US5022389A — Nasal splint device

Claim 1

Independent Claim 259 words

A nasal splint device for retaining a traumatized nose after surgery or injury comprising: a flexible inner splint portion adapted for direct application to nasal skin, including 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 attached to the inner planar 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 overlying the inner surface of the foam for direct application to the nasal skin; said flexible inner splint portion, foam layer and tacky adhesive layer forming an integral splint member adaptable to individual nasal application by trimming to fit; a splint stabilizer member comprising a thin sheet of malleable metal with a matching stabilizer bridge portion and lateral wing portions forming a T-shape, wherein 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 means 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, thereby permitting articulation of the flexible inner splint portion during application.

Claim 2

Dependent Claim 259 words

A nasal splint device for retaining a traumatized nose after surgery or injury comprising: a flexible inner splint portion adapted for direct application to nasal skin, including 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 attached to the inner planar 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 overlying the inner surface of the foam for direct application to the nasal skin; said flexible inner splint portion, foam layer and tacky adhesive layer forming an integral splint member adaptable to individual nasal application by trimming to fit; a splint stabilizer member comprising a thin sheet of malleable metal with a matching stabilizer bridge portion and lateral wing portions forming a T-shape, wherein 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 means 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, thereby permitting articulation of the flexible inner splint portion during application.

Claim 3

Dependent Claim 46 words

The nasal splint device of claim 1 wherein the splint stabilizer member lateral wing portions extend laterally from the upper bridge portion of the nose toward side edges of the inner splint portion to provide essentially uniform pressure to a traumatized nose with symmetrical nasal compression.

Claim 4

Dependent Claim 58 words

The nasal splint device of claim 1 wherein 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 of nasal edema or swelling; wherein the compressible polymeric foam inner layer comprises soft closed cell polyethylene; and wherein the malleable metal comprises annealed aluminum.

Claim 5

Dependent Claim 29 words

The nasal splint device of claim 1 wherein the tacky layer consists essentially of dermatologically acceptable adhesive and wherein the tacky layer is protected by peelable temporary stripping material.

Claim 6

Dependent Claim 249 words

A compound post-operative nasal splint comprising: a flexible integral inner splint member adapted for direct application to nasal skin, including a thin, resilient synthetic 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 or wrinkling of nasal skin during articulation; 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; a separate splint stabilizer member comprising a thin sheet of malleable metal for manual molding in situ over the inner splint member, said 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; and means for attaching the splint stabilizer member along the stabilizer bridge portion adjacent the lateral wing portions thereof to the integral splint member between the hinge lines at the central bridge portion thereof following nasal application of the flexible inner splint portion.

Claim 7

Dependent Claim 249 words

A compound post-operative nasal splint comprising: a flexible integral inner splint member adapted for direct application to nasal skin, including a thin, resilient synthetic 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 or wrinkling of nasal skin during articulation; 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; a separate splint stabilizer member comprising a thin sheet of malleable metal for manual molding in situ over the inner splint member, said 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; and means for attaching the splint stabilizer member along the stabilizer bridge portion adjacent the lateral wing portions thereof to the integral splint member between the hinge lines at the central bridge portion thereof following nasal application of the flexible inner splint portion.

Claim 8

Dependent Claim 49 words

The nasal splint of claim 5 wherein the splint stabilizer member lateral wing portions extend partially from the upper bridge portion of the nose toward side edges of the inner splint member and overlying central portions of the inner splint member to provide controlled pressure and symmetrical nasal compression.

Claim 9

Dependent Claim 53 words

The nasal splint of claim 6 wherein the inner splint portion is formed of semi-rigid, inert, thermoplastic polymer material having sufficient elasticity to permit controlled expansion and contraction of nasal edema during swelling; wherein the compressible polymeric foam inner layer comprises soft closed cell polymer; and wherein the malleable metal comprises annealed aluminum

Claim 10

Dependent Claim 17 words

The nasal splint of claim 5 wherein the inner splint member has a substantially trapezoidal peripheral shape.

Claim 11

Dependent Claim 21 words

The nasal splint of claim 5 wherein the synthetic polymer sheet of the inner splint member comprises thermoplatic polybutylene terephthalate resin.

Claim 12

Dependent Claim 46 words

The nasal splint of claim 9 wherein the synthetic polymer sheet contains 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.

Claim 13

Independent Claim 221 words

A method for treating a traumatized human nose by application of a post-operative nasal splint comprising the steps of: a) expressing edema from the traumatized nose and cleaning the nasal skin preparatory to receiving direct adhesive contact; b) manually molding a flexible integral inner splint member including a thin, resilient thermoplastic 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; c) attaching a splint stabilizer member comprising a thin sheet of malleable metal over the inner splint member, said 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; d) exposing a tacky layer of medical-grade pressure adhesive applied to said foam layer; and e) directly applying the flexible integral inner splint member to the nasal skin following removal of temporary protective stripping.

