the complete ring. Bottom piece 18< can also include projecting rods, filaments, or bumps for additional or enhanced tissue stimulation (not shown). A lens 5 shines light to illuminate and more clearly define the injection site. The ring has an opening 19 accessing the hollow interior through which coolant can be added. Two bosses (knoblike projections) 20 are spaced apart on the bottom piece 18< of the ring to define the effective vibration points with respect to contact with tissue.

The full or complete ring tip is not limited to a single size, the size can be adjusted. For example, an instrument 100 having a smaller ring than the ring of FIGS. 8A-8C is shown in FIG. 9. Tip member 44 is formed by a top piece 44« and a bottom piece 44b. Smaller ring sizes can be advantageous for efficiently targeting small areas of tissue for injection.

Full or complete ring tips can be made from translucent material. For example, an instrument 100 having a translucent ring tip 22 is shown in FIG. 10. Translucent ring tip 22 can be illuminated by a lightpipe having a fiber optic LED light. The glow effect created can increase the perceived effectiveness of the instrument at reducing the pain of injections.

An instrument 100 (FIGS. IB and 4B) fitted with a tip 23 in the configuration of a split or broken ring is shown in FIG. 11 A. The split or broken ring is open and is not a complete circle. Like the full ring, the split ring can be size adjusted. A top view is shown in FIG. 1 IB and a side view in FIG. 1 1C. Tip sleeve 23b is mounted to handle 8 at one end and connected with tip member 23a at the other end via overmold 4. As the full ring tip member, the split ring tip member can be formed from a single piece or from multiple pieces. In FIG. 1 1A, tip member 23a is in the form of a two piece clamshell-like ring that tapers toward the center. The tapering enables access to an injection site from all angles. The two pieces of ring tip member 23a, top piece 23c and bottom piece 23d, can be connected by a lap joint 28 to form the split ring. Lap joint 28 is shown in cross section in FIG. 12C and is shown linearized in FIG. 13 B. The split forms a gap 25 between each end of the ring to give a needle more flexibility at an injection site. Bottom piece 23d can also include projecting rods, filaments, or bumps for additional or enhanced tissue stimulation (not shown). A lens 5 shines light to illuminate and more clearly define gap 25 and the injection site. In medical procedures, standard practice involves strong overhead lights, thus lens 5 is less necessary in medical procedures than in dental procedures. Instrument 100 is shown without a lens in FIGS. 14 and 15. Further, the tip member can be constructed of translucent or transparent material such that light from the lightpipe can pass through the material. Considering the overhead light available for medical procedures, a lightpipe is not essential. Any rigid structure may be used which can transmit vibrations to the tip. The ring has an opening 26a (FIG. 12A, FIG. 13 A) accessing the hollow interior through which coolant can be added. Two bosses (knoblike projections) 24 are spaced apart on the bottom piece 23d of the ring to define the effective vibration points with respect to contact with tissue. In one embodiment, bosses 24 are positioned on bottom piece 23d adjacent gap 25. Gap 25 represents a space of about ¼ of an inch, thus the contact points represented by bosses 24 are about ¼ of an inch apart.

As noted above, both the full ring and the split ring tip members can taper towards the center to allow access to the injection site from all angles. In one embodiment, the ring has a right triangular or trapezoidal cross section with the exterior curve lying about 45 degrees to about 70 degrees with respect to the bottom surface. However, the rings are not limited to this embodiment. The cross section can vary. For example, the cross section can be a trapezoid that extends more to the exterior side enabling the ring to contact a greater tissue area surrounding the injection site.

FIGS. 12A -12C detail the coupling of the two pieces of tip member 23a. The pieces can be made using injection molding. Top piece 23c (FIG. 12A) is connected with bottom piece 23d (FIG. 12B) via lap joint 28. This connection forms interior hollow space 27 (cross section FIG. 12C).

Subsequent to the coupling of pieces 23c and 23d, tip sleeve 236, including lightpipe 29, is connected to the assembled tip member 23« via overmold 4 (FIG. 12D). The connection allows the tip member 23« to vibrate freely relative to tip sleeve 236. In one embodiment, the connection between tip member and tip sleeve can be enhanced with the use of a plastic snap 30 connected with overmold 4 (FIG. 13 A). The enhancement is not limited to plastic snap 30. Any suitable connection means made of any suitable material can also be used.

The hollow interior of the ring 27 can be accessed through opening 26a in top piece 23c of the tip member. Opening 26a is the fill point for coolant. Once hollow interior 27 is filled with coolant, fill cap 26 is inserted to close opening 26a. Fill cap 26 is shown in detail in FIG. 12E.

