WO2017033191A1

WO2017033191A1 - Bilateral fixation device

Info

Publication number: WO2017033191A1
Application number: PCT/IL2016/050926
Authority: WO
Inventors: Ariel MARGULIS
Original assignee: Ctz Medical
Priority date: 2015-08-24
Filing date: 2016-08-24
Publication date: 2017-03-02

Abstract

An applicator and a method of using the same are disclosed. The applicator comprises a needle, a cartridge storing therein a shaped wire that has a curled shape when undeformed, an advancement mechanism configured to advance the shaped wire from within the cartridge, through the needle and towards a distal end of the needle, and a cutting mechanism configured to cut the shaped wire.

Description

BILATERAL FIXATION DEVICE

CROSS REFERENCE TO RELATED APPLICATIONS

[001] This application claims priority to U.S. Provisional Patent Application No. 62/209,079, filed August 24, 2015, entitled "Bilateral Fixation Device", the contents of which are incorporated herein by reference in their entirety.

FIELD OF INVENTION [002] The invention relates to the field of fixation devices.

BACKGROUND

[003] The nasal septum separates the nasal cavity into two nasal airway passages. The septum consists of cartilage anteriorly and bone posteriorly, which are enclosed within the nasal mucosa.

[004] Nasal septum deviation is a common condition in which the nasal septum is off center, or crocked, causing imbalance in the sizes of the nasal passages. Deviated septum may be caused by impact trauma, a birth defect, natural deviations, and the like, and may be associated with genetic connective tissue disorder (e.g., Marfan syndrome). Deviated septum that causes severe imbalance in the sizes of the nasal passages may lead to a breathing problem that requires treatment.

[005] Septoplasty may be the correction a nasal septum deviation, such as be resection of the septal cartilage and bone, cartilaginous incision or scoring, Morselization, and the like. In many of these procedures, the mucosa lining attached to the nasal septum is opened, and one or more mucosa linings are separated from the septum cartilage and/or bone, thereby creating mucosal flaps. Structural changes are then made to the septum to correct the deviation. Many corrections may require closure, such as fixation, of the mucosa flaps, such as the nasal mucosa flaps on either side of the septal cartilage and the like, usually using a one or more sutures.

[006] The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.

SUMMARY

[007] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

[008] One embodiment provides an applicator comprising: a needle; a cartridge storing therein a shaped wire that is trained to a curled shape; an advancement mechanism configured to advance the shaped wire from within the cartridge, through the needle and towards a distal end of the needle; and a cutting mechanism configured to cut said shaped wire.

[001] Another embodiment provides a method for nasal septum fixation, comprising: sequentially piercing, using a needle of an applicator, a first mucosal flap of a nasal septum and a second mucosal flap of the nasal septum; extracting a distal portion of a shaped wire from a distal end of the needle, where the shaped wire is trained to a curled shape, such that the portion curls distally to the second mucosal flap upon exiting the distal end of the needle; pulling the needle out of the first and second mucosa flaps, while advancing the shaped wire from within a cartridge of the applicator, through the needle and out of the distal end of the needle; cutting the shaped wire using a cutting mechanism of the applicator, such that a proximal portion of the shaped wire curls proximally to the second mucosal flap, thereby affixing the first and second mucosa flaps together by the shaped wire.

[002] Another embodiment provides an applicator comprising a hollow needle. The applicator comprises a cartridge storing therein a shaped wire that has a curled shape when undeformed. The applicator comprises an advancement mechanism configured to manipulate the shaped wire from within the cartridge, through the needle and towards a distal end of the needle. The applicator comprises a cutting mechanism configured to cut the shaped wire.

[003] Another embodiment provides a method for nasal septum fixation. The method comprises sequentially piercing, using a needle of an applicator, a first mucosal flap of a nasal septum, a septal cartilage, and a second mucosal flap of the nasal septum. The method comprises extracting a distal portion of a shaped wire from a distal end of the needle, where the shaped wire is trained to a curled shape, such that the portion curls distally to the second mucosal flap upon exiting the distal end of the needle. The method comprises pulling the needle out of the first and second mucosa flaps, while advancing the shaped wire from within a cartridge of the applicator, through the needle and out of the distal end of the needle. The method comprises cutting the shaped wire using a cutting mechanism of the applicator, such that a proximal portion of the shaped wire curls proximally to the second mucosal flap, thereby affixing the first and second mucosa flaps together by the shaped wire.

