Umbilical Splint

Abstract

A use of an umbilical splint for shaping an umbilicus after an abdominal operation is described. The umbilical splint may comprise an insertion portion extending in a longitudinal direction and terminating at an insertion end for insertion into the umbilicus. Furthermore, the insertion portion may comprise a bulbous section near the insertion end. The bulbous section may be operable to apply pressure to a tissue of the umbilicus after the abdominal operation. The insertion portion may have different cross-sectional shapes including circular and oval. Finally, the insertion portion may be configured to engage the umbilicus such that the umbilical splint is retained within the umbilicus.

Claims

1-23. (canceled)

24. An umbilical splint adapted to shape an umbilicus by applying pressure to a tissue of the umbilicus, the umbilical splint comprising: an insertion portion extending in a longitudinal direction and terminating at an insertion end for insertion into an umbilicus, and an external flange having a flange diameter coupled to the insertion portion; wherein the insertion portion comprises: a bulbous section having a bulbous circumference and a bulbous diameter; and a retaining section having a retaining circumference less than the bulbous circumference; wherein the bulbous section is disposed between the retaining section and the insertion end, and wherein the retaining section is configured to engage a lip of the umbilicus such that the insertion portion is retained within the umbilicus; wherein the flange diameter extends beyond the bulbous diameter; wherein the flange diameter is at least 1.5 times greater than the bulbous diameter; wherein the external flange comprises: an underside surface facing the insertion end of the insertion portion; and an exterior surface, opposite the underside surface, and wherein the external flange is adapted to extend beyond the umbilical opening over the abdominal tissue surrounding the umbilical opening.

25. The umbilical splint of claim 0 wherein the longitudinal direction of the insertion end is normal to the underside surface of the external flange.

26. The umbilical splint of claim 0, wherein the underside surface of the external flange is substantially planar such that the underside surface is operable to lay against an abdominal surface surrounding the umbilicus.

27. The umbilical splint of claim 0, wherein the exterior surface of the external flange is rounded.

28. The umbilical splint of claim 0, wherein the insertion end is substantially planar.

29. The umbilical splint of claim 0, further comprising a medicament applied to the insertion portion of the umbilical splint.

30. The umbilical splint of claim 0, further comprising a silicone gel sheet applied to the insertion portion of the umbilical splint.

31. The umbilical splint of claim 0, wherein a ratio of the bulbous circumference to the retaining circumference is between 1.0 and 1.4.

32. The umbilical splint of claim 0, wherein the bulbous circumference is substantially ovular in shape.

33. The umbilical splint of claim 0 wherein the external flange is manufactured from a rigid material.

34. The umbilical splint of claim 0, wherein the insertion portion is manufactured out of a rigid material.

35. The umbilical splint of claim 0, wherein the umbilical splint is formed of a single piece.

36. The umbilical splint of claim 35, wherein the umbilical splint is formed of a hard plastic.

37. The umbilical splint of claim 0, wherein the bulbous portion is formed of a material selected from the group consisting of hard plastic, glass, metal, medical ceramic, medical plastic.

38. The umbilical splint of claim 24 wherein the flange diameter is at least 1.75 times greater than the bulbous diameter.

39. The umbilical splint of claim 24 wherein the flange diameter is at least 2.1 times greater than the bulbous diameter.

40. The umbilical splint of claim 24 wherein the flange diameter is at least 2.61 times greater than the bulbous diameter.

41. The umbilical splint of claim 24, wherein the umbilical splint is configured to: be inserted into an umbilicus after an abdominal operation, be retained within the umbilicus using the retaining section, apply pressure to the umbilicus using the bulbous section to shape the umbilicus, and be maintained within the umbilicus until the umbilicus has healed from the operation.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Reference may now be had to the following detailed description taken together with the accompanying drawings in which:

[0024] FIG. 1 shows a side profile view of an umbilical splint in accordance with an embodiment of the present invention;

[0025] FIG. 2A shows a patient with the various parts of the umbilicus in accordance with an embodiment of the present invention;

[0026] FIG. 2B shows a side view of a patient with an umbilical splint inserted into the umbilicus in accordance with an embodiment of the present invention;

[0027] FIG. 3 shows a frontal view of a patient with an umbilical splint inserted into the umbilicus in accordance with an embodiment of the present invention;

