Devices and methods for manipulating nasal tissues

Abstract

Described herein are devices and methods for applying tension to various tissues. The devices can be delivered in a minimally invasive manner and used to manipulate tissues in the nose, ears, and throat. Force can be maintained by the devices for a period of time to allow for shaping, compressing, or approximating tissue. The devices may include tension elements having distal anchors that can be inserted into or through tissue in an insertion configuration in one direction and, upon application of force in the opposite direction, can pivot to a deployed configuration and prevent passage of the distal anchor backward through the tissue. Tension can be applied to the tension elements and continued to be adjusted to the amount desired for the intended application.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 209,350, filed June 10, 2021, which is incorporated by reference in its entirety.

[0002] This application relates generally to devices and methods for applying tension to various tissues. The devices can be delivered in a minimally invasive manner and used to manipulate tissues in the nose, ears, and throat. The force can be maintained for a period of time to allow for shaping, compression, or approximation of the tissue. [Background technology]

[0003] A deviated nasal septum occurs in up to 75% of patients and is largely asymptomatic. When symptomatic, a deviated septum can cause nasal airway obstruction, which impairs the patient's ability to breathe. When symptoms are severe enough, the patient may require septal correction or extraseptal rhinoplasty surgery. Approximately 300,000 to 600,000 patients request this surgery annually in the United States. While many ENT surgeries have transitioned to office-based settings with minimally invasive approaches, septal surgery has generally lagged behind, and patients and physicians continue to seek minimally invasive approaches.

[0004] Septal surgery is not simple. For the patient, it requires a trip to the operating room and general anesthesia. Recovery can also be significant, especially in the case of extraseptal rhinoplasty. For the surgeon, operating room (OR)-based surgery presents increased risks and costs, while also introducing inefficiencies in the delivery of the procedure. Thus, both surgeons and patients may be interested in minimally invasive procedures that can be performed within lower resource settings.

[0005] Currently, there are no minimally invasive septum correction devices in clinical practice today. Thus, there is a need for new and useful devices and methods for manipulating and reshaping the nasal septum cartilage. New devices and methods for manipulating and reshaping other nasal tissues, as well as ear and throat tissues, may also be useful. Summary of the Invention [Means for solving the problem]

[0006] Described herein are devices and methods for applying tension to various tissues. The devices can be delivered in a minimally invasive manner and used to manipulate tissues in the nose, ears, and throat. The force can be maintained for a period of time to allow for shaping, compressing, or approximating the tissue. The devices may include a tensioning element having a distal anchor that can be inserted into or through tissue in an insertion configuration in one direction and, upon application of force in the opposite direction, can pivot to a deployed configuration and prevent the distal anchor from passing backwards through the tissue. Tension can be applied to the tensioning element and continued to be adjusted to an amount desired for the intended application. For example, tension can be adjusted to an amount that alters the shape of nasal tissue. As used herein, the terms "tensioning element" and "shaping element" are used interchangeably.

[0007] A device for manipulating tissue within a subject may include a tension element, the tension element including an elongate body having a proximal end and a distal end. A distal anchor having an insertion configuration and a deployed configuration may be provided at the tension element distal end and may include an anchor body and a pivot point. In response to application of a force to the elongate body, the distal anchor may be configured to pivot at the pivot point and transform from the insertion configuration to the deployed configuration. This applied force is generally in a direction opposite to the direction of insertion. In some cases, a longitudinal axis of the distal anchor is perpendicular to a longitudinal axis of the tension element in its deployed configuration.

[0008] Other devices for manipulating tissue within a subject may include a tension element including an elongate body having a proximal end and a distal end, and a distal anchor at the tension element distal end. The distal anchor may include an anchor body having a surface area, an insertion configuration, and a deployed configuration, where the distal anchor in the deployed configuration has a larger surface area for opposing tissue than the distal anchor in the insertion configuration.

[0009] The tension element may be made from biodegradable or non-biodegradable materials. When the tension element is biodegradable, it may be made from a biodegradable polymer. Exemplary biodegradable polymers include, but are not limited to, LPLA (poly(L-lactic acid), DLPLA (poly(DL-lactic acid), LDLPLA (poly(DL-lactic acid-co-L-lactic acid), LPLA-HA (poly(L-lactic acid) with hydroxyapatite), PGA (poly(glycolide), PGA-TMC (poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (poly(dioxanone), LPLG (poly(L-lactic acid-co-glycolide), DLPLG (poly(DL-lactic acid-co-glycolide), or copolymers or hybrids thereof. In some variations, the biodegradable polymer is poly(lactic acid). The tension element may comprise polylactic acid, poly(orthoesters), poly(phosphate esters), polyphosphazenes, polyanhydrides, polycaprolactones, polyurethanes, polycarbonates, chitosan, cyclodextrins, dextran, hyaluronic acid, chondroitin sulfate, dermatan sulfate, heparin, heparin sulfate, keratan sulfate, or copolymers or hybrids thereof. In one variation, the tension element or a portion of the tension element may be made from PDO (poly(dioxanone). In another variation, the tension element may be made from a metal, such as magnesium or a magnesium alloy. Other metals may also be used.

[0010] When the tension element is formed from a biodegradable material, it may degrade over a period of about 1 month, 2 months, 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, or about 12 months. In one variation, the tension element may degrade over a period ranging from about 4 months to about 9 months. In another variation, the tension element may degrade over a period of about 6 months.

[0011] When the tension element is non-biodegradable, it may be made of a non-biodegradable polymer or metal. Exemplary non-biodegradable polymers include, but are not limited to, poly(ethylene vinyl acetate), poly(vinyl acetate), silicone polymers, polyurethanes, polysaccharides, such as cellulose polymers and derivatives, acyl-substituted cellulose acetate and its derivatives, copolymers of poly(ethylene glycol) and poly(butylene terephthalate), polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, silk, nylon, polyamide, polypropylene, polyester, polybutester, and copolymers and hybrids thereof. Exemplary metals include, but are not limited to, silver, platinum, stainless steel, nickel, titanium, and alloys thereof.

[0012] The tension element may be configured to hold or maintain a force on the target tissue. The force may be a tension ranging from about 4.0 Newtons to about 70 Newtons, which may be generated by pulling the free proximal end of the tension element after the distal anchor is secured to the target tissue. The tensile strength of the tension element may range from about 100 MPa to about 800 MPa. In some cases, the tensile strength may be at least about 150 MPa. In other cases, the tensile strength may be at least about 300 MPa.

[0013] The length of the tension element may vary prior to delivery depending on the target tissue of deployment, the type of procedure being performed, and / or the subject's anatomy. The tension element length may range from about 10 cm to about 30 cm prior to delivery. In one variation, the tension element may have a length of about 15 cm prior to delivery. Once delivered to the target tissue, the tension element may be trimmed to a length that applies an appropriate amount of force, reshaping, etc. to the target tissue. Longer lengths may help facilitate handling of the tension element while the target tissue is being manipulated.

[0014] The devices described herein may include a distal anchor at a distal end of the tension element. The distal anchor may have an insertion configuration and a deployed configuration. Additionally, the distal anchor may include an anchor body and a pivot point. In response to application of a force to the elongate body of the tension element, the distal anchor may be configured to pivot at the pivot point and convert from the insertion configuration to the deployed configuration. This applied force is generally in a direction opposite to the direction of insertion. In some cases, the longitudinal axis of the distal anchor is perpendicular to the longitudinal axis of the tension element in its deployed configuration.

[0015] The distal anchor may be variously sized and shaped. Generally, in its deployed configuration, the distal anchor prevents passage of the distal end of the tension element backward through tissue. The anchor body may include multiple arms, which may be configured to pivot at a pivot point upon application of force to the elongate body. Each arm of the multiple arms may include a distal end that is angled or bevel cut to help pivot the distal anchor at the pivot point and facilitate its engagement with the tissue. Alternatively, the anchor body may be rectangular, square, triangular, circular, or oval shaped. The anchor body may also be diamond shaped or shaped like an arrow or dogbone. In some variations, the anchor body includes a heel-and-toe retainer. In other variations, the anchor body may be expandable from a collapsed configuration to an expanded configuration. Here, the collapsed configuration may allow insertion of the distal anchor through tissue in a first direction, and the expanded configuration prevents passage of the distal anchor through tissue in a second direction, e.g., a direction opposite the first direction, backwards. Non-limiting examples of expandable distal anchors include expandable knots or Molly bolt type anchors. In addition to Molly bolt type anchors, the distal anchor may include multiple components, where one component at the distal end of the tension element may be configured to interlock with a complementary component after insertion and passage of the tension element through tissue. The complementary components or combined structure of the interlocking components may prevent passage of the tension element through tissue in a backward direction.

[0016] A plurality of proximal anchors (anti-migration elements) may further be disposed between the distal anchor and the proximal end of the tension element. The distal anchor and the plurality of proximal anchors may be the same type of anchor or different types of anchors. An enlarged tip may also be provided at the distal end of the tension element distal to the distal anchor to further facilitate anchoring of the tension element to tissue and / or coupling to the anchor delivery element, as further described below. The distal anchor and the plurality of proximal anchors may be made of the same or different material as the tension element. In some variations, the distal anchor may be made of a non-biodegradable material and the plurality of proximal anchors may be made of a biodegradable material.

[0017] The devices described herein may further include a proximal needle that is removably attached to the proximal end of the elongate body of the tension element. The proximal needle may be used to place or manipulate the proximal end of the elongate body through or around tissue and may be removably attached to the tension element in a variety of ways. For example, the proximal needle may be removably attached to the tension element by crimping or crimping, or by threading the tension element through corresponding structure in the proximal needle.

[0018] At the distal end of the tension element, an anchor delivery element may be coupled to the distal anchor. The anchor delivery element may include a cutting tip configured to pass the distal anchor through tissue in its insertion configuration. The anchor delivery element may also include a keyhole shaped to removably couple the distal anchor to the anchor delivery element. For example, the keyhole may be sized to keep the distal anchor coupled to the anchor delivery element during tissue insertion, but allow disengagement of the distal anchor during removal of the anchor delivery element back through tissue. Some variations of anchor delivery elements include a seating area configured to removably secure the anchor to the anchor delivery element. The seating area may be shaped to correspond to the shape of the distal anchor. Additionally, the seating area may have a height that is generally the same height as the height of the distal anchor when the distal anchor is seated on the anchor delivery element. The leveling of the seating area and distal anchor height may present a flush surface to the tissue that may prevent the anchor delivery element from catching on the tissue during insertion. In some cases, disengagement of the distal anchor from the seating area may be accomplished using a release tab.

[0019] Tissues that may be manipulated using the devices described herein include, but are not limited to, nasal tissue, throat tissue, and ear tissue. Non-limiting examples of nasal tissue include nasal septum cartilage, lateral nasal cartilage, greater alar cartilage, lesser alar cartilage, alar fibroadipose tissue, nasal bone, or nasal turbinate. Exemplary throat tissues include, but are not limited to, the uvula, soft palate, laryngeal cartilage, thyroid cartilage, cricoid cartilage, epiglottis, and tonsils. Non-limiting examples of ear tissue include cartilage of the helix, antihelix, tragus, antitragus, crus of the antihelix, triangular fossa, turbinate, and connective tissue of the ear lobe. The device may also be used in orthopedic applications to manipulate or shape cartilage, bone, or other tissue, or in cardiovascular applications to manipulate or shape blood vessels, heart, or other tissue. The device may further be used to reshape or support tissue in aesthetic applications. The device may also be used to reshape or support tissue in urological or gynecological applications. For example, the devices may be used to reshape a penile curvature. The devices may also be used to support the pelvic floor muscles. In some cases, the devices described herein may be used to splint, hold, or support tissue.

[0020] In one variation, a device for manipulating tissue in a subject includes a tension element comprising an elongate body having a proximal end and a distal end, and a distal anchor at the tension element distal end. The distal anchor may include an anchor body, a pivot point, an insertion configuration, and a deployed configuration. The distal anchor body may be structured to include multiple arms, which may be configured to pivot at the pivot point from the insertion configuration to the deployed configuration in response to application of a force to the elongate body.

[0021] Also described herein are methods for manipulating tissue within a subject. The methods may generally include anchoring a tension element to tissue, the tension element comprising an elongated body having a proximal end and a distal end, and a distal anchor at the tension element distal end. In some variations, the distal end of the tension element may be directed through the tissue with an anchor delivery element. The distal anchor may include an anchor body, a pivot point, an insertion configuration, and a deployed configuration. After anchoring the tension element to the tissue, a force may be applied to the elongated body to pivot the distal anchor at the pivot point from the insertion configuration to the deployed configuration. An appropriate force for manipulating the tissue may then be adjusted by adjusting the tension of the tension element.

[0022] The proximal and distal ends of the elongated body of the tension element may be secured to the same tissue. Alternatively, the proximal and distal ends of the elongated body may be secured to different tissues. The tissue may be nasal tissue, throat tissue, or ear tissue. Exemplary nasal tissues include, but are not limited to, nasal septum cartilage, lateral nasal cartilage, greater alar cartilage, lesser alar cartilage, alar fibroadipose tissue, nasal bone, or nasal turbinate. Exemplary throat tissues include, but are not limited to, the uvula, soft palate, laryngeal cartilage, thyroid cartilage, cricoid cartilage, epiglottis, and tonsils. Non-limiting examples of ear tissues include cartilage of the helix, antihelix, tragus, antitragus, crus of the antihelix, triangular fossa, turbinate, and connective tissue of the ear lobe.

[0023] The methods described herein may be used to treat a variety of medical conditions and manipulate a variety of tissues. For example, manipulation of tissue with tension elements may be used to treat deviated nasal septum, collapsed lateral nasal valve, and other causes of nasal airway obstruction. In addition, manipulation of tissue may be used to medialize the middle turbinate, compress or lateralize the inferior turbinate, or reapproximate the nasal mucosa. Furthermore, manipulation of tissue with tension elements may alter the shape of various tissues. For example, the shape of nasal tissue, throat tissue, or ear tissue may be altered.

[0024] The force applied to manipulate or shape the tissue may range from about 4.0 Newtons to about 70 Newtons. The force applied may decrease over time as the tension element biodegrades. Generally, the tension element biodegrades over a period of about 3 months to about 12 months. For example, the tension element may biodegrade over a period of at least about 4 months, over a period of at least about 6 months, or over a period of at least about 9 months.

[0025] Delivery of the device is also described herein. In general, the delivery device may include a cannula with a proximal end, a distal end, and an atraumatic tip. The cannula may further include a lumen extending from the proximal end through the atraumatic tip and within which the tension element may be stored. The tension element may include a distal anchor configured to pivot at a pivot point from an insertion configuration to a deployed configuration upon application of force to the tension element. The tension element and anchor delivery element may be preloaded into the delivery device or loaded into the delivery device immediately prior to the procedure. A handle may be coupled to the cannula proximal end and an actuator may be concentrically disposed about the handle. The actuator may be coupled to the anchor delivery element and advance the anchor delivery element and the tension element coupled thereto out of the lumen of the cannula.

[0026] In some variations, the cannula of the delivery device may be made of a transparent material, such as a clear plastic selected from the group consisting of acrylic, polycarbonate, polyethylene terephthalate, polyvinyl chloride, polyethylene, polypropylene, and polystyrene. In other variations, the cannula may be made of stainless steel or other suitable metals. The cannula may also have various cross-sectional shapes. For example, the cross-sectional shape of the cannula may be circular, non-circular, semi-circular, or oval. In some variations where the cannula cross-section is non-circular, the shape may facilitate orientation of the cannula. One or more ports in fluid communication with the lumen may be provided within the cannula for delivery of the tension element from the lumen into the tissue. The one or more ports may be provided in any suitable location on the cannula, for example, at the distal tip or distal side wall of the cannula. The one or more ports may also have any suitable shape. For example, the one or more ports may be circular, semi-circular, or oval. When a port is provided at the distal tip of the cannula, the port may have a length and depth. The side profile of the port may also include curved and flat portions.

