U.S. patent application number 13/374669 was filed with the patent office on 2013-07-11 for umbilical splint and method of use.
The applicant listed for this patent is Kimberley Meathrel, Roula Vekios. Invention is credited to Kimberley Meathrel, Roula Vekios.
Application Number | 20130178873 13/374669 |
Document ID | / |
Family ID | 48744422 |
Filed Date | 2013-07-11 |
United States Patent
Application |
20130178873 |
Kind Code |
A1 |
Vekios; Roula ; et
al. |
July 11, 2013 |
Umbilical splint and method of use
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.
Inventors: |
Vekios; Roula; (Kingston,
CA) ; Meathrel; Kimberley; (Wolfe Island,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Vekios; Roula
Meathrel; Kimberley |
Kingston
Wolfe Island |
|
CA
CA |
|
|
Family ID: |
48744422 |
Appl. No.: |
13/374669 |
Filed: |
January 6, 2012 |
Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 2017/00637
20130101; A61B 17/08 20130101; A61F 5/30 20130101; A61B 17/0057
20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. Use of an umbilical splint for shaping an umbilicus after an
abdominal operation, the umbilical splint comprising: an insertion
portion extending in a longitudinal direction and terminating at an
insertion end for insertion into the umbilicus; wherein the
insertion portion comprises a bulbous section near the insertion
end, wherein the bulbous section is operable to apply pressure to a
tissue of the umbilicus after the abdominal operation, and wherein
the insertion portion is configured to engage the umbilicus such
that the umbilical splint is retained within the umbilicus.
2. The use of the umbilical splint as in claim 1, wherein the
insertion portion is used to counteract scar contracture of the
umbilicus by applying pressure to a scar.
3. The use of the umbilical splint as in claim 1, wherein the
bulbous section has a bulbous circumference and the insertion
portion further comprises: a retaining section having a retaining
circumference, wherein the bulbous section is between the retaining
section and the insertion end, and wherein the retaining
circumference is less than the bulbous circumference.
4. The use of the umbilical splint as in claim 3, wherein a ratio
of the bulbous circumference to the retaining circumference is
between 1.0 and 1.4.
5. The use of the umbilical splint as in claim 3, wherein the
bulbous circumference is substantially ovular in shape.
6. The use of the umbilical splint as in claim 3, wherein the
retaining section is configured to engage a lip of the
umbilicus.
7. The use of the umbilical splint as in claim 3, wherein the
umbilical splint further comprises an external flange coupled to
the insertion portion, the external flange comprising: an underside
surface facing the insertion end of the insertion portion, and an
exterior surface, opposite the underside surface.
8. The use of the umbilical splint as in claim 7, wherein the
underside surface faces towards the insertion end for contacting an
abdominal tissue surrounding the umbilicus.
9. The use of the umbilical splint as in claim 8, wherein the
longitudinal direction of the insertion end is normal to the
underside surface of the external flange; and wherein the underside
surface of the external flange lays against the abdominal tissue
surrounding the umbilicus and the external flange extends beyond an
opening of the umbilicus.
10. The use of the umbilical splint as in claim 1, wherein the
umbilical splint further comprises a medicament applied to the
insertion portion.
11. The use of the umbilical splint as in claim 1, wherein the
umbilical splint further comprises a silicone gel sheet applied to
the insertion portion.
12. An umbilical splint comprising: an insertion portion extending
in a longitudinal direction and terminating at a insertion end for
insertion into an umbilicus, the insertion portion comprising: a
bulbous section having a bulbous circumference, the bulbous section
near the insertion end; 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 an external flange coupled to the insertion
portion, the external flange comprising: an underside surface
facing the insertion end of the insertion portion, and an exterior
surface, opposite the underside surface.
13. The umbilical splint of claim 12, wherein the insertion portion
enables the umbilical splint to shape the umbilicus by applying
pressure to a tissue of the umbilicus after an abdominal
operation.
14. The umbilical splint of claim 12, wherein the retaining section
is configured to engage a lip of the umbilicus such that the
insertion portion is retained within the umbilicus.
15. The umbilical splint of claim 12, wherein the longitudinal
direction of the insertion end is normal to the underside surface
of the external flange.
16. The umbilical splint of claim 12, 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.
17. The umbilical splint of claim 12, wherein the insertion end is
substantially planar.
18. The umbilical splint of claim 12, further comprising a
medicament applied to the insertion portion of the umbilical
splint.