Claim 14

Independent Claim 221 words

A method for treating a traumatized human nose by application of a post-operative nasal splint comprising the steps of: a) expressing edema from the traumatized nose and cleaning the nasal skin preparatory to receiving direct adhesive contact; b) manually molding a flexible integral inner splint member including a thin, resilient thermoplastic 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; c) attaching a splint stabilizer member comprising a thin sheet of malleable metal over the inner splint member, said 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; d) exposing a tacky layer of medical-grade pressure adhesive applied to said foam layer; and e) directly applying the flexible integral inner splint member to the nasal skin following removal of temporary protective stripping.

Claim 15

Dependent Claim 58 words

The method of claim 11 wherein the stabilizer bridge portion adjacent the lateral wing portions has a layer of adhesive for attaching the splint stabilizer member between the hinge lines at a central bridge portion following nasal application of the flexible inner splint portion, and wherein the flexible inner splint member is trimmed to fit the traumatized nose.

Claim 16

Dependent Claim 40 words

The method of claim 12 wherein the inner splint member is prefitted to the individual nose prior to adhesion by placing said inner splint member on the nose and manually forming same prior to removing the temporary protective stripping therefrom.

Claim 17

Dependent Claim 28 words

The method of claim 11 including the step of taping over lateral wing portions of the splint and nose to provide controlled modeling of the nasal tip .

Claim 18

Dependent Claim 34 words

The method of claim 11 including the step of applying surgical tape horizontally across the columella of the nose to lateral portions of the splint to provide controlled modeling of the nasal tip .

Claim 19

Dependent Claim 26 words

The method of claim 11 herein the stabilizer member is attached to the inner splint member prior to adhering the compound splint to the nasal skin.

Claim 20

Dependent Claim 252 words

A post-surgical procedure for treating a human nose by application of a compound nasal splint including the sequential steps of: preparing the post-surgical nose for receiving direct adhesive contact by expressing edema from the nose and cleaning the nasal skin; fitting to the prepared nose a flexible integral inner splint member; said inner splint member 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; said inner splint member having attached thereto a splint stabilizer member; said splint stabilizer member comprising a thin sheet of malleable metal over the inner splint member and 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; exposing a tacky layer of medical-grade pressure adhesive applied to said foam layer of the inner splint member; directly applying the flexible integral inner splint member to the nasal skin; molding the splint stabilizer member by pressing the malleable metal sheet in compressive relation to the inner splint member.

Claim 21

Dependent Claim 252 words

A post-surgical procedure for treating a human nose by application of a compound nasal splint including the sequential steps of: preparing the post-surgical nose for receiving direct adhesive contact by expressing edema from the nose and cleaning the nasal skin; fitting to the prepared nose a flexible integral inner splint member; said inner splint member 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; said inner splint member having attached thereto a splint stabilizer member; said splint stabilizer member comprising a thin sheet of malleable metal over the inner splint member and 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; exposing a tacky layer of medical-grade pressure adhesive applied to said foam layer of the inner splint member; directly applying the flexible integral inner splint member to the nasal skin; molding the splint stabilizer member by pressing the malleable metal sheet in compressive relation to the inner splint member.

Claim 22

Dependent Claim 27 words

The procedure of claim 17 wherein individualized narrowing of portions of the nose width is achieved by variable compression with pinch molding of the splint stabilizer member.

Claim 23

Dependent Claim 31 words

The procedure of claim 18 wherein symmetrical nasal compression is applied in predetermined portions of the nose by the resilient polymer material, cutouts and bendable hinges of the inner splint member.

Claim 24

Dependent Claim 31 words

The procedure of claim 17 wherein individualized shaping of the nasal tip is achieved by localized compression of the splint stabilizer member on the nasal dorsum in the supratip region thereof.

Claim 25

Dependent Claim 60 words

The procedure of claim 17 including the step of applying surgical tape horizontally across the columella of the nose to lateral portions of the splint to provide controlled modeling of the nasal tip, and depressing the lower dorsal portion of the inner splint member inwardly by compressively shaping the splint stabilizer member overlying the desired depressed portion of the dorsum.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1994-06-10	1994-12-10	1995-06-11	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1998-06-10	1998-12-10	1999-06-11	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2002-06-10	2002-12-10	2003-06-11	$7700.00	Window Closed / Lapsed

Nasal splint device

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