Nasal splint device

A nasal splint device for retaining a traumatized nose after surgery or injury, and method of applying the nasal splint. A flexible inner splint portion adapted for direct application to nasal skin includes a planar sheet of semi-rigid polymer material having opposing lateral portions and a central bridge portion defined by a pair of substantially parallel outer surface grooves for articulation of the inner splint portion and having elongated cutouts defining a lower dorsal portion of the central bridge portion and lateral portions. A compressible polymeric foam inner layer is attached to the inner sheet material and coextensive with the lateral portions and bridge portion, with a pair of inner foam recesses substantially coextensive with the parallel outer surface grooves. A tacky layer of medical-grade adhesive overlies the inner surface of the foam for direct application to the nasal skin. The flexible inner splint portion, foam layer and tacky adhesive layer form an integral splint member adaptable to individual nasal application by trimming to fit. A compound splint is formed by joining the inner splint portion with a splint stabilizer member includes a thin sheet of malleable metal with a matching stabilizer bridge portion and lateral wing portions forming a T-shape. The stabilizer bridge portion is sufficiently large to overlie a major part of the lower dorsal portion of the lower dorsal portion of the central bridge portion of the integral splint member. Adhesive or another attachment source is provided for attaching the stabilizer bridge portion adjacent the lateral wing portions of the splint stabilizer member to the inner splint portion between the outer grooves along the central bridge portion.

BACKGROUND OF THE INVENTION 
This invention relates to splint devices adapted for use during healing of 
the human nose. In particular, it relates to a novel compound nasal splint 
or surgical brace device useful for retaining a traumatized nose after 
surgery or injury. 
Treatment of trauma or cosmetic corrective surgery are commonly employed 
medical procedures. Following surgical correction of external nasal 
deformities, there is a need to stabilize the external nasal framework 
until adequate healing has taken place. During the healing period a 
desired size and shape should be maintained to control edema and to assure 
symmetry of the healed proboscis member. Numerous attempts have been made 
to provide suitable casts, adhesive bandages and nasal splints for the 
purpose of maintaining immobility of bony segments following surgery. Many 
of these are difficult to fabricate, to apply to the traumatized area or 
to retain in position. Presently available nasal splints include the Conco 
"Alumafoam" product, which comprises a malleable metal outer sheath lined 
with resilient foam. Other splint devices are described by Shippert in 
U.S. Pat. Nos. 4,153,051; 4,313,452; and 4,274,402; incorporated by 
reference. The "Denver Splint" is a compound device requiring careful 
application of a series of adhesive strips as a base layer, a dorsum 
center pad, an intermediate Velcro loop segment layer, and a formed outer 
restraining member attached by opposing Velcro hook means. 
It is an object of the present invention to provide an articulated nasal 
splint with simple one-step application. It is another object to permit 
direct application of a splint to nasal skin without preliminary taping. A 
further object is to provide essentially uniform pressure to the 
traumatized nose, with symmetrical nasal compression and shaping forces 
with controlled, variable narrowing of the nose. Another object is to 
provide a comfortable device with cushioned, light-weight materials and 
resilient design, allowing for expansion/contraction with nasal edema or 
swelling. 
SUMMARY OF THE INVENTION 
A novel compound post-operative nasal splint has been devised comprising: a 
first flexible integral inner splint member adapted for direct application 
to nasal skin, including a thin, resilient polymer sheet having opposing 
lateral portions and a central bridge portion defined by a pair of spaced 
bendable hinge lines permitting articulation of the inner splint portion 
and having elongated cutouts defining a lower dorsal portion of the 
central bridge portion and lateral portions; a compressible polymeric foam 
inner layer bonded to the resilient sheet extending under the lateral 
portions and bridge portion and being recessed toward the resilient sheet 
opposite said hinge lines, thereby preventing bunching of the foam layer 
during articulation; and a tacky layer of medical-grade pressure adhesive 
applied to said foam layer for direct application to the nasal skin 
following removal of temporary protective stripping; said flexible inner 
splint member being shearable for trimming to fit. 
The compound splint also comprises a separate second splint stabilizer 
member comprising a thin sheet of malleable metal for manual molding in 
situ over the inner splint member, said outer splint stabilizer having a 
preformed stabilizer bridge portion sufficiently large to overlie a major 
part of the lower dorsal portion of the central bridge portion of the 
integral splint member and having lateral wing portions. The stabilizer 
may be attached to the inner splint portion by various means, preferably 
joining the compound splint before application to the nose. In one 
embodiment the entire stabilizer bridge portion adjacent the lateral wing 
portions is provided with adhesive means for attaching the splint 
stabilizer member between the hinge lines to the central bridge portion 
following nasal application of the flexible inner splint portion.

