WO2021230810A1

WO2021230810A1 - Device, kit and method for generating a vibrational stimulus

Info

Publication number: WO2021230810A1
Application number: PCT/SG2021/050175
Authority: WO
Inventors: Hong Liang TEY
Original assignee: National Skin Centre (Singapore) Pte Ltd
Priority date: 2020-05-15
Filing date: 2021-03-29
Publication date: 2021-11-18
Also published as: SG10202004553YA

Abstract

A device for generating a vibrational stimulus includes a body and a clip. The body includes a front portion and back portion, and is configured to generate a vibration at a selected frequency. The clip is detachably mounted to the front portion of the body and is configured to transmit the vibration to a site on a skin. The clip includes an applicator end that forms an annulus sector of an angle greater than 180°.

Description

DEVICE, KIT AND METHOD FOR GENERATING A VIBRATIONAL

STIMULUS

FIELD OF INVENTION

[0001] The present invention relates broadly, but not exclusively, to devices, kits and methods for generating a vibrational stimulus for pain management.

BACKGROUND

[0002] There are many minor procedures being routinely performed in outpatient clinics, especially in dermatology. Many of such procedures are painful, which precludes proper administration, especially in children.

[0003] For example, in dermatological practice, cryotherapy is a common outpatient procedure offered as part of treatment for viral warts and other benign lesions. With a temperature of -196 degrees Celsius, the liquid nitrogen used in cryotherapy can cause discomfort and pain when applied to skin lesions. Studies have shown high levels of pre-procedural anxiety in paediatric patients which, based on clinical experience, may lead to increased treatment duration or even treatment failure.

[0004] Pain modulation through the combined effect of vibratory stimulation of A3 mechanoreceptors and the gate control theory has been demonstrated to reduce pain associated with outpatient procedures, such as injections and intravenous (IV) cannulation. A study has shown that facial injection sites with the use of a vibration device for pain modulation may have a lower mean pain score of 2.3 ± 0.9 compared to those without vibration device (4.5 ± 1.5).

[0005] While vibratory devices have been shown to alleviate pain during outpatient clinical procedures, most of the currently used devices are not intended for use for clinical procedures and are hence unable to achieve maximum benefit for the patient in terms of pain relief. [0006] A need therefore exists to provide a device that can address at least some of the above problems.

SUMMARY

[0007] An aspect of the present disclosure provides a device for generating a vibrational stimulus. The device comprises a body comprising a front portion and back portion, wherein the body is configured to generate a vibration at a selected frequency, and a clip detachably mounted to the front portion of the body and configured to transmit the vibration to a site on a skin. The clip comprises an applicator end, the applicator end forming an annulus sector of an angle greater than 180°.

[0008] The frequency may be selected to stimulate A3 mechanoreceptors surrounding c-fibers in a skin layer adjacent the site for inducing analgesia at the site.

[0009] The clip may be made of a transparent material.

[0010] The body may further comprise a chassis extending from the front portion to the back portion, and the chassis may be made of a rigid material. The device may further comprise a vibration actuator mounted to the chassis at the front portion and a battery mounted to the chassis at the back portion.

[0011] The body may be substantially fluid-tight.

[0012] The front portion may be inclined at an obtuse angle relative to the back portion.

[0013] The annulus sector may be of an angle approximately 270°.

[0014] Another aspect of the disclosure provides a kit of parts for generating a vibrational stimulus. The kit comprises a body comprising a front portion and back portion, wherein the body is configured to generate a vibration at a selected frequency, and a plurality of clips, wherein each clip is selectable for detachably mounting to the front portion of the body and transferring the vibration to a site on a skin. Each clip comprises an applicator end, the applicator end forming an annulus sector of an angle greater than 180°, and wherein the plurality of clips comprise applicator ends of respective sizes.

[0015] Each of the clips may be made of a transparent material.

[0016] The respective sizes may comprise sets of inner and outer diameters of the annulus sector and/or angles.

[0017] Another aspect of the present disclosure provides a method for generating a vibrational stimulus. The method comprises providing a body comprising a front portion and back portion; mounting a clip to the front portion of the body, wherein the clip comprises an applicator end, the applicator end forming an annulus sector of an angle greater than 180°; generating a vibration at a selected frequency in the body; and placing the clip on a site on a skin to transmit the vibration to the site.