[0028] FIG. 4A shows a side profile view of an umbilical splint in accordance with a preferred embodiment of the present invention;

[0029] FIG. 4B shows a side profile view of an umbilical splint in accordance with a second preferred embodiment of the present invention;

[0030] FIG. 4C shows a side profile view of an umbilical splint in accordance with a third preferred embodiment of the present invention;

[0031] FIG. 4D shows a side profile view of an umbilical splint in accordance with a fourth preferred embodiment of the present invention;

[0032] FIG. 5 shows a side profile view of an umbilical splint having an application layer in accordance with an embodiment of the present invention;

[0033] FIG. 6 shows a flow chart of a method for using an umbilical splint in accordance with an embodiment of the present invention;

[0034] FIG. 7A shows a perspective view of an umbilical splint having an ovular insertion portion in accordance with an embodiment of the present invention;

[0035] FIG. 7B shows a top view of the umbilical splint seen in FIG. 7A;

[0036] FIG. 7C shows a front view of the umbilical splint seen in FIG. 7A;

[0037] FIG. 7D shows a side profile view of the umbilical splint seen in FIG. 7A;

[0038] FIG. 8A shows a perspective view of an umbilical splint having an ovular insertion portion in accordance with an embodiment of the present invention;

[0039] FIG. 813 shows a top view of the umbilical splint seen in FIG. 8A;

[0040] FIG. 8C shows a front view of the umbilical splint seen in FIG. 8A; and

[0041] FIG. 8D shows a side profile view of the umbilical splint seen in FIG. 8A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] Referring now to FIG. 1, an umbilical splint 10 is shown in accordance with an embodiment of the present invention. The umbilical splint 10 is configured with an insertion portion 20 terminating at an insertion end 22 and an external flange 40.

[0043] The insertion portion 20 extends in a longitudinal direction LD, shown in dashed lines, for insertion into an umbilicus. The insertion portion 20 includes an insertion end 22, a bulbous section 24 and a retaining section 26. The bulbous section 24 is disposed between the insertion end 22 and the retaining section 26.

[0044] The umbilical splint 10 may also include an external flange 40. The external flange 40 is configured with an external surface 42 and an underside surface 44. The underside surface 44 of the external flange 40 faces the insertion end 22 of the insertion portion 20. The insertion portion 20 and the external flange 40 may be joined at an intersection 28.

[0045] As seen in FIG. 2A, a patient 2 has an umbilicus 3 (i.e. a belly button or navel). As described herein, the umbilicus 3 includes umbilical tissue 4 interior to the umbilical opening 5. The umbilicus 3 is surrounded by abdominal tissue 6 surrounding the umbilical opening 5.

[0046] Furthermore, the umbilical opening 5 may include a lip 7. The lip 7 may consist of abdominal tissue 6, such as for example, the epidermis or skin.

[0047] Referring now to FIG. 2B, the umbilical splint 10 is inserted into the patient 2 by placing the insertion end 22 of the umbilical splint 10 into the umbilicus 3. The bulbous section 24 is operable to apply pressure to the umbilical tissue 4. The shape of the bulbous section 24 is configured to stretch or otherwise provide pressure to the umbilical tissue 4 of the umbilicus 3 to resist the forces of scar contracture. Furthermore, in some embodiments, the insertion portion 20 is designed to engage the umbilicus 3 such that the umbilical splint 10 is retained within umbilicus 3 without additional aid.

[0048] Upon insertion into the umbilicus 3, the retaining section 26 may be configured to be disposed at a level even with the umbilical opening 5. The retaining section 26 may be configured to engage a lip 7 of the umbilicus 3. In some embodiments, the retaining section 26 may interact with the lip 7 at the umbilical opening 5 to keep the umbilical splint 10 within the umbilicus 3.

[0049] In another preferred embodiment, when the insertion portion 20 of the umbilical splint 10 is inserted into the umbilicus 3, the external flange 40 covers the umbilical opening 5. Furthermore, the external flange 40 may extend beyond the umbilical opening 5 over the abdominal tissue 6 surrounding the umbilical opening 5. The underside surface 44 of the external flange 40 may lie against the abdominal tissue 6 surrounding the umbilical opening 5 and may protect the umbilicus 3 from outside moisture and debris. Similarly, if a medicament is used in combination with the umbilical splint 10, the external flange 40 may be operable to contain the medicament within the umbilicus 3.

