WO2015107543A2

WO2015107543A2 - A nasal splint and a method of fixing the nasal splint in a nose

Info

Publication number: WO2015107543A2
Application number: PCT/IN2014/000778
Authority: WO
Inventors: Sujai Jayprakash Joshi
Original assignee: Sujai Jayprakash Joshi
Priority date: 2013-12-13
Filing date: 2014-12-15
Publication date: 2015-07-23
Also published as: WO2015107543A3; IN2013MU03906A

Abstract

The invention provides a nasal splint and a method of fixing the nasal splint in a nose. The nasal splint includes an intranasal splint and an external nasal splint. The intra nasal splint includes two separate pieces, wherein each piece right angled triangle in shape with angles curved smoothly. A suture is tied to intranasal splint passes through the intranasal splint. The suture includes a cutting needle attached to the other end of the suture. The external nasal splint includes a superior edge smaller than a lower edge. Further, the external nasal splint also includes a notch on both left and right sides of the external nasal splint and there are small holes above the notch. The intranasal splint and external nasal splint is fixed such that a midline upward stretch is applied on a nasal dorsum to keep fragments the nasal dorsum at a fixed state.

Description

"A NASAL SPLINT AND A METHOD OF FIXING THE NASAL SPLINT IN A NOSE"

The following specification particularly describes the nature of this invention and the manner in which it is to be performed.

FIELD OF THE INVENTION

[0001] The invention generally relates to nasal splint. More specifically, the invention relates to a nasal splint which allows the fractured fragments to remain in the desired and stretched position without use of bandages, adhesives and intranasal packing for requisite duration of time and to splintage after fracture reduction.

BACKGROUND OF THE INVENTION AND PRIOR ART

[0002] Current techniques in addressing aesthetic and functional aspects of nasal framework fractures do not support the fracture fragments in a desired position for a requisite duration of time, especially the nasal dorsum in the keystone area. Further, the current techniques rely on adhesives or bandages to keep external splints in position, which makes the external splints less reliable in hot, humid or wet climates, or restrict normal activities in other climates.

[0003] US patent no. US3935859A discloses the "Surgical nasal splint" whereby one piece plastic nasal splint is presized to fit the nasal passage, an isthmus bridging the columella to provide anterior fixation while a single suture provides posterior fixation. [0004] US patent no. US5817039A discloses the "Nasal splint system" which comprises a nasal splint (6) with a central part designed to rest on the bridge of the nose and two lateral parts designed to rest on each side on the cheek adjacent the nose, wherein the nasal splint (6) is adaptable to the individual form of the nose of a patient and can be fixed, if necessary, additionally with a forehead support (7) consisting of a transversal part (8) designed to rest on the forehead (15) and a central part (9) designed to rest on the nasal splint (6). The nasal splint (6) and/ or the forehead support (7) are formed of a compound structure consisting of an intermediate flexible layer, of a foam rubber layer adjacent the nose being covered by a skin-compatible adhesive layer, and of a layer covering the adhesive layer. The fixation of the nasal splint (6) may be effected by means of skin-compatible adhesive tapes (11) on the left cheek and of the right cheek and, if necessary, by means of a forehead support (7), which is also fixed by adhesive tapes (17).

But both the cited prior art have the disadvantages as mentioned in paragraph [0002].

[0005] Thus, there is an unmet need to develop an improved nasal splint which overcomes all the problems faced by the prior art and which allows the fractured fragments to remain in the desired and stretched position without use of bandages, adhesives and intranasal packing for requisite duration of time

OBJECTS OF INVENTION:

[0006] The main object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which allows the fractured fragments to remain in the desired and stretched position without use of bandages, adhesives and intranasal packing for requisite duration of time. [0007] Another object of the invention is to provide a nasal splint which acts like a scaffolding on which fracture fragments are strung by the periosteal attachment such as pearls strung on a string, thereby giving each nasal fragment (pearl) a unique position relative to other nasal fragments.