A commercialized view of instrument 100 is shown in FIGS. 14 and 15. FIG. 14 shows a portion of the instrument in which the tip 23, shown in FIGS. 12A, 12B, 12D, and 13A, is connected with handle 8. An exploded view of the tip 23 shown in FIG. 14 is illustrated by FIG. 15.

FIGS. 16-20 show instrument 100 with a variety of tip member configurations.

FIGS. 16A-16C show instrument 100 having a tip 31 connected to handle 8. Tip 31 has a tip member 31« and a tip sleeve 316 connected via overmold 4. Tip member 31« is a non-angled or straight bifurcation having thick projections or bifurcations 32 as compared to bifurcations 6a and 6b shown in FIG. IB. FIGS. 17A-17B show instrument 100 having a tip 34 connected to handle 8. Tip 34 has a tip member 34« and a tip sleeve 346 connected via overmold 4. Tip member 34« is an angled bifurcation having thick projections or bifurcations 35 as compared to bifurcations 6a and 66 shown in FIG. IB. Instrument 100 having tip 34 is especially structures for use with the bags of FIGS. 17C-17D. For example, when instrument 100 is covered by either bag 10« (FIG. 17D) or bag 106 (FIG. 17C) a coolant in compartment 33 nests under or to the sides of vibrating projections 35.

FIGS. 18A-18C show instrument 100 having a tip 36 connected to handle 8. Tip 36 has a tip member 36« and a tip sleeve 366 connected via overmold 4. Tip member 31« is a non-angled or straight bifurcation having thin projections or bifurcations 37 as compared to bifurcations 6a and 6b shown in FIG. IB. Thinner projections 37 allow for increased visibility of the injection site during administration of an injection.

FIGS. 19A-19C show instrument 100 having a tip 38 connected to handle 8. Tip 38 has a tip member 38« and a tip sleeve 386 connected via overmold 4. Tip member 38« is a non-angled or straight tripod having three projections 39. The three projections 39 establish three points of vibration. Three points of vibration provide a stable base for application of the vibrating regardless of the contour of the tissue to which it is applied.

FIGS. 20A-20C show instrument 100 having a tip 40 connected to handle 8. Tip 40 has a tip member 40« and a tip sleeve 406 connected via overmold 4. Tip member 40« is an angular adjust tip and has two rotatable projections 41 which can be rotated to any angle.

Thus, tip 40 can be placed at any angle. Projections 41 and lens 5 are a single piece that can be articulated relative to the remainder of the tip 40. Projections 41 are formed together with lens 5 in the center and can be rotated via hinges 42 to any angle depending on where the injection site is located and how the doctor or operator prefers to hold the instrument.

Methods for using instruments modified with the described coolant structures and/or sterile, single-use bags are also encompassed by the invention. Generally, the methods include the steps of vibrating tissue of a human or an animal in proximity to a pre-selected injection site while simultaneously cooling the injection site, and injecting the needle (at the cooled, vibrating pre-selected injection site).

The methods involve injecting a liquid at a pre-selected or pre-determined site or area in the tissue of a human or of an animal. The methods can be carried out by a doctor or other trained user or operator of the instrument. In one embodiment, the steps can be carried out as follows: (a) providing an instrument including an elongated, tubular body, a disposable tip mounted on the elongated, tubular body or handle, the disposable tip including a tip sleeve for mounting on a forward end of the elongated, tubular body and a tip member for vibrating connected to the tip sleeve by a frangible, elastic overmold, and a coolant contained in at least one of a hollow interior of the tip sleeve and a hollow interior of the tip member;

(b) creating vibrations in the elongated, tubular body (handle);

(c) transmitting the vibrations to the tip to vibrate the tip;

(d) applying the vibrating tip to the tissue at the pre-selected site and vibrating the tissue;

(e) simultaneously with vibrating, reducing temperature at the pre-selected site with the coolant; and

(f) injecting by needle the liquid into the pre-selected site in the tissue.

The soothing, pulsed vibrations combined with cooling completely eliminate or substantially minimize the pain and discomfort accompanying the injection.

Methods of the invention are illustrated in FIGS. 8D; 1 ID; 16D; 17E; 18D; 19D; and

20D.

In FIG. 8D, instrument 100 is used to administer an injection via needle 21 to a patient at injection site 22. In this figure, tip 18 (full ring) is mounted to instrument 100.

In FIG. 1 ID, instrument 100 is used to administer an injection via needle 21 to a patient at injection site 22. In this figure, tip 23 (split ring) is mounted to instrument 100.

