Precision predicting marking device for neuromodulator administration

Abstract

A device and method for marking a surface, such as skin, to show the location of anticipated diffusion for a neuromodulator, such as botox, before administration of the neuromodulator is provided. The device comprises flexible leaf members having distal end surfaces and a separate tip end which transfer corresponding marks to the surface. The visualized anticipated diffusion pattern that results allows for a safer and more predictable outcome when administering the neuromodulator.

Description

PRECISION PREDICTING MARKING DEVICE FOR NEUROMODULATOR ADMINISTRATION

[0001] This application claims benefit of priority to U.S. Provisional Patent Application U.S. Serial No. 63 / 542,450, filed October 4, 2023, the entire contents of which are incorporated herein by reference.FIELD

[0002] The disclosure is to a device for precisely marking a surface, such as skin, to facilitate proper placement of neuromodulator administration, such as a botox injection, and a method of using same.BACKGROUND

[0003] Presently, the administration of neuromodulators, such as botox injections, is beset by various problems. For example, the neuromodulator is frequently over-injected or the site for the injection is poorly placed. These can result in the unwanted migration of the neuromodulator to muscle tissue. Current devices do not account for where the neuromodulator will spread by diffusion once administered; they merely pinpoint where the injection should be placed.

[0004] There is thus a need for device that will mark the area where the neuromodulator is anticipated to diffuse. Such visualization of the anticipated diffusion area provides a safer and more predictable outcome when administering a neuromodulator by, for example, showing where the spread of neuromodulator will be relative to the location of nearby muscle tissue.SUMMARY

[0005] In one aspect, the disclosure is to a marking device comprising a casing comprising a hollow interior, an upper end having an opening, and a lower end having a frustoconical portioncomprised of a plurality of leaf members adapted to flex outwardly and defining a flexible opening, each leaf member having a distal end surface; a rod movcably disposed within the hollow interior of the casing, the rod having an upper section and a lower section, the lower section comprising (i) an outwardly extending frustoconical flange configured to be sufficiently larger than the frustoconical portion of the casing so that when the frustoconical flange is contacted against the frustoconical portion the leaf members flex outwardly, (ii) a bottom end, and (iii) a channel extending longitudinally into the rod from the bottom end; a tip element secured in the channel having a tip end extending outwardly from the bottom end of the rod; a biasing member disposed within the channel and behind the tip element, the biasing member urging the rod away from the frustoconical portion of the casing in a first position; a sleeve configured to fit around the frustoconical portion of the casing, the sleeve comprising a distal open end configured to contact a surface to be marked; an ink source internally disposed laterally across at least a portion of the sleeve; and a knob movably disposed at the upper end of the casing and coupled to the upper section of the rod element through the opening and configured to displace the rod element along its longitudinal axis to a second position so that the frustoconical flange contacts the frustoconical portion to flex the leaf members outwardly whereby the distal end surface of each leaf member and the tip end respectively press against the ink source so as to transfer corresponding marks to the surface to be marked.

[0006] In another aspect, the disclosure is to a method of marking a surface comprising (a) providing a marking device as above; (b) placing the distal open end of the sleeve against the surface to be marked; and (c) moving the knob displace the rod element along its longitudinal axis to the second position so that the frustoconical flange contacts the frustoconical portion to flex the leaf members outwardly whereby the distal end surface of each leaf member and the tip end respectively press against the ink source so as to transfer corresponding marks to the surface to be marked.

[0007] In one practice, the surface to be marked in human tissue, such as skin, and the marking is to provide visualization of the anticipated diffusion area for a neuromodulator such as botox. The marking device of the disclosure marks not only the injection point of the neuromodulatorproduct, but also the anticipated diffusion of injected product, which will be sizable based on ncuromodulator reconstitution and type or brand of ncuromodulator. Thus the marking device of the disclosure helps prevent any unnecessary additional product being injected as well as improper placement of said product.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Fig. 1 is a perspective view showing an embodiment of the assembled marking device of the disclosure with the sleeve detached.

[0009] Fig. 2 is a perspective exploded view of the embodiment of Fig. 1.