[0018] Generating the vibration may comprise selecting the frequency to stimulate A3 mechanoreceptors surrounding c-fibers in a skin layer adjacent the site for inducing analgesia at the site.

[0019] The clip may be made of a transparent material.

[0020] Providing the body may further comprise providing a chassis extending from the front portion to the back portion, and the chassis may be made of a rigid material. The method may further comprises mounting a vibration actuator to the chassis at the front portion and mounting a battery to the chassis at the back portion.

[0021] Providing the body may comprise making the body substantially fluid-tight.

[0022] Providing the body may comprise disposing the front portion at an obtuse angle relative to the back portion.

[0023] The annulus sector may be of an angle approximately 270°.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Embodiments of the invention will be better understood and readily apparent to one of ordinary skill in the art from the following written description, by way of example only, and in conjunction with the drawings, in which: [0025] Figure 1 shows a perspective view of a device for generating a vibrational stimulus according to an example embodiment.

[0026] Figure 2 shows an exploded view of the device of Figure 1 .

[0027] Figure 3 shows a cross-sectional view of the device of Figure 1 .

[0028] Figure 4 shows a flow chart of a method for generating a vibrational stimulus according to an example embodiment.

DETAILED DESCRIPTION

[0029] The present disclosure provides a device that can provide a vibrational stimulus surrounding a central procedural site for pain alleviation for patients while still enabling the procedure to be properly performed. The surround feature of the vibrational stimulus as disclosed herein can alleviate pain more effectively. Also disclosed is a kit that can be quickly assembled to form the device based on practical requirements, and a method for generating a vibrational stimulus.

[0030] The device is now described in more details with reference to Figures 1 -3, in which Figure 1 shows a perspective view of a device 100 for generating a vibrational stimulus according to an example embodiment, Figure 2 shows an exploded view of the device 100 of Figure 1 , and Figure 3 shows a cross-sectional view of the device 100 of Figure 1 .

[0031] The device 100 includes a body 102 which can generate a vibration at a selected frequency. In one implementation, the frequency is determined during manufacture of the device 100 and cannot be altered during use (i.e. a single mode operation). In other implementations, the frequency may be selected from discrete preset levels (e.g. slow - medium - fast), or may be continuously varied. Typically, the frequency is in the range of 10 - 200 Hz. As non-limiting examples, the frequency may be selected to be between 75 and 150 Hz, and more preferably, 150 Hz. The body 102 includes a front portion 104 and a back portion 106 arranged such that the front portion 104 is inclined at an obtuse angle to the back portion. A clip 108 is detachably mounted to the front portion 104 of the body 102 such that the clip 108 can transmit the vibration to a site on a skin (not shown) when the clip is placed on the site. The vibration stimulates the Ab mechanoreceptors, which surround the pain-transmitting c-fibers present in a skin layer, to inhibit the onward transmission of pain signals at the spinal cord, thereby inducing analgesia at the site.

[0032] The clip 108 includes a mounting end 110 an applicator end 112. The mounting end 110 is sized and shaped to fit snugly to the front portion 104 of the body 102. For example, the mounting end 110 may include a circular opening that can first press-fit with a circular protrusion on the front portion 104, as can be seen in Figures 2 and 3, and then turned into a locked position. The applicator end 112 forms an annulus sector of an angle greater than 180° (i.e. an incomplete circular ring). The circular shape of the applicator end 112 can enable the vibratory effect from the ring to be concentrated in the center of the field of procedure, which is normally the site where pain management is required. In other words, the ring shape of the applicator end 112 is selected to direct or focus the vibration to a desired area within the ring. The incomplete part of the ring is provided so as not to obstruct the procedure and to allow fluids to flow out of the field of procedure. The space within the ring is typically sufficient for procedures to be performed, while keeping the size of the ring small enough for the vibratory effect to be effective throughout the whole area encompassed by the ring. In one implementation, the annulus sector has an angle of approximately 270°, while the inner and outer diameters are 19mm and 24mm respectively. It will be appreciated that other angles and diameters may be used in alternate embodiments.

[0033] The clip 108 is made of a transparent material to permit visualization of the underlying skin. For example, the clip 108 can be made from a medical-grade plastic material such as polycarbonate. After use, the clip 108 may be detached from the body 102 and disposed. Alternatively, the detached clip 108 may be cleaned and sterilized for a subsequent use.