DESCRIPTION OF PREFERRED EMBODIMENTS 
In the following description, primary emphasis is placed on surgical 
correction of external nasal deformities, as in cosmetic plastic surgery. 
In FIGS. 1A, 1B and 2, the nasal splint device is shown in its production 
form prior to articulation or bending of the first composite splint member 
10 for retaining a traumatized nose after surgery or injury. The flexible 
inner splint portion 10 includes a planar sheet main structural component 
12 of semi-rigid polymer material having opposing lateral portions 14R, 
14L and a central bridge portion 16 defined by a pair of substantially 
parallel outer surface grooves 18R, 18L for articulation. The inner splint 
portion also has elongated cutouts 19 defining a lower dorsal portion 16D 
of the central bridge portion and lateral portions 14. A compressible 
polymeric foam inner layer 20 is bonded or otherwise suitably attached to 
the inner planar sheet 1 and coextensive with the lateral portions and 
bridge portion, with a pair of inner foam recesses 22R, 22L substantially 
coextensive with the outer grooves 18R, 18L. A tacky layer 24 of 
medical-grade adhesive is applied overlying the inner surface of the foam 
sections 20B, 20R, 20L for direct application to the nasal skin. The 
flexible inner splint portion, foam layer and tacky adhesive layer forming 
an integral splint member adaptable to individual nasal application by 
trimming to fit the individual patient. The composite member 10 can be 
supplied with stripping paper or other non-adherent layer (not shown) for 
articulation of the first splint composite member over the post-surgical 
nose before removing the stripping layer for direct application to nasal 
skin, in a manner to be described. 
The splint stabilizer second member 30 comprises a thin sheet 32 of 
malleable metal with a matching stabilizer bridge portion 34 and lateral 
wing portions 36R, 36L forming a T-shape, wherein the stabilizer bridge 
dorsal extension portion 34 is sufficiently large to overlie a major part 
of the distal dorsal strut or lower portion 16D of the central bridge 16 
of the integral splint member 10. In order to attach the second splint 
stabilizer member to form the compound splint, at least the upper 
stabilizer bridge portion 34A adjacent the lateral wing portions 36 has a 
patch of foam padded tacky adhesive 38 for attachment to the splint 
stabilizer member 10 between the outer grooves along at least an upper 
part of the central bridge portion 16 after articulation of the flexible 
inner splint portion during application. In order to assure adequate 
adhesion during use, the adhesive may be applied along the entire length 
of the splint stabilizer bridge portion, either by initial bonding to the 
splint stabilizer or to the inner splint surface opposite the point of 
attachment. The particular means for attaching the stabilizer unit 30 to 
the inner splint unit 10 is not a critical aspect of the invention. For 
instance, a quick-setting cement can be used, alone or in combination with 
other fasteners or adhesives. It is preferred to preassemble the compound 
splint members by firmly adhering the stabilizer member to the inner 
splint bridge prior to application of the compound assembly to the nose. 
The compound splint can be readily removed without patient discomfort. 
This is achieved by employing solvent-softenable medical grade adhesive. 
Foam adhesive attachment unit 38 permits a secure, water resistant seal 
during the healing period; however, the surgeon can daub a small amount of 
acetone or the like onto the interior adhesive 38 to remove the compound 
splint stepwise. 
The nasal splint device is preferably configured with the splint stabilizer 
member lateral wing portions 36R, 36L extending laterally from the upper 
bridge portion of the nose toward side edges of the inner splint portion 
to provide essentially uniform pressure across areas 14R, 14L over the 
post-surgical nose with symmetrical nasal compression being thereby 
obtained. The inner splint member may have a substantially trapezoidal 
peripheral shape. Preferably, the semi-rigid polymer material of the inner 
splint portion is formed of a thermoplastic inert polymer having 
sufficient elasticity to permit controlled expansion and contraction for 
nasal edema or swelling. 
The compressible polymeric foam inner layer comprises soft closed cell 
"Volara" polyethylene having a thickness of about 1-4 mm (e.g., 1/16-1/8 
inch). The preferred material for the malleable metal is a thin annealed 
aluminum sheet (e.g., 0.5mm thick type 6061-TO). The tacky layer usually 
consists essentially of dermatologically acceptable adhesive and is 
protected by peelable temporary stripping material during shipment and 
pre-application articulation. 