[004] Another embodiment provides a system comprising a mechanical control adapted to control a plurality of motions of one or more shaped wires. The system comprises a mechanical connector adapted to mechanically connect a needle containing the one or more shaped wires. The system comprises a handle adapted to guide the needle through a tissue, the handle comprising a user control for transmitting operator commands to the first mechanical control, therein converting the motions of an operator to the penetration of the needle and a release of one or more wires for fixation of a tissue.

[005] Another embodiment provides an applicator comprising: a hollow needle storing therein, sequentially, multiple wire segments, each of the wire segments being a shaped wire that has a curled shape when undeformed; and an advancement mechanism configured to push each of said wire segments through said needle and towards a distal end of said needle.

[006] Optionally, the cutting mechanism implements one cutting technique from the group consisting of scissors, slicers, shear cutters, and edge on cutters.

[007] Optionally, a material of the cutting mechanism has a material hardness greater than that of the shaped wire.

[008] Optionally, the shaped wire is made of Nitinol. [009] Optionally, the shaped wire is made of a polymer.

[010] Optionally, the advancement mechanism is configured to perform one manipulation from the group consisting of forward, backwards, stopped, and sliding freely.

[011] Optionally, the advancement mechanism comprises a first lever to control the manipulations.

[012] Optionally, the advancement mechanism comprises a second lever to control the cutting mechanism. [013] Optionally, the hollow needle has a cavity with a cross section configured to match a cross section of the shaped wire.

[014] Optionally, the cross section is elongated, with a long cross section dimension in the direction perpendicular to the nasal septum, the long cross section dimension providing greater bending resistance and fixation strength.

[015] Optionally, the needle is curved, to facilitate: access through a nostril; the penetration of the needle through a nasal septum to a distal side; deployment of the shaped wire into the distal side; and deployment of the shaped wire into a proximal side of the nasal septum.

[016] Optionally, the curled shape has a diameter between 5 and 25 millimeters.

[017] Optionally, the hollow needle has a length between 30 and 300 millimeters

[018] Optionally, the piercing includes a nasal septum between the first and second mucosa flaps.

[019] Optionally, the cutting implements one cutting technique from the group consisting of scissors, slicers, shear cutters, and edge on cutters.

[020] Optionally, the one or more shaped wires is a pre-cut length of Nitinol wire.

[021] A further embodiment is a combination of two or more of the above embodiments, with or without one or more the above-listed options.

[022] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[023] Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.

[024] FIG. 1A is a schematic view of an embodiment of an applicator;

[025] FIG. IB is a schematic view of another embodiment of an applicator; [026] FIG. 2A is cross section views illustrating the nasal septum anatomy, deviation, operation, and fixation;

[027] FIG. 2B is a perspective side view illustrating the positioning of a shaped wire through nasal septum;

[028] FIG. 2C is a cross section view of what FIG. 2B shows;

[029] FIG. 3 is a flow chart of a method for using the applicator of Figs. 1A-B for nasal septum fixation;

[030] FIG. 4 is a schematic illustration of third applicator dimensions;

[031] FIG. 5A is a cross section view of a fourth embodiment of an applicator; and

[032] FIG. 5B is an outer perspective view of what FIG. 5A shows.

DETAILED DESCRIPTION

[033] Disclosed herein is an applicator capable of conveniently and efficiently deploying a shaped wire for Septoplasty bilateral mucosa flap fixation. The applicator may include a straight or a curved needle, a cartridge storing therein a shaped wire that is pre-curled to shape adapted to fit flush with a nasal septum. The applicator may include an advancement mechanism configured to advance the shaped wire from within the cartridge, through the needle and towards a distal end of the needle. The applicator may include a cutting mechanism configured to cut the shaped wire. The disclosed applicator may be used for a wide variety of applications such as for nasal septum fixation, soft tissue fixation, and the like. The example of septum mucosa lining fixation is used extensive by means of example, and the applicator and/or method may be used for other fixations with appropriate modifications to the geometry of the undeformed wire, the needle, the applicator, and the like.

[034] Reference is now made to FIG. 1A which shows an applicator 100 that may be used for nasal septum fixation or other fixation processes. Applicator 100 includes a straight needle 102 that can pierce one or more tissues (e.g., first and second mucosa flaps of nasal septum); a cartridge 106 storing therein a shaped wire 104 that is trained to a curled shape; and an advancement mechanism that advances the shaped wire out of the needle.