[0008] Yet another object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which keeps the nasal envelope along with the attached fractured fragments of the nasal framework well supported under the nasal dorsum in a fractured bone.

[0009] Yet another object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which allows a patient with the disclosed nasal splint fixed on the fractured nose to perform almost all routine activities without chances of dislodging the nasal splint and negatively impacting the results.

[0010] Yet another object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which facilitates a possibility to do dressing and remove sutures without removal of transversely placed cutting needle, Kirschner's wires or other fixator.

[0011] Yet another object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which facilitates reapplication of the externalnasal splint after dressing and removing sutures may not be difficult.

[0012] Yet another object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which is used in iatrogenic disruption of a quadrilateral cartilage-perpendicular plate of ethmoid bone during nasal septal surgeries. [0013] Yet another object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which is used as a splintage technique post rhinoplasty to provide a better dorsal nasal lines.

[0014] Yet another object of the invention is to provide a nasal splint and a method of fixing the nasal splint in a nose which is used after drainage of septal haematoma or abscess to reduce chances of saddling.

BRIEF DESCRIPTION OF THE FIGURES

[0015] The accompanying figures wherelike reference numerals refer to identical or functionally similar elements throughout the separate views and which together with the detailed description below are incorporated in and form part of the specification, serve to further illustrate various embodiments and to explain various principles and advantages all in accordance with the invention.

[0016] Fig. 1 illustrates a side view of an intranasal splint in accordance with various embodiments of the invention.

[0017] Fig. 2 illustrates a front cross- sectional view of the intranasal splint taken along plane 5-5 in Fig. 1 in accordance with various embodiments of the invention.

[0018] Fig. 3 illustrates a top view of an external- nasal splint in accordance with various embodiments of the invention.

[0019] Fig. 4 illustrates an elevationside/ sagittal view of the nasal splint in place and diagrafnmatically illustrates the surrounding anatomy in accordance with various embodiments of the invention.

[0020] Fig. 5 illustrates an enlarged transverse sectional view of the nasal splint in place taken along a plane corresponding to line 6-6 of Fig. 4in accordance with various embodiments of the invention. [0021] Fig. 6 illustrate snasal fractured fragments in a nasal trauma case.

[0022] Fig. 7 illustrates a nasal splintunder the nasal dorsum applying a pull on a pyramidal aperture anda maxillary crest for bringing back fractured fragments to pre-trauma position.

[0023] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0024] Before describing in detail embodiments that are in accordance with the invention, it should be observed that the embodiments reside primarily in a nasal splint and method steps for fixing the nasal splint in a nose. Accordingly, the nasal splint components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the invention so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

[0025] In this document, the terms "comprises," "comprising," or any olher variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article or apparatus that comprises a list of objects does not include only those objects but may include other objects not expressly listed or inherent to such process, method, article, or apparatus. An object proceeded by "comprises ... a" does not, without more constraints, preclude the existence of additional identical objects in the process, method, article, or apparatus that comprises the object. [0026] Referring to Figs. 1-5, a nasal splint and a method for fixing the nasal splint in a noseis illustrated in accordance with various embodiments of the invention. Fig. 1 illustrates a side view of an intranasal splint in accordance with various embodiments of the invention. The nasal splint includes two separate pieces, wherein each piece corresponds to each nostril. One of the two pieces is intranasal splint 1 which is right angled triangle in shape with the angles curved smoothly at 11, 12 and 13. The upper edge 14 is rounded and the lower edge 15 is the side of intranasal splint 1 opposite the right angle 12 of intranasal splint 1. Intranasal splint 1 is made using material such as, but not limited to, Teflon or any other suitable material which is apparent to the person skilled in the art. Thickness of intranasal splint 1 tapers from upper edge 14 to lower edge 15 can be 2 millimeter (mm) at upper edge 14 and 0.5 mm at lower edge 15. Fig. 2 illustrates a front cross- sectional view of the intranasal splint taken along plane 5-5 in Fig. 1 in accordance with various embodiments of the invention. A suture 19 is tied at 16 and passes through lower edge 14 through point 17, where intranasal splint 1 tapers sharply as illustrated in Fig. 2. Suture 19 includes a straight 0.5 mm cutting needle 10 attached to the other end of suture 19.