[0027] The delivery device may also include a handle with a grip. The grip may include a number of ridges to improve a user's grip on the handle. Directional indicators may also be provided on the handle for orienting the port relative to the anchoring location within the target tissue.

[0028] In some cases, a device for shaping a tissue structure of a subject may include an elongate member with a proximal end, a distal end sized for introduction into a body of a subject, and a lumen extending between the proximal end and a port in the distal end, and a shaping element. The shaping element may include a first end sized for introduction through the lumen to deploy the first end from the port and engage tissue adjacent the tissue structure, a second end opposite the first end, and one or more elements that maintain a force on the engaged tissue to alter the shape of the tissue structure.

[0029] In other cases, a device for shaping a tissue structure of a subject may include an elongate member having a proximal end, a distal end sized for introduction into a body of a subject, and a lumen extending between the proximal end and a port at the distal end, and a needle removably coupled to the elongate member. A shaping element may further be included having a first end deployable from the port to engage tissue at a first location adjacent the tissue structure, a second end carried by the needle to anchor the second end to tissue at a second location adjacent the tissue structure, and one or more elements that maintain tension on the engaged tissue to modify the shape of the tissue structure.

[0030] Other variations of devices for shaping a tissue structure of a subject may include an elongate member with a proximal end, a distal end sized for introduction into a body of a subject, and a lumen extending between the proximal end and a port at the distal end, a needle removably coupled to the elongate member, and a shaping element. The shaping element may include a first end deployable from the port to engage tissue at a first location adjacent the tissue structure, a second end carried by the needle to anchor the second end to tissue at a second location adjacent the tissue structure, and one or more elements that maintain tension on the engaged tissue to modify the shape of the tissue structure.

[0031] In some variations, a device for shaping a tissue structure of a subject may include an elongate member having a proximal end, a distal end sized for introduction into a body of a subject, a lumen extending between the proximal and distal ends, a first port at the distal end, and a second port located proximal to the first port, and a shaping element. The shaping element may include a first end deployable from the first port to engage tissue at a first location adjacent the tissue structure, a second end deployable from the second port to engage tissue at a second location adjacent the tissue structure, and one or more elements that maintain tension on the engaged tissue to modify the shape of the tissue structure.

[0032] Additional methods for modifying the shape of a tissue structure of a subject are also described herein. According to an exemplary variation, the method may employ a device including an elongate member with a proximal end, a distal end sized for introduction into a body of a subject, and a lumen extending between the proximal end and a port at the distal end, and a shaping element. The shaping element may include a first end sized for introduction through the lumen for deploying the first end from the port and engaging tissue adjacent to the tissue structure, a second end opposite the first end, and one or more elements that maintain a force on the engaged tissue to modify the shape of the tissue structure.

[0033] A method for modifying the shape of nasal tissue of a subject is also provided, comprising inserting a distal end of a delivery device into a nasal airway of a subject, deploying a first end of a shaping element from the distal end into the nasal airway, anchoring the first end of the shaping element to tissue adjacent the nasal airway, manipulating the shaping element to modify the shape of the tissue, and removing the delivery device such that the shaping element at least temporarily maintains the modified shape of the tissue.

[0034] Additionally, a method for modifying the shape of nasal tissue of a subject is provided, comprising deploying a first end of a shaping element into a nasal airway of a subject, anchoring the first end of the shaping element to tissue at a first location adjacent the nasal airway, manipulating the shaping element to modify the shape of the tissue, and anchoring the shaping element to tissue at a second location to maintain the modified shape of the tissue.

[0035] Still further described herein is a method for modifying a shape of a target tissue structure of a subject, comprising the steps of anchoring a first end of a shaping element to tissue adjacent the structure, manipulating the tissue to modify the shape of the structure, and applying a force to the shaping element to maintain the modified shape of the structure.

[0036] According to some variations, a method is described that provides for modifying the shape of a subject's nasal tissue, including introducing an anchor into the subject's nasal airway, anchoring the anchor to the subject's nasal septum at a first location, introducing a first end of a shaping element into the subject's nasal airway, anchoring the first end of the shaping element to the anchor, manipulating the shaping element to modify the shape of the tissue, and anchoring the shaping element to the tissue at a second location to maintain the modified shape of the tissue.

[0037] Methods for modifying the shape of nasal tissue of a subject described herein may also include inserting a distal end of a delivery device into a nasal airway of the subject, deploying a first end of a shaping element from the distal end into the nasal airway, anchoring the first end of the shaping element to tissue at a first location adjacent the nasal airway, removing the delivery device such that the shaping element extends from the nasal airway, inserting a needle coupled to a second end of the shaping element into the nasal airway, manipulating the shaping element to modify the shape of the tissue, and anchoring the second end at a second location adjacent the nasal airway to at least temporarily maintain the modified shape of the tissue. [Brief description of the drawings]

[0038]

[0013] Illustrative aspects of the present disclosure are described in detail below with reference to the following drawings: It should be understood that the example devices shown in the drawings are not necessarily drawn to scale, emphasis instead being placed on illustrating various features of the depicted variations.

[0039] [Figure 1] FIG. 1 depicts an exemplary tensioning element for use in altering the shape of nasal tissue.

[0040] [Diagram 2] FIG. 2 depicts an exemplary method for shaping the nasal septum cartilage.

[0041] [Diagram 3] FIG. 3 depicts an exemplary method for shaping the lateral nasal cartilages, the greater and lesser alar cartilages, the alar fibroadipose tissue, the nasal bones, and the nasal turbinates.

[0042] [Figure 4] FIG. 4 depicts another example tension element comprising a suture having an anchoring element at one end and a needle at the other end.

[0043] [Diagram 5] FIG. 5 depicts an exemplary method for shaping nasal tissue using tensioning elements configured to act on multiple regions of the targeted nasal tissue.

[0044] [Figure 6] FIG. 6 depicts another example tension element that includes multiple anti-migration elements and force distribution regions.

[0045] [Figure 7] FIG. 7 depicts a further exemplary tension element including multiple anti-migration elements and a mesh-like force distribution region.

[0046] [Figure 8]FIG. 8 depicts yet another exemplary tension element that includes multiple components that interact in an adjustable manner to apply tension to tissue.

[0047] [Figure 9] FIG. 9 depicts an example tension element according to another variation that includes an adjustable fastening element.

[0048] [Figure 10] FIG. 10 depicts yet another example tension element in which an adjustable fastening element interacts with ribs or fins positioned along the length of the tension element.

[0049] [Figure 11] FIG. 11 shows a device according to another variation in which multiple tension elements are held together with a removable element.

[0050] [Figure 12] 12 and 13 depict exemplary devices for delivering the tension element. In Fig. 12, the delivery device includes a tip for storing the tension element. The delivery device shown in Fig. 13 includes a pistol grip. [Figure 13] 12 and 13 depict exemplary devices for delivering the tension element. In Fig. 12, the delivery device includes a tip for storing the tension element. The delivery device shown in Fig. 13 includes a pistol grip.

[0051] [Figure 14] FIG. 14 depicts an exemplary delivery device according to another variation that includes an attachment site on the delivery device shaft for attachment to or removal from the body of the device.

[0052] [Figure 15] FIG. 15 depicts an exemplary delivery device that includes a blunt tip and an opening on the side of the delivery device shaft for lateral or orthogonal deployment of the tension element relative to the elongated shaft.

[0053] [Figure 16] FIG. 16 depicts another exemplary delivery device that includes a visualization element at the tip of the device.

[0054] [Figure 17] FIG. 17 depicts yet another exemplary delivery device that includes a mounting mechanism to assist in the deployment of tension elements into tissue.

[0055] [Figure 18] FIG. 18 depicts a further exemplary delivery device that places a first anchoring element at the distal end of the tension element and a second anchoring or anti-migration element at the proximal end of the tension element.

[0056] [Figure 19] FIG. 19 depicts an exemplary delivery device that includes a retractable mechanism for deploying tension elements into tissue.

[0057] [Figure 20] 20 and 21 depict other exemplary delivery devices that include a mounting mechanism having a reloading element. [Figure 21] 20 and 21 depict other exemplary delivery devices that include a mounting mechanism having a reloading element.

[0058] [Figure 22] FIG. 22 depicts yet another exemplary delivery device that includes multiple mounting mechanisms.

[0059] [Diagram 23] FIG. 23 depicts a further exemplary delivery device that includes a visualization element and an actuator arm that facilitates deployment of the tension element.

[0060] [Figure 24]FIG. 24 depicts an exemplary delivery device according to another variation that includes a mechanical element for manipulating the tissue into a desired altered shape before using the tension element to fix the shape, and a fastening mechanism for fastening the tension element from its initial deployed position to a final position.

[0061] [Diagram 25] 25 and 26 depict an exemplary device for delivering a tension element that alters the shape of the nasal septum. [Figure 26] 25 and 26 depict an exemplary device for delivering a tension element that alters the shape of the nasal septum.

[0062] [Figure 27] 27 and 28 depict example tension elements that include components for anchoring the tension element in tissue. In Fig. 27, the tension element includes an enlarged distal end that interfaces with the anchoring element, and in Fig. 28, the anchoring element includes tissue interacting features designed to hook into tissue. [Figure 28] 27 and 28 depict example tension elements that include components for anchoring the tension element in tissue. In Fig. 27, the tension element includes an enlarged distal end that interfaces with the anchoring element, and in Fig. 28, the anchoring element includes tissue interacting features designed to hook into tissue.

[0063] [Figure 29] FIG. 29 depicts an exemplary delivery device including an expandable tissue displacement feature.

[0064] [Diagram 30] FIG. 30 depicts another exemplary delivery device that includes a tissue cutting feature.

[0065] [Diagram 31] FIG. 31 depicts yet another exemplary delivery device that includes a tissue retraction feature.

[0066] [Diagram 32]32 and 33 depict additional exemplary delivery devices including a tissue cutting instrument that does not engage tissue when moved in a first direction, but does engage tissue when moved in a second direction. [Diagram 33] 32 and 33 depict additional exemplary delivery devices including a tissue cutting instrument that does not engage tissue when moved in a first direction, but does engage tissue when moved in a second direction.

[0067] [Diagram 34] FIG. 34 depicts an exemplary accessory tissue cutting instrument having first and second positions and including head features that allow for puncturing through tissue in the first position but prevent pulling backward through the tissue when in the second position.

[0068] [Diagram 35] FIG. 35 depicts an exemplary accessory tissue retraction instrument designed to file or abrade tissue.

[0069] [Diagram 36] FIG. 36 depicts an exemplary accessory tissue displacement instrument.

[0070] [Figure 37] 37 and 38 depict an accessory tissue displacement instrument according to another variation that displaces tissue in response to changing from a first position to a second position. [Figure 38] 37 and 38 depict an accessory tissue displacement instrument according to another variation that displaces tissue in response to changing from a first position to a second position.

[0071] [Figure 39] FIG. 39 depicts another exemplary tissue displacement instrument that includes an expandable element and an expansion activation element.

[0072] [Diagram 40] FIG. 40 depicts an exemplary tissue retaining element that applies a force to tissue to hold the tissue in an altered shape.

[0073] [Diagram 41] FIG. 41 depicts yet another exemplary delivery device including a tissue separation element.

[0074] [Diagram 42] FIG. 42 depicts a further exemplary delivery device that includes alignment features for holding a tissue retaining element in a position relative to the delivery device.

[0075] [Diagram 43] FIG. 43 depicts a top view of another example tension element including a distal anchor having arms that pivot from an insertion configuration to a deployed configuration.

[0076] [Diagram 44] FIG. 44 depicts an enlarged view of the distal end of the tension element shown in FIG.

[0077] [Figure 45A] FIG. 45A depicts a top view of an exemplary Z-flex anchor.

[0078] [Figure 45B] FIG. 45B depicts a top view of an exemplary Y-flex anchor.

[0079] [Diagram 46] FIG. 46 depicts another exemplary distal anchor pivoting from an insertion configuration to a deployed configuration.

[0080] [Figure 47A] 47A and 47B depict a further variation of the distal anchor. [Figure 47B] 47A and 47B depict a further variation of the distal anchor.

[0081] [Figure 48A] 48A-48E depict another exemplary distal anchor shaped like a dogbone and its deployment through tissue. [Figure 48B] 48A-48E depict another exemplary distal anchor shaped like a dogbone and its deployment through tissue. [Figure 48C] 48A-48E depict another exemplary distal anchor shaped like a dogbone and its deployment through tissue. [Figure 48D] 48A-48E depict another exemplary distal anchor shaped like a dogbone and its deployment through tissue. [Figure 48E] 48A-48E depict another exemplary distal anchor shaped like a dogbone and its deployment through tissue.

[0082] [Figure 49A] 49A-49D depict yet another exemplary distal anchor including a heel and toe retainer and its deployment through tissue. [Figure 49B] 49A-49D depict yet another exemplary distal anchor including a heel and toe retainer and its deployment through tissue. [Figure 49C] 49A-49D depict yet another exemplary distal anchor including a heel and toe retainer and its deployment through tissue. [Figure 49D] 49A-49D depict yet another exemplary distal anchor including a heel and toe retainer and its deployment through tissue.

[0083] [Figure 50A] 50A and 50B depict an exemplary quick release needle for use at the proximal end of the tension element. [Figure 50B] 50A and 50B depict an exemplary quick release needle for use at the proximal end of the tension element.

[0084] [Figure 51A] 51A-51C depict exemplary keyhole shapes for removably coupling the tow of the tension element to the anchor delivery element. [Figure 51B] 51A-51C depict exemplary keyhole shapes for removably coupling the tow of the tension element to the anchor delivery element. [Figure 51C] 51A-51C depict exemplary keyhole shapes for removably coupling the tow of the tension element to the anchor delivery element.

[0085] [Figure 52A] 52A-52C depict an exemplary anchor delivery element. [Figure 52B] 52A-52C depict an exemplary anchor delivery element. [Figure 52C] 52A-52C depict an exemplary anchor delivery element.

[0086] [Diagram 53] FIG. 53 depicts an exemplary Z-flex anchor seated within the anchor delivery element of FIGS. 52A-52C.

[0087] [Figure 54] FIG. 54 depicts an exemplary distal anchor surface that is flush with the anchor delivery element surface.

[0088] [Figure 55] FIG. 55 depicts another distal anchor and its mechanism of release from the anchor delivery element according to a further variation.

[0089] [Figure 56] FIG. 56 depicts another example tension element that includes multiple knots as proximal anchors.

[0090] [Figure 57A] 57A-57C depict an exemplary method for medializing the middle turbinate. [Figure 57B] 57A-57C depict an exemplary method for medializing the middle turbinate. [Figure 57C] 57A-57C depict an exemplary method for medializing the middle turbinate.

[0091] [Figure 58A] 58A-58D depict an exemplary method for treating inferior turbinate hypertrophy. [Figure 58B] 58A-58D depict an exemplary method for treating inferior turbinate hypertrophy. [Figure 58C] 58A-58D depict an exemplary method for treating inferior turbinate hypertrophy. [Fig. 58D] 58A-58D depict an exemplary method for treating inferior turbinate hypertrophy.

[0092] [Figure 59A] 59A-59D depict an exemplary method for treating lateral nasal valve collapse. [Figure 59B] 59A-59D depict an exemplary method for treating lateral nasal valve collapse. [Figure 59C] 59A-59D depict an exemplary method for treating lateral nasal valve collapse. [Fig. 59D] 59A-59D depict an exemplary method for treating lateral nasal valve collapse.

[0093] [Figure 60A] 60A-60C depict an exemplary method for reshaping the tip of the nose. [Figure 60B] 60A-60C depict an exemplary method for reshaping the tip of the nose. [Figure 60C] 60A-60C depict an exemplary method for reshaping the tip of the nose.

[0094] [Figure 61] FIG. 61 depicts an exemplary method for anchoring the nasal mucosa and preventing nasal septum hematoma formation.

