FIELD OF INVENTION:

[001] The present invention relates to a device meant for pain abatement during surgical procedures. More particularly, the present invention relates to a pain abatement device, employing vibration, tactile, temperature variations, and other stimulus to alleviate, diminish or abolish perception of pain without the use of drugs.

BACKGROUND & PRIOR ARTS:

[002] Most of the surgical procedures requires a patient to be in an anesthetic state. Anesthesia is a state of controlled and temporary loss of sensation to touch or pain by administering a suitable drug to the patient. Such anesthesia may be (i) local, where only a particular target area of the skin loses sensation, (ii) regional, and (iii) general where the patient becomes unconscious. However, these are invasive methods, and precisely for this reason, many patients tend to avoid or delay any surgical procedure. Besides the fear of the needle, some patients are allergic to the drugs administered for the purpose of anesthesia.

[003] In recent times, alternative methods replacing the invasive way of administering anesthetic drug are on the rise. The alternative methods include, topical anesthesia in which a drug in the form of a gel, cream, ointment, sprays etc. is applied as a local anesthetics that temporarily block the nerve near the area of application. The effect of topical anesthetic lasts for a short time.

[004] Some other alternative methods involve application of heat or cold to diverge the pain, soft-talking with patient & holding his/her hand, tactile anesthesia, or vibrational anesthesia. The anesthesia through application of cold is called cryoanelgesia. In vibration anesthesia, the pain sensation is alleviated by reducing pain transmission from peripheral receptors of the brain. [005] These methods are also employed in combination with one another to get greater output, for example first applying topical drug on the desired region to numb the tissues therein and then administering local anesthesia by invasive method to enhance the effect. The medical community is in agreement with the fact that the said alternate methods do not achieve the results comparable to administering drugs by invasive methods. Yet, the alternate methods sufficiently ease the pain patient may suffer during surgical procedure.

[006] Since the present invention relates to non-invasive method of vibration anesthesia, few prior arts have been cited herein. One such publication WO2015120451 relates to methods, systems, and devices for reducing or eliminating the pain of various procedures which generate pain in a patient's skin. It specifically relate to devices and systems having at least two stimulation components that stimulate the target area with at least one of vibration and electrical stimulation. Stimulation components of the devices are positioned on the fingers of the user. The device also consists of a controller which is configured to be wearable on a wrist of the user and is coupled to the first and second stimulation components. This controller further comprises stimulation generation module which helps to generate vibration and electrical stimulus.

[007] WO2011159317 describes a hand held device, comprising a handle, a removable controllable vibration head coupled to the distal end of the handle to selectively generate, which is used for providing pain abatement during medical procedures by utilizing sensory inputs such as vibratory motion, tactile sensation, heat, and cold. The device is provided with plurality of vibrating head attachments which comprises a Peltier thermoelectric device to transmit heat or cold to the patient's skin. Use of multiple vibrating heads allows to utilise variety of vibratory modes, selectable by the clinician, in order to provide the most effective treatment to an individualized patient. Power to the device can be supplied from an outside power source via a power cord or from a plurality of rechargeable batteries. [008] US20110022115 discloses Body Worn Topical Anesthesia Inducing (TAI) apparatus for inducing topical anesthesia at a desired treatment site and TAI electrodes therefor. Body worn TAI device configurations can be hand worn TAI device, a wrist worn TAI device, and a belt worn TAI device. These devices can also administer vibration stimulus and/or cold application at the desired treatment site for increased topical anesthesia. The devices can be used for chronic and acute pain relief management suitable for a wide range of clinical purposes. For example, clinical practitioners may use the TAI apparatus for injection procedures.

[009] US9775769 describes an electronic vibrating compression glove which simultaneously provides compression and vibration therapy to arthritic hands. The device is capable of simultaneously compresses and vibrates the user’s hand. The device has five individual vibrating motors which are electrically connected by wires to power source such as battery. Battery is inside of plastic housing and carries an on/off switch and has a charger plug in. The motors are placed on the top side of the digits to enhance vibration at locations where there is less fibrous or fatty tissue to absorb vibration. With respect to the thumb, it is preferred to have the motor at the base of the thumb.

