WO2011119084A1

WO2011119084A1 - Adjustable nasal implant

Info

Publication number: WO2011119084A1
Application number: PCT/SE2011/000053
Authority: WO
Inventors: Sanda Hadziavdic
Original assignee: Sanda Hadziavdic
Priority date: 2010-03-23
Filing date: 2011-03-22
Publication date: 2011-09-29

Abstract

The invention relates to an implant device for correcting deformities of the nose, wherein the implant device comprises one or two elongated members (304) arranged so as to form a straight portion (307) of the implant, said straight portion extending between a first end (308) and a second end (309) and lying along a straight axis MC-MC, and at said second end (309) the elongated member or members (204) extend with at least one branch in a direction deviating from the MC-MC central axis and in a curve back towards said first end (308) of the straight portion (307), so that the elongated member (304) at least partly encloses an orifice of a nostril on the nose.

Description

ADJUSTABLE NASAL IMPLANT

TECHNICAL FIELD

The present invention relates to a surgical implant made of extraneous material for semi- permanent correction or alleviation of deformities in the nose. The invention pertains to the field of medical devices.

BACKGROUND OF THE INVENTION

Several medical conditions cause facial deformations that affect the nose and adjacent facial parts, often as a tissue collapse or inwards displacements, particularly in the frontal parts around and below the nasal bone, normally supported and given its form by cartilage. Examples of such conditions are Apert's and Crouzon's syndromes, which cause cranial defects and face skeletal deformities. Another example is Treacher-Collins syndrome with underdeveloped facial bones such as the cheek bone (zygomatic) and the bone of the upper jaw (maxilla). In severe cases these bones may be seriously undeveloped or even completely missing. Yet another condition with symptoms of facial deformities is the Mobius syndrome, usually displaying, among other afflictions, a cleft palate.

The number of individuals suffering from the above mentioned syndromes should be added to the number of infants born with the much more common congenital lip, jaw and palatal cleft. The latter is a condition which, not necessarily causes serious physiological afflictions, as it usually allows the affected individuals to lead an almost normal everyday life and to participate in society. However, individuals inflicted with the syndromes mentioned above or with lip, jaw and cleft palate may suffer from impaired speech and deformities in the upper lip and nose. Especially the latter can be a serious social handicap, and in particular during youth and adolescent stages of life. Therefore, during many years in the early life until adolescence, the affected individuals normally undergo a number of surgical operations in order to mend the hard- and support tissues in the palate and upper lip, and plastic surgery to correct the appearance of the nose (rhinoplasty). During this period the nose and upper lip region of the face will show some degree of deformation.

Common procedures for correcting such highly visible and sometimes displeasing deformities involve use of external scaffolds and/or suspension devices attached onto the head or face. Albeit over a limited period of time, wearing such rigs in the face will cause most individuals to suffer severe social trauma.

US patent application 2007/0270899 describes a flat, roofshaped and rather large implant for spreading the nasal wings, thereby giving support for the cartilage in dorsum and lateral crus but not for the columella. This implant requires a rather large surgical incision and, since it is rigid in shape and form, will need to be replaced several times up until adult age.

There are several patent documents describing surgical implants with a shape roughly similar to the letter L, for example the US patent 5133754 "Multi hardness silicone implants" and the Chinese patents CN 2439847 "Artificial nose body", CN 2855364 "Hump nose prosthesis", CN 2487354 "Composite nasal prosthesis", and patent application CN 200939182 "Nose prosthesis having active joints", These implants are designed to support cartilage in the dorsum by a part that is narrower than the roofshaped implant mentioned above (the long leg of the "L"). Also, as opposed to the roofshaped implant, they have a pin (the short leg of the "L") for support of the columella, but no parts are present to support the lateral crus.

Although the L-shaped implants usually allow smaller surgical incisions, they are less effective in yielding a natural and agreeable aesthetic appearance of the complete nose. Furthermore, the presence of the short leg of the "L" to provide support for the columella, and thereby the shape and position of the nose tip, in order to prevent the nose of becoming too flat, is not suitable for individuals with cleft palate because these individuals have no or very poor hard-tissue in the region of the palate and upper lip to offer support for this part of the implant. It is nevertheless important to render some form of shape also to the columella in order to yield a natural aesthetic appearance of the nose.