[0034] With reference to Figures 2 and 3, the body 102 further includes a chassis 114 that extends from the front portion 104 to the back portion 106. The chassis 114 is typically made of a rigid material to improve structural integrity of the body 102. A vibration actuator 116 is mounted to the chassis 114 at the front portion 104, and a battery 118 is mounted to the chassis 114 at the back portion 106. The vibration actuator 116 is enclosed by a front housing 120, while the battery 118 is enclosed by a back housing 122 and a battery door 124. The battery door 124 is removably attached to the back housing 122, e.g. by snap-fit, such that the battery door 124 can be opened to replace the battery 118. The back portion 106 including the back housing 122 and battery door 124 form a handle that a user can use to hold the device 100. A button 126 is disposed on the back housing 122 to activate/deactivate the vibration actuator 116. Further, a sealing material may be disposed at external interfaces between the front housing 120, back housing 122, battery door 124, and button 126, such that the body 102 is substantially fluid-tight. This can improve hygiene as fluid from the clinical procedure cannot get into the interior of the body 102. Cleaning and maintenance can also be simplified.

[0035] In practical use, the device 100 may be packaged as a kit comprising the body 102 and a plurality of clips 108. The plurality of clips 108 have applicator ends 112 of varying sizes to fit different types of clinical procedures. For example, different sets of inner and outer diameters may be used, such that the applicator ends 112, which are in the form of annulus sectors or incomplete rings, have a range of sizes. Alternatively or in addition, the annulus sectors may have different angles.

[0036] To generate a vibrational stimulus and induce analgesia at a site on a skin, a clip 108 is first selected from the plurality of clips and mounted to the front portion 104 of the body 102. The selection of the clip 108 may be based on factors including but not limited to the type of clinical procedure, the contour of the skin region where the site is located, the age of the person undergoing the procedure. The vibration actuator 116 is then activated to generate a vibration at the desired frequency, and the applicator end 112 of the clip 108 is firmly placed on the site on the skin to transmit the vibration to the site. Alternatively, the applicator end 112 of the clip 108 may be firmly placed on the site before the vibration actuator 116 is activated. As described above, the frequency is selected to stimulate A3 mechanoreceptors surrounding c-fibers in a skin layer adjacent the site for inducing analgesia at the site. In some instances, a pressure may be applied by the user of the device 100 (e.g. a clinician) to ensure consistent contact of the applicator end 112 with the skin.

[0037] After the procedure has been completed, the clip 108 can be detached from the body 102. In some procedures where multiple clips 108 may be required (e.g. the site is enlarged during the course of the procedure), one clip can be detached and replaced by another. The detached clip 108 may be safely disposed, or cleaned and sterilized for a subsequent use. The body 102 can also be cleaned and sterilized for use in another procedure.

[0038] Figure 4 shows a flow chart illustrating a method for generating a vibrational stimulus according to an example embodiment. At step 402, a body comprising a front portion and back portion is provided. At step 404, a clip is mounted to the front portion of the body. The clip comprises an applicator end which forms an annulus sector of an angle greater than 180°. At step 406, a vibration is generated at a selected frequency in the body. At step 408, the clip is placed on a site on a skin to transmit the vibration to the site.

[0039] The device and method as disclosed in example embodiments can alleviate procedure pain and discomfort in a safe manner without compromising on treatment outcome. Accordingly, patient distress may be reduced and this can promote treatment compliance across all age groups, especially for treatments requiring multiple and/or repeated administration. For example, children may be a major target group for this intervention, as pain is a major factor precluding invasive bedside procedures to be performed in the paediatric population. The clip of the device is changeable by the user to fit the different types of procedure to be performed. The changeable and semi-disposable nature of the clips of the device is also important for infection control reasons, since clips stained with blood should be changed.

[0040] A study has been performed to demonstrate that the device can significantly reduce the pain experienced by patients during cryotherapy (administration of liquid nitrogen) of viral warts. Patients aged 7-70 years old with clinically diagnosed plantar warts were recruited. The patients were randomized into 2 groups, with each group receiving intervention with the device at either the first or second freeze-thaw cycle of cryotherapy. Pain scores were recorded on a 1 -10 numerical rating scale or Wong-Baker Faces pain scale after each cycle. The results revealed that there was a statistically significant difference in the mean pain scores, with intervention at 3.9 ± 1.7 and without intervention at 5.8 ± 1.7 (p<0.0001). The median pain scores with intervention was 4.0, and without intervention 6.0. There was no significant difference in pain score reduction whether the device was used during the first or second cycle of cryotherapy. No adverse events were reported.