19. The umbilical splint of claim 12, further comprising a silicone
gel sheet applied to the insertion portion of the umbilical
splint.
20. The umbilical splint of claim 12, wherein a ratio of the
bulbous circumference to the retaining circumference is between 1.0
and 1.4.
21. The umbilical splint of claim 12, wherein the bulbous
circumference is substantially ovular in shape.
22. A method of post-operative care comprising: inserting an
umbilical splint into an umbilicus after an abdominal operation,
the umbilical splint comprising an insertion portion extending in a
longitudinal direction and terminating at an insertion end;
retaining the umbilical splint within the umbilicus using a
retaining section of the insertion portion to engage the umbilicus;
applying pressure to the umbilicus using a bulbous section of the
insertion portion to shape the umbilicus after the abdominal
operation; and maintaining the umbilical splint within the
umbilicus for a period of time until the umbilicus has healed from
the abdominal operation.
23. The method of post-operative care as claimed in claim 22,
wherein the umbilical splint is used to counteract scar contracture
of the umbilicus by applying pressure to a scar.
Description
FIELD OF THE INVENTION
[0001] This invention relates to an umbilical splint, and more
particularly towards an umbilical splint for post-operative care
and methods of use.
BACKGROUND OF THE INVENTION
[0002] During certain types of abdominal surgery, incisions are
made in the umbilicus or the surrounding umbilical (belly button)
region. Examples of such procedures include abdominoplasty (i.e.
tummy tuck), panniculectomy, Transverse Rectus Abdominis
Myocutaneous (TRAM) flap procedures, endoscopic surgeries, and the
like. Circumferential umbilical incisions can lead to contracture
and closure of the umbilicus or umbilical opening due to the
physiological forces of scar contracture. This can lead to
deformities of the umbilicus, as well as infections.
[0003] Deformity of the umbilicus can also occur after pregnancy,
especially if a caesarean section is required, and after weight
loss.
[0004] Current products used to counteract the forces of scar
contracture following umbilical or other abdominal surgery include
using a marble or a foam earplug. However, marbles are difficult to
keep in place and may be difficult to ensure sterility.
Furthermore, foam earplugs are not stiff enough to counteract the
forces of scar contracture and can lead to infection due to its
porous nature.
[0005] Accordingly, there is a need for a device and method to
counteract the forces of scar contracture within the umbilicus and
to reduce the risk of infection after abdominal surgery.
SUMMARY OF THE INVENTION
[0006] Accordingly, it is an object of this invention to at least
partially overcome some of the disadvantages of the prior art.
[0007] The present invention is directed to an umbilical splint for
post-operative care. For example, the umbilical splint may be used
post-abdominoplasty or after other cosmetic procedures. Similarly,
the umbilical splint may be used after an endoscopic, abdominal or
laparoscopic surgery or after a hernia repair. The umbilical splint
may also be used as a paediatric device, such as, for example, for
children recovering from congenital abdominal repair. In some
instances, the umbilical splint may also be used to transform a
protruding umbilicus (i.e. "an outie") into a depression (i.e. "an
innie"). In general, the present invention may be used to avoid
stenosis of the belly button. Other uses within the umbilicus may
also be possible.
[0008] The umbilical splint is designed to be inserted into the
umbilicus at the time of surgery to counteract the forces of scar
contracture. In this way, in at least one embodiment, the umbilical
splint may be configured to decrease stenosis of the umbilicus
following surgery. The umbilical splint may be configured to
prevent cosmetic deformities and late infections at the site. In
post-partum women, the splint may be inserted immediately
post-partum to help shape the umbilicus during retraction of the
distended pregnant abdomen. Once inserted, the umbilical splint may
be worn periodically or continuously, except for personal hygiene
purposes, to aid in the healing process. In some embodiments, the
umbilical splint may be maintained within the umbilicus for a
pre-determined period of time.
[0009] The shape of the umbilical splint is designed to promote the
healing of the umbilicus and to reduce scarring by applying
constant pressure to the entire umbilical region. In surgical
patients where a scar is present, a silicone gel sheet may be
applied to the splint following suture removal to improve the
overall cosmesis (i.e. physical appearance) of the scar. Past
research has shown that application of silicone to scars, as well
as the application of pressure, improves the overall cosmesis of
the mature scar.