[0010] Figs. 3A and 3B are respectively top and bottom perspective views of an embodiment of a knob for a marking device of the disclosure. Fig. 3C is a cross sectional side view of the knob.

[0011] Figs. 4A and 4B are respectively front and side views of an embodiment of a casing for a marking device of the disclosure. Fig. 4C is a top perspective view of the casing.

[0012] Figs. 5A and 5B are respectively front and side views of an embodiment of a rod for a marking device of the disclosure. Fig. 5C and 5D are respectively top and bottom perspective views of the rod.

[0013] Figs. 6A and 6B are respectively front and side views of an embodiment of a tip element for a marking device of the disclosure. Fig. 6C is a top perspective view of the tip element.

[0014] Fig. 7A is a cross sectional side view of an embodiment of a frustoconical portion for a marking device of the disclosure. Figs. 7B is a bottom view of the frustoconical portion. Figs. 7C and 7D are top and bottom perspective views of a frustoconical portion.

[0015] Fig. 8A is a cross sectional side view of an embodiment of a sleeve for a marking deviceof the disclosure showing an ink source. Fig. 8B is a top view of the sleeve. Figs. 8C and 8D are respectively top and bottom perspective views of the sleeve without the ink source.

[0016] Figs. 9A and 9B are schematic cross sections of an embodiment of the marking device in a first position and in a second position, respectively.DETAILED DESCRITPION

[0017] The following detailed description of embodiments of the disclosure is made with reference to the accompanying figures. This is for purposes of convenience only and is not restrictive of the scope of the disclosure and the practice thereof. Explanation of related functions or constructions known in the art are omitted for the sake of brevity.

[0018] As used herein terms such as “a,” “an,” and “the” are not intended to refer to only a single entity but include the general class of which a specific example may be used for illustration.Terms defined herein in the singular are intended to include those terms defined in the plural and vice versa.

[0019] Reference to any numerical range as used herein expressly includes each numerical value (including fractional numbers and whole numbers) encompassed by that range and including endpoints of that range. For illustrative purposes only, a reference to a range of “0.0001 to 5000” includes whole numbers such as 5000, 4999, 4998...3, 2, 1; and includes fractional numbers such as 0.00011, 0.00012...0.1, 0.2, 0.3...1.1, 1.2, 1.3....100.5, 100.6...4900.5, 4990.6, 4990.7 etc.

[0020] As used herein, the term “about” includes the value listed and indicates that the value listed may be somewhat altered, as long as the alteration does not result in nonconformance of the article or method or system herein described. For example, the term “about” as used herein can refer to a variation of between ±1% up to ±10%, including any value therebetween. As used herein, the term “substantially” or “substantial” is equally applicable when used in a negativeconnotation, and refers to a complete or near complete action, characteristic, property, state, structure, item, or result. For example, a surface that is “substantially” flat would cither be completely flat or so nearly flat that the effect would be the same as if it were completely flat.

[0021] As used herein the term “subject” refers to any animal, including mammals. Exemplary subjects include, but are not limited to, mice, rats, rabbits, dogs, cats, swine, cattle, sheep, horses, primates, and humans. In one embodiment, the subject is a human.

[0022] Referring to Figs.l to 9, thereat is depicted non-limiting embodiment of the marking device 100 of the disclosure. In the practice depicted, marking device 100 comprises a casing 110 which comprises a hollow interior 120 such as an internal passageway extending through the casing as shown; an upper end 130 which has an opening 140; and a lower end 150 having a frustoconical portion 160 comprised of a plurality of leaf members 170 adapted to flex outwardly and defining a flexible opening 180, each leaf member having a distal end surface 190. In one non-limiting practice, the plurality of leaf members 170 is comprised four leaf members of the same shape and size and are formed by axial slots 350 extending through the frustoconical portion 160. Marking device 100 can be single use or multi-use.