In FIG. 16D, instrument 100 is used to administer an injection via needle 21 to a patient at injection site 22. In this figure, tip 31 (bifurcated, non-angled tip having thick projections) is mounted to instrument 100.

In FIG. 17E, instrument 100 is used to administer an injection via needle 21 to a patient at injection site 22. The entire instrument 100 is covered by sterile, single-use bag 10«. Compartment 33 of bag 10« is filled with a coolant. In this figure, tip 34 (bifurcated, angled tip having thick projections) is mounted to instrument 100.

In FIG. 18D, instrument 100 is used to administer an injection via needle 21 to a patient at injection site 22. In this figure, tip 36 (bifurcated, non-angled tip having thin projections) is mounted to instrument 100.

In FIG. 19D, instrument 100 is used to administer an injection via needle 21 to a patient at injection site 22. In this figure, tip 38 (tripod having three projections) is mounted to instrument 100. In FIG. 20D, instrument 100 is used to administer an injection via needle 21 to a patient at injection site 22. In this figure, tip 40 (bifurcated, rotatable projections) is mounted to instrument 100.

After the injection is administered, the frangible, elastic overmold connecting the tip member and tip sleeve can be torn. This tearing separates the tip member from the tip sleeve such that the overmold connection cannot be repaired. Thus, the tip design is for a single use or injection.

The methods can also include illuminating the injection site during the procedures with the lightpipe of the instrument and/or carrying out particularly -timed pulsed vibrations. For example, the timing of pulsing can be about 1 second on (vibrating tissue) and l/10^th of a second off (no vibration of the tissue).

An operator can also continue vibrating the tissue at the injection site after the injection has been given to dissipate the liquid (of the injection) and/or distribute it throughout the surrounding tissue.

Furthermore, greater pressure can be applied with vibrations after the injection to reach bone underlying the tissue at the injection site as vibrating the bone is thought to provide enhanced pain relief. In one embodiment, pressure on the bone is maintained for a time period of about 1 to 90 seconds.

Additionally, any of the above-described methods can be carried out by covering the entire instrument or at least the tip of the instrument with a sterile, single-use bag having a coolant stored in a compartment in the bag.

All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. It is to be understood that while a certain form of the invention is illustrated, it is not intended to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification. One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The instruments, disposable tips, sterile bags, coolant structures, and methods described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention. Although the invention has been described in connection with specific, preferred embodiments, it should be understood that the invention as ultimately claimed should not be unduly limited to such specific embodiments. Indeed various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the invention.

Claims

CLAIMS What is claimed is:

Claim 1. A single-use disposable tip for use with an instrument including a vibration unit and a lightpipe vibrated by the vibration unit, the single-use disposable tip comprising:

(a) an elongated, conical tip sleeve having a hollow interior and rigidly mounted on a forward end of the instrument;

(b) a tip member having a hollow interior and a pre-selected shape for vibrating tissue at a pre-determined injection site on a human or on an animal, the tip member having a free end and an end connected to the tip sleeve by a frangible elastic overmold; and

(c) a coolant for reducing temperature at the pre-determined injection site filling at least one of the hollow interior of the tip sleeve and the hollow interior of the tip member.

Claim 2. The single-use, disposable tip according to claim 1, wherein the coolant is brought to reduced temperature or frozen prior to placement in at least one of the hollow interior of the tip sleeve and the hollow interior of the tip member.

Claim 3. The single-use, disposable tip according to claim 1, wherein the tip member further comprises a lens positioned adjacent to the tip sleeve, the lens shining light from the lightpipe onto the injection site.

Claim 4. The single-use, disposable tip according to claim 1, wherein the tip further comprises a surface that acts as a retractor.

Claim 5. The single-use, disposable tip according to claim 1, wherein the free end of the tip member comprises a bifurcation forming two spaced projections for contacting and vibrating tissue, the two spaced projections defining a space therebetween for an injection site.

Claim 6. The single-use, disposable tip according to claim 5, wherein each of the two projections is rotatable and can be rotated at any angle with respect to the injection site.

Claim 7. The single-use, disposable tip according to claim 5, wherein the two projections each comprise a plurality of ridges.

Claim 8. The single-use, disposable tip according to claim 1, wherein the free end of the tip member comprises a single projection for contacting and vibrating tissue.

Claim 9. The single-use, disposable tip according to claim 1, wherein the free end of the tip member comprises three projections for contacting and vibrating tissue.

Claim 10. The single-use, disposable tip according to claim 1, wherein the free end of the tip member comprises a complete ring, the complete ring tapering toward the center on an interior surface.