[0041] In addition to cryotherapy, the device can also be applied in multiple other painful procedures to improve clinical management. These include dermatological procedures, such as botulinum injections for wrinkles or hyperhidrosis, filler injections, laser procedures, cutaneous injection of local anaesthesia before skin surgeries, and general medical procedures such as subcutaneous injections of insulin or drugs (e.g. biological agents), intramuscular injections of vaccines or drugs (e.g. antibiotics).

[0042] It will be appreciated by a person skilled in the art that numerous variations and/or modifications may be made to the present invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. For example, dimensions may be varied and substitute materials may be used. The present embodiments are, therefore, to be considered in all respects to be illustrative and not restrictive.

Claims

1 . A device for generating a vibrational stimulus, the device comprising: a body comprising a front portion and back portion, wherein the body is configured to generate a vibration at a selected frequency; and a clip detachably mounted to the front portion of the body and configured to transmit the vibration to a site on a skin; wherein the clip comprises an applicator end, the applicator end forming an annulus sector of an angle greater than 180°.

2. The device as claimed in claim 1 , wherein the frequency is selected to stimulate A3 mechanoreceptors surrounding c-fibers in a skin layer adjacent the site for inducing analgesia at the site.

3. The device as claimed in claim 1 or 2, wherein the clip is made of a transparent material.

4. The device as claimed in any one of the preceding claims, wherein the body further comprises a chassis extending from the front portion to the back portion, and wherein the chassis is made of a rigid material.

5. The device as claimed in claim 4, further comprising a vibration actuator mounted to the chassis at the front portion and a battery mounted to the chassis at the back portion.

6. The device as claimed in any one of the preceding claims, wherein the body is substantially fluid-tight.

7. The device as claimed in any one of the preceding claims, wherein the front portion is inclined at an obtuse angle relative to the back portion.

8. The device as claimed in any one of the preceding claims, wherein the annulus sector is of an angle approximately 270°.

9. A kit of parts for generating a vibrational stimulus, the kit comprising: a body comprising a front portion and back portion, wherein the body is configured to generate a vibration at a selected frequency; and a plurality of clips, wherein each clip is selectable for detachably mounting to the front portion of the body and transferring the vibration to a site on a skin; wherein each clip comprises an applicator end, the applicator end forming an annulus sector of an angle greater than 180°, and wherein the plurality of clips comprise applicator ends of respective sizes.

10. The kit as claimed in claim 9, wherein each of the clips is made of a transparent material.

11. The kit as claimed in claim 9 or 10, wherein the respective sizes comprise sets of inner and outer diameters of the annulus sector and/or angles.

12. A method for generating a vibrational stimulus, the method comprising: providing a body comprising a front portion and back portion; mounting a clip to the front portion of the body, wherein the clip comprises an applicator end, the applicator end forming an annulus sector of an angle greater than 180°; generating a vibration at a selected frequency in the body; and placing the clip on a site on a skin to transmit the vibration to the site.

13. The method as claimed in claim 12, wherein generating the vibration comprises selecting the frequency to stimulate A3 mechanoreceptors surrounding c-fibers in a skin layer adjacent the site for inducing analgesia at the site.

14. The method as claimed in claim 12 or 13, wherein the clip is made of a transparent material.

15. The method as claimed in any one of claims 12 to 14, wherein providing the body further comprises providing a chassis extending from the front portion to the back portion, wherein the chassis is made of a rigid material.

16. The method as claimed in claim 15, further comprising mounting a vibration actuator to the chassis at the front portion and mounting a battery to the chassis at the back portion.

17. The method as claimed in any one of claims 12 to 16, wherein providing the body comprises making the body substantially fluid-tight.

18. The device as claimed in any one of claims 12 to 17, wherein providing the body comprises disposing the front portion at an obtuse angle relative to the back portion.

19. The method as claimed in any one of claims 12 to 18, wherein the annulus sector is of an angle approximately 270°.