A representative splint size has the following typical approximate 
dimensions relative to a cephalad (top splint edge) length of about 30 
millimeters: Inner splint trapazoidal periphery--about 150 mm; bridge 
width--8 mm; top and side edges--32 mm; cutouts--15.times.3 mm; flare 
angle 15-20 degrees each side; splint stabilizer top edge--28 mm; wing 
height--15 mm; dorsal strut length--12 mm; bridge width--9mm; overall 
width--38 mm; foam/adhesive attachment pad--8.times.12 mm. These relative 
dimensions provide for the dorsal strut extending over a major part of the 
underlying portion of the inner splint, while permiting the dorsal 
extremity to extend caudally for enhancing supratip depression of the 
nose. 
FIG. 3 is an enlarged view of the compound splint in the depicting one-step 
application of a pre-assembled splint to a post-surgical nose 40. Inner 
splint bridge portion 20B is pressed onto the front of the nose 40 and 
held by adhesive layer 24. The bridge portions of the splint 16, 34 are 
joined by adhesive foam layer 38, extending along substantially the entire 
length of bridge member 34. The inner splint later portion 14R is bent 
along recessed hinge line 18R, and pressed inwardly to adhere the lateral 
foam layer to the nasal skin via adhesive 24. After fixing the resilient 
inner splint member in place on the nose, the lateral wing member 36R and 
other portions of malleable metal sheet member 34 are pressed inwardly, as 
indicated by the reversible arrow to provide a splint stabilizing force 
against the resilient inner splint member 12. This bending action can be 
reversed during post-healing removal of the compound splint to retract the 
metal wings from the inner splint for manipulation thereof. 
The surgical method for treating a post-surgical or traumatized human nose 
by application of a post-operative nasal splint includes the sequential 
steps of: a) expressing edema from the traumatized nose and cleaning the 
nasal skin preparatory to receiving direct adhesive contact; b) trim 
fitting and manually molding the flexible integral inner splint member, 
optionally before or after the surgical procedure, as described; c) 
attaching the splint stabilizer member over the inner splint member, 
whereby the splint stabilizer overlies a major part of the lower dorsal 
portion of the lower dorsal portion of the central bridge portion of the 
integral splint member; d) exposing a tacky layer of medical grade 
pressure adhesive applied to the foam layer; and e) directly applying the 
flexible integral inner splint member to the nasal skin following removal 
of temporary protective stripping, with initial contact being made with 
the dorsal aspect of the nose and the composite inner splint then being 
folded over the sides of the nose. The above sequence can be altered to 
join the stabilizer to the inner splint member after separate application 
of the inner splint member. Usually, the splint stabilizer is 
compressively molded manually to conform to the inner splint surface by 
pinching and bending the malleable metal to obtain the desired degree of 
narrowing and controlled nasal width. The distal dorsal strut portion 16D 
of the inner splint can be displaced inwardly by bending the partially 
overlying lower (caudal) portion 34 of the stabilizer, resulting in a 
spring-like action which assists in modeling the supratip region of the 
nose during healing. 
The invention has a number of advantages and features which can be realized 
by employing a relatively few basic manufactured sizes which can be 
trimmed to fit children and adult nasal structures of different size 
ranges. The device accommodates various nasal shapes, due to its 
articulated design. By employing the composite inner splint, a simple 
one-step application follows a trial fitting (with adhesive protected by 
the pull-off layer) and trimming with ordinary surgical scissors. The flat 
inner splint design permits custom "tailoring" of the plastic composite 
and provides a wide range of adaptability of a single size. Direct 
application of the inner splint member to nasal skin using medical grade 
tacky adhesive eliminates preliminary taping of the nose. 
It is understood that the application techniques can be employed with 
strips of medical grade adhesive tape (e.g.--"Steri-strip") to achieve 
"fine-tuning" and modeling of the nasal tip. For instance, horizontally 
strapping a thin piece of adhesive tape across the base or columella of 
the nose to the side members of lateral portions of the inner splint 
narrowing to produce a desirable tip effect. This technique elevates the 
nasal tip against the distal-most (caudal) part of the inner splint member 
dorsal strut. The elasticity of the lateral portions of the inner splint 
member further enhances the ability of the lower, inferior (or more 
caudal) aspect of the nose to expand by swelling, with greatly diminished 
incidence of pressure damage to the skin during healing. 
The skilled plastic surgeon will appreciate that the tri-sectional 
foam-lined inner splint with recessed foam at the lateral bridge creases 
or hinge lines will prevent "bunching" of the foam layer adjacent the skin 
(as depicted in FIG. 3), thus preventing wrinkling of the skin during the 
healing process. The device diminishes skin damage, since elasticity of 
the polymeric sheet component allows for expansion with nasal edema or 
swelling, and subsequent contraction as the swelling subsides. The results 
in essentially uniform pressure being applied to the nose, which 
distributes and accommodates swelling effects. As opposed to prior 
malleable splint devices, the new compound splint has predetermined bridge 
fold lines, whereby articulation during the surgical procedure is 
maintained within the configuration of the prefolded starting shape. This 
is achieved in the manufacturing process by forming the metal stabilizer 
member at the desired crease lines to facilitate the manual molding 
process during attachment of the splint stabilizer to the inner composite. 