[0095] [Figure 62A] 62A-62C depict an exemplary method of elevating the uvula and soft palate to treat obstructive sleep apnea. [Figure 62B] 62A-62C depict an exemplary method of elevating the uvula and soft palate to treat obstructive sleep apnea. [Figure 62C] 62A-62C depict an exemplary method of elevating the uvula and soft palate to treat obstructive sleep apnea.

[0096] [Figure 63A] 63A and 63B depict example areas of the ear for placement of tension elements to reshape the ear. [Figure 63B] 63A and 63B depict example areas of the ear for placement of tension elements to reshape the ear.

[0097] [Fig. 64A] FIG. 64A depicts an exemplary device for delivering a tension element.

[0098] [Fig. 64B] 64B-64D depict further features of the distal port of the cannula shown in FIG. 64A. [Fig. 64C] 64B-64D depict further features of the distal port of the cannula shown in FIG. 64A. [Fig.64D] 64B-64D depict further features of the distal port of the cannula shown in FIG. 64A.

[0099] [Figure 64E] FIG. 64E depicts a cross-sectional view of the actuator of the delivery device shown in FIG. 64A coupled to an anchor delivery element.

[0100] [Figure 65] FIG. 65 depicts an exemplary method for deploying the tension element from a delivery device.

[0101] [Figure 66] FIG. 66 depicts another exemplary handle for a delivery device.

[0102] [Figure 67] FIG. 67 depicts an exemplary distal anchor having arms with beveled distal ends.

[0103] [Figure 68A] 68A-68E depict an exemplary method of shaping the nasal septum using a tension element. [Figure 68B] 68A-68E depict an exemplary method of shaping the nasal septum using a tension element. [Figure 68C] 68A-68E depict an exemplary method of shaping the nasal septum using a tension element. [Figure 68D] 68A-68E depict an exemplary method of shaping the nasal septum using a tension element. [Figure 68E] 68A-68E depict an exemplary method of shaping the nasal septum using a tension element. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0104] Detailed Description Described herein are devices and methods for applying tension to various tissues. The devices can be delivered in a minimally invasive manner and used to manipulate tissues in the nose, ears, and throat. Force can be maintained by the device for a period of time to allow tissue to be shaped, compressed, or approximated. The devices may include a tension element having a distal anchor that can be inserted into or through tissue in an insertion configuration in one direction and can pivot, expand, rotate, or spread out to a deployed configuration upon application of force in an opposite direction to prevent passage of the distal anchor backward through the tissue. Once the distal anchor transitions to the deployed configuration, additional force can be applied to the tension element and adjusted to an amount desired for the intended application. For example, the tension element can be placed in one or more nasal tissues and the tension adjusted to an amount that alters the shape of the nasal tissue. Also described herein are accessory devices that cut or abrade tissue, aid in shaping tissue, or aid in displacing or moving tissue into position for fixation by the tensioning elements. Further described herein are devices for delivering one or more tensioning elements.

[0105] device A device for manipulating tissue within a subject generally includes a tension element, the tension element including an elongate body having a proximal end and a distal end. A distal anchor having an insertion configuration and a deployed configuration is provided at the tension element distal end and may include an anchor body and a pivot point. In response to application of force to the elongate body, the distal anchor may be configured to pivot, rotate, or spread at the pivot point and convert from the insertion configuration to the deployed configuration, as described above. In the deployed configuration, the distal anchor generally anchors or anchors the distal end of the tension element within the tissue. This applied force is generally in a direction opposite to the direction of insertion. In some cases, the longitudinal axis of the distal anchor is orthogonal to the longitudinal axis of the tension element in its deployed configuration. Additionally, the distal anchor may be configured to expand and provide anchoring within the tissue. The tension element may also include multiple proximal anchors between the distal anchor and the proximal end of the elongate body. A needle may further be provided at the proximal end of the elongate body to facilitate advancement or placement of the tension element through tissue after the distal anchor has been deployed.

[0106] One or more tension elements may be delivered to manipulate or shape tissue. When multiple tension elements are used, they may be attached to a common core or central element. For example, multiple tension elements may be connected to create a "Y" or other configuration to achieve multiple tension vectors.

[0107] Tension element The tension element may be made from biodegradable or non-biodegradable materials. When the tension element is biodegradable, it may be made from a biodegradable polymer. Exemplary biodegradable polymers include, but are not limited to, LPLA (poly(L-lactic acid), DLPLA (poly(DL-lactic acid), LDLPLA (poly(DL-lactic acid-co-L-lactic acid), LPLA-HA (poly(L-lactic acid) with hydroxyapatite), PGA (poly(glycolide), PGA-TMC (poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (poly(dioxanone), LPLG (poly(L-lactic acid-co-glycolide), DLPLG (poly(DL-lactic acid-co-glycolide), or copolymers or hybrids thereof. In some variations, the biodegradable poly The mer comprises polylactic acid, poly(orthoester), poly(phosphate ester), polyphosphazene, polyanhydride, polycaprolactone, polyurethane, polycarbonate, chitosan, cyclodextrin, dextran, hyaluronic acid, chondroitin sulfate, dermatan sulfate, heparin, heparin sulfate, keratan sulfate, or copolymers or hybrids thereof. In one variation, the tension element may be made from PDO (poly(dioxanone). In another variation, the tension element may be made from a metal, such as magnesium or a magnesium alloy. Other metals may also be used.

[0108] When the tension element is formed from a biodegradable material, it may degrade over a period ranging from about 3 months to about 12 months. For example, the tension element may degrade over a period ranging from about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, or about 12 months. In one variation, the tension element may degrade over a period ranging from about 4 months to about 9 months. Depending on the material from which the tension element is made, loss of tensile strength may occur prior to complete degradation of the tension element. In these variations, the tension element may be made from a material that provides a sufficient amount of tensile strength over a desired period of time.

[0109] When the tension element is non-biodegradable, it may be made of a non-biodegradable polymer or metal. Exemplary non-biodegradable polymers include, but are not limited to, poly(ethylene vinyl acetate), poly(vinyl acetate), silicone polymers, polyurethanes, polysaccharides, such as cellulose polymers and derivatives, acyl-substituted cellulose acetate and its derivatives, copolymers of poly(ethylene glycol) and poly(butylene terephthalate), polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, silk, nylon, polyamide, polypropylene, polyester, polybutester, and copolymers and hybrids thereof. Exemplary metals include, but are not limited to, platinum, silver, stainless steel, nickel, titanium, and alloys thereof.

[0110] The tension element may be formed to have any suitable cross-sectional shape. For example, the cross-sectional shape may be circular, semicircular, oval, rectangular, square, or triangular. When rectangular in cross-section, the width and thickness of the tension element may range from about 0.25 mm to about 1.5 mm, including all values ​​and subranges therein. For example, the width may be about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1.0 mm, about 1.25 mm, or about 1.5 mm. In one variation, the width of the tension element may be about 0.65 mm. Similarly, the thickness of the tension element may be about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1.0 mm, about 1.25 mm, or about 1.5 mm. In one variation, the thickness of the tension element may be about 0.7 mm.

[0111] The tension element may be configured to hold or maintain a force on the target tissue. The force may be a tension ranging from about 4.0 Newtons to about 70 Newtons, including all values ​​and subranges therein, which may be generated by pulling the free proximal end of the tension element after the distal anchor is secured to the target tissue. For example, the tension may be about 4.0 Newtons, about 5.0 Newtons, about 10 Newtons, about 15 Newtons, about 20 Newtons, about 25 Newtons, about 30 Newtons, about 35 Newtons, about 40 Newtons, about 45 Newtons, about 50 Newtons, about 55 Newtons, about 60 Newtons, about 65 Newtons, or about 70 Newtons. The tensile strength of the tension element may range from about 100 MPa to about 600 MPa, including all values ​​and subranges therein. For example, the tensile strength may be about 100 MPa, about 110 MPa, about 120 MPa, about 130 MPa, about 140 MPa, about 150 MPa, about 155 MPa, about 160 MPa, about 165 MPa, about 170 MPa, about 175 MPa, about 180 MPa, about 185 MPa, about 190 MPa, about 195 MPa, about 200 MPa, about 210 MPa, about 220 MPa, about 230 MPa, about 240 MPa, about 250 MPa, about 260 MPa, about 270 MPa, about 280 MPa, about 290 MPa, about 300 MPa, about 350 MPa, about 400 MPa, about 450 MPa, about 500 MPa, about 550 MPa, or about 600 MPa. In some cases, the tensile strength of the tension element may be at least about 150 MPa. In other cases, the tensile strength of the tension element may be at least about 300 MPa.

[0112] The overall length of the tension element may vary prior to delivery depending on the target tissue of deployment, the type of procedure being performed, and / or the subject's anatomy. The total tension element length prior to delivery may range from about 10 cm to about 30 cm, including all values ​​and subranges therein. For example, the overall length may be about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, or about 30 cm. In one variation, the tension element may have an overall length of about 15 cm prior to delivery. Once delivered to the target tissue, the tension element may be trimmed to a length that applies an appropriate amount of force, reshaping, etc. to the target tissue. A longer length can help facilitate handling of the tension element while the target tissue is being manipulated.

[0113] The length of the tension element between the distal anchor and the most distally positioned proximal anchor ranges from about 10 mm to about 25 mm, including all values ​​and subranges therein. For example, the length may be about 10 mm, about 15 mm, about 20 mm, or about 25 mm. The length may be adjusted to be longer or shorter depending on the tissue to be manipulated. A length of about 10 mm to about 25 mm may be useful when the nasal septum cartilage is to be manipulated.

[0114] The length of the tension element between the needle at the proximal end of the elongate body and the most proximal positioned proximal anchor ranges from about 50 mm to about 70 mm, including all values ​​and subranges therein. For example, the length may be about 50 mm, about 55 mm, about 60 mm, about 65 mm, or about 70 mm. The tension element may or may not include any proximal anchors along its length. Additionally, the tension element may be trimmed to a final length along its length.

[0115] Anchor The devices described herein may include a distal anchor at a distal end of the tension element. The distal anchor may have an insertion configuration and a deployed configuration. Additionally, the distal anchor may include an anchor body and a pivot point. In response to application of a force to the elongated body of the tension element, the distal anchor may be configured to pivot or flex at the pivot point and convert from the insertion configuration to the deployed configuration. The applied force is generally in a direction opposite to the direction of insertion. In some cases, the longitudinal axis of the distal anchor may be perpendicular to the longitudinal axis of the tension element in its deployed configuration. However, the distal anchor may pivot about the pivot point in any suitable amount to achieve the deployed configuration. The distal anchor may pivot about the pivot point at a pivot angle ranging from about 30 degrees to about 90 degrees relative to the longitudinal axis of the tension element, including all values ​​and subranges therein. For example, the pivot angle may be about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, or about 90 degrees.

[0116] The distal anchor may be variously sized and shaped. Generally, in its deployed configuration, the distal anchor prevents passage of the distal end of the tension element rearwardly through tissue. The distal anchor may have a length ranging from about 0.5 mm to about 15 mm and a width ranging from about 0.5 mm to about 5.0 mm.

[0117] In some variations, the anchor body may include multiple arms, and the arms may be configured to pivot or flex at a pivot point in response to application of a force to the elongated body. Any suitable number of arms may be employed. For example, two, three, or four arms may be included. When the anchor body includes two arms, the distal anchor may be referred to as a "Z-flex anchor." The body of the Z-flex anchor may have a width ranging from about 0.5 mm to about 5.0 mm, including all values ​​and subranges therein. For example, the Z-flex anchor body may have a width of about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, or about 5.0 mm. In one variation, the Z-flex anchor body has a width of about 2.5 mm. Additionally, the Z-flex anchor body may have a length ranging from about 0.5 mm to about 15 mm, including all values ​​and subranges therein. For example, the length of the Z-flex anchor body may be about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, about 5.5 mm, about 6.0 mm, about 6.5 mm, about 7.0 mm, about 7.5 mm, about 8.0 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm. In one variation, the Z-flex anchor body has a length of about 2.75 mm. The arms of the Z-flex anchor body may also have a length and width. Here, the arm length may be about 1.5 mm and the width about 0.6 mm. In some variations, it may be useful for the arm width to be about one-third the width of the Z-flex anchor body.

[0118] Each arm of the multiple arms of the anchor body may include a distal end that is bevel cut to form a slope that may help pivot the distal anchor at a pivot point and facilitate its engagement with tissue. The bevel may be cut through the entire thickness of each arm. The angle of the bevel may range from about 15 degrees to about 75 degrees, including all values ​​and subranges therein. For example, the bevel angle may be about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, or about 75 degrees. In one variation, the bevel angle is about 45 degrees. Referring to FIG. 67, an exemplary distal anchor (70) is shown and includes an anchor body (71) and multiple arms (72). The distal end (73) of each of the arms (72) is bevel cut to form a beveled surface (74). A bevel angle (75) may be formed at the point where the beveled surface (74) intersects with the longitudinal axis (76) of the distal anchor (70). In some variations, the distal anchor may be a Z-flex anchor comprising two arms, each of which includes a distal end with a bevel angle of approximately 45 degrees.

[0119] Alternatively, the anchor body may be rectangular, square, triangular, circular, or oval shaped. The anchor body may also be diamond shaped or shaped like an arrow or dogbone. In some variations, the anchor body may include a heel-and-toe retainer. In other variations, the anchor body may be expandable from a collapsed configuration to an expanded configuration, where the collapsed configuration may allow insertion of the distal anchor through tissue in a first direction, and the expanded configuration prevents passage of the distal anchor through tissue in a second direction, e.g., backwards, opposite the first direction.

[0120] A plurality of proximal anchors (anti-migration elements) may further be disposed between the distal anchor and the proximal end of the tension element. The distal anchor and the plurality of proximal anchors may be the same type of anchor or different types of anchors. Generally, the proximal anchors are sized to be smaller than the distal anchors, but may be the same size, if desired. Any suitable number of proximal anchors may be employed. The number of proximal anchors provided between the distal anchor and the proximal end of the elongated body may range from 5 to 40. For example, the plurality of proximal anchors may include 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 anchors. The length of the tension element, including the proximal anchor, may be about 75 mm. The spacing between the proximal anchors may be the same or different. When the spacing is uniform between the proximal anchors, the length of the space may be about 3.0 mm. The spacing between the distal anchor and the most distal proximal anchor may be about 10 mm. In one variation, the proximal anchors include Z-flex anchors, where the arms of the Z-flex anchor may have a length ranging from about 0.25 mm to about 1.25 mm. For example, the arms may have a length of about 0.25 mm, about 0.50 mm, about 0.75 mm, about 1.0 mm, or about 1.25 mm. The arms of the Z-flex anchor may have a width of about 0.6 mm.

[0121] An enlarged tip may also be provided at the distal end of the tension element distal to the distal anchor to further facilitate anchoring of the tension element to tissue and / or coupling to the anchor delivery element, as described further below. The distal anchor, enlarged tip, and multiple proximal anchors may be made from the same or different material as the tension element. In some variations, the distal anchor may be made from a non-biodegradable material and the multiple proximal anchors may be made from a biodegradable material, e.g., a biodegradable polymer. Exemplary biodegradable polymers include, but are not limited to, LPLA (poly(L-lactic acid), DLPLA (poly(DL-lactic acid), LDLPLA (poly(DL-lactic acid-co-L-lactic acid), LPLA-HA (poly(L-lactic acid) with hydroxyapatite), PGA (poly(glycolide), PGA-TMC (poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (poly(dioxanone), LPLG (poly(L-lactic acid-co-glycolide), DLPLG (poly(DL-lactic acid-co-glycolide), or copolymers or hybrids thereof. Additional exemplary biodegradable polymers include polylactic acid, poly(orthoesters), poly(phosphate esters), polyphosphazenes, polyanhydrides, polycaprolactones, polyurethanes, polycarbonates, chitosan, cyclodextrins, dextran, hyaluronic acid, chondroitin sulfate. , dermatan sulfate, heparin, heparin sulfate, keratan sulfate, or copolymers or hybrids thereof. In some variations, the distal anchor, the enlarged tip, and the plurality of proximal anchors may be made from PDO (poly(dioxanone). The non-biodegradable material may include a non-biodegradable polymer or metal. Exemplary non-biodegradable polymers include, but are not limited to, poly(ethylene vinyl acetate), poly(vinyl acetate), silicone polymers, polyurethanes, polysaccharides, such as cellulose polymers and derivatives, acyl-substituted cellulose acetate and its derivatives, copolymers of poly(ethylene glycol) and poly(butylene terephthalate), polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, and copolymers and hybrids thereof.Exemplary metals include, but are not limited to, stainless steel, nickel, titanium, magnesium, and alloys thereof.