In addition to the above mentioned syndromes and conditions with more or less serious anatomical consequences, as will be evident from the description below, the present invention may be of beneficial use in plastic surgery, where otherwise healthy individuals are displeased with the shape of their nose and want it surgically reshaped. Also, many individuals suffer from functional inconveniences such as difficulty to inhale through the nose, caused by more or less deviant properties of the nose tissues. This is normally rectified by alarplastic, conchaplastic or other functional nasalplastic surgery. It will be evident that the present invention is highly useful also in these situations.

The present invention attempts to rectify the severe aesthetic deformation of the face as a consequence of a deformed nose, with the social suffering that may result from this, by providing an implant that is surgically inserted into the nasal lower dorsum and columella. The implant can be adjusted and adapted by the surgeon in the operating theater to a shape that fits the patient at hand. This is an important advantage since nose shapes differ between individuals. Also, patients with cleft palate start their treatment in early years and, as they grow the shape of the nose changes, and hence the implant needs to be adjusted several times over a long period of years. It is therefore highly desirable that the surgical operations are as few, small, and simple as possible.

SUMMARY OF THE INVENTION

The present invention relates to an implant device for correcting deformities of the nose, wherein the implant device comprises at least one elongated member arranged so as to form a straight portion of the implant, said straight portion extending between a first end and a second end and lying along a straight axis MA-MA, and at said second end the elongated member extends with at least one branch in a direction deviating from the MA- MA central axis and in a curve back towards said first end of the straight portion.

Under certain circumstances the implant device comprises two elongated members placed parallel to each other so as to form a central straight portion of the implant, said central portion extending between a first end and a second end and lying along a central axis MC-MC, and at said second end the two elongated members extend in opposite directions deviating from the central axis MC-MC in a curve back towards said first end

(308) of the central portion. The two elongated members may be inseparably joined at the central portion.

The elongated members comprise a skeleton core extending throughout the length of the elongated members, and said skeleton core is completely encapsulated in an elastic coating that may comprise an elastic polymer. The elastic polymer may be of the group comprising silicon rubber materials of medical grade.

The skeleton core is of a material that allows bending by manual normal manual force, such as for example of a group comprising a polymer, a metal, a steel alloy or a medical grade ductile stainless steel.

The skeleton core may also be of a material that has elastic properties with spring tension such as for example of a group comprising a polymer, a metal, a steel alloy or medical grade spring steel.

The skeleton core may also be a spiral spring, made from a metal, a polymer, a steel alloy, medical grade spring steel or a medical grade ductile stainless steel. The elongated member may be provided in sections connected by means of locking pins. BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 A depicts deformations in the lower cartilage parts in nasi, tip, and columella of the nose, given as but one example of the deformations resulting from the conditions given above, and for which the present invention presents a welcome solution.

Fig 1 B shows the nose in Fig. 1A with the implant of the present invention inserted and the shape of the rectified.

Fig. 2 shows the general shape of the elongated member of the implant device as a cutaway view, indicating the skeleton core (solid grey) and the elastic coating (stripes). Fig. 3 is a view of the implant device of the present invention, wherein the lower nose parts are indicated by the dotted lines.

Fig. 4a shows an embodiment of the present invention, in which the section for support of the nasal wing can be attached to the columella and tip section, and secured by an internal locking pin. The drawing shows only one of the two elongated members as a cutaway view, indicating the skeleton core (solid grey) and the elastic coating (stripes).

Fig. 4b shows the same embodiment of the present invention as in Fig. 4a, in which the section for support of the nasal wing can be detached from the columella and tip section by cutting. The drawing shows only one of the two elongated members as a cutaway view, indicating the skeleton core (solid grey) and the elastic coating (stripes). DETAILED DESCRIPTION OF THE INVENTION

