System, Device, and Method to Adapt Electrodes to the Skin to Reduce Injection Pain

Systems, devices and methods for reducing injection pain by ensuring that one or more skin stimulators are within a predefined range of operating distances from the patient's skin. In some examples, a sensor detects a distance between the patient's skin and a stimulator. A practitioner can be alerted when the stimulator is outside the predefined range. The predefined range can depend on several factors.

BACKGROUND

Summary

In order to adapt the electrodes to various body contours, one may increase the pressure of the electrodes on the skin. However, this undesirably causes the tissue to bulge around the electrodes2. Bulging tissue can be especially problematic when the device that provides the electrical stimulation to the skin includes one or more other physical stimulations to the skin, such as tapping on the skin, rubbing the skin, or blowing gas, etc, where the stimulator mechanism is preferably positioned at a certain distance from the skin. Bulging tissue can unpredictably alter or distort the distance between the stimulating mechanism and the skin, thereby reducing the effectiveness of the pain relieving device.

Thus, there is a need for improved adaptability of pain relieving electrodes to the skin of different patients.

In general terms, the present disclosure is directed to a device and a method to effectively supply electricity to the skin at an injection site and physically stimulate the injection site prior to an injection in order to reduce the pain of an injection.

According to certain aspects of the present disclosure, the device and method are adapted to at least substantially provide a consistent, predefined distance, or at least a predefined range of distances, between the skin of the recipient and the mechanism of the device that physically stimulates the skin. In some examples, the predefined distance or predefined range of distances is selected to optimize the injection-pain reduction qualities of the device. In some examples, the optimization depends on one or more factors, including but not limited to: the number of stimuli provided by the device, the type(s) of stimuli provided by the device, the intensity of the stimuli provided by the device, the relative timing of application of the different stimuli provided by the device to the patient's skin, the location of the injection on the person, qualities of the skin and other tissues at and around the location of the injection, the type of needle or other injection device, the depth of the injection, the duration of the injection, and so forth.

DETAILED DESCRIPTION

An example device16in accordance with the present disclosure is shown inFIG. 1. The device16is used to reduce a pain of skin invasion such as an injection, lancing, intubation, drawing blood, and tattooing. The device16includes a housing30that houses and/or supports various operating features and components and of the device16. The device16can be positioned on the skin and apply electricity and physical stimulation to the skin on or in the vicinity of an injection site before and/or during an injection to reduce the pain of the injection. The device16includes a housing30that retains one or more stimulators15that physically stimulate the skin at least at the injection site. Physical stimulation can, for example, take the form of tapping, rubbing, and blowing gas among others. Examples of stimulators that can provide one or more of these modalities include among others, e.g., a rotating tapper than rotates around an axis and taps the skin on or around the injection site, a wheel rotating around an axis that is mainly perpendicular to the skin at the injection site, or a nozzle that blows compressed gas on or around the injection site. The device16may further include one or more electrodes2having two sides. The one or more electrodes are positioned so that one side of the electrode will come in electrical contact with the skin when in ready position. The side that comes in contact with the skin may include an electrolyte or an electrode gel that facilitates electrical transmission to the skin.

Physical stimulation to the skin is effected by one or more stimulators15that may be positioned at a distance from the injection site that makes it possible for the one or more stimulators15to effectively stimulate the skin. When physical stimulation such as tapping, rubbing, or blowing gas is applied, it is especially important that the stimulator(s)15is/are placed at a preset or predefined distance from the injection site and its adjacent areas to bring about effective stimulation, or within a predefined range of distances from the injection site and its adjacent areas. If the stimulator(s)15is/are too close or too far from the injection site, physical stimulation may be adversely affected. It is possible to use only one modality or more than one modality of physical stimulation at one time. A stimulator15with one modality of physical stimulation may require a different distance or range of distances from the skin than a stimulator15with another modality of physical stimulation in order to operate effectively. Similarly, the parameters of a particular modality or combination of modalities of physical stimulation may be modulated in a way that affects the optimal distance or range of distances between a particular stimulator15and the injection site.

In some examples, the device16includes a sensor17(seeFIG. 2) supported by the housing30. The sensor17is adapted to detect a distance between the stimulator15and the injection site and determine if the detected distance is within or without a predefined acceptable operating for the device16. The user presses the device16towards the skin. As the device16moves towards the skin, the sensor17gages the distance between the stimulator15and the skin and signals the processor18when the distance is in an acceptable range. The processor18, for example, compares the signal received from the sensor17with a look-up table stored on a memory to detect when the stimulator15is in an acceptable range.