Claim 11. The single-use, disposable tip according to claim 10, wherein the complete ring is trapezoidal in cross section.

Claim 12. The single-use, disposable tip according to claim 10, wherein the complete ring is made of a translucent material and is illuminated by a fiber optic colored LED light.

Claim 13. The single-use, disposable tip according to claim 10, wherein the complete ring comprises two pieces.

Claim 14. The single-use, disposable tip according to claim 1, wherein the free end of the tip member comprises a split ring, the split ring tapering toward the center on an interior surface.

Claim 15. The single-use, disposable tip according to claim 14, wherein the split ring comprises two pieces.

Claim 16. An instrument for minimizing pain during administration of an injection, the instrument comprising:

(a) an elongated tubular body having a forward end and a rear end; (b) a lightpipe mounted in the elongated tubular body and projecting from the forward end of the elongated tubular body;

(c) a tip according to claim 1 mounted on the lightpipe; and

(d) a vibration unit mounted in the elongated tubular body and coupled to the lightpipe, the lightpipe transmitting vibration from the vibration unit to the tip.

Claim 17. A sterile, single-use bag for covering an instrument for minimizing pain during administration of an injection, the sterile, single-use bag comprising:

(a) a front portion covering a tip mounted on a lightpipe projecting from a forward end of the instrument; the tip configured and dimensioned to vibrate tissue at a predetermined injection site on a human or on an animal and the front portion of the single-use bag conforming to shape of the tip such that vibration of the tip is not attenuated; and

(b) a rear portion covering an elongated tubular body mounted to the lightpipe of the instrument; whereby the front portion and the rear portion of the single-use bag cover the instrument.

Claim 18. The sterile, single-use bag according to claim 17, wherein the rear portion of the bag includes an elastic drawstring for tightening the bag around at least a part of the instrument.

Claim 19. The sterile, single-use bag according to claim 17, wherein the bag is made of a flexible, translucent plastic material.

Claim 20. The sterile, single-use bag according to claim 17, further comprising a compartment in the front portion.

Claim 21. The sterile, single-use bag according to claim 20, wherein the compartment contains a coolant for reducing temperature at an area of an injection site.

Claim 22. The sterile, single-use bag according to claim 21, wherein the coolant is brought to a reduced temperature or frozen prior to placement in the compartment.

Claim 23. A sterile, single-use bag for covering a tip of an instrument for minimizing pain during administration of an injection, the sterile, single-use bag comprising: (a) a front portion covering a front end of the tip mounted on a lightpipe projecting from a forward end of the instrument; the tip configured and dimensioned to vibrate tissue at a pre-determined injection site on a human or on an animal and the front portion of the single-use bag conforming to shape of the tip such that vibration of the tip is not attenuated; and

(b) a rear portion covering a rear end of the tip; whereby the front portion and the rear portion of the single-use bag cover the tip of the instrument.

Claim 24. The sterile, single-use bag according to claim 23, wherein the rear portion of the bag includes an elastic drawstring for tightening the bag around the tip of the instrument.

Claim 25. The sterile, single-use bag according to claim 23, wherein the bag is made of a flexible, translucent plastic material.

Claim 26. The sterile, single-use bag according to claim 23, further comprising a compartment in the front portion.

Claim 27. The sterile, single-use bag according to claim 26, wherein the compartment contains a coolant for reducing temperature at an area of an injection site.

Claim 28. The sterile, single-use bag according to claim 27, wherein the coolant is brought to a reduced temperature or frozen.

Claim 29. An instrument for minimizing pain during administration of an injection, the instrument comprising:

(a) an elongated tubular body having a forward end and a rear end;

(b) a lightpipe mounted in the elongated tubular body and projecting from the forward end of the elongated tubular body;

(c) a tip portion mounted on the lightpipe, the tip portion configured and dimensioned to vibrate tissue at a pre-determined injection site on a human or on an animal;

(d) a vibration unit mounted in the elongated tubular body and coupled to the lightpipe, the lightpipe transmitting vibration from the vibration unit to the tip portion; and (e) a sterile, single-use bag having a front portion and a rear portion, the single- use bag covering at least part of the instrument.

Claim 30. The instrument according to claim 29, wherein the tip portion is non- disposable and is mounted directly to a nose portion of the forward end of the elongated tubular body.

Claim 31. The instrument according to claim 29, wherein the front portion of the single-use bag covers and conforms to a shape of the tip portion of the instrument such that vibration of the tip is not attenuated.

Claim 32. The instrument according to claim 31, wherein the front portion of the single-use bag covers the tip portion and the rear portion of the single-use bag covers the rear end of the elongated tubular body such that the entire instrument is covered by the single-use bag.