In the following the invention will be described in a non-limiting way and in more detail with reference to exemplary embodiments illustrated in the enclosed drawings. The present invention relates to an implant device intended for corrective surgery of the nose (rhinoplasty), primarily as a consequence of palatal cleft but also of a number of other ailments and conditions as exemplified above. An implant according to the present invention is surgically inserted into the frontal lower parts of the nasal columella (101 ), tip (102), and left and/or right wings (see Fig. 1 B). The general design of the device is that it comprises at least one elongated member 204 having a skeleton core 205 that extends throughout the length of the elongated member. The skeleton core is completely encapsulated in an elastic coating 206, giving an impenetrable seal of the skeleton core and providing for optimal tissue compatibility. Preferably the coating is an elastic polymer and more preferably the coating is a silicon rubber material of medical grade. The exterior cross-sectional shape of the coating 206 is elliptical, oval, or elongated round, with the long dimensional axis lying in parallel to the broad side of the skeleton core. Or put in other words, a broad and flat skeleton core is positioned in the interior centre of the cross- sectional shape of the elastic coating. The thickness of the elastic coating measured from the skeleton core surface to the coating surface lies within the same interval all around the cross-sectional profile and the ends of the elongated member, although the thickness need not be equal all around on any particular elongated member. The coating thickness is preferably larger than or equal to 1 mm and smaller than or equal to 3 mm. The manufacturing process ensures a very tight contact between skeleton core and coating with no gas, extraneous particles, or other material present, and completely sealed ends of the elongated member.

One of the main objects of the present invention is to provide an implant that is flexible and that can be easily adapted according to the need of the patient. Thus, in certain situations when only one side of the nose requires correction, the implant device comprises only one elongated member 204 arranged so as to form a straight portion 207 of the implant and lying along an axis MA-MA. The straight portion is inserted into, and supports the columella 101 and extends from a first end 208 arranged at the lower part of the columella 101 to a second end 209 supporting the nasal tip 102. At the second end 209 i.e. at the nasal tip, the elongated member 204 extends with at least one branch in a direction deviating from the MA-MA axis and in a curve back towards said first end 208 of the straight portion 206 so that the elongated member 204 is made to at least partly enclose an orifice of a nostril on a nose. The endpoint 212 of the elongated member 204 rests on the tissue of the maxilla.

In the situation when both sides of the nose require reconstruction, two elongated members 304, 304' may be placed parallel to each other whereby the straight sections form a central portion 307,307' of the implant. The elongated members 304,304' may be inseparably joined to each other or merely arranged next to each other at the central portion 307,307'. The central portion 307,307' is generally straight and lying along a central axis MC-MC (see Fig. 3). The central portion 307,307' where the elongated members 304,304' are placed in parallel or are inseparably joined, is inserted into, and supports the columella 101. The central portion 307,307' extends from a first end 308 arranged at the lower part of the columella 101 to a second end 309 supporting the nasal tip 102. At the second end 309 the two elongated members 304,304' branch and extend in opposite directions deviating from the MC-MC central axis, and back towards said first end 308 of the central portion 307,307' so that each elongated member 304,304' at least partly encloses the orifices 310,311 of the nostrils on the nose.

This design with closely placed, or inseparably joined elongated members 304,304' at the central portion 307,307' that bend sharply one to the left and one to the right, mimics the natural form of the greater alar cartilage, with a more or less prominent cleft in the appearance of the nose tip. After the sharp bends the elongated members 304,304' adopt equally curved forms, symmetrically one to the left and one to the right, which is intended for support of the lateral cms and alae nasi on both sides in the nasal wings, and which is surgically inserted with one elongated member 304,304' each into the nasal wings with the two endpoints 312,312' of the curved elongated members resting on tissue over the maxilla 103.

The general shape of the implant and the cross-sectional shape of the constituent elongated members that make up the implants are the same for the preferred

embodiments described below.

In one embodiment, the present invention comprises a solid skeleton core (205 in Fig. 2) of any material with properties suitable for good skeleton support while still allowing bending by normal manual force, and when the force is released it will retain its shape given at the end of the bending process (plastic bending). Consequently, the implant can be plastically adjusted and adapted in every detail to the desired shape of the nose, during surgery in place in the operating theater. Preferably the skeleton core material is a ductile polymer or metal, more preferably this material is a steel alloy, yet more preferably this material is a medical grade ductile stainless steel. Preferably the skeleton core material has the flat cross-section of a band, with a thickness of less than or equal to 1 mm and more preferably the skeleton core material is between 0.1 and 0.3 mm thick. The width of the skeleton core is preferably smaller than or equal to 5 mm, more preferably broader than or equal to 1 mm and narrower than or equal to 3 mm.