[010] The known vibration anesthesia methods employ a vibratoary motor having a particular frequency that blocks the receptors of the brain. Studies have indicated that there may exist a particular frequency that provides maximum efficacy in gaining local/regional anesthesia. Further, studies have indicated that the patient may get accustomed to a stable vibrational frequency, which negates the functioning of the vibratory motors. The present invention addresses the said drawback.

SUMMARY OF INVENTION:

[Oi l] To address the issues stated, the present invention proposes a pain abatement device which utilizes vibration, tactile, and other stimulus to alleviate, diminish or abolish perception of pain without the use of drugs. [012] The present invention further describes the pain abatement device, which is simple, cost-effective and does not require a presence of an assistant to alleviate the patient’s pain during the surgical procedure.

[013] The present invention further proposes the device for inducing anesthesia at a desired area of a body of a subject during surgical procedure.

[014] The device comprises a first mechanical stimulant configured to operate at a first frequency at any phalanx of a finger; and a second mechanical stimulant configured to operate at a second frequency f2 different than the first frequency fl at any phalanx of a different finger. A first pressure sensitive switch and a second pressure sensitive switch are provided, which are electrically connected to the first mechanical stimulant and the second mechanical stimulant respectively.

[015] The device is further provided with a controller electronically configured to randomly modify the frequencies of the first mechanical stimulant and the second mechanical stimulant to prevent the subject being adjusted to a particular frequency, thereby maintaining state of anesthesia for required duration of time.

[016] The pain abatement device further comprises a power source to power the controller and other power based elements.

[017] The pain abatement device, for the purpose of the present invention, may be any portable device. Preferably, the pain abatement device may be a wearable device.

[018] The present invention most preferably discloses the pain abating device in the form of a wristwom device. [019] The pain abating wristwom device comprises a first mechanical stimulant provided at a distal phalanx of a thumb configured to operate at a frequency; and a second mechanical stimulant provided at a distal phalanx of an index finger configured to operate at a frequency different than the frequency of vibration of the first mechanical stimulant.

[020] The pain abating wristwom device is further provided with a first pressure sensitive switch and a second pressure sensitive switch electrically connected to the first mechanical stimulant and the second mechanical stimulant respectively at phalanges lower to the distal phalanges.

[021] The pain abating wristwom device further comprises of a controller situated at a wrist inside a module and electronically configured to randomly modify the frequencies of vibrations of both the mechanical stimulants to prevent the subject being adjusted to a particular frequency, thereby maintaining state of anesthesia for required duration of time.

[022] The pain abating wristwom device also has a provision of a power source to power the controller, and other components.

[023] In yet another embodiment, the pain abating device is a handwom device, such as handglove.

[024] The present invention further discloses a method of operation of the pain abatement device. The said method comprises applying pressure on phalanges to activate a first pressure sensitive switch and a second pressure sensitive switch; triggering a first mechanical stimulant and a second mechanical stimulant to vibrate at frequencies f 1 & f2 respectively for inducing anesthesia to a desired area of a body of a patient; randomly modifying the frequencies fl & f2 by a controller for inducing anesthesia. BRIEF DESCRIPTION OF DRAWINGS:

[025] The following figures, accompanied with the specification, demonstrate the preferred embodiment as well as various other embodiments:

FIGURE la illustrates a schematic diagram illustrating the top plan view of the pain abating device.

FIGRE lb is a schematic diagram illustrating the bottom view of the pain abating device.

FIGURE 2 is an exploded view showing the essential components constituting the pain abating device.

FIGURE 3 illustrates the block diagram of the controller

FIGURE 4 illustrates a top view of the controller.

FIGURE 5 illustrates a bottom view of the controller.

The essential components of the device are listed below:

Definitions:

[026] Meaning of certain terms, wordings and expressions are defined herein for the purpose of appropriate interpretation while referring to the specifications:

[027] “Surgical Procedure” means any surgery is any operative procedure carried out by surgeon or medical expert on the patient. In the context of the present invention, the surgical procedure includes manual, computer-controlled or laser surgery. Further in the context of the present invention, the surgery includes any minor operative procedure, and even the act of injecting the needle in the patient’s skin.

[028] “Subject” or “Patient” are similar terms in the context of the present invention. It generally includes human being, but does not have limiting effect.

[029] “Anesthesia” is a state of controlled and temporary loss of sensation to touch or pain by administering a suitable drug to the patient.