[0050] Referring now to FIG. 3, a front profile of a patient 2 is shown with an umbilical splint 10 inserted into the umbilicus 3. As illustrated, only the exterior surface 42 of the external flange 40 is visible, once the umbilical splint 10 is inserted into the umbilicus 3.

[0051] To retain the umbilical splint 10 within the umbilicus 3, the umbilical splint 10 is configured to utilize the forces applied to the components of the insertion portion 20 to maintain contact between the umbilical splint 10 and the patient 2. In a preferred use, a force (not shown) is exerted by the umbilical tissue 4 of the patient 2 against the bulbous section 24 of the insertion portion 20 to hold the umbilical splint 10 in place. For example, in some embodiments, enough friction and pressure may be generated by the umbilical tissue 4 against the bulbous section 24 to maintain the insertion portion 20 within the umbilicus 3.

[0052] In another preferred use, a different force (not shown) may be exerted against the retaining section 26 to impede any longitudinal force acting to withdraw or expunge the umbilical splint 10 from the umbilicus 3. For example, the lip 7 of the umbilical opening 5 may exert a force or pressure against the retaining section 26, holding the insertion portion 20 in place within the umbilicus 3. In this manner, the retaining section 26 is configured to aid in positioning the umbilical splint 10 within the umbilicus 3. Furthermore, the combination of pressure and friction from the umbilical tissue 4 and lip 7 acting on the bulbous section 24 and retaining section 26, respectively, may cooperatively retain the umbilical splint 10 within the umbilicus 3 without any external aid.

[0053] In alternate embodiments, additional retaining means may also be utilized. For example, tape or any other adhesive (not shown) may be used to keep the umbilical splint 10 within the umbilicus 3. Furthermore, a bandage or any other wrapping device may be used to wrap the umbilical splint 10 against the abdominal tissue 6 of the patient 2, keeping the umbilical splint 10 in place.

[0054] Referring now to FIG. 4A-FIG. 4D, umbilical splints 10A, 10B, 10C and 10D (hereinafter referred to collectively as umbilical splints 10) are illustrated in different preferred embodiments. As different patients 2 may have differently sized and/or shaped umbilici, the umbilical splint 10 may also be configured for different sizes and/or shapes. Furthermore, a patient 2 may desire a differently shaped umbilicus 3 than another patient 2. Accordingly, the appropriate umbilical splint 10 for a given patient 2 may be dependent on a preferred outcome of what the healed umbilicus 3 should look like. Values may be dependent on the starting size of the umbilicus 3 post-surgery, prior to weight loss or subsequent to pregnancy. Furthermore, the umbilical splint 10 used may be dependent on the desired aesthetic. Other values for the different measurements listed may be used in alternate embodiments. The provided values described in the preferred embodiments should not be construed as limiting.

[0055] Referring briefly to FIG. 1, the umbilical splint 10 includes an insertion portion 20 having a bulbous section 24, a retaining section 26 and an intersection 28 of the insertion portion 20 and the external flange 40. Referring now to FIG. 4A to FIG. 4D in view of FIG. 1, the bulbous section 24 is defined by a bulbous circumference. As the umbilical splint 10A, 10B, 10C, 10D are shown as substantially circular in the preferred embodiments; the bulbous circumference of the bulbous section 24 in the preferred embodiments is defined by a bulbous diameter 30 and equation (1):

Circumference=π×Diameter  (1)

[0056] Similarly, a retaining circumference of the retaining section 26 of the umbilical splint 10A, 10B, 10C, 10D may be defined by a retaining diameter 32 and equation (1). Finally, an opening circumference may be defined by an opening diameter 34 at the intersection 28 of the insertion portion 20 and the external flange 40 and equation (1). The opening circumference may be substantially related to the size of the umbilical opening 5.