[0122] The tension element, distal anchor, enlarged tip, and plurality of proximal anchors may comprise a coating. In some variations, the coating may include an antimicrobial agent. Exemplary antimicrobial agents include, but are not limited to, aminoglycosides, amphenicols, ansamycins, beta-lactams (β-lactams), such as penicillins, lincosamides, macrolides, nitrofurans, quinolones, sulfonamides, sulfones, tetracyclines, vancomycin, and any of their derivatives, or combinations thereof. Examples of penicillins that may be suitable for use with the described methods and devices include, but are not limited to, amdinocillin, amdinocillin pivoxil, amoxicillin, ampicillin, apalcillin, aspoxilin, azidocillin, azlocillin, bacampicillin, benzylpenicillin acid, benzylpenicillin sodium, carbenicillin, carindacillin, clomethocillin, cloxacillin, cyclacillin, dicloxacillin, epicillin, fenbenicillin, floxacillin, hetacillin, lenampicillin, methampicillin, methicillin sodium, mezlocillin, nafcillin, and nafcillin. These include penicillin sodium, oxacillin, penamecillin, penethamate hydroiodide, penicillin G benethamine, penicillin G benzathine, penicillin G benzhydrylamine, penicillin G calcium, penicillin G hydrabamine, penicillin G potassium, penicillin G procaine, penicillin N, penicillin O, penicillin V, penicillin V benzathine, penicillin V hydrabamine, penimepicycline, phenethicillin potassium, piperacillin, pivampicillin, propicillin, quinacillin, sulbenicillin, sultamicillin, talampicillin, temocillin, and ticarcillin.

[0123] In other variations, the coating may include growth factors that promote cartilage remodeling. Exemplary growth factors include, but are not limited to, TGF-β1 (transforming growth factor-β), BMP-2 (bone morphogenetic protein-2), BMP-7 (bone morphogenetic protein-7), IGF-I (insulin growth factor-I), FGF-2 (fibroblast growth factor-2), FGF-18 (fibroblast growth factor-18), and PDGF (platelet-derived growth factor).

[0124] In further variations, the coating may include a hydrophobic polymer to slow down the degradation of the tension element. Examples of hydrophobic polymers that may be used to form the coating include, but are not limited to, fluoropolymers such as polytetrafluoroethylene (PTFE) and expanded polytetrafluoroethylene (ePTFE), polyvinyl chloride (PVC), polyvinyl acetate, poly(ethylene terephthalate), silicone, polyester, polyamide, polyurea, styrene-block copolymers, polymethylmethacrylate, acrylic-butadiene-styrene copolymers, polyethylene, polystyrene, polypropylene, natural and synthetic rubber, acrylonitrile rubber, and mixtures and copolymers of any of the foregoing.

[0125] In still further variations, the coating may include a vasoconstrictor. Examples of vasoconstrictors include, but are not limited to, epinephrine, levonordefrin, and adrenaline. In some variations, the coating may include a decongestant. Exemplary decongestants include, but are not limited to, epinephrine, pseudoephedrine, oxymetazoline, phenylephrine, tetrahydrozoline, and xylometazoline. The coating may also include an anti-inflammatory agent. Exemplary anti-inflammatory agents include, but are not limited to, 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, defazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, zilprednate, enoxolone, fluazacort, fuccloronide, flumethasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurane including drenolide, fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate, prednisolone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortol, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, any of their derivatives, and combinations thereof.

[0126] Needle and Anchor Delivery Elements The devices described herein may further include a proximal needle removably attached to the proximal end of the elongated body of the tension element. The proximal needle may be a cutting needle having a length ranging from about 5.0 mm to about 25 mm, including all values ​​and subranges therein. For example, the proximal needle may have a length of about 5.0 mm, about 10 mm, about 15 mm, about 20 mm, or about 25 mm. In one variation, the proximal needle has a length of about 13 mm. The proximal needle diameter may range from about 0.4 mm to about 2.0 mm, including all values ​​and subranges therein. For example, the proximal needle diameter may be about 0.4 mm, about 0.5 mm, about 1.0 mm, about 1.5 mm, or about 2.0 mm. In one variation, the proximal needle diameter is about 1.0 mm. In another variation, the proximal needle diameter is about 1.5 mm.

[0127] The proximal needle may be used to place or manipulate the proximal end of the elongated body through or around tissue and may be removably attached to the tension element in a variety of ways. For example, the proximal needle may be removably attached to the tension element by crimping or crimping, or by threading the tension element through a portion of the proximal needle. In some variations, the proximal needle is a quick-thread needle. In other variations, the proximal needle may be crimped to a loop of material, such as PDO (poly(dioxanone), which may then be bonded to the tension element.

[0128] At the distal end of the tension element, an anchor delivery element (long thin needle) may be coupled to the distal anchor. The anchor delivery element may include a cutting tip configured to pass the distal anchor through tissue in its insertion configuration. The anchor delivery element may be made from a variety of metals, including but not limited to stainless steel, spring steel, and nitinol. In some variations, the anchor delivery element may include a keyhole shaped to removably couple the distal anchor to the anchor delivery element. For example, the keyhole may be sized to keep the distal anchor coupled to the anchor delivery element during tissue insertion, but allow disengagement of the distal anchor during removal of the anchor delivery element back through tissue.

[0129] In other variations, the anchor delivery element may include a tip component and a metal strip. The tip component may include a cutting tip shaped to removably secure the enlarged distal end (tow) of the tension element, a cockpit or pocket, a clip region that removably secures the region of the tension element between the tow and the distal anchor to the anchor delivery element, and a seating region onto which the distal anchor may be positioned prior to deployment. In one variation, the tip component and the metal strip may comprise different sections of a single component. In another variation, the tip component and the metal strip may be separate components that are joined together. Materials that may be used to make the tip component and the metal strip include, but are not limited to, stainless steel, spring steel, and nitinol. The tip component and the metal strip may be made of the same or different metal materials. For example, in some variations, the tip component may be made of stainless steel and the metal strip may be made of nitinol. When the tip component and the metal strip are separate components, they may be joined to form the anchor delivery element via one or more rivets. Alternatively, the tip component and the metal strip may be joined by crimping, welding, or riveting. The tip component may be made by processes such as laser sintering, injection molding, or machining.

[0130] Additionally, the tip component may be formed so that it or the distal anchor does not have any leading edge that may catch on tissue during delivery to the target tissue. For example, the anchor delivery element and the distal anchor of the tension element may form a horizontal surface that may prevent the distal anchor from catching on tissue during insertion. In some cases, disengagement of the distal anchor from the seating area may be accomplished using a release tab. For example, referring to FIG. 55, a distal anchor (5000) including a release tab (5006) is shown seated within the seating area of ​​the anchor delivery element.

[0131] The tension elements described herein may have a variety of configurations. With reference to FIG. 43, an example tension element is shown. The tension element (1200) may include an elongated body (1202) having a proximal end (1204) and a distal end (1206). A distal anchor, such as a Z-flex anchor (1208), may be disposed at the distal end (1206) of the elongated member (1202). As shown in the close-up view of the distal end (1206) in FIG. 44, the Z-flex anchor (1208) includes an anchor body (1210), a pivot point (1212), a first arm (1218), and a second arm (1220). A number of proximal anchors (1214) may also be disposed between the distal Z-flex anchor (1208) and the proximal end (1204) of the tension element (1202) to help prevent migration of the tension element (1200) once deployed in tissue. The number of proximal anchors (1214) may also be Z-flex anchors facing in an opposite direction to that of the distal Z-flex anchor (1208). An enlarged distal end (toe) (1216) may also be provided distal to the Z-flex anchor (1208) for deployment into tissue to couple the Z-flex anchor to an anchor delivery element (not shown). At the proximal end (1204), the needle (1201) may be removably attached to the elongated body (1202). After deployment of the Z-flex anchors into the tissue, the needle (1201) may be used to place or manipulate the proximal end (1204) of the elongated body (1202) through or around the tissue. In another variation, the multiple proximal anchors may be multiple knots (6000), as shown in FIG. 56. In this variation, the distal anchor may be the Z-flex anchor (6002). To apply tension to the tension element (6008), the proximal needle (6004) may be threaded through an anchoring feature, such as a ring (6006) located on the tissue surface, configured to slide unidirectionally across the multiple knots (6000).

[0132] Once inserted into tissue, application of force to the elongated body of the tension element may cause the arms of the Z-flex anchor to pivot or flex, converting the anchor from an insertion configuration to a deployed configuration. As shown in FIG. 45A, the Z-flex anchor (1300) includes an anchor body (1302), a first arm (1304), and a second arm (1306). In response to application of force to the tension element (1308) in the direction of arrow A, which is opposite the direction of device insertion, the first and second arms (1304, 1306) pivot out of plane along the z-axis, perpendicular to the axis (B) of the tension element. In the deployed configuration, passage of the Z-flex anchor (1300) backwards through tissue is prevented. Each arm of the multiple arms of the anchor body may include a distal end that is bevel cut to form a slope that may help to pivot the distal anchor at a pivot point and facilitate its engagement with tissue.

[0133] In another variation, as shown in FIGURE 45B, a distal anchor, a Y-flex anchor (1310), includes an anchor body (1312) having a first arm (1314) and a second arm (1316). However, instead of pivoting out of plane, upon application of a force to a tension element (1318) in the direction of arrow (A), the first and second arms (1314, 1316) pivot or flex in-plane, preventing passage of the Y-flex anchor (1310) posteriorly through tissue.

[0134] Further variations of distal anchors configured to pivot to convert from an insertion configuration to a deployed configuration are shown in FIG. 46, FIG. 47A and 47B, FIG. 48A-48E, and FIG. 49A-49D. Referring to FIG. 46, a distal anchor (1400) may be disposed at a distal end of a tension element (1402) at a pivot point (1404). The distal anchor (1400) may include a component (1406) designed to interface with or be received by an anchor delivery element (not shown). The component (1406) may have a tapered portion (1408) to facilitate insertion through tissue. In FIG. 47A and 47B, the distal anchor includes a flexible body (1500) that is folded over the anchor delivery element (1502) and coupled thereto by manual insertion of an engagement feature. The anchor is released by interaction with tissue, which provides sufficient force to cause the distal anchor to dislodge.

[0135] In Figures 48A-48E, a distal anchor shaped like a dogbone is shown. With reference to Figure 48A, the dogbone (1600) may include two enlarged differentiated ends (1602) connected by a thinner central section (1604). Each of the enlarged differentiated ends (1602) includes an opening (1606). The openings are shown as circular in shape, but may have any suitable shape. The connection of the tension element to the dogbone is shown in Figure 48B. With reference to the figure, the tension element (1608) may be connected to the dogbone (1600) by threading the tension element (108) through one of the openings (1606). The enlarged distal end (toe) (1610) may prevent the tension element from passing backward through the opening (1606). The connection of the dogbone to the anchor delivery element is depicted in Figure 48C. With reference to FIG. 48C, the differentiated ends that are not coupled to the tension element may be coupled to the anchor delivery element (1612) by threading the enlarged differentiated ends (1602) through openings (1614) in the anchor delivery element (1612) until the thinner central section (1604) is reached. The openings (1614) are sized and / or shaped to prevent the enlarged differentiated ends (1602) from passing backward through the openings (1606). Delivery and deployment of the dog bone through tissue is shown in FIGS. 48D and 48E. With reference to the figures, the anchor delivery element (1612) with the dog bone anchor (1600) in its insertion configuration and the tension element (1608) coupled thereto is inserted through tissue (1616). The dogbone anchor (1600) may then pivot and transition to the deployed configuration by removing the anchor delivery element (1612) and applying a force to the tension element (1608). Further force applied to the tension element (1608) may then decouple the differentiated end (1602) from the opening (1614) in the anchor delivery element (1612).

[0136] Similarly, in Figures 49A-49D, another distal anchor is shown including a raised heel that facilitates pivoting of the anchor into its deployed configuration. With reference to Figure 49A, a distal anchor (1700) is shown coupled to an anchor delivery element (1702). The distal anchor (1700) may include a body (1704) having a raised heel (1706) and toe (1708) that fit into corresponding structures in the anchor delivery element (1702), i.e., a heel indentation (1710) and a toe retainer (1712), respectively. In Figures 49B-49D, passage of the distal anchor (1700) through tissue (1714) by the anchor delivery element (1702) is illustrated. More specifically, FIG. 49B shows the distal anchor (1700) in its insertion configuration being passed through tissue (1714). After passing through tissue (1714), the tension element (1716) may be retracted, applying a force on the raised heel (1706), which in turn causes the body of the distal anchor (1700) to pivot to its deployed configuration. In a further variation, as shown in FIG. 55, disengagement of the distal anchor from the seating area may be accomplished using a release tab. With reference to the figure, the distal anchor (5000) may include a heel (5002) and a toe (5004). The release tab (5006) may be provided on one side of the heel (5002). After passage of the distal anchor (5000) through tissue in the direction of arrow C, a force applied to the release tab (5006) can disengage the heel (5002) and toe (5004) from the anchor delivery element (5008) in the direction of arrow D, similar to the way a boot is released from a ski binding.

[0137] The proximal needle may be used to place or manipulate the proximal end of the elongated body through or around tissue and may be removably attached to the tension element in a variety of ways. For example, as shown in Figures 50A and 50B, the proximal needle may be a quick-thread needle designed to allow an operator to manually connect the proximal end immediately prior to insertion into the patient.

[0138] At the distal end of the tension element, an anchor delivery element (elongated needle) may be coupled to the distal anchor. The anchor delivery element may have various configurations and may be reversibly secured to the tension element in various ways. In general, the anchor delivery element may include a cutting tip configured to pass the distal anchor through tissue in its insertion configuration. In some variations, as shown in FIGS. 51A-51C, the anchor delivery element (1900) may include keyholes (1902, 1904, 1906) that are variously sized and shaped to removably couple the distal anchor (not shown) to the anchor delivery element (1900). For example, the keyholes (1902, 1904, 1906) may be sized to keep the toe portion of the distal anchor coupled to the anchor delivery element during tissue insertion, but allow disengagement of the distal anchor during removal of the anchor delivery element back through tissue.

[0139] In other variations, the anchor delivery element may include a tip component and a metal strip. With reference to Figures 52A-52C, the tip component (2002) of the anchor delivery element (2000) may include a cutting tip (2004), a cockpit or pocket (2006) shaped to removably secure the enlarged distal end (toe) of the tension element (see, for example, element 2020 in Figure 53), a clip region (2008) that removably secures the region of the tension element between the toe and the distal anchor to the anchor delivery element, and a seating region (2010) onto which the distal anchor may be positioned prior to deployment. Figure 53 shows an exemplary Z-flex anchor (2018) seated within the anchor delivery element illustrated in Figures 52A-52C.

[0140] In one variation, the tip component and the metal strip may comprise different sections of a single component. In another variation, the tip component (2000) and the metal strip (2012) may be separate components that are joined together, as shown in Figures 52A and 52B. In this variation, the tip component (2000) includes rivet holes (2014) that may align with corresponding rivet holes in the metal strip (2012). A rivet (2016) may be placed in the rivet hole to secure the tip component (2000) and the metal strip (2012) together to form the anchor delivery element. The tip component and the metal strip may also be joined by crimping or welding.