[035] Optionally, the advancement mechanism includes a wire advancement button 108 that, when pushed forward (in the direction of needle 102), grasps shaped wire 104 and advances it from within cartridge 106, through needle 102 and towards a distal end of needle 102. When wire advancement button 108 is released, a spring 110 pushes it backwards. A ratchet mechanism (not shown) internal to applicator 100 may be used to prevent shaped wire 104 from being pulled backwards when wire advancement button 108 is pushed backwards by spring 110.

[036] Optionally, wire advancement button 108 may control shaped wire 104 in four configurations: (1) a wire advancement configuration to push wire into needle 102; (2) a wire reversal configuration to pull shaped wire 104 from needle 102; (3) a freewheeling configuration to allow shaped wire 104 to slide freely in needle 102; and (4) a stop wire configuration to prevent shaped wire 104 from sliding freely in needle 102. For example, shaped wire 104 is advanced once needle 102 has penetrated tissue. For example, shaped wire 104 is reversed when needle 102 is incorrectly positioned. For example, shaped wire 104 is allowed to move freely once needle 102 is ready to be removed. For example, shaped wire 104 is stopped from moving freely in needle 102 to pull shaped wire 104 out of tissue using the applicator.

[037] Optionally, shaped wire 104 is cut by a blade 118 after a portion of sufficient length of the shaped wire is extracted from needle 102. For example, a length of 4 centimeters is cut from the wire to make a small coil with 5 mm coil diameter. For example, 6 cm is cut from the wire to form the smallest 4-loop embodiment. For example, 38 cm is cut for the biggest 8-loop embodiment. Optionally, blade 118 may be controlled by a cutting trigger 114 that may be manually moved from a released to a depressed position. When released, cutting trigger 114 is biased to an anterior position by a spring 116 and when depressed posteriorly, cutting trigger 114 pushes blade 118 towards the wire in order to cut shaped wire 104.

[038] Optionally, blade 118 has a material property Rockwell hardness greater than the hardness of shaped wire 104. For example, blade 118 is harder than shaped wire 104 so many wire cuts can be performed before replacing blade 118. Optionally, blade 118 cuts shaped wire 104 in a pinching motion. Optionally, blade 118 is a wire cutter and has two blades in a scissors configuration. Optionally, blade 118 is a wire cutter and has two blades with the sharpest blade parts collinear in a cutting position, such as in a pinching motion of the blades. Optionally, blade 118 has two sliding parts that define a hole through which shaped wire 104 passes, and the parts cut shaped wire 104 using a shearing motion of the blade edges around the hole. [039] Shaped wire 104 may be pre-curled to a preset shape, as known in the art of memory shape materials, elastic materials, super-elastic materials, and the like, such that, when a distal portion of shaped wire 104 is extracted from a distal end of needle 102, the distal portion assumes its preset shape or close to it. For example, when extracted, shaped wire 104 coils and assumes a spiral, helical, or coil shape to which it was trained during manufacturing, in the undeformed state. The cross-section of the spiral or helical coil may be circular, rectangular, oval, or have another noncircular shape. The distance between individual coils or helical turns of the coils may be consistent or variable. Optionally, in an embodiment of application 100 that is used for nasal septum fixation, the diameter of the spiral or helical construct may range from 5 millimeters to 25 millimeters (mm). This size may be large enough to provide strong fixation of the two nasal septum mucosa flaps, but small enough to be accommodated inside the patient's nostrils. For example, a Nitinol wire has a diameter of 0.3 mm, a loop diameter of 9.6 mm and a round wire profile.

[040] The numerical examples and ranges of the examples are for selected applications and are not brought forward to be limiting in any way. When a range of values is given as an example, the range includes each significantly different value in the range both inclusively and as a limit for other sub-ranges. It is implied that the largest range includes all combinations of subranges and individual values between the upper and lower range limits.