[0057] As seen in FIGS. 1 to 5, the bulbous circumference, retaining circumference and opening circumference may lay in one or more planes normal to the longitudinal direction LD. In a preferred embodiment, the bulbous, retaining and opening circumferences are parallel to one another. Furthermore, although the term circumference has been used, it should be understood that the cross-sectional shape of the insertion portion 20 and/or bulbous section 24, retaining section 26 and intersection 28 of the umbilical splint 10 is not limited to a circular shape. In other embodiments, the perimeter or cross-sectional shape may be ovular (as shown in FIGS. 7A to 7D and 8A to 8D, for example) or asymmetric, rather than a circular circumference. Accordingly, the circular cross-section of the insertion portion 20, as illustrated in FIGS. 1 to 5, should not be construed as limiting.

[0058] The insertion portion 20 of the umbilical splint 10 may also be defined by an insertion length 36 in the longitudinal direction LD. This is the length of the umbilical splint 10 that is inserted into the patient 2. Although dependent on a particular patient 2, the insertion length 36 may be closely associated with the other values, shapes and/or sizes of the insertion portion 20 of the different umbilical splints 10.

[0059] The external flange 40 of the umbilical splint 10 may not be patient dependent. The external flange 40 must be large enough to extend beyond the umbilical opening 5; however, the external flange 40 is not inserted into the umbilicus 3 and therefore, the external flange 40 of the umbilical splint 10 may take a standard size and/or shape, as shown in FIG. 4A through FIG. 4D. Similarly, as the exterior surface 42 of the eternal flange 40 is not inserted into the umbilicus 3, it may take on any suitable form to satisfy the aesthetic preference of the patient 2. Different shapes, sizes, patterns, textures and the like, may be used on the external surface 42 of the external flange 40.

[0060] In FIG. 4A-FIG. 4D in view of FIG. 1, the external flange 40 includes a flange circumference, defined by a flange diameter 46, and a flange length 48. As the external flange 40 is not inserted into the umbilicus 3, the external flange in each of FIG. 4A-FIG. 4D is standard with a flange diameter of 21.00 mm and a flange length of 2.71 mm. These values should not be construed as limiting as other values are possible in various embodiments.

[0061] Table 1 provides a listing of the different values for the preferred embodiments of the umbilical splint 10A, 10B, 10C, 10D illustrated in FIG. 4A to FIG. 4D.

TABLE-US-00001 TABLE 1 Measured Values of the Preferred Embodiments Umbilical Umbilical Umbilical Umbilical Splint Splint Splint Splint 10A 10B 10C 10D (in mm) (FIG. 4A) (FIG. 4B) (FIG. 4C) (FIG. 4D) Bulbous Circ.  8.04 π 10.00 π 12.00 π 14.00 π Retainer Circ.  7.22 π  9.21 π 11.91 π 12.69 π Opening Circ. 10.00 π 12.00 π 14.00 π 14.00 π Insertion 8.07 10.00 12.00 12.00 Length Flange Circ. 21.00 π 21.00 π 21.00 π 21.00 π Flange Length 2.71  2.71  2.71  2.71

[0062] In seen in FIG. 4A, the insertion end 22 is substantially planar. A planar insertion end 22 (i.e. a flat bottom) may be desirable for some patients. In other embodiments, as illustrated in FIG. 4B-FIG. 4D, the insertion end 22 may be rounded.

[0063] As also seen in FIG. 4A-FIG. 4D, particular ratios between the bulbous circumference and retaining circumference have been discovered to be particularly advantageous. The ratios may be based upon the bulbous diameter 30 and the retaining diameter 32. Table 2 provides a listing of the bulbous circumference to retaining circumference described in the preferred embodiments illustrated in FIG. 4A-FIG. 4D:

TABLE-US-00002 TABLE 2 Calculating Bulbous Circ. to Retaining Circ. Ratios Bulbous Retaining (in mm) Diameter 30 Diameter 32 Ratio 10A (FIG. 4A)  8.04  7.22 1.11 10B (FIG. 4B) 10.00  9.21 1.09 10C (FIG. 4C) 12.00 11.91 1.01 10D (FIG. 4D) 14.00 12.69 1.10

[0064] Although the above ratios are described with respect to preferred embodiments, it should be understood that additional ratios relating the bulbous circumference to the retaining circumference are also possible. For example, in some embodiments a ratio of 1.2 to 1.4 may be particularly desirable.