[0141] The tip component may be formed so that it or the distal anchor does not have any leading edge that may catch on tissue during delivery to the target tissue. For example, as shown in FIG. 54, the anchor delivery element (3000) and distal anchor (3002) of the tension element (not shown) may form a horizontal surface that may prevent the distal anchor from catching on tissue during insertion.

[0142] Tissues that may be manipulated using the devices described herein include, but are not limited to, nasal tissue, throat tissue, and ear tissue. Non-limiting examples of nasal tissue include nasal septum cartilage, lateral nasal cartilage, greater alar cartilage, lesser alar cartilage, alar fibroadipose tissue, nasal bone, or nasal turbinates. Exemplary throat tissues include, but are not limited to, oropharyngeal soft tissue, uvula, soft palate, and tonsils. Non-limiting examples of ear tissue include cartilage of the helix, antihelix, tragus, antitragus, superior crus of the antihelix, triangular fossa, turbinate, and connective tissue of the ear lobe.

[0143] In one variation, a device for manipulating tissue in a subject includes a tension element comprising an elongate body having a proximal end and a distal end, and a distal anchor at the tension element distal end. The distal anchor may include an anchor body, a pivot point, an insertion configuration, and a deployed configuration. The distal anchor body may be structured to include multiple arms, which may be configured to pivot at the pivot point from the insertion configuration to the deployed configuration in response to application of a force to the elongate body.

[0144] In some variations, the device generally includes one or more tensioning or shaping elements configured to apply and maintain a force against tissue to alter the shape of the tissue. The force may be tension. The tensioning element may include an elongated body having a proximal end, a distal end, a relaxed state, and a tensioned state. At the distal end, an anchoring element may be coupled to or disposed on the tensioning element to secure or anchor the tensioning element to the tissue. One or more anti-migration elements may be provided on the proximal end of the tensioning element to hold the tensioning element in its tensioned state after deployment. A needle may also be provided on the proximal end to direct or facilitate placement of the tensioning element through the tissue.

[0145] In some variations, a device for shaping a tissue structure of a subject may include an elongate member (e.g., an elongate member of a delivery device) with a proximal end, a distal end sized for introduction into a body of a subject, and a lumen extending between the proximal end and a port at the distal end, and a shaping element. The shaping element may include a first end sized for introduction through the lumen to deploy the first end from the port and engage tissue adjacent the tissue structure, a second end opposite the first end, and one or more elements that maintain a force on the engaged tissue to alter the shape of the tissue structure.

[0146] The tension elements may be made from a variety of materials. Exemplary materials include, but are not limited to, LPLA (poly(L-lactic acid), DLPLA (poly(DL-lactic acid), LDLPLA (poly(DL-lactic acid-co-L-lactic acid), LPLA-HA (poly(L-lactic acid) with hydroxyapatite), PGA (poly(glycolide), PGA-TMC (poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (poly(dioxanone), LPLG (poly(L-lactic acid-co-glycolide), DLPLG (poly(DL-lactic acid-co-glycolide), copolymers of any of these or other suitable polymers, or any other suitable material. In one variation, the tension elements are made from PDO (poly(dioxanone).

[0147] The length of the tension element may range from about 3.0 cm to about 30 cm, including all values ​​and subranges therein. For example, the length of the tension element may be about 3.0 cm, about 4.0 cm, about 5.0 cm, about 6.0 cm, about 8.0 cm, about 9.0 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, or about 25 cm. In one variation, the length of the tension element is about 15 cm.

[0148] The shaping element may include an anchoring element that anchors or secures the shaping element to tissue, e.g., nasal tissue. The anchoring element may be configured such that a first end of the shaping element can be directed through tissue but prevented from passing backward through the nasal tissue. In some variations, the anchoring element comprises one or more of a T-fastener, an X-shaped fastener, an expandable anchor, a knot, a button, a shape-retaining structure, a barb, a plurality of barbs. In one variation, the anchoring element includes a plurality of barbs. In other variations, the anchoring element may be adjustable or slidable relative to the first end along the shaping element. In some cases, the shaping element may include a plurality of protrusions spaced apart from one another adjacent the first end. The anchoring element coupled to the shaping element may be configured to releasably engage the protrusions and adjust the position of the anchoring element relative to the first end.

[0149] One or more anti-migration elements may be provided between the first (distal) and second (proximal) ends of the shaping element to hold the shaping element in its tensioned state after deployment. In one variation, the anti-migration elements may be located closer to the second (proximal) end than the first (distal) end. The one or more anti-migration elements may comprise a number of ratchet elements on a region of the shaping element spaced from the first end. A number of barbs may also be used as anti-migration elements. In some variations, the anti-migration elements may be a number of hooks, sagittal, bulbous shaped elements, or other shaped elements located along the shaping element. Alternatively, the one or more anti-migration elements may be configured to allow the shaping element to be directed through tissue in a first direction, but prevent passage backwards through tissue in a second direction.

[0150] The device may further include a force distribution region on the shaping element spaced from the first end to provide atraumatic contact of the shaping element with tissue. In some variations, the force distribution region may have a width and / or surface area greater than the shaping element adjacent to the force distribution region. The force distribution region width may range from about 0.25 mm to about 2.5 mm, including all values ​​and subranges therein. For example, the force distribution region width may be about 0.25 mm, about 0.50 mm, about 0.75 mm, about 1.0 mm, about 1.25 mm, about 1.5 mm, about 1.75 mm, about 2.0 mm, about 2.25 mm, or about 2.50 mm. In some variations, the force distribution region width may range from about 0.50 mm to about 1.0 mm. Delivery of the shaping element to the target region of tissue may be accomplished using suturing techniques or via an elongated member, e.g., an elongated member of a delivery device. The elongate member may have any length suitable for accessing the target tissue region and placing the shaping element therein. In some variations, the length of the elongate member may range from about 3.0 cm to about 10 cm, including all values ​​and subranges therein. For example, the length of the elongate member may be about 3.0 cm, about 3.5 cm, about 4.0 cm, about 4.5 cm, about 5.0 cm, about 5.5 cm, about 6.0 cm, about 6.5 cm, about 7.0 cm, about 7.5 cm, about 8.0 cm, about 8.5 cm, about 9.0 cm, about 9.5 cm, or about 10 cm.

[0151] The elongate member may include one or more ports for deployment of the shaping element from the lumen of the elongate member. In one variation, the elongate member includes a single port. In another variation, the elongate member includes two ports. The one or more ports may be located on a sidewall of the distal end and may be any suitable size and shape. For example, the port may be circular, oval, triangular, rectangular, square, slit-shaped, etc. In one variation, the device further includes a guide element sized for introduction into the lumen. The guide element may be movable relative to the elongate member to direct a tip of the guide element from the side port into the tissue. The guide element may also include a guide interface, and a first end of the shaping element engages with the guide interface such that the first end is deployable from the tip. In some variations, the guide element comprises a needle terminating in a sharp distal tip configured to penetrate through tissue. In other variations, the guide element may include a hollow needle with a lumen. The length of the guide element may range from about 3.0 cm to about 10 cm, including all values ​​and subranges therein. For example, the length of the elongate member may be about 3.0 cm, about 3.5 cm, about 4.0 cm, about 4.5 cm, about 5.0 cm, about 5.5 cm, about 6.0 cm, about 6.5 cm, about 7.0 cm, about 7.5 cm, about 8.0 cm, about 8.5 cm, about 9.0 cm, about 9.5 cm, or about 10 cm. In some variations, the length of the guide element may range from about 9.0 cm to about 11 cm, including all values ​​and subranges therein.

[0152] The elongate member may further include an actuator on the proximal end of the elongate member for selectively directing the guide element from a proximal position where the tip of the guide element is within the distal end of the elongate member and a distal position where the tip of the guide element extends from a side port. In one variation, the tip of the guide element may be biased into a curved shape to direct the tip laterally relative to the distal end of the elongate member. In another variation, the elongate member includes an imaging or visualization element on its distal end. Exemplary imaging and visualization elements include, but are not limited to, fiber optic visualization devices, CCD, CMOS, or other cameras. In a further variation, a handle may be provided at the proximal end of the elongate member and include one or more actuators for deploying the shaping element.

[0153] In another variation, a device for shaping a tissue structure of a subject may include an elongate member having a proximal end, a distal end sized for introduction into a body of a subject, and a lumen extending between the proximal end and a port at the distal end, and a needle removably coupled to the elongate member. A shaping element may further be included having a first end deployable from the port to engage tissue at a first location adjacent the tissue structure, a second end carried by the needle to anchor the second end to tissue at a second location adjacent the tissue structure, and one or more elements that maintain tension on the engaged tissue to modify the shape of the tissue structure.

[0154] Other variations of devices for shaping a tissue structure of a subject may include an elongate member with a proximal end, a distal end sized for introduction into a body of a subject, and a lumen extending between the proximal end and a port at the distal end, a needle removably coupled to the elongate member, and a shaping element. The shaping element may include a first end deployable from the port to engage tissue at a first location adjacent the tissue structure, a second end carried by the needle to anchor the second end to tissue at a second location adjacent the tissue structure, and one or more elements that maintain tension on the engaged tissue to modify the shape of the tissue structure.

[0155] In still a further variation, a device for shaping a tissue structure of a subject may include an elongate member having a proximal end, a distal end sized for introduction into a body of a subject, a lumen extending between the proximal and distal ends, a first port at the distal end, and a second port located proximal to the first port, and a shaping element. The shaping element may include a first end deployable from the first port to engage tissue at a first location adjacent the tissue structure, a second end deployable from the second port to engage tissue at a second location adjacent the tissue structure, and one or more elements that maintain tension on the engaged tissue to modify the shape of the tissue structure.

[0156] The shaping of the nasal tissue may further be aided by the delivery of one or more fluids to the nasal tissue. In these variations, the tension element may be configured with a fluid delivery mechanism, such as a conduit, channel, or other mechanism for suitable delivery of fluid to the nasal tissue. The fluid delivery mechanism may allow the passage of fluid to achieve a therapeutic or physiological effect. For example, the fluid delivery mechanism may be used to deliver cryogenic gas or liquid for cryotherapy purposes.

[0157] Other Exemplary Devices Described below is a device that includes a tension element for modifying the shape of nasal tissue. The tension element (200) functions to fixate the nasal tissue in a modified state by applying force, pressure, or tension to the nasal tissue. In some variations, the tension element may have variable physical properties, e.g., flexible or rigid shapes, be formed from inelastic or elastic materials, and / or include multiple sections of different stiffness and / or other mechanical properties. In variations where some or all of the tension element are rigid, the tension element may be optionally configured such that a shape is set and maintained immediately prior to or immediately after fixation into the nasal tissue. In some variations, the shape may be modifiable as desired by the patient or physician, or as needed to obtain a desired modification in tissue shape. In some variations, the tension element may be configured with some or all portions of the tension element having a shape memory or tendency to return toward a pre-set shape when deflected. In some variations, most or all of the tension element may be flexible and apply tension to the nasal tissue when the tension element is secured in place. In some variations, the tension element may be applied directly onto the tissue to be modified. In some variations, the tension element may be applied to tissue adjacent to, underlying, superficial to, or on either side of the nasal tissue to be modified. The tension element may be of any suitable size, shape, length, or width.

[0158] In some variations, the tension element is configured to be reversible or removable. In such variations, the tension element can be configured to have at least some portion accessible above the nasal mucosa. The accessible portion can specifically comprise an anchoring portion at the distal end of the tension element, configured to reside above the mucosa on the concave surface of the contralateral curve of the body of the tension element. Alternatively, the tension element can be configured to include another or additional accessible portion or portions. The accessible portion can specifically be configured to be removed or retrieved, such as by scissors or scalpel inserted into the nostril, such that the remainder of the tension element can be pulled out of the nasal tissue without the anchoring portion. Alternatively, the accessible portion can be configured to be removed by another suitable retrieval method. In such reversible or removable variations, the tension element can be easily retrieved and removed from the nasal tissue, allowing the procedure to be easily reversible.

[0159] In some variations, the tension element is used to correct a deviated septum. In this case, the tension element may be delivered preferentially beneath the nasal septum mucosa on the convex curve of the curve, but may also be configured to be placed above the nasal septum mucosa. Once delivered beneath the nasal septum mucosa, a delivery device may be used to anchor an anchoring element, such as a T-fastener located on the distal end of the tension element, to the nasal septum cartilage. The delivery device may accomplish this using a piercing feature or other mechanism, e.g., made from Nitinol, spring steel, and the like, designed to deploy the anchoring element. Once placed, the anchoring element may reside above or below the contralateral nasal septum mucosa. For example, the anchoring element may be placed on the most distal surface of the curve. The proximal end of the tension element may have a piercing feature that allows the tension element to be passed across the nasal septum to the contralateral nasal airway. Alternatively, the proximal end of the tension element may be passed across the septum via a piercing feature on the delivery device. Between the distal anchoring element and the proximal end of the tension element, there may be one or more anchoring elements, such as barbs, designed to prevent posterior migration of the tension element. The one or more proximal anchoring elements may be designed to allow the tension element to gradually correct the septal deviation. For example, barbs along the length of the tension element may be gradually pulled through the septal cartilage until the desired correction is achieved.

[0160] In some variations, devices used for correction of a deviated nasal septum using tension elements may be designed to maintain the structural integrity of the nasal septum cartilage without significantly weakening it.

[0161] As shown in FIG. 6, in some variations, the tension element may contain one or more anchoring portions (210) at one or both ends. Optionally, the tension element may additionally or alternatively have one or more anti-migration elements (220) or one or more force distribution regions (230). The anti-migration elements may each take the form of a barb, a ratchet, a protrusion, or any other suitable configuration to prevent migration of the tension element, e.g., to prevent the element from being pulled backwards through tissue while allowing the element to be introduced through tissue in a first direction. The anchoring portion or portions (210) function primarily to resist migration of the tension element through the nasal tissue, and may be configured similarly to a T-fastener, an X-shaped fastener, an expandable anchor, a button, a shape-retaining structure, a barb, barbs, or any other suitable structure for resisting migration. In some variations, the anchoring portion may be tension or position adjustable. In some variations, the tension element may be configured without an anchoring portion. The anchoring portion may be made of the same material or materials as adjacent portions of the tension element, or may be constructed of a different material or materials. The optional anti-migration element (220) may be configured as one or more barbs, arranged in a parallel or spiral pattern, or in any arrangement suitable for anchoring the tension element. In some variations, such barbs may have a fixed or variable size and may be made of a fixed or variable material or materials. In some variations, the tension element may include barbs at one end, in other variations, the tension element may include barbs along multiple regions, and in other variations, all or none of the tension elements may include barbs. The force distribution region (230) functions primarily to increase surface area and distribute pressure across the nasal tissue. The force distribution region may be of fixed or variable length and may have fixed or variable positions on the tension element. For example, in some variations, the force distribution region may be fixed in position relative to the tension element, or may slide on, off, along, or around the tension element.The force distribution region may be made of the same material or materials as adjacent portions of the tension element, or may be made of different materials or materials. In some variations, the tension element contains one force distribution region. In other variations, the tension element does not contain any force distribution regions, or contains multiple force distribution regions. In some variations, the tension element may not have a needle at either end of the tension element, or may have a needle at one or more ends of it. In some variations, the needle or needles may be flat or curved. The needle or needles may be made of any suitable material to allow the tension element to be passed through tissue.

[0162] In some variations, the tension element may be solid. In some variations, the tension element may be porous or non-porous. In some variations, the tension element may be configured to promote tissue regrowth or prevent blood clot formation. The tension element may optionally be coated with, bonded to, impregnated with, or otherwise designed to release a suitable functional agent to modify physiological properties. The functional agent may be configured as a therapeutic agent, such as an antibiotic agent, an anti-inflammatory agent, a growth promoter, a hemostatic agent, an anti-clotting agent, an analgesic agent, or any suitable drug, molecule, or compound to achieve a therapeutic effect.