Claim 33. The instrument according to claim 31, wherein the front portion of the single-use bag covers a front end of the tip portion and the rear portion of the single-use bag covers a rear end of the tip portion such that the tip portion is covered by the single-use bag.

Claim 34. The instrument according to claim 29, wherein the rear portion of the single-use bag includes an elastic drawstring for tightening the bag around at least part of the instrument.

Claim 35. The instrument according to claim 29, wherein the single-use bag is made of a flexible, translucent plastic material.

Claim 36. The instrument according to claim 29, wherein the single-use bag further comprises a compartment in the front portion.

Claim 37. The instrument according to claim 36, wherein the compartment contains a coolant for reducing temperature at an area of an injection site.

Claim 38. The instrument according to claim 37, wherein the coolant is brought to a reduced temperature or frozen.

Claim 39. A method for injecting a liquid at a pre-selected site in tissue of a human or of an animal, the method comprising:

(a) providing an instrument including an elongated, tubular body, a disposable tip mounted on the elongated, tubular body, the disposable tip including a tip sleeve for mounting on a forward end of the elongated, tubular body and a tip member for vibrating connected to the tip sleeve by a frangible, elastic overmold, and a coolant contained in at least one of a hollow interior of the tip sleeve and a hollow interior of the tip member;

(b) creating vibrations in the elongated, tubular body;

(c) transmitting the vibrations to the tip to vibrate the tip;

(f) injecting by needle the liquid into the pre-selected site in the tissue.

Claim 40. The method according to claim 39, further including, after injecting, tearing the frangible, elastic overmold to separate the tip member from the tip sleeve rendering the tip unfit for further use.

Claim 41. The method according to claim 39, further including, when vibrating, illuminating the pre-selected site and pulsing vibrations.

Claim 42. The method according to claim 41, further including timing the pulsing at about 1 second on and 1/10 of a second off.

Claim 43. The method according to claim 39, further including, after injecting the liquid, continually vibrating the tissue at the pre-selected site.

Claim 44. The method according to claim 43, wherein continually vibrating the tissue includes applying greater pressure to the tissue to reach underlying bone.

Claim 45. A method for injecting a liquid at a pre-selected site in tissue of a human or of an animal, the method comprising:

(a) providing an instrument including a sterile, single-use bag covering a tip mounted on a lightpipe projecting from a forward end of the instrument and an elongated, tubular body mounted to the lightpipe of the instrument; the tip configured and dimensioned to vibrate tissue and the single-use bag conforming to shape of the tip such that vibration of the tip is not attenuated;

(b) creating vibrations in the elongated, tubular body;

(c) transmitting the vibrations to the tip to vibrate the tip;

(e) simultaneously with vibrating, reducing temperature at the pre-selected site with a coolant contained within a compartment in the single-use bag; and

(f) injecting by needle the liquid into the pre-selected site in the tissue.

Claim 46. The method according to claim 45, wherein the sterile, single-use bag has a front portion covering the tip and a rear portion covering the elongated, tubular body such that the entire instrument is covered by the sterile, single-use bag.

Claim 47. The method according to claim 45, wherein the sterile, single-use bag has a front portion covering a front end of the tip and a rear portion covering

a read end of the tip such that the entire tip is covered by sterile, single-use bag.

Claim 48. The method according to claim 45, further including, when vibrating, illuminating the pre-selected site and pulsing vibrations.

Claim 49. The method according to claim 48, further including timing the pulsing at about 1 second on and 1/10 of a second off.

Claim 50. The method according to claim 45, further including, after injecting the liquid, continually vibrating the tissue at the pre-selected site.

Claim 51. The method according to claim 50, wherein continually vibrating the tissue includes applying greater pressure to the tissue to reach underlying bone.

Claim 52. The method according to claim 51, further including maintaining pressure for a time period of about 1 to 90 seconds when the underlying bone beneath the tissue is sensed

Claim 53. The single-use, disposable tip according to claim 1, wherein the coolant is a eutectic gel.

Claim 54. The sterile, single-use bag according to claim 21, wherein the coolant is a eutectic gel.

Claim 55. The sterile, single-use bag according to claim 27, wherein the coolant is a eutectic gel.

Claim 56. The instrument according to claim 37, wherein the coolant is a eutectic gel.

Claim 57. The method according to claim 44, wherein when the underlying bone beneath the tissue is sensed, pressure is maintained for a time period of about 1 to 90 seconds.

Claim 58. The single-use, disposable tip according to claim 15, wherein the split ring is trapezoidal in cross section.