In another embodiment, the implant device of the present invention comprises a solid skeleton core (205 in Fig. 2) of any material with properties suitable for good skeleton support while having elastic properties with appropriate spring tension, allowing deformation and subsequent elastic reshaping in order to restore the nose shape for instance after accidental deformation from a blow or fall. Preferably the skeleton core material is polymeric or metallic in nature, more preferably this material is a steel alloy, yet more preferably this material is a medical grade spring steel. Preferably the skeleton core material has a thickness of less than or equal to 0.5 mm, more preferably the skeleton core material is between 0.05 and 0.2 mm thick. The width of the skeleton core is preferably smaller than or equal to 5 mm, more preferably broader than or equal to 1 mm and narrower than or equal to 3 mm.

In yet another embodiment, the implant device of the present invention comprises a skeleton core (205 in Fig. 2) in the form of a spiral spring with properties suitable for good skeleton support and having elastic properties with appropriate spring tension, allowing deformation and subsequent elastic reshaping in order to restore the nose shape for instance after accidental deformation from a blow or fall. The skeleton core spring has a rounded flat, oval, or elongated round cross-sectional profile and is made of metal or polymer, preferably this material is a steel alloy, yet more preferably this material is a medical grade spring steel, and even more preferably this material is a medical grade ductile stainless steel. Preferably the skeleton core spring has a thickness of less than or equal to 3 mm, more preferably the skeleton core material is between 1 and 2 mm thick. The width of the skeleton core is preferably smaller than or equal to 5 mm, more preferably broader than or equal to 1 mm and narrower than or equal to 3 mm.

In yet a further embodiment of the invention, pertaining to all types of skeleton cores as mentioned above, the elongated members of the implant device may be provided in different sections. As is evident for everybody, not only to the person skilled in the art, the size and shape of the nose differs significantly between individuals. It is thus imperative to cater for this in the present invention, which therefore encompasses all possible shapes and sizes of the constituent sections. For instance, for a high pointed nose with a "sharp tip" and with narrow wings, the central portion 307,307' of the columella sections of the implant need to be higher, the sharp bends of the elongated members at the second end 309 need to be sharper, and elongated members 307,307' in the nasal wings need to be narrower or closer to each other. For a broad flat nose the invention encompasses a different design, i.e. the central portion section 307,307' needs to be shorter, the sharp bends of the elongated members at the second end 309 need to be more shallow, and the elongated members 304,304' in the nasal wings need to be broader or further apart. Also, the invention encompasses implants where the shallow bends in the nasal wing lower parts have different angles. All these structural features can be combined in all possible ways in any individual implant and in all possible implant sizes, to cater for nose sizes from the small child to the adult.

In order to provide an implant for every kind of nose the elongated members of the implant device may involve attachable and detachable sections (413,414 in Fig. 4). These sections can thereby be easily attached or detached prior to surgery, or during surgery while in place in the tissue, in order to satisfy different aesthetic requirements and to provide for simple replacements with minimal surgical incisions as the nose grows.

Each elongated member of the invention 304 can be provided as two more separate parts, each split at the upper portion of the nasal wing arcs below the nasal tip bend (415 in Fig. 4a). The skeleton core but not the coating is retracted at each end of this cut resulting in crevices 416,417 in the coating for insertion of a locking pin 418 connecting the two sections. This locking pin is preferably made of the same material as the skeleton core for each of the embodiments given above and has a similar elongated flat general shape. Its length coincides with the sum of the depths of the two crevices 416,417 in the parts of one of the two elongated members of the implant. Furthermore, the locking pin 418 has rounded ends in order to facilitate insertion into the crevices 416,417 and may be provided with barbs or fluke-like structures 419 at both ends to provide a secure and permanent lock.