[0163] The tension element may be partially or completely attached beneath the nasal mucosa (110) or exposed within the nasal airway. In some variations, the tension element may be fabricated from a single material or may be comprised of a composite of multiple materials. In some variations, the tension element may have a monofilament or suture-like structure. In other variations, the tension element may have a rod-like structure, a braided structure, a woven structure, a flat structure, or any other structure suitable for providing the desired mechanical properties. In some variations, all or certain components of the tension element may be degradable, absorbable, resorbable, biodegradable, or bioabsorbable. Such variations may include components made of LPLA (poly(L-lactic acid), DLPLA (poly(DL-lactic acid), LDLPLA (poly(DL-lactic acid-co-L-lactic acid), LPLA-HA (poly(L-lactic acid) with hydroxyapatite), PGA (poly(glycolide), PGA-TMC (poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (poly(dioxanone), LPLG (poly(L-lactic acid-co-glycolide), DLPLG (poly(DL-lactic acid-co-glycolide), copolymers of any of these or other suitable polymers, or any other suitable material. In some variations, the tension elements may be non-biodegradable or non-bioabsorbable or removable at a later time. In other variations, the tension elements may be permanent. In some variations, at least a portion of the tension elements may be modified after placement, such as by cutting off an excess portion of one end of the tension element.

[0164] In some variations, the tension element, when deployed submucosally, may induce a remodeling response in the target tissue, particularly using absorbable polymers. In some variations where nasal cartilage is the target tissue, this remodeling response may include the formation of a pseudocapsule, which functions, first, to prevent pressure necrosis as reported after the implantation of some non-absorbable implants, and, second, to allow chondrocyte nutrition. The pseudocapsule may allow the cartilage directly beneath the tension element to remain completely unchanged from a histological point of view. In some variations, the tension element may also induce the recruitment or formation of new chondroblasts and the deposition of new cartilage at the border of the pseudocapsule or tension element. In some variations, this remodeling process may be optimized to occur within 5-25 weeks. In some variations, the process may be further optimized such that chondroblasts and new cartilage growth along the border of the cartilage defect occurs after about 5 weeks, and resorption of the tension element is noted after about 8-12 weeks, with complete resorption within about 25 weeks.

[0165] As shown in Figure 7, in some variations, the force distribution region (230) may have a solid, mesh, or other suitable configuration such that the force distribution region can be compressed within the delivery element. For example, as shown in Figure 7, the force distribution region (230) may optionally be configured to be rolled within the elongated shaft (330) of the delivery tool.

[0166] As shown in FIG. 8, in some variations, the tension element (200) may be configured as at least two components (202) that may contain an interaction mechanism (250). The interaction mechanism functions primarily to secure the components with relative position in an adjustable manner. In some variations, the interaction mechanism may be configured as a capture mechanism such as a zipper, ring grip, fastener, clasp, webbing buckle, or pressure grip. In some variations, the interaction mechanism may be configured as a locking mechanism such as a button, tongue buckle, or snap buckle. In some variations, the interaction mechanism may be configured as a pinning mechanism, adhesive mechanism, or in any other suitable configuration to resist relative movement of the components. In some variations, the interaction mechanism may be permanently set. In some variations, the interaction mechanism may be adjustable over time or at different times. In some variations, the components are secured on the non-interacting ends with a position fixing or movement resistance element or elements. In some variations, multiple components are connected as one tension element, but the relative position of each component may be adjustable and fixable via interaction mechanisms.

[0167] In some variations, the tension element may be equipped with an energy delivery element, such as one or more permanent or temporary electrodes, heating elements, or other energy delivery mechanisms that allow the tension element to deliver energy to the nasal tissue. The energy delivery mechanism may be used to enhance reshaping or remodeling of the nasal tissue by application of heat, electrical current, or any suitable form of energy. In some variations, the energy delivery mechanism may be removed after the energy is applied. In some variations, the energy delivery mechanism may be embedded with the tension element. In some variations, the energy delivery mechanism may be bioabsorbable or biodegradable. In some variations, the energy delivery mechanism is attached directly to the tension element. In some variations, the energy delivery mechanism is mounted adjacent to the tension element.

[0168] In some variations, the tensioning element may be configured with a fluid delivery mechanism, such as a conduit, channel, or other mechanism for suitable delivery of fluid to the nasal tissue, as described above. The fluid delivery mechanism may allow the passage of fluid to achieve a therapeutic or physiological effect. For example, the fluid delivery mechanism may be used to deliver cryogenic gas or liquid for cryotherapy purposes.

[0169] In some variations, the tensioning element may induce tissue remodeling. In some variations, the tensioning element may maintain the shape of the nasal tissue for a period of time sufficient to induce tissue remodeling. In other variations, the tensioning element may maintain a force acting on the nasal tissue for a period of time sufficient to induce tissue remodeling.

[0170] As shown in FIG. 9, the tension element (200) may optionally have an adjustable fastening element (252) that may alter the tension, pressure, or position of the tension element. Optionally, multiple adjustable fastening elements may be provided on the tension element (not shown), for example, initially adjacent each end of the tension element. In some variations, the adjustable fastening element uses a ball-in-cone ratchet mechanism. In one variation, the tension element has one or more bulges, protrusions, spheres, or nodes (250) positioned along its length. These protrusions are designed to pass first through the expanded end of the adjustable fastening element (252) and then through the narrowed end of the adjustable fastening element. The protrusions (250) and adjustable fastening element (252) interaction may allow the tension element to be gradually tightened or shortened in a one-way manner to prevent retraction of the tension element and / or increase pressure application. In one variation, the protrusions are bulbous in shape. In another variation, the adjustable fastening element (252) may have a reversible configuration, allowing the protrusions (250) to be retracted backwards through the adjustable fastening element. The protrusions (250) and adjustable fastening element (252) may be made from the same or different material as the tension element (200).

[0171] As shown in FIG. 10, in some variations, the adjustable fastening element (258) is designed to interact with ribs or fins (256) positioned along the length of the tension element and be advanced through the adjustable fastening element (258) in a unidirectional manner. In another variation, the adjustable fastening element (258) may be modified to allow the tension element to be pulled in the opposite direction. The ribs (256) and adjustable fastening element (258) may be made from the same or different materials as the tension element (200). The ribs may be oriented parallel, perpendicular, or oblique to the longitudinal axis of the tension element. The tension element and adjustable fastening element may be deployed by the same or different devices.

[0172] In some variations, the multiple tension elements may be held together using a removable element (260). The removable element (260) is designed to allow multiple repeating tension elements to be held together for loading into a delivery device. The removable element may be made of a polymer, metal, composite, alloy, or any suitable material to allow for the intended functionality. In another variation, the multiple tension elements may be held together in a cartridge. In another variation, the multiple tension elements may be held together in a sheet or any other configuration that allows the multiple tension elements to be delivered via a deployment mechanism of a delivery device, either individually or simultaneously.

[0173] Turning to FIGS. 12 and 13, an exemplary variation of a delivery device (300) configured to deliver a tensioning element for modifying the shape of nasal tissue is shown including a body (310), at least one action mechanism (320), an elongated shaft (330), and an optional tip (340). In some variations, the deployment device (300) may have an elongated or "pistol grip" shaped body (320) (FIG. 13). In some variations, the at least one action mechanism (320) may be on the front, back, upper, lower, or lateral side of the deployment device. The action mechanism may be a trigger, button, lever, arm, or any alternative structure suitable to achieve the desired function. In some variations, the optional tip (340) may be blunt or sharp. In some variations, the tip (340) may be parallel to the elongated shaft (330) or oriented at an angle relative thereto. In some variations, the elongated shaft (330) and / or the tip (340) house the tensioning element and a mounting mechanism for delivering the tensioning element through, onto, or adjacent to the nasal tissue.

[0174] As shown in FIG. 14, in some variations, the elongated shaft (330) may include attachment sites (332) for attachment to or removal from the body of the device (310). In such variations, the device may be configured to utilize various attachments using the same attachment sites on the body of the device. In some variations, this would allow the elongated shaft to be replaced with another identical elongated shaft with the same configuration. For example, in cases where an elongated shaft includes only one tension element, it may be necessary to use multiple elongated shafts throughout the same procedure. The different attachments may be configured with the same primary function and different sizes and shapes, or may be configured with alternative functions. In some variations, the body of the device may be configured with multiple attachment sites.

[0175] In some variations, the delivery device may be configured to allow for determining the extent of tissue shape modification, for example, the extent of nasal septum deviation correction. In one variation, the extent of shape change is determined by visual inspection of the nasal airway diameter. In another variation, the delivery device is configured to measure force. For example, the delivery device may be configured to measure tension along the length of the tension element.

[0176] As shown in FIG. 15, some variations of the delivery device for modifying the shape of nasal tissue may include a blunt tip (340) of an elongated shaft (330). In this variation, the elongated shaft may optionally house at least one tension element (200) to be used to modify the shape of nasal tissue. The elongated shaft may have an optional opening (350) on the side of the elongated shaft to allow for lateral or orthogonal deployment of the tension element relative to the elongated shaft. In another variation, the opening (350) for delivery of the tension element may be located at the distal end of the elongated shaft at its tip (340) to allow for parallel or oblique delivery of the tension element relative to the shaft. In some variations, the delivery device (300) may be configured to receive more than one tension element via a cartridge, sheet, or any other suitable configuration of multiple braces. In variations in which a delivery device is used to modify the shape of the nasal septum (100), the tip (340) of the delivery device may be inserted beneath the septal mucosa (110) and advanced to the desired location. In this case, the tip may contain a visualization element that may be used to track the location of the tip beneath the septal mucosa. Once at the desired site of placement, the delivery device may be activated to place at least one anchoring element of the at least one tensioning element. In other cases, the delivery device may be positioned above the nasal septal mucosa prior to activation for placement of at least one anchoring element of the at least one tensioning element.

[0177] As shown in FIG. 16, some variations of the delivery device for modifying the shape of nasal tissue may include an optional visualization element (342) on the optional tip (340). The visualization element functions primarily to aid in positioning the device while it is underneath the nasal mucosa (110). The visualization element may be configured as an LED, a magnetic component, an electronic transmitter or receiver, or any other material suitable for localization underneath the mucosa. In some variations, the tip of the delivery device may include a fin (344). The fin functions primarily to displace the overlying mucosa and aid in positioning the device while it is underneath the nasal mucosa (110). The fin may be configured to temporarily deploy or change shape to allow for transient displacement of the overlying mucosa. In some variations, the extension shaft or tip of the delivery device may be adjustable in length. This may be accomplished via a telescopic mechanism, a sliding mechanism, or any other suitable mechanism to modify the length of the extension shaft or tip. In other variations, the elongated shaft or tip may have an adjustable diameter. The elongated shaft or tip may also be malleable or shape adjustable. The elongated shaft or tip may also be capable of rotating along its long axis. The elongated shaft or tip may also be equipped with a suction element to allow for the aspiration of fluids. The elongated shaft or tip may also be equipped to hold or receive an endoscope. The elongated shaft or tip may also be equipped with a light to allow for enhanced visualization. The tip (340) may be any suitable shape to allow for atraumatic navigation within the nasal airway and / or submucosal space. For example, the tip may be cylindrical or flat. It may alternatively have an asymmetric configuration, such as a shovel or scoop tip. In some variations, the tip may also be configured to include a cutting edge. The cutting edge may be configured to be retractable or fixed and can be used to facilitate the introduction of the tip into the nasal tissue, the separation of the nasal tissue, or otherwise aid in the positioning of the device.

[0178] As shown in FIG. 17, some variations of delivery devices for modifying the shape of nasal tissue have a placement mechanism (360) (also known as a delivery or deployment mechanism) that allows placement of the tensioning element. The placement mechanism may optionally extend out of an opening in the elongated shaft (350) and be designed to pierce or otherwise traverse the nasal tissue. Such an opening may be located at the distal end of the tip, or on the side of the elongated shaft, or in any other suitable location to allow optimal placement of the tensioning element. The placement mechanism (360) may be activated by an action mechanism located on the delivery device (310). In some variations, the placement mechanism may be pointed or sharp. In some variations, the placement mechanism may have an arc or other suitable shape appropriate for the desired function of penetrating or crossing the nasal tissue. Optionally, the placement mechanism may be equipped with an energy delivery element to facilitate tissue penetration. Optionally, the placement mechanism (360) may have an inner cannula, which houses the tensioning element (200). In other variations, the tension element may be otherwise secured to an outer portion of the mounting mechanism. Once activated, the mounting mechanism (360) may eject or otherwise release the desired end of the tension element (200). Once deactivated by the means for releasing its action mechanism, the mounting mechanism (360) may retract rearwardly through the opening (350) and into the housing of the extension shaft (330).

[0179] As shown in FIG. 18, one variation of the delivery device is configured with a placement mechanism (360) to allow for a first placement of an anchoring element (210) beneath the septal mucosa (110) and across the septal cartilage (100) at the distal end of the tensioning element (200), followed by a second placement of an anchoring or anti-migration element (220) at the proximal end of the tensioning element. In some variations, the placement mechanism (360) has a reloading action such that it is capable of capturing the next desired face of the current or next tensioning element. In some variations, the placement mechanism (360) is designed to reload additional tensioning elements delivered from a cartridge, sheet, or other suitable configuration of multiple tensioning elements.

[0180] As shown in FIG. 19, one variation of a delivery device for altering the shape of nasal tissue has a mounting mechanism (360) that captures a first end of a tensioning element. An activation mechanism (320) may be used to push the mounting mechanism (360) so that it penetrates or otherwise crosses the nasal tissue and subsequently expels the first end of the tensioning element. Once deactivated by a means that releases the actuation mechanism, the mounting mechanism (360) may retract back through the opening (350) and into the housing of the tip (340) and / or extension shaft (330). In some variations, the mounting mechanism will be designed to capture the second end (220) of the tensioning element so that it may be mounted in a different location than the first end.

[0181] As shown in FIG. 20, one variation of a delivery device for altering the shape of nasal tissue has a mounting mechanism (360) with a reloading element (332) that is capable of reloading additional ends of additional tension elements (200) into the mounting mechanism. This feature allows a user to mount multiple tension elements with a single device without having to insert additional tension elements into the device. After ejection of a first end of a tension element, a reloading mechanism (352) functions to load the second end of the current tension element or the first end of the next tension element into the mounting mechanism. The reloading mechanism may include a spring, a push rod, or any suitable configuration to enable the intended purpose.

[0182] 21, one variation of the mounting element (360) may have a receiving feature (362) that facilitates reloading of the next desired end of the tension element (210 or 220) by the reloading mechanism (332). This feature is designed to interact with either end of the tension element such that it temporarily anchors the tension element onto the mounting mechanism (360).

[0183] As shown in FIG. 22, in some variations of a delivery device for modifying the shape of nasal tissue, the device may be configured with multiple mounting features (360). In such variations, the mounting features may be configured to deploy multiple anchoring elements of one or more tension elements simultaneously or sequentially, or may be configured to deploy multiple sections of a single tension element simultaneously or sequentially. In some variations, by utilizing multiple mounting features, the device may be configured to apply the tension element to a final anchoring position and may reduce the need to anchor the tension element after its initial deployment. The optional multiple mounting features may be located either consecutively along the length of the elongated shaft or tip, or adjacent to one another at a specific length along the elongated shaft or tip.

[0184] As shown in FIG. 23, some variations of delivery devices for modifying the shape of nasal tissue may include a visualization instrument (370) and / or an actuator arm (380) within the elongated shaft (330). The visualization element functions primarily to aid in visualization and may be configured as a disposable or reusable endoscope, a fiber optic visualization device, a CCD, CMOS, or other camera, or any other suitable imaging or visualization modality, either flexible or rigid. The visualization instrument may be configured with a wired connection or may be wireless. In some variations, the visualization instrument is included within the device, while in other variations, the device is configured to store a standard sized external or separate visualization instrument that may be inserted prior to use and removed afterwards. Optionally, the visualization instrument may include an adjustable lens (372) configured for visualization within the nasal tissue. In some variations, the delivery device may include an actuator arm (380) that may extend from within the elongated shaft (330). The actuator arm may extend parallel to the extension shaft or may have a joint or axis to allow for additional positional freedom. The actuator arm may include an opening (382) to facilitate deployment of the tension element (200).

