TONGUE RETRACTORS FOR FRENOTOMIES

Abstract

This disclosure provides tongue retractors for oral medical procedures such as frenotomies. The retractors include first and second planar members extending from a vertex, wherein the first and second members extend from the vertex at a predetermined angle so as to provide upward retraction of the tongue of a subject when the retractor is placed in the subject's mouth; and an opening within at least one of the members. The opening is arranged to expose the frenulum of the subject and to permit an operator to surgically operate on the frenulum while the retractor is placed in the subject's mouth. The disclosure also provides uses of the retractors in procedures to cut a frenelum, e.g., to treat ankyloglossia.

Claims

1. A tongue retractor for oral medical procedures comprising: first and second planar members extending from a vertex, the first and second members extending from the vertex at a predetermined angle so as to provide upward retraction of the tongue of a subject when the retractor is placed in the subject's mouth; and an opening within at least one of the members, the opening arranged to expose the frenulum of the subject and to permit an operator to surgically operate on the frenulum while the retractor is placed in the subject's mouth.

2. The tongue retractor of claim 1, wherein the opening comprises a slit extending through each of the two planar members, wherein the slit runs in parallel with a longitudinal axis of each member beginning at the vertex.

3. The tongue retractor of claim 2, wherein the slit extends through at least about half of the length of each of the first and second members.

4. The tongue retractor of claim 2, wherein the width of the slit is configured to fit a frenulum within the slit.

5. The tongue retractor of claim 1, wherein the predetermined angle is about 45 degrees.

6. The tongue retractor of claim 1, wherein the two planar members are made of one elongate piece of metal or plastic folded or curved at the vertex to form the two planar members in a V-shape or U-shape.

7. The tongue retractor of claim 1, wherein the two planar members are made of two elongate pieces of metal or plastic connected at the vertex to form a V-shape or U-shape.

8. The tongue retractor of claim 1, further comprising a handle member extending from an end portion of one of the first and second planar members, wherein the handle member is arranged so that the retractor can be moved and manipulated by the operator when holding the handle member.

9. The tongue retractor of claim 8, wherein the handle member comprises an elongate post extending at an angle relative to a plane of the planar member.

10. The tongue retractor of claim 9, wherein the angle is an oblique angle.

11. The tongue retractor of claim 10, wherein the oblique angle is about 100 to 130 degrees.

12. The tongue retractor of claim 1, wherein each of the first and second planar members are about 20 to 40 mm in length and 15 to 25 mm in width.

13. The tongue retractor of claim 1, wherein the tongue retractor consists of materials suitable for use in an autoclave.

14. The tongue retractor of claim 1, wherein the planar members of the tongue retractor comprise one or more metal materials.

15. The tongue retractor of claim 1, wherein the planar members of the tongue retractor comprises one or more plastic materials.

16. The tongue retractor of claim 1, wherein the handle member comprises one or more metal materials.

17. The tongue retractor of claim 1, wherein the handle member comprises one or more plastic materials.

18. A tongue retractor of claim 1 for use in frenotomies.

19. A method of surgically operating on the frenulum of a subject, the method comprising: placing a tongue retractor of claim 1 in the mouth of a subject; retracting the tongue of the subject upwardly with the retractor; exposing the frenulum of the patient's tongue through the opening; and cutting the frenulum of the subject by way of surgical operation through the opening.

Description

DESCRIPTION OF DRAWINGS

[0016] FIG. 1 is a schematic perspective view of one embodiment of the new tongue retractor device with two planar members at an angle, e.g., about 45 degrees, from a vertex where they join, and a handle member extending from an end portion of one of the first two members.

[0017] FIGS. 2A and 2B are images of two different embodiments, one of metal (FIG. 2A) and one of a stiff plastic (FIG. 2B) of the new devices.

DETAILED DESCRIPTION

[0018] In general, this disclosure provides tongue retractors for oral medical procedures.

[0019] Tongue Retractors

[0020] As shown in FIG. 1, the tongue retractor 10 includes two, flattened, planar members 14, 18, extending from a vertex 12 to form a V. The members 14, 18 extend from the vertex 12 at a predetermined angle so as to provide upward retraction of the tongue of a subject when the retractor is placed in the subject's mouth. The retractor 10 includes an elongate opening or slit 16 and/or 20 within at least one of the members 14, 18, wherein the opening is arranged to enable the frenulum of the subject to fit into the slit and to permit an operator to surgically operate on the frenulum while the retractor is placed in the subject's mouth.

[0021] In some embodiments, the opening includes both a slit 16 extending through member 14 and slit 20 extending through member 18, wherein the two slits are located along a central axis of each member, proximate to and connecting at vertex 12.