[0010] The umbilical splint may be configured to have several
advantages, such as, resist the forces of scar contracture to
maintain an aesthetically pleasing shape and size of the umbilicus,
apply pressure to the surrounding scar tissue, and apply silicone
gel sheeting in combination with the applied pressure to promote
healing. Furthermore, a slow-release antibiotic covering or
medicament may be used to decrease the chances of wound
infection.
[0011] The overall form of the umbilical splint is designed both to
improve the shape of the umbilicus and to retain the splint within
the umbilicus. Accordingly, the umbilical splint may be configured
with a bulbous section with a pre-determined shape. The bottom
bulbous portion may be manufactured out of hard plastic. However,
it should be understood that other materials may be used, such as
glass, metal, medical ceramic, silicone, medical plastics,
minerals, and the like. Furthermore, in some embodiments, the
umbilical splint may have a rigid core surrounded by a softer more
flexible outer material for improved comfort. For example, the
outer material may be a soft, flexible plastic or an alternative
material such as medical grade silicone, and the like.
[0012] The bulbous section may be configured to provide an
idealized shape for the umbilicus to conform to. Furthermore, the
bulbous section may stretch or otherwise provide pressure to the
umbilicus to resist the forces of scar contracture. In some
embodiments, the shape of the bulbous section may be symmetric. A
symmetric bulbous section may provide even, constant pressure to
the umbilical tissue. Furthermore, in some embodiments, the
cross-section of the bulbous section or the entire insertion
portion may be selected for aesthetic purposes and may be symmetric
or asymmetric. The cross-sectional shape of the bulbous section
provided in the preferred embodiments should not be construed as
limiting.
[0013] To retain the umbilical splint within the umbilicus, the
umbilical splint may have a retaining section located adjacent the
bulbous section. The retaining section and the bulbous section may
form the insertion portion of the umbilical splint. The bulbous
section of the insertion portion may be between an insertion end of
the insertion portion and the retaining section.
[0014] The retaining section may be configured to engage the
umbilicus so as to retain the umbilical splint within the
umbilicus. For example, the retainment section may engage an
umbilical lip of the umbilicus near the umbilical opening, with the
bulbous section being inserted further into the umbilicus to apply
pressure to the tissue inside the umbilicus.
[0015] The shape of the bulbous section may also help to retain the
umbilical splint within the umbilicus. In some embodiments, a
bulbous section with an asymmetric shape may be better at being
retained within the umbilicus or may provide an advantageous
distribution of pressure to the surrounding tissue. Finally, in
some embodiments, an adhesive may be used or a further mechanism,
such as a tape or a bandage, may be placed over the umbilical
splint and against the abdominal wall in order to retain the
umbilical splint within the umbilicus.
[0016] In some embodiments, the umbilical splint may have an
external flange for covering the umbilical opening, protecting
against dust and pathogens entering the umbilical opening. The
external flange may also apply direct pressure to the external
circumferential umbilical scar. In this manner, the external flange
may reduce the formation and/or the appearance of scars.
Furthermore, the external flange may help retain any medicament
placed inside the umbilicus prior to the insertion of the umbilical
splint.
[0017] The external flange may be manufactured out of a rigid
material; for example, the same hard plastic as the rest of the
umbilical splint. In such embodiments, the umbilical splint may be
formed as a single piece. Alternatively, the protective lip may be
manufactured out of a softer plastic or a flexible material. A
flexible external flange may be operable to bend and move with the
abdominal wall when inserted into the umbilical cavity.
[0018] In one aspect, the present invention resides in a use of an
umbilical splint for shaping an umbilicus after an abdominal
operation. 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. Finally, the
insertion portion may be configured to engage the umbilicus such
that the umbilical splint is retained within the umbilicus.
[0019] In another aspect, the present invention resides in an
umbilical splint. The umbilical splint may include an insertion
portion extending in a longitudinal direction and terminating at a
insertion end for insertion into an umbilicus. The insertion
portion may include a bulbous section having a bulbous
circumference, the bulbous section near the insertion end; a
retaining section having a retaining circumference less than the
bulbous circumference; and an external flange coupled to the
insertion portion. The bulbous section may be disposed between the
retaining section and the insertion end. The external flange may
include an underside surface facing the insertion end of the
insertion portion, and an exterior surface, opposite the underside
surface. In a preferred embodiment, a ratio of the bulbous
circumference to the retaining circumference may be between 1.0 and
1.4. In a more preferred embodiment, the ratio of the bulbous
circumference to the retaining circumference may be between 1.1 and
1.2.