[0185] As shown in FIG. 24, some variations of delivery devices for modifying the shape of nasal tissue may be configured to adjust the tensioning element (200). In some variations, the device may include a mechanical element (400) that functions primarily to mechanically manipulate the nasal tissue into a desired modified shape before fixing the shape with the tensioning element. In some variations, the mechanical element may be attachable to the body of the device (310) via an attachment site (410). In some variations, the mechanical element may incorporate a sensing modality (420) to facilitate modification of the nasal tissue into a desired shape. In an exemplary variation, the sensing modality or modalities may be selected from sensors, including, but not limited to, pressure sensors, accelerometers, force meters, angle sensors, tilt sensors, distance sensors, or any other sensing modality suitable for assessing the shape of nasal tissue. In some variations, the device may include a fastening mechanism (500). In some variations, the fastening mechanism is attached to the main body (310) via an attachment site (510). The tightening mechanism functions primarily to secure the tension element (200) from its initial deployment to its final position. Optionally, the tightening mechanism may include a locking mechanism (520) that functions to secure the tension element to the device so that it can be tightened in a controlled manner. In other variations, the tightening mechanism has a sensor feedback device that adjusts the rate, strength, speed, or other measurable aspect of tightening relative to measurements obtained from an applicable sensor. For example, in one variation, the tightening element may have a force or tension meter that modulates tightening based on the output from the sensor. In some variations, tightening may stop once a certain threshold is detected by such a sensor.

[0186] As shown in FIG. 25, some variations of delivery devices for modifying the shape of nasal tissue may be specifically configured to modify the nasal septum and may be configured to be deployed symmetrically on both sides of the septum. In some variations, the device may include multiple extension shafts (330). In some variations, the relative positions of the extension shafts may be adjusted via one or more adjustable mechanisms (334). The adjustable mechanisms may function to manipulate the position of the extension shafts to position the device for deployment of the brace across the nasal septum cartilage. The adjustable mechanisms may also function to apply a force to the nasal septum cartilage or nasal bone to at least temporarily modify the shape prior to anchoring the brace. The device may include a deployment mechanism (360). In some variations, the deployment mechanism is configured to pass the brace between the extension shafts and across the nasal septum cartilage, as shown in FIG. 26.

[0187] As shown in FIG. 27, some variations of tension elements have an enlarged distal end (240) relative to the body of the tension element (200). The distal end may be any shape, including but not limited to, circular, spherical, hemispherical, rectangular, x-shaped, spiral, and the like. It may be designed, for example, as a ball-and-socket structure, to interface with the anchoring element (210). In some variations, the anchoring element moves in any plane relative to the tension element. In the particular variation shown in FIG. 27, the anchoring element is a rectangular structure that slides along the long axis of the tension element.

[0188] As shown in Fig. 28, in some variations, the anchoring element may have tissue interaction features (250) designed to hook into tissue and cause the anchoring element to rotate, change position, or change shape. For example, shown in Fig. 28 is a fin feature that is triangular shaped such that when the anchoring feature is passed through tissue with the end of the anchoring feature facing the end containing the fin, the fin is allowed to pass through the tissue but not backwards. In some variations, the anchoring element may be designed to interface with the mounting feature of the delivery device such that the anchoring element is displaced from the mounting feature of the delivery device, either passively or actively.

[0189] As shown in Figure 29, some variations of delivery devices may include an expandable tissue displacement feature (370) designed to at least temporarily displace tissue. One example of such an expandable tissue displacement feature would be an inflatable balloon designed to at least temporarily fracture or manipulate nasal tissue into a desired shape.

[0190] As shown in Figure 30, some variations of delivery devices may include a tissue-cutting feature (382). In some variations, this tissue-cutting feature may be stored within a deployable, expandable, adjustable, rigid, and / or flexible housing (380) such that the cutting feature does not engage tissue when the delivery device is moved in one direction, but engages tissue when the delivery device is moved in another direction.

[0191] As shown in Figure 31, some variations of the delivery device include a tissue retraction feature (390). In one variation, the tissue retraction feature may be a motorized rotating borer designed to abrade or file the tissue. The delivery device may include a housing for a battery or motor and may have a button or switch designed to turn the tissue retraction feature on or off.

[0192] As shown in Figures 32 and 33, some variations of the device may include an accessory tissue cutting instrument (400). In some variations, the tissue cutting instrument includes a tissue cutting feature (412) that may be stored within a deployable, expandable, adjustable, rigid, or flexible housing (410) such that the cutting feature does not engage tissue when the cutting instrument is moved in one direction, but engages tissue when the cutting instrument is moved in another direction.

[0193] As shown in FIG. 34, some variations of the accessory tissue cutting instrument include a rotatable or expandable head feature (414) that changes from a first position to a second position such that the instrument is capable of piercing through tissue in its first position, but not pulling backward through it when in its second position.

[0194] As shown in FIG. 35, some variations of the device include an attached tissue retraction instrument (500). In one variation, the tissue retraction instrument has a body, an elongated shaft (510), and a tissue retraction feature (520). In some variations, the tissue retraction feature includes ridges, ribs, or other features that allow the tissue retraction feature to file the tissue when manually moved. In other variations, the tissue retraction feature may be a motorized rotating borer designed to abrade or file the tissue. The tissue retraction instrument may include a housing for a battery or motor and may have a button or switch designed to turn the tissue retraction feature on or off.

[0195] As shown in FIG. 36, some variations of the device may include an accessory tissue displacement instrument (600). The instrument may have an elongated shaft and a head (610) that can displace tissue at least temporarily when moved, rotated, expanded, or otherwise activated. In one variation, the tissue displacement instrument may be designed such that when the instrument is rotated about the axis of the elongated shaft, the head also rotates so that tissue is displaced at least temporarily away from the elongated shaft. In the case of a deviated nasal septum secondary to a bowing of the bony nasal septum, this may involve inward fracturing of the bony septum to move it toward a more straightened configuration. In the case of a deviated nasal septum, the instrument may be placed above or below the nasal septum mucosa.

[0196] As shown in Figures 37 and 38, some variations of the device include a tissue displacement instrument with an expandable or deployable head (812) on one end of the elongation shaft (800) that changes from a first position to a second position when deployed by an activation mechanism, such as a switch, knob, button, inflation pump, or other suitable mechanism located either at the second end of the elongation shaft (810) or along the body of the elongation shaft (820), such that tissue is at least temporarily displaced.

[0197] As shown in FIG. 39, some variations of tissue displacement instruments include an internal balloon or expandable element (700) connected by a tube or elongated shaft (710) to an external expansion activation element (720).

[0198] As shown in FIG. 40, some variations of the device include a tissue retaining element designed to hold the tissue in a modified shape (1000). The tissue retaining element may also be known as a splint or stent. In some variations, the tissue retaining element may be designed to straighten a curved nasal septum cartilage (100). The tissue retaining element may be placed above or below the mucosa. It may be placed on the concave or convex side of the curve. It may include one or more tissue engaging features (10) that allow the tissue retaining element to apply force or remain connected to the tissue. The tissue retaining element may be absorbable or non-absorbable.

[0199] As shown in FIG. 41, some variations of the delivery device include a tissue separation element (332) that allows the distal end of the delivery device to traverse within a tissue plane.

[0200] As shown in FIG. 42, some variations of delivery devices include an alignment feature (1110) that connects to either the elongate shaft (330) or body (310) of the delivery device such that it holds the tissue retention element in a certain position relative to the delivery device.

[0201] method Also described herein are methods for manipulating tissue within a subject. The methods may generally include anchoring a tension element to tissue, the tension element comprising an elongated body having a proximal end and a distal end, and a distal anchor at the tension element distal end. In some variations, the distal end of the tension element may be directed through the tissue with an anchor delivery element. The distal anchor may include an anchor body, a pivot point, an insertion configuration, and a deployed configuration. After anchoring the tension element to the tissue, a force may be applied to the elongated body to pivot the distal anchor at the pivot point from the insertion configuration to the deployed configuration. An appropriate force for manipulating the tissue may then be adjusted by adjusting the tension of the tension element.

[0202] The proximal and distal ends of the elongated body of the tension element may be secured to the same tissue. Alternatively, the proximal and distal ends of the elongated body may be secured to different tissues. The tissue may be nasal tissue, throat tissue, or ear tissue. Exemplary nasal tissues include, but are not limited to, nasal septum cartilage, lateral nasal cartilage, greater alar cartilage, lesser alar cartilage, alar fibroadipose tissue, nasal bone, or nasal turbinates. Exemplary throat tissues include, but are not limited to, the uvula, soft palate, and tonsils. Non-limiting examples of ear tissues include cartilage of the helix, antihelix, tragus, antitragus, superior crus of the antihelix, triangular fossa, turbinate, and connective tissue of the ear lobe.

[0203] The methods described herein may be used to treat a variety of medical conditions and manipulate a variety of tissues. For example, manipulation of tissue with tension elements may be used to treat deviated septum, collapsed lateral nasal valve, and other causes of nasal airway obstruction. In addition, manipulation of tissue with tension elements may be used to medialize the middle turbinate, compress or lateralize the inferior turbinate, or reapproximate the nasal mucosa. Furthermore, manipulation of tissue with tension elements may modify the shape of various tissues. For example, the shape of nasal tissue, throat tissue, or ear tissue may be modified. When the tissue is nasal tissue, the tissue may include lateral cartilage, alar cartilage, ear trabeculae, or combinations thereof. In addition, manipulation of tissue may be used to increase the firmness or rigidity of nasal tissue, throat tissue, or ear tissue. In some variations, tension elements may be employed in minimally invasive facelift procedures.

[0204] The method may be used to shape a nasal septum, as shown in Figures 68A-68E. A curved nasal septum (83) is illustrated in Figure 68C. With reference to Figures 68A-68E, a method for shaping a curved nasal septum (83) may include inserting a delivery cannula (80) of a deployment device (81) into a nostril (82) through the nasal septum (83) at a first location (89), anchoring a distal anchor (86) into nasal cartilage (91), and deploying a tension element (84) from the delivery cannula (80). A proximal end (87) of the tension element (84) may then be passed through the nasal septum (83) at a second location (90). A force may be applied to the proximal end (87) of the tension element (84), which may generate an inward force against the curved septum (83) to shape the tissue by straightening the tissue, as shown in FIG. 68D. Additional inward force may be applied by the surgeon straightening the septum (83) using an instrument (88). Once the desired amount of shaping has been achieved, the force on the tension element (84) may be maintained by anchoring the proximal end (87) of the tension element (84) to the septum (83) or nasal cartilage (91) near a second location (90).

[0205] As shown in Figures 57A-57C, the devices described herein may be used to medialize the middle turbinate. Referring to Figure 57A, the method may include inserting a distal anchor (8001) of a tension element (8000) into the nasal septum cartilage (8002), wrapping the tension element around the middle turbinate (8004), applying a force to the tension element to draw the middle turbinate (8004) inward toward the nasal septum cartilage (8002), and maintaining the medial position of the middle turbinate by anchoring the proximal end of the tension element (8000) to the nasal septum cartilage (8002). Anchoring the proximal end of the tension element may be accomplished by any suitable method. In one variation, suturing the proximal end to the septal cartilage anchors the tension element such that it maintains the force required to medialize the middle turbinate. Alternatively, as shown in FIG. 57B, a method for medializing the middle turbinate may involve inserting a distal anchor (8001) of the tension element (8000) into the middle turbinate (8004), applying a force to the tension element (8000) to draw the middle turbinate (8004) inward toward the septal cartilage (8002), and maintaining the medial position of the middle turbinate (8004) by anchoring the proximal end of the tension element (8000) to the septal cartilage (8002). Anchoring the proximal end of the tension element may be accomplished by any suitable method. As described above, suturing the proximal end to the nasal septum cartilage anchors the tension element such that it maintains the force required to medialize the middle turbinate. In yet a further variation, as shown in FIG. 57C, a method for medializing the middle turbinate may include inserting a distal anchor (8001) of the tension element (8000) into the nasal septum cartilage (8002), passing a proximal end of the tension element (8000) through the middle turbinate (8004), and anchoring the middle turbinate (8004) in a medialized position by anchoring the proximal end of the tension element (8000) to the middle turbinate (8004).

[0206] As shown in FIGS. 58A-58D, a method for treating inferior turbinate hypertrophy may include wrapping a tension element (7000) around the inferior turbinate (7002). A single wrap may be used to wrap the tension element (7000) around the lateral edge of the inferior turbinate (7002) to reduce its diameter (FIG. 58A). In another variation, multiple wraps may be used to wrap the tension element around the entire inferior turbinate to compress and reduce the inner diameter of the inferior turbinate (FIG. 58B). Alternatively, a single wrap may be used to wrap the tension element (7000) so that it is mobilized laterally (FIG. 58C) or superiorly (FIG. 58D).

[0207] External nasal valve collapse may also be treated with tension elements described herein. As shown in Figs. 59A-59D, a tension element (9000) may be anchored between two nasal tissues and tension applied therebetween to increase patency of the nasal valve. For example, in Figs. 59A and 59B, the distal end (9002) of the tension element (9000) may be anchored in the upper lateral cartilage (9004) and the proximal end (9006) of the tension element (9000) may be anchored in the maxilla (9008). As shown in Fig. 59C, the distal end (9002) of the tension element (9000) may be anchored in the fibroadipose tissue (9010) and the proximal end (9006) may be anchored in the maxilla (9008) or the lower lateral cartilage (9012). Alternatively, as shown in FIG. 59D, a distal end (9002) of the tension element (9000) may be anchored within the fibroadipose tissue (9010) and a proximal end (9006) may be anchored to fibroadipose tissue (9014) on the opposite side of the nose.

[0208] Nasal tip reshaping may also be accomplished using tension elements described herein. As shown in Figs. 60A-60C, the shape of the nasal tip (10) may be altered by retracting the lateral cartilages (12) inward. To accomplish this goal, a tension element (14), coupled to an anchor delivery element (18), may be deployed from a delivery cannula (16) such that a distal anchor (20) of the tension element (14) is anchored to one nasal cartilage (12) and a proximal end (22) of the tension element (14) is anchored to the other nasal cartilage (12). Tension provided between the distal anchor and the tension element proximal end may draw the lateral cartilages together, thereby altering the shape of the nasal tip (10).

[0209] In some variations, the method may include steps to reapproximate the nasal mucosa and prevent the formation of nasal hematomas, for example, after septal correction. Referring to Fig. 61, tension elements (24) may be placed on the surface of the nasal mucosa (26) in one or more locations shown in the figure to anchor the mucosa and prevent the formation of any negative spaces that may fill with blood.

[0210] In other variations, the method may include placing one or more tension elements in throat tissue to treat obstructive sleep apnea. As shown in Figures 62A-62C, the method may include advancing a delivery cannula (28) carrying a tension element (30) coupled to an anchor delivery element (32) into the subject's throat, inserting the anchor delivery element (32) into the uvula (34), setting a distal anchor (36) of the tension element (30) into the tissue of the uvula, applying tension in the direction of arrow E on the tension element (30) and the distal anchor (36) to lift the uvula, and anchoring a proximal end (38) of the tension element (30) into the tissue of the soft palate (40) and maintaining tension on the uvula (34). One or more tension elements may be employed to lift the uvula and treat obstructive sleep apnea.