[041] Shaped wire 104 may be made of a memory shape alloy, such as, for example, Nitinol. Alternatively, shaped wire 104 may be made of polymer(s) (e.g., poly (lactide-co- glycolide) (PLGA) and poly (L- lactic acid) (PLLA)). Optionally, the polymer(s) may comprise biodegradable or bio-absorbable materials (e.g., polysacarides, poly (vinyl alcohols), polyamides) and/or elements. One or more other materials may prove suitable, as will be appreciated by one skilled in the art. Regardless of the material used and the other material properties, the material property of being elastic enough to recover to an undeformed shape of a curled spiral after being stored in a wire cassette and pushed through applicator needle 102 is sufficient to be a suitable material for the present application. Examples of alloys that may be used for this application are superelastic alloys, pseudoelastic alloys, shape memory alloys, highly elastic alloys, and the like. For example, biocompatible titanium alloys, stainless steel alloys, cobalt alloys, and the like, may be used for shaped wire inserts. [042] Each type of material may have a dedicated manufacturing process to provide the undeformed shaped wire 104 the spiral diameter adapted to press the two mucosa flaps together. For example, heating is used to give the material it's undeformed shape. For example, quenching is used to give the material it's undeformed shape. For example, machining is used to give the material it's undeformed shape. For example, plastic deformation is used to give the material it's undeformed shape. Once shaped wire 104 has been shaped, it may be loaded onto spools or cassettes for storage prior to insertion into an applicator.

[043] Optionally, shaped wire 104 material has a high bending yield strain. The high bending yield strain allows shaped wire 104 coils to be passed through the straight portion of needle 102 without plastic deformation. Any suitable biocompatible material may be used for shaped wire 104 such that the material properties and shaped wire geometry allow shaped wire 104 to be straightened without elastic deformation. For example, shaped wire 104 has a cross section that makes it more flexible along the curved direction, and stiffer along the coil axis, such as an elongated cross sectional profile with the long edge perpendicular to the plane of the mucosa flaps. Needle 102 may have a hollow center with a shape matched to shaped wire 104 cross section.

[044] Optionally, applicator 100 further includes a handle 112 for grasping applicator 100 by a user's hand.

[045] Reference is now made to FIG. IB, which shows another embodiment of an applicator 150 which is generally similar to applicator 100 of FIG. 1A but has a curved needle 152 instead of a straight one. Curved needle 152 may be more convenient for insertion into a patient's nostril and then for piercing the mucosa flaps of the nasal septum. Namely, the piercing axis is approximately perpendicular to the axis of insertion of curved needle 152 into the nostril. The curvature of curved needle 152 allows piercing the nasal septum with only minimal lateral manipulation inside the nostril.

[046] Reference is now made to FIG. 2A, which is cross section views illustrating the nasal septum 210 anatomy, deviation, operation, and fixation. Nasal septum 210 is lined on either sides by mucosa lining 204a and 204b. When a deviation 222 of the septum exists, an operation 224 may be performed that detaches the mucosa, such as right mucosa 204b, from the septal cartilage and/or bone(s), and structural changes are performed to the septal cartilage and/or bone(s). Once operation 224 is complete, fixation 226 is performed with shaped wire coil segment 200. [047] Reference is now made to FIG. 2B, which is a side view illustrating the positioning of a shaped wire 200 (which may be a portion of wire 104 extracted from applicator 100 of FIG. 1) in a nasal septum comprised of two mucosa flaps, a left mucosal flap 204a and a right mucosal flap 204b. Shaped wire 200 is threaded through a puncture 202 which sequentially penetrates left mucosal flap 204a and right mucosal flap 204b.

[048] Reference is now made to FIG. 2C, which is a perspective view of what FIG. 2B shows. A proximal portion of shaped wire 200 is shown here in its curled shaped proximally to right mucosal flap 204b. A main portion of shaped wire 200 penetrates right mucosal flap 204b through puncture 202. A distal portion of shaped wire 200 (not shown) is positioned in its curled shaped proximally to left mucosal flap (not shown). These bilateral curls of shaped wire 200 serve as anchors which prevent left mucosal flap 204a and right mucosal flap 204b from separating.

[049] Reference is now made to FIG. 3, which is a flow chart of a method for using applicator 100 of FIG. 1A and the like for nasal septum fixation. A first mucosal flap of a nasal septum and a second mucosal flap of the nasal septum are sequentially pierced using a needle 102 (FIG. 1 A and the like) of applicator 100 (FIG. 1 A) (step 300). A distal portion of shaped wire 104 (FIG. 1A) is extracted from a distal end of needle 102/152 (FIGs. 1A and IB), where the shaped wire 104 (FIG. 1A) is trained to a curled shape, such that the portion curls distally to the second mucosal flap upon exiting the distal end of needle 102/152 (FIGs. 1A and IB) (step 302). Needle 102 (FIG. 1A) is pulled out of the first and second mucosa flaps, while shaped wire 104 (FIG. 1A) is advanced from within cartridge 106 (FIG. 1A), through needle 102/152 (FIGs. 1A and IB) and out of the distal end of the needle (step 304). Shaped wire 104 (FIG. 1A) is cut using a cutting mechanism of the applicator, such that a proximal portion of the shaped wire curls proximally to the second mucosal flap, thereby affixing the first and second mucosa flaps together by shaped wire 104 (FIG. 1A) (step 306).