[0027] Fig. 3 illustrates a top view of an external nasal splint 2 in accordance with various embodiments of the invention. The external nasal 2 splint is made using material such as, but not limited to, quadrangular rubberised aluminium material and thermoplastic material. Any other material which is apparent to a person skilled in the art can be used to make the external nasal splint 2. Referring to Fig. 3, external nasal splint 2 includes a superior edge 21 smaller than a lower edge 22. External nasal splint 2 also includes a notch 23 on both left and right sides 24 of external nasal splint 2, which lies at l/3rd the distance between the superior edge and the lower edge. Further, above notches 23, there are small holes 25.

[0028] Fig. 4 illustrates an elevation view of the nasal splint in place and diagrammatically illustrates a surrounding anatomy in accordance with various embodiments of the invention. Cutting needle 10 is passed through a keystone area of nasal bones or nearby to the midline of a nasal dorsum (inside to outside) and suture 19 is pulled up. Thereafter, intranasal splint 1 is guided in with angle 11 being a leading edge and upper edge 14 lying under upper lateral cartilages and the keystone area of the nasal bones. The same procedure is repeated on the other side of a nasal septum. Thereafter, cutting needle 10 is passed through holes 25 and external nasal splint 2 is placed on the nasal dorsum and crimped. The left and right sides 24 of external nasal splint 2 above notch 23 hugs a bony part of a fractured nose and lower part hugsa cartilaginous part of the fractured nose.

[0029] Fig. 5 illustrates an enlarged transverse sectional view of the nasal splint in place taken along a plane corresponding to line 6-6 of Fig. 4 in accordance with various embodiments of the invention. Traction is applied firmly upwards on sutures 19 and cutting needle 10 is passed across the fractured nose as shown in Fig.5. Suture 19 is wound around cutting needle 10 on both sides of the fractured nose in "figure of eight" manner. The ends of cutting needle 10 are bent downwards as intranasal splint 1 and external nasal splint 2 are held firmly through the nasal dorsum. Thereafter, external nasal splint 2 is fixed onto the nasal framework resting on a frontal process of a maxilla of the nasal bone.

[Θ030] Intranasal splint 1 is designed such that an increase of the traction on the suture tied to intranasal splint 1 bends the intranasal splint at 17, thereby providing increased support to a lateral part of the nasal bone and upper lateral cartilages. Intranasal splint 1 can be designed as may be desired in some cases, by decreasing the distance between 14 and 15.

WORKING OF INVENTION

[0031] The present nasal splint is placed in the nose using a tripod suspension technique.

[0032] The disclosed nasal splint applies a midline upward stretch on the nasal dorsum and keeps all the components of the nasal dorsum in the midlineat a fixed state. In case of nasal trauma, fractured fragments can be represented as pearls attached to the enveloping periosteum which act like strings that keep the pearls in fixed positions in relation to each other, as illustrated in Fig. 6. The nasal splint determines and maintains the position of nasal fragments with other fragments thereby aiding realignment of the fractured nasal fragments very precisely. Thus, the nasal splint acts like a scaffolding on which fracture fragments are strung by the periosteal attachment such as pearls strung on a string, thereby giving each nasal fragment (pearl) a unique position relative to other nasal fragments. A periosteal or perichondrial envelope is attached to a pyramidal aperture and a maxillary crest of a nose on one side and to the nasal dorsum on the other side as illustrated in Fig. 7. Therefore, on application of a stretch in the direction of the nasal dorsum and maintaining that stretch in the midline for the desired duration can easily reduce the fracture fragments to a pretrauma location and achieve a near-pretrauma nasal profile of a patient. The disclosed nasal splint and the method of fixing the nasal splint in a fractured bone keeps the nasal envelope along with the attached fractured fragments of the nasal framework well supported under the nasal dorsum. The disclosed nasal splint allows the fractured fragments to remain in the desired and stretched position without use of bandages, adhesives and intranasal packing. A patient with the disclosed nasal splint fixed on the fractured nose can perform almost all routine activities without chances of dislodging the nasal splint and negatively impacting the results. Additionally, the disclosed method maintains patency of a nasal valve area along the entire length by use of a smooth and atraumatic intranasal splint. The disclosed method cf fixing the nasal splint also provides haemostasis by the compression of the nasal dorsum, on both surfaces, between the external nasal splint and intranasal splint. The disclosed nasal splint arrangement also provides a possibility to do dressing and remove sutures without removal of transversely placed cutting needle, Kirschner's wires or other fixator. Additionally, reapplication of the externalnasal splint after dressing and removing sutures may not be difficult.