[0020] In yet another aspect, the present invention resides in a
method of post-operative care. The method may include inserting an
umbilical splint into an umbilicus after an abdominal operation,
the umbilical splint comprising an insertion portion extending in a
longitudinal direction and terminating at an insertion end;
retaining the umbilical splint within the umbilicus using a
retaining section of the insertion portion to engage the umbilicus;
applying pressure to the umbilicus using a bulbous section of the
insertion portion to shape the umbilicus after the abdominal
operation; and maintaining the umbilical splint within the
umbilicus for a period of time until the umbilicus has healed from
the abdominal operation.
[0021] Further and other features of the invention will be apparent
to those skilled in the art from the following detailed description
of the embodiments thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Reference may now be had to the following detailed
description taken together with the accompanying drawings in
which:
[0023] FIG. 1 shows a side profile view of an umbilical splint in
accordance with an embodiment of the present invention;
[0024] FIG. 2A shows a patient with the various parts of the
umbilicus in accordance with an embodiment of the present
invention;
[0025] 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;
[0026] 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;
[0027] FIG. 4A shows a side profile view of an umbilical splint in
accordance with a preferred embodiment of the present
invention;
[0028] FIG. 4B shows a side profile view of an umbilical splint in
accordance with a second preferred embodiment of the present
invention;
[0029] FIG. 4C shows a side profile view of an umbilical splint in
accordance with a third preferred embodiment of the present
invention;
[0030] FIG. 4D shows a side profile view of an umbilical splint in
accordance with a fourth preferred embodiment of the present
invention;
[0031] FIG. 5 shows a side profile view of an umbilical splint
having an application layer in accordance with an embodiment of the
present invention;
[0032] FIG. 6 shows a flow chart of a method for using an umbilical
splint in accordance with an embodiment of the present
invention;
[0033] FIG. 7A shows a perspective view of an umbilical splint
having an ovular insertion portion in accordance with an embodiment
of the present invention;
[0034] FIG. 7B shows a top view of the umbilical splint seen in
FIG. 7A;
[0035] FIG. 7C shows a front view of the umbilical splint seen in
FIG. 7A;
[0036] FIG. 7D shows a side profile view of the umbilical splint
seen in FIG. 7A;
[0037] FIG. 8A shows a perspective view of an umbilical splint
having an ovular insertion portion in accordance with an embodiment
of the present invention;
[0038] FIG. 8B shows a top view of the umbilical splint seen in
FIG. 8A;
[0039] FIG. 8C shows a front view of the umbilical splint seen in
FIG. 8A; and
[0040] FIG. 8D shows a side profile view of the umbilical splint
seen in FIG. 8A.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0041] 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.
[0042] 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.
[0043] 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.
[0044] 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. 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.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] 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.
[0049] 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.
[0050] 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.
[0051] 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.
[0052] 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.
[0053] 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=.pi..times.Diameter (1)
[0054] 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.
[0055] 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.
[0056] 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.
[0057] 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.
[0058] 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.
[0059] 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 Splint Splint Umbilical Umbilical 10A 10B
Splint Splint (in mm) (FIG. 4A) (FIG. 4B) 10C (FIG. 4C) 10D (FIG.
4D) Bulbous Circ. 8.04 .pi. 10.00 .pi. 12.00 .pi. 14.00 .pi.
Retainer Circ. 7.22 .pi. 9.21 .pi. 11.91 .pi. 12.69 .pi. Opening
Circ. 10.00 .pi. 12.00 .pi. 14.00 .pi. 14.00 .pi. Insertion 8.07
10.00 12.00 12.00 Length Flange Circ. 21.00 .pi. 21.00 .pi. 21.00
.pi. 21.00 .pi. Flange Length 2.71 2.71 2.71 2.71
[0060] In seen in FIG. 4A, the insertion end 22 is substantially
planar. A planar insertion end 22 (i.e. a flat bottom) maybe
desirable for some patients. In other embodiments, as illustrated
in FIG. 4B-FIG. 4D, the insertion end 22 may be rounded.
[0061] 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
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] 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.
[0070] 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.
[0071] 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.
[0072] 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.
[0073] 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.
[0074] 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.
[0075] 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.
[0076] 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.
[0077] 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 10E 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.
[0078] 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
30E-, 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).
[0079] 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.
[0080] 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.
[0081] 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.
* * * * *