FIG. 5shows two electrodes2that are flexible and springy in nature. When the device16is pressed on the skin, the electrodes2flex and adapt to the contour of the skin while the stimulator15comes closer to the skin and reaches a preset calculated range of distances from the injection site40. In another example, the two electrodes are each held by a hinge35to the device16and can rotate around the hinges and better adapt to the contour of the skin. In an example, at least one hinge35has two general components, component a and component b, with component a fixed to the rigid part of the housing30, and component b bearing a rotating electrode2, as inFIG. 16. A conductive strip5is positioned on each component a and b so that at certain angles during the rotation of the component b over component a, the conductive strips slide over each other, during which time electricity can pass from wire4ato wire4b. The hinge35acts as a sensor and senses the angle degrees that the electrode2opens. When the electrode2opens to a predefined range of degrees, the hinge35sends a signal that can alert the user, that a processor18uses to activate the stimulator15and/or the electrodes2that provide electric stimulation, or that is used to directly activate the stimulator15and/or the electrodes2. One or more electrodes2can be spring loaded to keep the electrodes in un-flexed/un-rotated position when the device16is idle.

In one example, a signal corresponding to a detected distance between the stimulator15and the injection site is provided by the sensor17to a processor18,FIG. 3. The processor18, which can be adapted to execute computer-readable instructions stored in a non-transitory computer readable medium (such as a memory37), can process the received signal to alert the user to stop pressing the device16on the skin any further if, for example, the detected distance is smaller than a minimum acceptable distance. In another example, e.g., if the detected distance is within a predefined operating range, the processor18processes the signal from the sensor17and causes the one or more stimulators15to start stimulating the skin. In another example, the processor18processes the signal from the sensor17and initiates application of electricity to the skin by one or more electrodes2. In another example, the sensor17routinely generates signals corresponding to a detected distance between the stimulator15and the injection site, but stops providing distance signals when one or more of the stimulators15included in the device16is/are within an acceptable operating distance range from the injection site.

In one or more of the foregoing examples, the processor18can be coupled to a controller34, the controller34being adapted to control activation and deactivation (e.g., by generating electronic control signals) of the one or more stimulators15.

The sensor17may use one or more of a variety of mechanisms to gage the distance between a stimulator15and the injection site. For example, as shown inFIG. 3, the device16may use a sensor17that generates laser36to measure the distance between the stimulator15and the injection site40. Alternatively, the sensor17can emit sound waves and measure the time it takes for the echo to bounce from the injection site or its vicinity back to the sensor. In another example, as shown inFIG. 4, the sensor17is so positioned on the housing30as to come in contact with the skin in close proximity to the injection site when the device16is pressed against and moves towards the skin. When the sensor17comes in contact with the skin, the sensor17alerts the user or signals the processor that a stimulator15is within an acceptable distance range from the injection site. In another example, when the sensor17comes in contact with the skin, it initiates electrical transmission via the one or more electrodes2and/or operation of the stimulator15.

In an example of the devices of the present disclosure, sensor17is attached to a rigid part of the housing30, is physically movable with respect to the housing30, and can be moved by the rising or descending level of the skin at or in the vicinity of the injection site40,FIG. 13.FIG. 13shows the sensor17to be mounted on a hinge35that is attached to the rigid part of the housing35. When the device16, along with the housing35is pressed towards the skin, the tissue bulges under the sensor17and presses the sensor17away from the skin. The sensor17then moves away from the skin. Due to the rigidity of the housing30, the distance between the stimulator15mounted thereon to the point where sensor17joins the rigid housing30is known. When the level of the skin at or in the vicinity of the injection site40varies with respect to the housing30, for example by pressing the device16to the skin and causing the skin to bulge, the level of the sensor17that moves with the level of the skin also varies in tandem. By measuring the position of the sensor17with respect to its joint point with the rigid part of the housing30, one can accurately estimate the distance between the stimulator15and the injection site. One example of measuring the position of the sensor17with respect to its joint point with the rigid part of the housing30is by gaging the angle of the sensor17to the rigid part of housing30. The hinge35can simply have an on-off switch that turns on the stimulator15and the electrodes2when the angle is in an acceptable range. Alternatively, the hinge35can send signals to a controller34when the angle is in an acceptable range. Or the hinge35can alert the user that the angle is in an acceptable range. In a related example of the disclosed device, at least one electrode2or part thereof acts as a sensor17when for example the at least one electrode2or part thereof is placed in close proximity to or on the injection site.