[0065] Referring now to FIG. 5, an application layer 50 is applied to the insertion portion 20 of the umbilical splint 10. For example, the application layer 50 may include a medicament or a silicone gel sheet. For example, an antibiotic may be used to reduce the chances of infection. Furthermore, other forms of silicone than silicone gel sheets may be added. The external flange 40 of the umbilical splint 10 is then operable to contain the medicament within the umbilicus 3 when laid securely against the abdominal tissue 6 surrounding the umbilical opening 5.

[0066] If the application layer 50 comprises a silicone gel sheet, the silicone gel sheet is used to reduce the effects of scarring. The inventors have appreciated that the umbilical splint 10 is ideal for providing constant pressure to the umbilical tissue 4. This pressure may also be used to apply silicone against the umbilical tissue 4 of the umbilicus 3 to promote healing and improve the overall cosmesis of the area. When placed on the exterior of the insertion portion 20, the application layer 50 comprising a silicone gel sheet is operable to be pressed up against the walls of the umbilicus 3 for as long as the umbilical splint 10 is retained within the umbilicus 3. As silicone is known to reduce the appearance of scarring, the umbilical splint can combine both pressure and silicone against the umbilical tissue 4 to aid in the healing of the umbilicus 3, for example, after an abdominal operation.

[0067] Although the application layer 50 in FIG. 5 is shown surrounding the entire insertion portion 20, it should be understood that a more localized application layer 50 may also be used. For example, the application layer 50 may surround the insertion end 22 and/or bulbous section 24 only, without extending over the retaining section 26.

[0068] A flow chart illustrating a method 60 of using an umbilical splint 10 is now shown in FIG. 6. In Block 61, the umbilical splint 10 is inserted into an umbilicus 3 after an abdominal operation. As described in reference to FIG. 1, the umbilical splint comprises an insertion portion 20 extending in a longitudinal direction LD and terminating at an insertion end 22.

[0069] Next, in Block 62, the umbilical splint 10 is retained within the umbilicus 3 using a retaining section 26 to engage the umbilicus 3. For example, the retaining section 26 may engage a lip 7 of the umbilical opening 5 to impede any withdrawal or expunging force acting on the umbilical splint 10.

[0070] Once inserted into the umbilicus 3, in Block 63, the umbilical splint 10 applies pressure to the umbilicus 3 using a bulbous section 24 of the insertion portion 20 to shape the umbilicus 3 after the abdominal operation. In a preferred embodiment, as seen in Block 64, the bulbous section 24 of the umbilical splint 10 counteracts scar contracture of the umbilicus 3 by applying pressure to a scar.

[0071] Finally, in Block 65, the umbilical splint 10 is maintained within the umbilicus 3 for a period of time until the umbilicus 3 has healed from the abdominal operation. While lengths will vary by patient 2, different approaches may be used.

[0072] In a preferred embodiment, a patient 2 may use the umbilical splint 10 continuously. The umbilical splint 10 may be removed for personal hygiene purposes such as cleaning the umbilicus 3, applying medication to the umbilicus 3 or scar, applying an application layer 50 to the insertion portion 20 of the umbilical splint 10 and/or washing the umbilical splint 10. Otherwise, the umbilical splint 10 may be retained within the umbilicus 3 until the umbilicus 3 has healed.

[0073] In another preferred embodiment, the patient 2 may use multiple umbilical splints 10 during the healing process. For example, the patient 2 may begin with a first umbilical splint 10 having a relatively small bulbous section 24. The bulbous section 24 is configured with a first bulbous circumference. Subsequently, as the umbilicus 3 of the patient 2 heals, the patient 2 may progress to one or more larger umbilical splints 10 having progressively larger bulbous sections 24 (and corresponding larger bulbous circumferences). In this manner, the umbilical splint 10 will continue to apply pressure to the umbilicus 3 as the umbilicus 3 heals and may allow the umbilical splint 10 to progressively shape the umbilicus 3 after an abdominal operation.

[0074] In other embodiments, the patient 2 may use or begin to use the umbilical splint 10 for repeated brief periods of time. For example, a patient 2 may use the umbilical splint three times a day for 20 minute intervals. In other embodiments, a patient 2 may insert the umbilical splint 2 for longer periods of hours, days or weeks. Furthermore, different regimens may be used to steadily increase the period of time the umbilical splint 10 is worn by the patient 2. The patient 2 may continue to use the umbilical splint 10 until the umbilicus 3 has healed from the abdominal operation or the chance of scar contracture is reduced or no longer present.