[050] Reference is now made to FIG. 4, which is a schematic illustration of third applicator dimensions. Length of needle, denoted N_L, may be between 1 and 30 centimeters (cms), depending on application site. Total length of needle, denoted TN_L, may be between 0.5 and 7 centimeters longer than N_L. Bend length, denoted B_L, may be between 0.4 and 5 centimeters. Needle bend angle, denoted NA, may be between 30 and 170 degrees. For example, bend angle between 90 and 170 degrees when the needle points distally, not proximally. For example, when a proximal approach is desired for a procedure, the angle of the needle may be below 90 degrees. Body length of an applicator housing, denoted L_B, may be between 30 and 150 millimeters (mm). Handle length of an applicator housing, denoted L_H, may be between 40 and 200 millimeters. Total length of an applicator housing, denoted T_BL, may be between 30 and 300 millimeters. Cutter length of an applicator housing, denoted C_L, may be between 5 and 100 millimeters. The values described may be varied for different sized patients, different sized nasal septums, different applications, and the like. For example, a device has the dimensions of the following table:

[051] Other embodiments may have other linear dimensions, based on the procedure of the shaped wire fixation, ergonomics of the operator shaped wire deployment, and the like.

[052] For example, a device may have a size and shape adapted to let a surgeon use a javlin holding position of the device, with levers placed like a hair curler. Optionally, the needle may rotate around the longitudinal axis to allow application of the shaped wire from different angles. Optionally, the needle rotation around the longitudinal axis is fixed to allow application of the shaped wire from a single angle, such as a 45-degree angle counterclockwise.

[053] Reference is now made to FIG. 5A, which is a cross section view of a fourth embodiment of an applicator 600. Applicator 600 comprises a needle 602, optionally bent, a shaped wire holder 606, which dispenses a shaped wire 604, and a cutting blade 618. A guiding handle 612 may be used to guide the needle into position for dispensing of shaped wire 604. A second handle 608 may be used to dispense the wire in one or more motions, and a third handle 614 may activate the cutting blade to cut the dispensed wire. The operator may insert needle 602 through the tissues to be fixed, press handle 608 until enough wire 604 has been dispensed to the distal side of the tissues, and fully press handle 608 until handle 614 is also pressed and shaped wire 604 has been cut. Applicator 600 is then withdrawn from the patient, thereby also withdrawing needle 602 from the fixed tissues and leaving dispensed wire 604 on the proximal side of the tissues. Optionally, handles 608, 612, and 614 are substantial parallel to needle 602.

[054] Reference is now made to FIG. 5B, which is an outer perspective view of what FIG. 5A shows, and emphasizing the three-dimensional aspect of applicator 600.

[055] Optionally, the wire comes in a pre-cut size and undeformed shape, such as not come in a cartridge disposed in the handle. The discrete (pre-cut) wire segments come inside the needle, and the handle includes a mechanism to control the wire, such as to push out, to freewheel, and the like. Optionally, more than one segment comes with each needle, such as in a loading chamber, cassette, and the like. When all the wire segments are consumed, such as in a cassette, the operator can disconnect the needle and connect another needle preloaded with additional wire segments. Further optionally, if the operator requires to deploy wire segments of a different length (or other characteristics, such as curl diameter, profile, and/or wire diameter) from the one presently used, he or she could replace the presently- used needle with a different needle pre-loaded with other wire segments.

[056] A further embodiment of the invention is a combination of two or more of any of the above embodiments, unless if such a combination clearly results in a contradiction.

[057] The embodiments described herein may provide benefits over existing techniques, such as simplifying the post-surgical procedure of most common nasal deviation surgery by avoiding nasal packing or suturing. Another benefit may be to minimize patients post procedure suffering. Another benefit may be that embodiments have a simple design, such as low cost and maintenance, is easy to use, and the like.