[0033] The disclosed nasal splint is used in iatrogenic disruption of a quadrilateral cartilage-perpendicular plate of ethmoid bone during nasal septal surgeries. The disclosed nasal splint is also be used as a splintage technique post rhinoplasty to provide a better dorsal nasal lines. The disclosed nasal splintmay also be used after drainage of septal haematoma or abscess to reduce chances of saddling.

[0034] Those skilled in the art will realize that the above-recognized advantages and other advantages described herein are merely exemplary and are not meant to be a complete rendering of all of the advantages of the various embodiments of the invention.

[0035] In the foregoing complete specification, specific embodiments of the invention have been described. However, one of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the invention. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of the invention. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, or required.

EXPERIMENTAL DATA:

[0036] 21 patients (12 male and 9 female) underwent splintage using the present nasal splint following various nasal procedures. While 16 patients were adults, 5 were paediatric patients (under 17 yrs).

[0037] Sixteen patients had presented with primary nasal fractures, 3 had this technique of splintage done after rhinoplasty and 2 after septoplasty following inadvertent disruption of quadrilateral cartilage-ethmoid perpendicular plate joint. All the patients were informed of the procedure and due consent taken (except the septoplasty cases where they were informed post procedure and consent taken). Thermoplastic splints or rubberised aluminium splints were used after punching holes in them as the external splint.

[0038] Kirschners wires (0.8mm), Teflon intranasal splints were used after applying longitudinally cut plastic suction catheter to round off the edges(fig 1) along with 2-0/3-0 mersilk /nylon sutures.

[0039] The splints were kept on for a minimum period of 7 days in 4 cases and a maximum of 20 days in 6 cases. The others had the splints removed on the 11th postoperative day (5 cases) and 6 patients on the 15^th postoperative day. After the reduction of the fracture internal nasal Teflon splints are placed on either side of the nasal septum. A 2-0 silk or nylon suture is already passed through intranasal splints. The External nasal splint used often is the rubberised aluminium foil in which perforations have been made (or thermoplastic splints) .While placing the intranasal splints the 2-0 silk/nylon suture tied to the intranasal splint is passed through the nasal dorsum close to the keystone area of the nose and then passed through the upper midline hole in the external nasal splint. While the External nasal splint is applied on the nasal dorsum and held firmly, the assistant applies a traction on the intranasal splint sutures so that the splints and therefore the nasal dorsum are pulled on to the undersurface of the external nasal splint Still better positioning of the splints can be achieved by additionally using Ashe forceps to elevate the nasal tissues along with firmly elevating the internal nasal splints. Kirschners wires (0.8mm) are then used to pass across the nose from one side to the other through the holes on the external nasal splints, the upper lateral cartilages, intranasal splints and the nasal septum. We often use two such wires to secure the splints in the desired place and the internal nasal splint sutures are then securely tied to these wires. These are then further held in place by silk sutures knotted under the needles and tied on the dorsum of the external splint as shown forming a tripod arrangement to support the nasal framework.