[030] “Phalanges” are parts or digits of the finger bones. “Distal phalanges” is the tip of the finger.

DETAILED DESCRIPTION OF THE INVENTION: [031] Accordingly, the present invention describes a pain abating device for inducing anesthesia to a patient in any surgical procedure. The present invention also describes the embodiments of the pain abating device. The present invention further describes a method of operation of the pain abating device.

[032] The pain abating device generally comprises a first mechanical stimulant configured to operate at a first frequency at any phalanx of a finger; a second mechanical stimulant configured to operate at a second frequency f2 different than the first frequency fl at any phalanx of a different finger; a first pressure sensitive switch and a second pressure sensitive switch electrically connected to the first mechanical stimulant and the second mechanical stimulant respectively; a controller electronically configured to randomly modify the frequencies of the first mechanical stimulant and the second mechanical stimulant to prevent the subject being adjusted to a particular frequency, thereby maintaining state of anesthesia for required duration of time; and a power source to power the components.

[033] The pain abating device may be a portable, handheld or handwom device. Preferably the pain abating device is a handwom device. Most preferably, the pain abating device is a wristwom device.

[034] In another embodiment, the pain abating device is wearable handglove.

[035] The present invention further describes a method of operation of the pain abatement device. The said method comprises applying pressure on phalanges to activate a first pressure sensitive switch and a second pressure sensitive switch; triggering a first mechanical stimulant and a second mechanical stimulant to vibrate at frequencies f 1 & f2 respectively for inducing anesthesia to a desired area of a body of a patient; randomly modifying the frequencies fl & f2 by a controller for inducing anesthesia. [036] The embodiments of the present invention may be realized by referring to figures 1-5 appended with this specification. It may be noted that the figures are provided to for better understanding of the invention, and the manner in which it functions. The scope of the present invention does not remain confined to the provided figures. Any obvious variations, alterations in the embodiment will fall within the scope of the present invention.

[037] Figures la & lb illustrate the pain abating device. The pain abating deice comprises of the first mechanical stimulant (203) and a second mechanical stimulant (204), wherein the first mechanical stimulant (203) is provided at a distal phalanx of the index finger (201) and the second mechanical stimulant (204) provided at a distal phalanx of the thumb (202). The first mechanical stimulant (203) is electrically connected to the first pressure sensitive switch (205), whereas the second mechanical stimulant (204) is electrically connected to the second pressure sensitive switch (206). The controller (103) and the power source (104) are provided in the casing module (101) of the device. The pressure sensitive switches (205,206) are provided in the vicinity of the mechanical stimulators (203,204). The mechanical stimulants (204,204) receive the trigger from the pressure sensitive switches (205,206) respectively when the pressure sensitive switches (205,206) sense sufficient pressure to generate the signal.

[038] In a preferred embodiment, the controller (103) is electronically configured to cause the mechanical stimulants (2,3) to vibrate at frequencies fl & f2. It may be noted that the frequency of vibration fl has a value different than that of f2. Further, the controller (103) is electronically configured to randomly modify the frequencies of vibration fl as well as f2.

[039] The functioning of the device is explained herein. At the time of surgical procedure, the device is either worn or held in a non-dominant hand by the surgeon. Generally, the surgeon holds and gently presses the body part to be operated before penetrating the patient’s skin with the surgical instrument or injection. Similarly, the surgeon holds and presses the patient’s skin with his/her index finger and the thumb while wearing the said pain abating device in his/her non-dominant hand. When gently pressed, the pressure sensitive switches (205,206) toggle to start the mechanical stimulants (203,204) respectively, thereby prompting to the stimulants to vibrate at two different frequencies f 1 & f2 respectively. The corpuscles in skin beneath the index finger and the thumb respond to the vibrational frequencies of the mechanical stimulants (203,204), inducing anesthesia in the area that lies between the index finger and the thumb.

[040] As stated in the Background & Prior Art, the studies have indicated that there exists a possibility where the patient may become accustomed to the frequency of vibration. To prevent such an acclimatization, the controller (103) is electronically configured to randomly modify both the frequencies fl & f2. In a preferred embodiment, frequencies f 1 & f2 are adapted to fluctuate between 50 hz to 200 hz. It is important to note that f 1 & f2 do not obtain the same values at a given instant. With random modification of the vibrational frequencies, the patient does not get used to the vibration, due to which anesthesia lasts for the sufficiently longer time.