In an example of the disclosed device, as shown inFIG. 5, at least a portion of an electrode2of the device16is resiliently flexible. As the device16is pressed on the recipient's skin and moving towards the injection site, the flexible portion of the electrode2flexes and/or rotates around an axis in order to stay relatively stationary with respect to the skin around the injection site. A sensor17gages the distance of the flexible portion of the electrode2with respect to the stimulator15and signals when it is in an acceptable range. In a preferred example of the devices of the present disclosure, the force needed to flex the electrodes to conform to the contour of the skin is less than the force needed to invaginate the skin 1 mm. In some examples, the flexibility of the electrodes2is such that the force needed to flex the electrodes2to conform to the contour of the skin is less than 0.1 N.

As shown inFIG. 5, in an example device according to the present disclosure, one or more electrodes2are each held by a support19extending from the housing30of the device16. For example, the one or more electrodes2may be flexible; or in another example, one or more electrodes2may be springy. When the device16is pressed against the skin of the injection recipient, the one or more electrodes2flex and better adapt to the contour of the skin so as to improve the supply of electricity to the skin.

In another example, one or more electrodes2are rigidly held to the housing30,FIG. 2. When the device16is pressed against the skin, the one or more electrodes2also press against the skin causing the skin to bulge around the electrodes2. A sensor17gages the distance of the bulging skin with respect to a stimulator15and signals when the skin is in a preset range of distance from the stimulator15. That signal can be used to alert the user to stop pressing further and/or to cause the stimulator15to physically stimulate the skin. A signal from a sensor17may also cause the one or more electrodes2to apply electricity to the skin.

In a different example, as shown inFIG. 6, one or more electrodes2are each held to the device16by at least one support19extending from the housing30of the device16. Each of one or more supports19can be rigid or resiliently flexible. When the device16is pressed against the skin, at least one of the one or more supports19move or flex to the side and allow the stimulator15to draw closer to the skin. For example, the supports19can be mounted on the device16and rotate around an axis so that the supports19move to the side and allow the device16to approach the skin.

Referring toFIG. 7, in one example the one or more electrodes2are held by the one or more supports19through one or more swivels20. A swivel20allows the electrode2some play with respect to the support19and helps the electrode2to better adapt to the contour of the skin,FIG. 7.

In a further example of a device of the present disclosure, as shown inFIG. 8, a support19that supports an electrode2is movably coupled to the housing30. For example, the support19can travel back-and-forth inside a channel20, provided in housing30, that allows the electrode2to get closer to or farther from the housing30. A spring inside the channel20exerts a force on the support19to push it out of the channel20. When the housing30is pressed towards the skin, the spring in the channel20forces the support19outwardly towards the skin, which in turn pushes and presses one or more electrodes2onto the skin. Due to the force exerted on the one or more electrodes2, the one or more electrodes2adapt to the contour of the skin. If the housing30is pressed further towards the skin, the skin reciprocates the force back to the one or more electrodes2, keeping the one or more electrodes2relatively stationary while the housing30keeps moving towards the skin, in effect causing the supporting carrier19to move inside channel provided in the housing30.

AsFIG. 9Shows, in a further example of a device in accordance with the present disclosure, the housing30includes one or more electrodes2touching the skin. The housing30can be tilted relative to the skin, e.g., in either direction represented by the arrow60, seeFIG. 14, so as to vary the distance d (seeFIG. 14) between the included stimulator15and the skin. InFIG. 14, the distance between the stimulator15and the skin is shown as d when the device16is resting on the skin. When the device16is tilted, the distance between the stimulator15and the skin is represented as dl which is different than d depending on the direction and the extent of the tilt.

In an alternative variation of the example, the device16does not include a sensor17. A skilled user tilts the device16until the user senses adequate physical stimulation on the skin. The user then keeps the device16in that angulation on the skin until the skin is properly anesthetized. For example, after the user places the device16on the skin, he may tilt it 10, 15, 20, 25, 30 or any other degrees to obtain a proper distance d between the stimulator and the injection that effectively causes anesthesia.

In order to better conduct electricity to the skin, the one or more electrodes2can be coated with an electrically conducting solution (electrolyte) such as saline or an electrode gel. These solutions sometimes dry over time and lose their conductivity. In order to prevent these solutions from drying, two or more electrodes2are brought together or an electrode2is folded over itself or another surface when not in use to avoid the solution liquid evaporation. For example, as shown inFIG. 10a, a device16includes two supports19, each holding an electrode2. At least one of the supports19is adapted to move with respect to the other support19so as to bring together or to separate the held electrodes2.