[0040] The wires are cut and bent to reduce chances of getting entangled and causing injury. Micropore tapes are applied primarily for additional support and to cover the wire ends. Sterile foam/merocele is used to pack the nostrils. Finally pinching the external splint and placing ribbon gauze under the splint edges prevents injury to the underlying skin of the face and applies further anterior traction on the nasal dorsum for better alignment. While the nasal packs are routinely removed in 24 hours we leave the splints for two to three weeks depending on the fracture severity.

Results:

[0041] In all so far (21) patients have been splinted in this way. All were comfortable with the splint and the splintage technique even when kept for three weeks. The splints remained secure even when the adhesive tapes came off. The nasal dorsum appeared quite satisfactory in comparison to the pretrauma photographs that were routinely requested from the patients for comparison. The patient satisfaction was quite high at the time of splint removal and the nose looked even better after the oedema further settled over the next week. The few patients that were radiographed post reduction and splint removal (we routinely avoid unwarranted radiography in our cases) as a followup review showed good realignment of the nasal bones and front and profiles bore testimony to this fact.

ADVANTAGES OF INVENTION:

[00421 The present invention has the following advantages:

- Acts like a scaffolding on which fracture fragments are strung by the periosteal attachment such as pearls strung on a string, thereby giving each nasal fragment (pearl) a unique position relative to other nasal fragments.

- Keeps the nasal envelope along with the attached fractured fragments of the nasal framework well supported under the nasal dorsum in a fractured bone.

- Allows the fractured fragments to remain in the desired and stretched position without use of bandages, adhesives and intranasal packing.

- A patient with the disclosed nasal splint fixed on the fractured nose can perform almost all routine activities without chances of dislodging the nasal splint and negatively impacting the results.

- It facilitates a possibility to do dressing and remove sutures without removal of transversely placed cutting needle, Kirschner's wires or other fixator.

- Also facilitates reapplication of the externalnasal splint after dressing and removing sutures may not be difficult.

- Used in iatrogenic disruption of a quadrilateral cartilage- perpendicular plate of ethmoid bone during nasal septal surgeries. - Used as a splintage technique post rhinoplasty to provide a better dorsal nasal lines.

- Used after drainage of septal haematoma or abscess to reduce chances of saddling.

Claims

A nasal splint mainly comprises of two separate pieces, wherein each piece corresponds to each nostril whereby, one of the two pieces is intranasal splint 1 which is right angled triangle in shape comprises the angles curved smoothly at 11, 12 and 13; upper edge 14 which is rounded; the lower edge 15 opposite to the right angle 12; point 16 tied with suture 19 having needle 10 at one end which passes through upper edge 14 through point 17 where intranasal splint 1 tapers sharply whereby an increase of the traction on the said suture 19 tied to intranasal splint 1 bends the intranasal splint at 17, thereby providing increased support to a lateral part of the nasal bone and upper lateral cartilages and the other piece is external nasal splint 2 comprises a superior edge 21 smaller than a lower edge 22; both left and right sides 24 each having notch 23 at l/3rd the distance between the superior edge and the lower edge and small holes 25 above notch 23.

A nasal splint as claimed in claim 1, whereby the intranasal splint 1 is made using material such as teflon and alike.

A nasal splint as claimed in claim 1, whereby the thickness of intranasal splint 1 tapers from upper edge 14 to lower edge 15 is 2 mm at upper edge 14 and 0.5 mm at lower edge 15.

A nasal splint as claimed in claim 1, whereby the needle 10 is straight 0.5 mm cutting needle.

A nasal splint as claimed in claim 1 , whereby the intranasal splint 1 is provided with decreased distance between upper edge 14 and lower edge 15.

6. A nasal splint as claimed in claim 1, whereby the external nasal splint (2) is made using material such as quadrangular rubberised aluminium material and thermoplastic material.