[0075] Although the insertion portion 20 of the umbilical splint 10 has been illustrated in FIGS. 1 to 5 as being round such that its bulbous circumference and retaining circumference have a substantially circular cross-section, it should be understood that other shapes, sizes and perimeters for the insertion portion 20 are possible. For example, as illustrated in FIGS. 7A to 7D and FIGS. 8A to 8D, the insertion portion 20 of umbilical splint 10 is shaped such that its bulbous circumference and retaining circumference are substantially ovular or non-circular, with different major and minor axes.

[0076] In some embodiments, the inventors have appreciated that bulbous and retaining circumferences having an oval or ovular shape are better retained within the umbilicus 3 compared to circular bulbous, retaining and/or opening circumferences. Furthermore, an ovular insertion portion 20 may result in a more pleasing umbilicus 3, once the umbilicus 3 has healed.

[0077] In other embodiments, the bulbous, retaining and/or opening circumferences may be asymmetric and/or different shapes from each other. For example, in one embodiment, the bulbous circumference may be an asymmetric shape, or even free-form, and the retaining circumference may be ovular. It should be understood that other shapes and configurations for the insertion portion 20 are possible and that the bulbous circumference, retaining circumference and opening circumference are not limited to the shapes described herein.

[0078] Referring now to FIGS. 7A to 7D, an umbilical splint 10E having an insertion portion 20 with an ovular opening circumference or cross-section is shown. Many features of umbilical splint 10 are similar to those previously described, such as the flange length 48 and insertion length 36. In FIG. 7B, a top view of the umbilical splint 10E illustrates a circular external flange 40. However, as previously mentioned, other shapes for the external flange 40 are also possible.

[0079] Referring to FIG. 7A, the umbilical splint 10E having an ovular insertion portion 20 is configured with an ovular bulbous circumference and an ovular opening circumference. As seen in FIG. 7C and FIG. 7D in front and side profile view, with the major axes (+) larger than the minor axes (−), such that each of the bulbous diameters 30E+, 30E− and opening diameters 34E+, 34E− are different from front-to-back and side-to-side. As shown in FIG. 7C, a front view of the umbilical splint 10E is shown with a major bulbous diameter 30E+ and a major opening diameter 34E+. In comparison to the side profile view in FIG. 7D, the major bulbous diameter 30E+ and the major opening diameter 34E+, seen in FIG. 7C, are larger than the minor bulbous diameter 30E− and the minor opening diameter 34E−, respectively. Such an ovular insertion portion 20 may provide a better distribution of pressure to the umbilical tissue 4 when placed inside the umbilicus 3. Furthermore, the shape may allow the umbilical splint IGE to stay retained within the umbilicus 3 unaided. Different shapes may also provide improved comfort for patients 2 than insertion portions 20 having circular or ovular shapes.

[0080] A similar relationship can be seen in the umbilical splint 10F shown in FIGS. 8A to 8D. The major bulbous diameter 30F+, seen in front view in FIG. 8C, is larger than the minor bulbous diameter 30F−, seen in side profile view in FIG. 8D. Similarly, the major opening diameter 34F+, seen in front view in FIG. 8C, is larger than the minor opening diameter 34F−, seen in side profile view in FIG. 8D. A similar relationship may exist with the retaining circumference having different side-to-side and front-to-back retaining diameters (not shown).

[0081] Finally, it should be understood that while the umbilical splints 10 and 10A to 10F have been described with respect to specific shapes, other shapes are also possible. Furthermore, the umbilical splints 10 and 10A to 10F, as described herein, may be constructed in different sizes for different sized patients 2, from infants and small children to adults.

[0082] Although this disclosure has described and illustrated certain preferred embodiments of the invention, it is also to be understood that the invention is not restricted to these particular embodiments rather, the invention includes all embodiments which are functional, or mechanical equivalents of the specific embodiments and features that have been described and illustrated herein. Similarly, the scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.

[0083] It will be understood that, although various features of the invention have been described with respect to one or another of the embodiments of the invention, the various features and embodiments of the invention may be combined or used in conjunction with other features and embodiments of the invention as described and illustrated herein.