[0023] In the non-limiting practice depicted in Figs. 1 and 2, the casing 110 in addition to the cylindrical body shown is defined herein as also comprising section 111 which comprised of the frustoconical portion 160. In the practice shown, section 111 is detachable from casing 110; it another practice (not shown) casing 110 is a unitary structure with frustoconical portion 160. A rod element 200 is moveably disposed within the hollow interior 120 of the casing 110; in the non-limiting practice shown, rod element 200 is displaceable along its longitudinal axis. Rod element 200 comprises an upper section 210 and a lower section 220, the lower section 220 comprises (i) an outwardly extending frustoconical flange 230 which is configured to be sufficiently larger than the frustoconical portion 160 of casing 110 so that when the frustoconical flange 230 is contacted against the frustoconical portion 160, e.g. when rod element is displaced downward along its longitudinal axis, the leaf members 170 flex outwardly; lower section 220 also comprises (ii) a bottom end 240, and (iii) a channel 250 that extends longitudinally into therod element 200 from the bottom end 240.

[0024] A tip element 260 is secured in channel 250 and has a tip end 270 that extends outwardly from the bottom end 240 of rod element 200. In one practice, tip end 270 is substantially circular, e.g. of about 1 to about 3 mm diameter, including smaller or larger sizes depending upon, e.g. the area to be marked. In another practice, tip end 270 is a hollow substantially circular shape. In one practice, tip element slides into the lower portion of channel 250 and is configured to turn and lock in place using configurations known in the ail. A biasing member 280, which can comprise a coil spring as shown or other biasing members as known in the art, is disposed behind tip element 260 and within channel 250. Biasing member 280 will compress and decompress as tip element 260 is contacted and pressed onto a surface (compress) and decompress when contact ceases. In one instance, tip end 270 remains flush with the leaf distal end surfaces 190 at all times. In one practice, tip end 270 comprises an ink membrane, such as felt, mesh fibrous material, or like stretchable material to facilitate inking when in contact with ink source 310. In another practice, distal end surfaces 190 comprise an ink membrane, which can be the same or different than the ink membrane on tip end 270 , such as felt, mesh fibrous material, or the like to facilitate inking when in contact with ink source 310. Tip end 270 serves to transfer a central dot to the surface to be inked. In another practice, the ink membranes on tip end 270 and / or the ink membranes on distal end surfaces 190 themselves comprise ink; this is in addition to or in lieu of the ink source 310 in sleeve 290; in such practices, an ink source can be located elsewhere in the device, such as an ink reservoir in knob 320 where the ink reservoir is in fluid communication with tip end 270 and or distal end surfaces 190 by methods known in the art. The biasing member 280 is configured to urge the rod element 200 away from the frustoconical portion 160 of casing 110 in a first position (see Fig. 9A).

[0025] As depicted, a sleeve 290 that is configured to fit around the frustoconical portion 160, e.g. around section 111 of same or otherwise so long as the leaf members 170 can flex outwardly. The sleeve 290 comprises a distal open end 300 which is configured to contact a surface, such as human tissue, including e.g. skin, to be marked. An ink source 310, such as an ink pad or other suitable ink sources as known in the art, is internally disposed laterally across atleast a portion of the sleeve 290. Ink source 310 can be located laterally across all or a portion of the sleeve at the distal open end 300, or it can be located laterally across all or a portion of the sleeve proximate the distal open end 300, e.g. located just slightly above the open distal end. In non-limiting practices, the ink source comprises dye ink, alcohol ink, gentian violet ink, or a chalk-based marking material or combinations of any of the foregoing.

[0026] Knob 320 is movably disposed, e.g. by being rotatable, at the upper end 130 of the casing 110 and coupled to the upper section 210 of the rod element 200 through the opening 140. In the practice depicted, a thread connection comprising thread portion on rod element 200 and complimentary thread portion 361 on knob 320. In the practice shown, knob 320 comprises downwardly extending member 362 which is disposed in opening 140 and comprises complimentary thread portion 361 which is coupled to thread portion 360 on rod element 200. In another practice (not shown) knob 320 is configured to act as a plunger which pushes down on rod element 200 to displace it along its longitudinal axis.