This feature provides symmetrical nasal compression and shaping. 
During the post-operative healing period patient comfort is assured by 
light weight and cushioning of the device. The relatively thin compound 
splint can be worn with eyeglasses, since the splint is designed to accept 
an ordinary eyeglass frame unobtrusively. Other desirable features include 
flesh-colored or decorative materials of construction or coatings, with 
the entire compound splint being manufactured of water-resistant 
materials. 
Ease of removal of the compound splint will be appreciated by the skilled 
practitioner. Localized central attachment of the stabilizer over the 
bridge permits the malleable metal material to be straightened outwardly 
by unbending the stabilizer member to an open spread position, thus 
relieving pressure on the inner splint member. This procedure permits 
insertion of an absorbent applicator tip soaked with adhesive 
remover/solvent (if needed) beneath the gently lifted edge of the inner 
splint member, thus freeing it from the nasal skin. Reduced discomfort 
during removal is assured in addition to maximum skin protection during 
healing. 
Materials and methods of manufacture for the present invention are varied. 
Polyesters, polyolefins, polyamides and other resins have mechanical 
properties suitable for use as the main structural component. Polyalkylene 
phthalic ester synthetic resins, such as polyethylene terephthalate (PET) 
or polybutylene terephthalate (PBT) are commercially available with an 
elastic modulus and orientation properties which can provide a "living 
hinge" effect at the bending point of the bridge grooves. The preferred 
PBT polymeric materials are commercially available as alloys or blends 
with other synthetic resins, such as elastomers, PET, etc sold under the 
designations "Celanex 5330, Valox, Arlon 101, Ultradur, Rynite", etc. 
Copolymers and blends with polycarbonates, urethanes, nylons, polyethers, 
acrylics, ABS are within the skill of the art in selection of suitable 
materials. Impact modifiers, fibrous reinforcement, fillers, colorants and 
biocides are possible resin additives. The desired fatigue resistance, 
dimensional stability and water resistance properties of the resin system 
can be chosen according to known parameters. Material handling, molding, 
adhesive bonding, machining and embossing techniques are described in 
Modern Plastics Encyclopedia (1986-87),pp.6-111. The preferred PBT blends 
have a tensile strength of at least 10,000 psi and melt point of about 
400F. 
Thermoplastic sheet (i.e. about 1-4 mm thickness) can be laminated with 
adhesive-coated foam and the individual composite inner splint member 
die-cut from a larger uniform composite sheet material. The preferred 
synthetic polymer sheet of the inner splint member comprises thermoplastic 
polybutylene terephthalate resin obtained as a preformed sheet having a 
uniform thickness of about 0.8mm (0.032 in). Preferred synthetic polymers 
typically contain about 5 to 95 wt% polybutylene terephthalate resin in 
alloy resin blend, having a tensile strength of about 4000 20,000 psi, 
tensile modulus of about 2000-4000 psi, high dynamic fatigue strength, and 
cold working properties. The bridge grooves can be formed in the 
thermoplastic sheet surface by mechanical scoring simultaneously with 
cutting of the splint shape, resulting in a cold working of the polymeric 
structure to impart desirable "living hinge" properties to the scored 
portions of the sheet. Alternatively, the hinge lines may be thermally 
formed, cut or milled into the surface of the composite splint in a 
separate operation, which can also include the step of removing excess 
foam material from the opposite side by milling, hydraulic cutting, etc. 
Bonding of the composite materials can be effected with various adhesives, 
such as cyanoacrylate, epoxy, urethane and/or silicone; however, it is 
advantageous to prefabricate the foam members from double coated sheet 
protected on both sides by removable protective layers over medical grade 
tacky adhesive, which can be used not only in contact with the nasal skin 
but also to adhere the composite materials. A suitable soft foam sheet, 
such as "Volara 2A/2E" crosslinked polyethylene, may have a normal density 
of about 2 PCF, compression strength of 5.5 psi (pounds/square inch) at 
25% psi, compression set of 16% original thickness, K factor 0.25 and 
maximum water absorption of 0.004 pounds/cut surface area. Other elastic 
foams of polyurethane, polypropylene, etc., may be used as desired. 
It is desirable to preshape the stabilizer unit shown in FIG. 1B by forming 
a slight (ie -15 degree) angle to facilitate manipulation of the compound 
splint during application. The foam bridge and lateral portions can also 
be precut and later bonded to a precut and formed main inner splint 
component.