[041] In a most preferred embodiment, the mechanical stimulants (203) are vibrational motors, having 7,000-12,000 rpms, a nominal voltage of 3 V, a nominal current of approximately 90 mA (max) and a starting current of approximately 120 mA (max), with a terminal resistance of 31 ohm (max). However, any stimulant capable of producing the vibrations of the required frequencies may be used for the working of the present invention.

[042] For the present invention to work, the pressure sensitive switches (205,206) are selected from mechanical component, electronic component. Most preferably, the pressure sensors of lightweight are employed, which have minimum pressure detection capacity of approximately 0.1 Newtons. [043] In a preferred embodiment, the power source (104) is a DC battery such as a 3.7 V flat Lithium Polymer battery. Further in a preferred embodiment, the power source (104) is a rechargeable battery, having provided with a charging circuit (501). However, the power source may also be solar powered source which is capable of running the device efficiently.

[044] Figure 2 illustrates an embodiment of the invention, where the pain abating device is a wristwom device. In addition to the components described above, the device is further provided with an attachment means (102) to fasten with the wrist of the non-dominant hand.

[045] Figure 3 shows a simplified electronic block diagram of the preferred embodiment of the pain abating device for the purpose of understanding its function. The device is powered by Li-ion battery (502) having the charging circuit (501) when plugged with USB input (508). The pressure sensor (503), connected to the microcontroller (504). When the pressure sensor (503) is pressed due to the gentle pressure generated by the surgeon, the microcontroller (504) senses it, thereby toggling the vibrational motors. The microcontroller output is relayed to vibration motor drivers (505), which drives the vibrator motors (506). The device status along with battery (502) is indicated on the indicator (507).

[046] As shown in Figure 4, a USB type-C cable is plugged to the USB type-C connector (602), to charge the battery (502), through battery charging circuit 603. The red indicator in the LED (604) turns ON to indicate the charging the process. Once the battery (502) is fully charged, blue indicator in LED (604) turns ON. The battery low detection is indicated using the transistor (605).

[047] According to another embodiment of the invention, the handglove is made of electrically insulating fabric. The fabric is selected from natural fiber, synthetic fiber, or mixed fiber. Further, the handglove may be worn inside the surgical handglove. [048] The present invention further discloses a method of operating a pain abatement device, which comprises applying pressure on phalanges to activate a first pressure sensitive switch (205) and a second pressure sensitive switch (206); triggering a first mechanical stimulant (203) and a second mechanical stimulant (204) to vibrate at frequencies fl & f2 respectively for inducing anesthesia to a desired area of a body of a patient; and randomly modifying the frequencies fl & f2 by a controller (103).

[049] The device eliminates or substantially reduces pain during a medical and/or cosmetic procedure, or while administering an injection. Such pain reduction or elimination is particularly useful in dermatology, pediatrics, needle-phobic patients, and others who need numerous shots. The device may be used by a medical professional, including a doctor, a nurse, or a physician's assistant, by a relative or friend of the patient, or by the patient himself or herself who gives their own shots.

[050] Working examples:

The device was compared against standard vibratory anesthesia devices on 20 patients. The patients were subjected to microneedling on both sides of the face or intralesional injections on more than one patch of alopecia on both sides of the scalp. The procedure was carried out after application of topical anesthesia cream for half an hour on each site. A standard vibratory anesthesia device was used on one site while on the other site, the present pain abating device was used on the skin on either side of the site of injection, throughout the duration of the procedure. The patients were asked to score their level of pain for either site at the end of the procedure. The scoring was on a 10-point, 0 being no pain, 5 being moderate pain, and 10 being the worst pain experienced. The overall pain score on the side where the present device was applied was found to be 2.80 ± 1.73 while the pain score for the side with standard vibration was 4.6 ± 1.26. Further, 17 out of twenty patients stated that they preferred the randomized vibration anesthesia device for future procedures. Further, 16 patients reported that there was an increase in the duration of anesthesia with the present device as compared to standard vibration. On probing further, patients revealed that with the standard device the strength of vibration decreased proportionally to the procedure. In contrast, the side on which the present device was used the sensation of anesthesia persisted.