[0027] In the practice shown, knob 320 is configured to displace rod element along its longitudinal axis to a second position so that the frustoconical flange 230 contacts the frustoconical portion 160 so as to flex the leaf members 170 outwardly whereby the distal end surface 190 of each leaf member 170 and the tip end 270 respectively press against the ink source 310 so as to transfer corresponding marks to the surface to be marked (see Fig. 9B). In one instance, the knob 320 is rotatable to move rod element 200 up and down along its longitudinal axis. In one practice, as depicted, any one or more of the frustoconical portion 160, the sleeve 290, and the knob 320 may be detachable from the casing using snap fittings or other suitable detachable connections as known in the art. In another practice, any one or more of the casing, the rod element, the sleeve, and the knob may be substantially cylindrical. Other geometric shapes and / or cross sections may be used. Suitable materials of construction for the casing, rod element, sleeve and knob include, e.g. plastics, metals and the like.

[0028] In one embodiment, rod element 200 comprises at least one slot 330 along its length, and the casing 110 comprises at least one projection 340 extending into the hollow interior 120 of thecasing and configured to extend into slot 330 which serve as stopping points for the up and down movement of rod element 200 along its longitudinal axis. In the non-limiting practice shown the projection 340 is a pin that spans the hollow interior 120 of casing 110 and both the casing 110 and the rod element 200 each comprise two diametrically opposed holes, 329 and 331 respectively, through which pin 340 extends. In another embodiment, casing 110 comprises a slit 330 through which casing pin 327 is slotted through rod element hole 328, which moves up and down as rod element 200 is displaced along its longitudinal axis and serves as an indicator for marker circumference and which pin 327 configuration prevents the rod element 200 from rotating when knob 320 is turned; in one practice of this embodiment, a sticker having diameter values is placed on the outside of the casing 110 for reference.

[0029] In another aspect, the disclosure is to a method of marking a surface comprising (a) providing a marking device as hereinabove described; (b) placing the distal open end of the sleeve against the surface to be marked; and (c) moving the knob displace the rod element along its longitudinal axis to the second position so that the frustoconical flange contacts the frustoconical portion to flex the leaf members outwardly whereby the distal end surface of each leaf member and the tip end respectively press against the ink source so as to transfer corresponding marks to the surface to be marked. In one instance, the corresponding marks transferred from the distal end surface 190 of each leaf member 170 form a substantially circular pattern; concurrently or separately, the corresponding mark transferred from the tip end 270 is a point or dot located substantially in the center of the substantially circular pattern formed by distal end surfaces 190. In one practice, the distal end surfaces 190 form a substantially circular pattern about 15 mm to about 40 mm in diameter and all values therebetween when flexed outwardly, including about 18 mm, about 24 mm, and about 34 mm in diameter, which markings represent the anticipated diffusion of neuromodulator; and the tip end 270 forms a central dot of up to about 3 mm in diameter, which represents the point of injection. A user of the marking device will be able to avoid overdosing if subsequent markings overlap with previous ones

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A marking device comprising: a casing comprising a hollow interior, an upper end having an opening, and a lower end having a frustoconical portion comprised of a plurality of leaf members adapted to flex outwardly and defining a flexible opening, each leaf member having a distal end surface; a rod moveably disposed within the hollow interior of the casing, the rod having an upper section and a lower section, the lower section comprising (i) an outwardly extending frustoconical flange configured to be sufficiently larger than the frustoconical portion of the casing so that when the frustoconical flange is contacted against the frustoconical portion the leaf members flex outwardly, (ii) a bottom end, and (iii) a channel extending longitudinally into the rod from the bottom end; a tip element secured in the channel having a tip end extending outwardly from the bottom end of the rod; a biasing member disposed within the channel and behind the tip element, the biasing member urging the rod away from the frustoconical portion of the casing in a first position; a sleeve configured to fit around the frustoconical portion of the casing, the sleeve comprising a distal open end configured to contact a surface to be marked; an ink source internally disposed laterally across at least a portion of the interior of the sleeve; anda knob movably disposed at the upper end of the casing and coupled to the upper section of the rod clement through the opening and configured to displace the rod clement along its longitudinal axis to a second position so that the frustoconical flange contacts the frustoconical portion to flex the leaf members outwardly whereby the distal end surface of each leaf member and the tip end respectively press against the ink source so as to transfer corresponding marks to the surface to be marked.