[0022] In some embodiments, one or both slits extend through about half or more of the length of each of the members. In some embodiments, the width (w) of the slit is about 2 to 10 mm, e.g., 3 to 7 mm, e.g., 3, 4, or 5 mm. In some embodiments, the first and second members can be made of one piece of metal or plastic, and can be folded, e.g., in half, to form the two members on either side of the vertex. The vertex 12 can be a sharp curve to form a V-shape or a somewhat gentler curve to form a U-shape (still maintaining angle ), but the underlying goal is not to manufacture an apex that is sharp enough to cut into the tissue. The slit 16, 20 can be made through both halves of the single piece of metal or plastic when the two halves are folded together, or can be cut or stamped through the one piece before it is folded. Alternatively, the two members 14, 18 can be manufactured separately, and the slit cut into them. Then the two members can be connected, e.g., by soldering or gluing, at vertex 12. As noted above, the vertex should not be made sharp enough to cut into tissue. However, the vertex must also be sufficiently rigid to prevent the two planar members from flexing much with respect to each other, thus maintaining an adequate exposure of the surgical field.

[0023] In different embodiments, the predetermined angle is about 30 to 60 degrees, e.g., about 35 to 55 degrees, 40 to 50 degrees, e.g., 43, 44, 45, 46, or 47 degrees.

[0024] In some embodiments, the tongue retractor further includes an elongate handle member 22 extending for a length (L) from an end portion of member 14 at an angle . The handle member 22 is arranged so that the retractor 10 can be moved and manipulated by the user when holding the handle member. In some embodiments, the handle member 22 comprises an elongate post extending at angle , which can be, for example, a right angle or an oblique angle, relative to the plane of member 14. This angle can be about 80 to 140 degrees, e.g., about 80 to 120 degrees, 90 to 120 degrees, or about 90, 100, 110, or 120 degrees.

[0025] In different embodiments, each of the two flattened planar members 14, 18 are about 20 to 40 mm in length (l), e.g., 25 to 35 m, e.g., 30 mm in length and 15 to 25 mm, e.g., 20 mm in width (W).

[0026] As shown in FIG. 2A, the tongue retractors can be constructed of materials suitable for use in an autoclave, such as certain metals, e.g., stainless steel, titanium, or alloys, e.g., titanium or cobalt alloys. Alternatively, as shown in FIG. 2B, the tongue retractors can also be constructed of plastic, such as polyethers, polyetherimides, polyphenylenes, polyphenylsulfones, nylons, polyphenylsulfones, polycarbonates, and polyesters. These can be self-reinforced, or reinforced with glass fibers or particles or carbon fibers or particles, and can be suitable for disposal after a single use.

[0027] In all embodiments and for both metal and plastic materials, the new tongue retractors can be sterilized using conventional sterilization methods, including autoclaving, gamma radiation, ethylene oxide, boiling, and steam. For metal tongue retractors, they can be sterilized and used repeatedly. The plastic retractors can be initially sterilized, but can then be disposed of after a single use.

[0028] Methods of Use of the Tongue Retractors

[0029] This disclosure also provides new methods for surgically operating on the frenulum of a subject. In general, the methods include placing a tongue retractor as described herein in the mouth of the subject so that the tongue of the subject is retracted upwardly. The tongue retractor further includes an opening or slit within at least one of the members that is arranged so that the frenulum of the subject is exposed. The method includes cutting the frenulum of the subject by way of surgical operation through the opening.

[0030] More specifically, the infant is first swaddled to keep the hands away from the surgical area. An assistant opens the corners of the mouth as wide as possible with his or her fingers. The user then places the vertex of the device into the mouth, keeping the handle above the planar members, in front of the patient's face. The vertex of the planar members is then pushed backwards between the bottom of the tongue and the floor of the mouth, allowing the lingual frenulum to slide into the middle slit. The user continues to push the retractor back fully to the blind end of the mouth where the tongue meets the floor of the mouth, maximizing the exposure and extension of the lingual frenulum. At this point, the user will use a pair of surgical scissors appropriate for the infant size, and cut the frenulum. If an adequate amount of frenulum has been cut, the retractor is removed from mouth, and the infant is returned to the mother to reinitiate breastfeeding. If the frenulum was not adequately cut, the retractor stays in place to allow the user to continue cutting as needed.

[0031] The following example does not limit the scope of the claims.

Example

[0032] The new tongue retractors have been used experimentally in 34 newborn patients (e.g., on average they are 2 to 3 days old). The new retractors fit well into the mouth of all of these patients, and also properly exposed the frenulum in all of these patients. The stability and protection of the mouth was assessed by the users on a scale of 1 to 5 (with 5 being the best) and the overall assessment for the 34 cases was 4.97. There were no complications in any of the patients.

Other Embodiments

[0033] It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.