This has great advantage, both from a surgical and a patient point of view, since irrespective of the type of skeleton core in the implant, the shape of the implant can be adapted to any individual nose shape and size prior to implantation. By attaching for instance broad wide-arced long wing sections 41 to a high and pointed columella/tip section 413 will render one particular nose shape, while, on the other hand, attaching broad wide-arced short wing sections 414 to a high and pointed columella/tip section 413 will render a different nose shape, and, as yet another example, attaching short narrow- arced wing sections 414 to a short and broad columella/tip section 413 will render yet a different nose shape, and so on with a very large number of possible combinations. By the possibility to attach wing sections 414 of any shape and size to a columella/tip section 413 of any shape and size, all possible nose shapes and sizes are catered for. It is even possible to build an asymmetrical nose shape with this system.

Additionally, in the present locking pin embodiments the skeleton core is retracted a distance from the locking pin 420. In Fig. 4 this is depicted in the lower part 414, i.e. the part for insertion into the nasal wing, but is in no way exclusive. The gap 420 between locking pin and skeleton core is filled with coating material, resulting in a skeleton core gap which is soft but short enough to still give ample stability to the implant. This gap 420 may be cut, as indicated by the pair of scissors in Fig. 4b, allowing insertion/removal or replacement of the wing sections 414 or the columella/tip section 413 individually by a simple surgical procedure while leaving the other sections in place in the tissue. This system provides for simple replacements with minimal surgical incisions for instance as the nose grows. It is contemplated that the flexible design and use of the elongated member as described above can be adapted so as to fit and reconstruct other areas of the face. For example the helix rim, the antihelix of the outer ear comprises parts wherein the elongated member, if reshaped as to fit the appropriate area or areas, can provide a simple and flexible solution during reconstruction.

Claims

1. An implant device for correcting deformities of the nose, characterized in that

the implant device comprises at least one elongated member (204) arranged so as to form a straight portion (207) of the implant, said straight portion extending between a first end (208) and a second end (209) and lying along a straight axis MA-MA, and at said second end (209) the elongated member (204) extends with at least one branch in a direction deviating from the MA-MA . central axis and in a curve back towards said first end (208) of the straight portion (207). The elongated member (204) is provided in sections (413,414) fig.4

2. An implant device according to claim 1 , characterized in that two elongated members (304,304') are placed parallel to each other so as to form a central straight portion (307,307') of the implant, said central portion (307,307') extending between a first end (308) and a second end (309) and lying along a symmetrical central axis MC-MC, and at said second end (309) the two elongated members (304,304') which are adjustable in lenght an in angle relative to symmetrical axis MC-MC extend in opposite directions deviating from the central axis MC-MC in a curve back towards said first end (308) of the central portion (307,307').

3. An implant device according to claim 2, characterized in that the two elongated and adjustable members (304,304') are inseparably joined at the central portion

(307,307') The adjustable portions of ( 204-204) sections(413-414) are connected with a locking pin which is designed to allow adjustment in more than one direction.

4. An implant device according to claims 1-3, characterized in that the elongated

members (204) comprise a skeleton core (205) extending throughout the length of the elongated members (204), said skeleton core (205) being completely encapsulated in an elastic coating (206).

5. An implant device according to claim 4, characterized in that the elastic coating (206) is an elastic polymer.

6. An implant device according to claim 5, characterized in that the elastic polymer is a silicon rubber material of medical grade.

7. An implant device according to claim 4, characterized in that the skeleton core (205) is of a material that allows bending by manual normal manual force.

8. An implant device according to claim 7, characterized in that the skeleton core (205) is made of a polymer, a metal, a steel alloy or a medical grade ductile stainless steel.

9. An implant device according to claim 4, characterized in that the skeleton core (205) is of a material that has elastic properties (with spring tension).

10. An implant device according to claim 9, characterized in that the skeleton core (205) is made of a polymer, a metal, a steel alloy or a medical grade spring steel.

11. An implant device according to claim 4, characterized in that the skeleton core (205) is a spiral spring.

12. An implant device according to claim 11 , characterized in that the skeleton core (205) is made of a metal, a polymer, a steel alloy, a medical grade spring steel or a medical grade ductile stainless steel or cartilage.

13. An implant device according to claim 1 , characterized in that the elongated member sections (413,414) are connected by means of locking pins which are designed with grooves, barbes or finges for secure locking (419).