2. The device of Claim 1 wherein the rod comprises at least one slot along its length, and the casing comprises at least one projection extending into the hollow interior and configured to extend into the slot to stop the movement of the rod along its longitudinal axis.

3. The device of Claim 2 wherein the projection is a pin that spans the hollow interior of the casing and the rod comprises two diametrically opposed slots through which the pin extends.

4. The device of Claim 1 wherein the plurality of leaf members comprises four leaf members of the same shape and size, and are formed by axial slots extending partially through the frustoconical portion.

5. The device of Claim 1 wherein the biasing member is a coil spring.

6. The device of Claim 1 wherein one or more of the following is detachable: the frustoconical portion, the tip element, the sleeve.

7. The device of Claim 1 wherein the knob is coupled to the upper section of the rod element by a thread connection.

8. The device of Claim 1 wherein one or more of the following is substantially cylindrical: the casing, the rod, the sleeve, the knob.

9. The device of Claim 1 wherein the knob is movable disposed by rotating it.

10. The device of Claim 1 wherein the ink source is an ink pad.

11. The device of Claim 1 wherein the hollow interior is substantially cylindrical.

12. The device of Claim 1 wherein the ink source is disposed laterally across the sleeve at or proximate to the distal open end of the sleeve.

13. A method of marking a surface comprising:(a) providing a marking device which comprises: a casing comprising a hollow interior, an upper end having an opening, and a lower end having a frustoconical portion comprised of a plurality of leaf members adapted to flex outwardly and defining a flexible opening, each leaf member having a distal end surface; a rod moveably disposed within the hollow interior of the casing, the rod having an upper section and a lower section, the lower section comprising (i) an outwardly extending frustoconical flange configured to be sufficiently larger than the frustoconical portion of the casing so that when the frustoconical flange is contacted against the frustoconical portion the leaf members flex outwardly, (ii) a bottom end, and (iii) a channel extending longitudinally into the rod from the bottom end; a tip element secured in the channel having a tip end extending outwardly from the bottom end of the rod; a biasing member disposed within the channel and behind the tip element, the biasing member urging the rod away from the frustoconical portion of the casing in a first position; a sleeve configured to fit around the frustoconical portion of the casing, the sleeve comprising a distal open end configured to contact a surface to be marked; an ink source internally disposed laterally across at least a portion of the sleeve; anda knob movably disposed at the upper end of the casing and coupled to the upper section of the rod clement through the opening and configured to displace the rod clement along its longitudinal axis to a second position so that the frustoconical flange contacts the frustoconical portion to flex the leaf members outwardly whereby the distal end surface of each leaf member and the tip end respectively press against the ink source so as to transfer corresponding marks to the surface to be marked;(b) placing the distal open end of the sleeve against the surface to be marked; and(c) moving the knob displace the rod element along its longitudinal axis to the second position so that the frustoconical flange contacts the frustoconical portion to flex the leaf members outwardly whereby the distal end surface of each leaf member and the tip end respectively press against the ink source so as to transfer corresponding marks to the surface to be marked.

14. The method of Claim 13 wherein the surface to be marked is human tissue.

15. The method of Claim 13 wherein the knob is coupled to the upper section of the rod element by a thread connection and wherein moving the knob comprises rotating it.

16. The method of Claim 13 wherein the ink source is an ink pad disposed laterally across the sleeve at or proximate to the distal open end of the sleeve.

17. The method of Claim 16 wherein the ink pad comprises dye ink, alcohol ink, gentian violet ink, or a chalk-based marking material.

18. The method of Claim 13 wherein the corresponding marks transferred from the distal end surface of each leaf member form a substantially circular pattern.

19. The method of Claim 18 wherein the corresponding mark transferred from the tip end is located substantially in the center of the pattern.

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