[058] Aspects of the present invention are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.

[059] The flowchart and block diagrams in the drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative implementations, the functions noted in the block may occur out of the order noted in the drawings. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

[060] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

CLAIMS What is claimed is:

1. An applicator comprising:

a hollow needle;

a cartridge storing therein a shaped wire that has a curled shape when undeformed;

an advancement mechanism configured to manipulate said shaped wire from within said cartridge, through said needle and towards a distal end of said needle; and

a cutting mechanism configured to cut said shaped wire.

2. The applicator according to claim 1, wherein said cutting mechanism implements one cutting technique from the group consisting of scissors, slicers, shear cutters, and edge on cutters.

3. The applicator according to claim 1, wherein a material of said cutting mechanism has a material hardness greater than that of the shaped wire.

4. The applicator according to claim 1, wherein the shaped wire is made of Nitinol.

5. The applicator according to claim 1, wherein the shaped wire is made of a polymer.

6. The applicator according to claim 1, wherein said advancement mechanism is configured to perform one manipulation from the group consisting of forward, backwards, stopped, and sliding freely.

7. The applicator according to claim 1, wherein said advancement mechanism comprises a first lever to control said manipulations.

8. The applicator according to claim 1, wherein said advancement mechanism comprises a second lever to control said cutting mechanism.

9. The applicator according to claim 1, wherein said hollow needle has a cavity with a cross section configured to match a cross section of the shaped wire.

10. The applicator according to claim 1, wherein the cross section is elongated, with a long cross section dimension in the direction perpendicular to the nasal septum, the long cross section dimension providing greater bending resistance and fixation strength.

11. The applicator according to claim 1, wherein said needle is curved, to facilitate:

access through a nostril;

the penetration of said needle through a nasal septum to a distal side;

deployment of said shaped wire into said distal side; and

deployment of said shaped wire into a proximal side of said nasal septum.

12. The applicator according to claim 1, wherein said curled shape has a diameter between 5 and 25 millimeters.

13. The applicator according to claim 1, wherein said hollow needle has a length between 30 and 300 millimeters

14. The applicator according to claim 1, wherein said hollow needle has a bend angle between 90 and 170 degrees.

15. The applicator according to claim 1, wherein said hollow needle has a bend angle between 20 and 90 degrees.

16. A method for nasal septum fixation, comprising:

sequentially piercing, using a needle of an applicator, a first mucosal flap of a nasal septum, a septal cartilage, and a second mucosal flap of the nasal septum; extracting a distal portion of a shaped wire from a distal end of the needle, wherein the shaped wire is trained to a curled shape, such that the portion curls distally to the second mucosal flap upon exiting the distal end of the needle;

pulling the needle out of the first and second mucosa flaps, while advancing the shaped wire from within a cartridge of the applicator, through the needle and out of the distal end of said needle;

cutting the shaped wire using a cutting mechanism of the applicator, such that a proximal portion of the shaped wire curls proximally to the second mucosal flap, thereby affixing the first and second mucosa flaps together by the shaped wire.

17. The method according to claim 16, wherein said piercing includes a nasal septum between the first and second mucosa flaps.

18. The method according to claim 16, wherein said cutting implements one cutting technique from the group consisting of scissors, slicers, shear cutters, and edge on cutters.

19. The method according to claim 16, wherein a material of said cutting mechanism has a material hardness greater than that of the shaped wire.

20. The method according to claim 16, wherein said shaped wire is made of Nitinol.

21. The method according to claim 16, wherein said needle is curved, to facilitate access through a nostril and through nasal mucosa flaps.

22. A system comprising:

a mechanical control adapted to control a plurality of motions of at least one shaped wire; a mechanical connector adapted to mechanically connect a needle containing the at least one shaped wire; and a handle adapted to guide the needle through a tissue, the handle comprising a user control for transmitting operator commands to the first mechanical control, therein converting the motions of an operator to the penetration of the needle and a release of at least one wire for fixation of a tissue.

23. The system according to claim 22, wherein said at least one shaped wire is a pre-cut length of Nitinol wire.

24. An applicator comprising:

a hollow needle storing therein, sequentially, multiple wire segments, each of the wire segments being a shaped wire that has a curled shape when undeformed; an advancement mechanism configured to push each of said wire segments through said needle and towards a distal end of said needle.