In another example, one or more supports19are rigid and rotate around an axis as inFIG. 6. When the device16is pressed towards the skin, the one or more supports19rotate outwardly allowing the device16to approach the skin. In another example, at least part of at least one of the supports19is resiliently flexible so as to enable to bring together or to separate the held electrodes2. When the device16is pressed towards the skin, the supports16flex outwardly and allow the device16to approach the skin.

In another example, at least one of the electrodes2is resiliently flexible. When the electrodes2are pressed against the skin, they flex and adapt to the skin. When they disengage the skin, they flex back to a relatively straight shape.

FIG. 10ashows two supports19, each carrying an electrode2. The supports19can move up and down inside a channel20provided inside the housing30. When not in use, the supports19can be stowed up the channel20so that the electrodes2come in contact with each other. This arrangement prevents drying of any electrolyte that may be placed on the electrodes2. Once they are required to apply electricity, they are extruded out of the channel20allowing the electrodes2to contact the skin.

FIG. 10bshows a device16including two electrodes2. The electrodes2can fold on each other, when the device16is not in use, so as to preserve any electrolyte that is on them. Before operation, the user can flap open the electrodes and expose the electrolyte on them.

FIG. 11shows a device16that can have two or four electrodes2. If the device has two electrodes2, then each electrode2folds on itself when the device16is not in use. If the device has four electrodes2, then two of the electrodes flap closed so as to face and contact the other two electrodes of four when the device16is idle. Before operation, the user can unfold the electrodes and expose the electrolyte on them.

FIG. 12similarly shows two electrodes2included in a device16. One electrode2is stationary on the device16, whereas the second electrode2can face and contact the first electrode2when the device16is not in use, and can also flap open when the device16is intended to be used.

In a preferred example of the invention, at least part of at least one electrode2moves in a range of motion. In one point in the range of motion, which could be an endpoint, at least part of the electrode2reaches another surface. If there is an electrolyte applied to the electrode, this contact with the other surface helps prevent drying of the electrolyte, for example, when the device16holding the electrode2is not in use. At another point in the range of motion of the moving part of the electrode2, which could be the other endpoint of the range of motion, the moving part of electrode2rests on the skin and brings at least one stimulator15to a proper distance from the injection site in order for the stimulator to adequately stimulate the injection site. The other surface that comes in contact with the electrolyte on the electrode2can for example be another electrode2, another part of the same electrode2, or part of the housing30, as illustrated inFIGS. 10a, 10b,11, and12. Part of the electrode2can move in a range of movement because, for example, at least part of the electrode2is flexible and allows folding or flexing part of the electrode2on a different surface, at least part of the electrode2can rotate around a hinge, or at least part of the electrode2is transported by a support19.

FIG. 10bshows 2 electrodes2that fold over each other when not in use to take less space, to prevent drying of electrolytes on them, and to keeps the stimulator15inside the device16sterile. When intended to be used, the electrodes2flip open and expose their side with electrolytes that then can contact the skin

InFIG. 15, an embodiment of the present device16is exemplified showing the housing30at least partially included inside a conduit45. The housing30, having at least one stimulator15, is movable inside the conduit45. The conduit45has at least one opening. At least one opening in conduit45is protected by at least one flap12that closes the opening when the device16is not intended for use in the near future. When a user intends to use the device16, the at least one flap12opens. For example, the housing30moves at least partially out of the conduit45so that the stimulator15can physically stimulate the injection site. In an example, one or more electrodes112are included on the housing30. In another example, the at least one flap12is an electrode. In an example, the electrodes12and/or112have a layer of electrolyte on their surface that will be exposed to the skin. In a preferred example of the embodiment, moving the housing30towards the at least one flap12causes the at least one flap12to flap open. For example, the housing30physically pushes the flap12open. This feature of the embodiment covering the stimulator15and electrodes12and/or112prevents the stimulator from contamination and the electrolyte from drying. In an example, at least one flap12is mounted on a hinge35to facilitate opening and closing of the flap12. In an example, at least one hinge35acts as a sensor and senses the angle degrees that the flap12opens. When the flap12opens to a predefined range of degrees, the hinge35sends a signal that can alert the user, that a processor18uses to activate the stimulator15and/or the electrodes2,12, and/or112that provide electric stimulation, or that is used to directly activate the stimulator15and/or the electrodes2,12, and/or112. One or more flaps12can be spring loaded to keep the flap closed when the device16is idle.

One skilled in the art will appreciate that the present invention can be practiced by other than the described embodiments, which are presented here for purposes of illustration and not of limitation, and the present invention is limited only by the claims that follow.