[0211] Reshaping of ear tissue may also be accomplished with the devices described herein. In some variations, reshaping is used to treat a poorly defined antihelix, for example, by creating or increasing the antihelical fold. In other cases, reshaping may be used to correct an enlarged turbinate cartilage. As shown in Figures 63A and 63B, a method for more clearly defining the antihelix may include placing tension elements in one or more of the locations shown in the figures. For example, tension elements may be placed in the superior crus of the antihelix or the triangular fossa, the central portion of the scaphoid fossa, the inferior portion of the scaphoid fossa or the turbinate, or the mastoid process of the pinna and the caudal helix region of the posterior ear.

[0212] The force applied to manipulate or shape the tissue may range from about 4.0 Newtons to about 70 Newtons, including all values ​​and subranges therein. The force may be generated by pulling the free proximal end of the tension element after the distal anchor is secured to the target tissue. For example, the tension may be about 4.0 Newtons, about 5.0 Newtons, about 10 Newtons, about 15 Newtons, about 20 Newtons, about 25 Newtons, about 30 Newtons, about 35 Newtons, about 40 Newtons, about 45 Newtons, about 50 Newtons, about 55 Newtons, about 60 Newtons, about 65 Newtons, or about 70 Newtons. The tensile strength of the tension element may range from about 100 MPa to about 300 MPa, including all values ​​and subranges therein. For example, the tensile strength may be about 100 MPa, about 110 MPa, about 120 MPa, about 130 MPa, about 140 MPa, about 150 MPa, about 155 MPa, about 160 MPa, about 165 MPa, about 170 MPa, about 175 MPa, about 180 MPa, about 185 MPa, about 190 MPa, about 195 MPa, about 200 MPa, about 210 MPa, about 220 MPa, about 230 MPa, about 240 MPa, about 250 MPa, about 260 MPa, about 270 MPa, about 280 MPa, about 290 MPa, or about 300 MPa. In some cases, the tensile strength of the tension element may be at least about 150 MPa. In other cases, the tensile strength of the tension element may be at least about 300 MPa. The applied force may decrease over time as the tension element biodegrades. Typically, the tension elements biodegrade over a period of about 1 month to about 12 months. For example, the tension elements may biodegrade over a period of at least about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, or about 12 months. In one variation, the tension elements may degrade over a period ranging from about 4 months to about 9 months.

[0213] Other methods for modifying the shape of a target tissue structure are also described herein. The methods generally include deploying a shaping or tensioning element into the tissue and applying a force to the tissue to manipulate the shaping element and modify the shape of the nasal tissue. The force may be tension. Various body tissues may be shaped using tension. Exemplary tissues include, but are not limited to, nasal septum cartilage, lateral nasal cartilage, greater or lesser alar cartilage, alar fibroadipose tissue, nasal bone, and nasal turbinates.

[0214] The methods described herein may be used to treat nasal airway obstruction, treat a deviated nasal septum, straighten the nasal septum, treat a thickened, deformed or dislocated nasal septum, repair a fractured nasal septum, alter the shape of the nasal septum, treat a nasal septal spur or nasal bone spur, alter the shape of the internal or external shape of the nose, treat or modify a structural deformity of the nasal cartilage other than the nasal septum, treat a collapsed internal nasal valve, or treat turbinate hypertrophy. The methods may also be employed to treat or reduce sleep apnea, nasal snoring, or configured for any other suitable modification of nasal tissue or any combination of tissues.

[0215] When the shape of the nasal septum cartilage is to be altered, for example to correct a curved nasal septum, the method may include passing a suture, barbed suture, or shaping element through the nasal septum, tightening the suture until the septum is straightened, and trimming excess suture. In some variations, the method for adjusting the shape of a curved septum may include applying a force of about 4.0 Newtons to about 70 Newtons to the nasal septum using a shaping element. In other variations, the method may include applying a force of about 12 Newtons to about 25 Newtons to the nasal septum using a shaping element.

[0216] In some variations, the methods may employ a device including an elongate member with a proximal end, a distal end sized for introduction into a subject's body, and a lumen extending between the proximal end and a port at the distal end, and a shaping element. The shaping element may include a first end sized for introduction through the lumen for deploying the first end from the port and engaging tissue adjacent the tissue structure, a second end opposite the first end, and one or more elements that maintain a force on the engaged tissue to alter the shape of the tissue structure.

[0217] The step of manipulating the shaping element may include manipulating a second end of the shaping element and applying a force to the tissue. In some variations, the second end of the shaping element may be anchored to tissue adjacent to the nasal airway after applying the force. Anchoring the second end may include directing the second end through the tissue at a location spaced apart from the first end. In one variation, the first end may be anchored to tissue on one side of the curved septum and the second end may be anchored to tissue on the opposite side of the curved septum, and a force may be applied to modify the shape of the curved septum. In another variation, the first end may be anchored to tissue distal to the curved septum and the second end may be anchored to tissue proximal to the curved septum, and a force may be applied to modify the shape of the curved septum. The force applied by the shaping element is generally a tension force.

[0218] Alternatively, the step of manipulating the shaping element may include engaging an intermediate region of the shaping element with tissue at a second location spaced from the first location to which the first end is secured, and applying a force to the shaping element between the first and second locations to modify the shape of the tissue between the first and second locations. One or more elements in the intermediate region may be engaged with the tissue at the second location and maintain tension. Additionally, the step of engaging the intermediate region may include directing the second end of the shaping element through the tissue at the second location, and retracting the second end until the intermediate region engages the tissue at the second location. The intermediate region may include a plurality of anti-migration elements spaced from each other. Here, the second end may be retracted until at least one of the migrating elements passes through the tissue at the second location, thereby preventing the intermediate region from passing backward through the tissue at the second location.

[0219] In some variations, the step of manipulating the shaping element may further include adjusting a location of the anchoring element on the intermediate region with the tissue at the second location to maintain tension. In other variations, the method further includes separating the second end of the shaping element from the intermediate region, for example, by cutting the shaping element adjacent the intermediate region and removing excess material from the shaping element.

[0220] In another variation, a method for modifying the shape of nasal tissue of a subject is provided, comprising inserting a distal end of a delivery device into a nasal airway of the subject, deploying a first end of a shaping element from the distal end into the nasal airway, anchoring the first end of the shaping element to tissue adjacent the nasal airway, manipulating the shaping element to modify the shape of the tissue, and removing the delivery device such that the shaping element at least temporarily maintains the modified shape of the tissue.

[0221] In a further variation, a method for modifying the shape of a subject's nasal tissue includes deploying a first end of a shaping element into a nasal airway of a subject, anchoring the first end of the shaping element to tissue at a first location adjacent to the nasal airway, manipulating the shaping element to modify the shape of the tissue, and anchoring the shaping element to tissue at a second location to maintain the modified shape of the tissue. Anchoring the shaping element at the second location may include anchoring the second end of the shaping element at the second location. In one variation, anchoring the shaping element at the second location includes anchoring one or more anti-migration elements onto the shaping element at the second location. In another variation, the method further includes removing excess material of the shaping element once the one or more anti-migration elements are anchored at the second location. In a further variation, the second location may be located closer to the nasal mouth than the first location.

[0222] Some methods for modifying the shape of a subject's nasal tissue include introducing an anchor into the subject's nasal airway, anchoring the anchor to the subject's nasal septum at a first location, introducing a first end of a shaping element into the subject's nasal airway, anchoring the first end of the shaping element to the anchor, manipulating the shaping element to modify the shape of the tissue, and anchoring the shaping element to the tissue at a second location to maintain the modified shape of the tissue. The anchor may be introduced into the subject's first nasal airway and anchored by directing the anchor partially through the nasal septum into the subject's second nasal airway, or the first end of the shaping element may be introduced into the second nasal airway and anchored to a portion of the anchor that extends into the second nasal airway. In one variation, the first end of the shaping element is introduced submucosally into the nasal airway before anchoring the first end to the anchor.

[0223] Other methods for modifying the shape of a subject's nasal tissue may include inserting a distal end of a delivery device into a nasal airway of a subject, deploying a first end of a shaping element from the distal end into the nasal airway, anchoring the first end of the shaping element to tissue at a first location adjacent the nasal airway, and removing the delivery device such that the shaping element extends from the nasal airway. A needle coupled to a second end of the shaping element may then be inserted into the nasal airway and the shaping element may be manipulated to modify the shape of the tissue. Anchoring the second end at a second location adjacent the nasal airway may temporarily maintain the modified shape of the tissue.

[0224] In some methods, shaping of the nasal tissue may be accomplished using a shaping element or tensioning element equipped with an energy delivery element. For example, one or more permanent or temporary electrodes, heating elements, or other energy delivery mechanisms may be included with the shaping element, allowing the tensioning element to deliver energy to the nasal tissue. The energy delivery mechanism may be used to enhance the reshaping or remodeling of the nasal tissue by application of heat, electrical current, or any suitable form of energy. In some variations, the energy delivery mechanism may be removed after the energy is applied. In some variations, the energy delivery mechanism may be embedded with the tensioning element. In some variations, the energy delivery mechanism may be bioabsorbable or biodegradable. In some variations, the energy delivery mechanism is attached directly to the tensioning element. In some variations, the energy delivery mechanism is mounted adjacent to the tensioning element.

[0225] Fluids may also be delivered before, during, or after placement of the molding element using a fluid delivery mechanism. The fluid may provide a therapeutic or physiological effect. For example, the fluid may include a therapeutic agent or a cryogenic gas or liquid for cryotherapy purposes.

[0226] Other Exemplary Methods As shown in FIG. 1, an exemplary method for modifying the shape of nasal tissue (100) includes deploying at least one tensioning or other shaping element (200) into the nasal airway adjacent to the nasal tissue and anchoring the tensioning element (200) such that the nasal tissue at least temporarily maintains the modified shape. The tensioning element may also be known as a brace, suture, graft, buttress, implant, or support element. The method may utilize one tensioning element or multiple tensioning elements arranged in a parallel or non-parallel manner. In some variations, anchoring the tensioning element may allow for the application of a force to the nasal tissue configured to allow the nasal tissue to at least temporarily maintain the modified shape. In some variations, the force may be a tensioning force. In some variations, anchoring the tensioning element may involve anchoring a portion of the tensioning element through the target nasal tissue or through another nasal tissue. In some variations, the tissue through which the tensioning element is anchored is cartilage, bone, any semi-rigid tissue, or any combination thereof. The method may be configured to adjust the shape of the nasal tissue to a final state in a single application, or may be configured with adjustable tensioning elements that allow adjustments to the force or shape to be made over time. The method may also be configured to utilize tensioning elements deployed at variable times to sequentially alter the shape of the nasal tissue.

[0227] In some variations, the method may involve applying an external force to alter the shape of the nasal tissue before or during deployment of the tensioning device. In some variations, application of the external force may be accomplished with a force application element, such as a nasal speculum, spreader, suture passer, forceps, or other tool or device suitable for manipulating nasal tissue. In some variations, the force may be applied transmucosally or transepidermally. In some variations, the method may involve applying an external force to alter the shape of the nasal tissue after initial deployment of the tensioning element but before final anchoring of the tensioning element. In some variations, the method may involve applying an external force to alter the shape of the nasal tissue before or after deployment of the tensioning element.

[0228] In some variations, the method may be configured to be suitable for use in a medical clinic or office. In some variations, the method may be configured to be suitable for use in an ENT clinic or office. In some variations, the method may be configured to be suitable for use in a surgical center or setting. In some variations, the method may be configured to include the use of a painkiller. In some variations, the method may be configured to include the use of an anesthetic. In some variations, the method may be configured to include the use of a support element, which may also be known as a splint. In some variations, the method may be configured to include the step of elevating the nasal mucosa away from the target tissue using an instrument, a balloon, or other method of mucosa elevation. In some variations, the method may be configured to include the use of a scope or other means of visualization. The methods described herein may be configured and / or adapted for one or more of the following: treatment of nasal airway obstruction, treatment of a deviated nasal septum, straightening of the nasal septum, treatment of a thickened, deformed or dislocated nasal septum, repair of a fractured nasal septum, alteration of the shape of the nasal septum, treatment of a nasal septum spur or nasal bone spur, alteration of the shape of the internal or external shape of the nose, treatment or alteration of structural deformities of nasal cartilage other than the nasal septum, treatment of internal nasal valve collapse, or treatment of nasal turbinate hypertrophy. The methods may also be configured and / or adapted for sleep apnea, nasal snoring, or any other suitable alteration of nasal tissue or any combination of tissues.

[0229] In some variations, the method for modifying the shape of nasal tissue may also include inserting a delivery device into the nasal airway, deploying at least one tensioning element (200), anchoring the tensioning element, and removing the device such that the nasal tissue at least temporarily maintains the modified shape. For example, the delivery device may be inserted into the nasal airway, inserted beneath the nasal mucosa, or positioned in any other configuration suitable for facilitating placement or deployment of the tensioning element. In some variations, some or all of the delivery device may be disposable. In some variations, some or all of the delivery device may be reusable and configured to be suitable for sterilization.

[0230] As shown in FIG. 2, the method for modifying the shape of nasal tissue may be specifically optimized for adjusting the shape of the nasal septal cartilage (102). The method may be configured to adjust the shape of a curved septum of any type, classification, or location, including, but not limited to, a "C-shaped" curve, an "S-shaped" curve, a subluxation of the septal cartilage, a sagittal curve, a coronal curve, a bony deformity, a cartilaginous deformity, an ossified cartilage, a dislocation of bone or cartilage, a thickened or enlarged cartilage or bone, a cartilage or osteophyte, a curve caused by trauma to the bone or cartilage, or any other form of septal deformity or combinations thereof. In some variations, the method is used for the correction of anterior-posterior septal deformity. In some variations, the method is used to modify the shape of the posterior septal cartilage. In some variations, the method is used for the correction of an external nasal deformity involving an "L-strut", but may additionally or alternatively be used for any suitable application, clinical, functional, aesthetic, or otherwise. In some variations, the tension element may be anchored to or through the cartilage. In some variations, the tension element may be anchored to or through bone or any other suitable nasal tissue. In some variations, the tension element may be placed on the convex side of the curve. In some variations, the tension element may be placed on the concave side of the curve. In some variations, where the method is configured for modifying the shape of the nasal septum cartilage, the method may be configured as a correction of a curved nasal septum using the steps of passing a suture or barbed suture through the nasal septum, tightening the suture until the septum is straightened, and trimming the excess suture. In some variations, where the method is configured for adjusting the shape of the curved septum, the method may be specifically optimized to provide a force of 4 to 40 Newtons. In some variations, the method may be further optimized to provide a force of 12 to 25 Newtons.

[0231] As shown in Figure 3, the method for modifying the shape of nasal tissue may be specifically optimized for adjusting the shape of nasal tissue other than the nasal septum cartilage (102). In some variations, the method may be configured to adjust the shape of the lateral nasal cartilage (104), the greater or lesser alar cartilage (106), the alar fibroadipose tissue (108), the nasal bone (140), the nasal turbinates (150), or any other suitable nasal tissue.

[0232] As shown in FIG. 4, in some variations, the method may be configured to use a suture or multiple sutures as the tension element (200). In some variations, the tension element may be optionally configured as a barbed suture or multiple sutures. The suture may be of any diameter, size, shape, length, or width. In some variations, the suture may be arranged in a pattern to sufficiently modify the shape of the nasal tissue. The method may be configured for any number of suture passes or patterns. The suture may include an anchoring element (210) designed to prevent migration or transfer of the suture through the nasal tissue. The configuration may include a series of at least one vertical or horizontal mattress suture. In some variations, the suture may be placed and anchored submucosally, transmucosally, or transepidermally. In some variations, the suture may be introduced via a needle (240) attached to at least one end of the suture. The method may be configured to use a needle or needles that are straight, curved, flat, or otherwise shaped. The method may be configured to use a needle or needles that are attachable to or detachable from a suture. The method may be configured to utilize a kit or packaged set of instruments, tools, or suture material to place and tension the sutures and alter the shape of the nasal tissue.

[0233] As shown in FIG. 5, in some variations, the method may be configured to alter the shape of nasal tissue in multiple regions. In some variations, the method may be configured to utilize a single tensioning element (200) configured to act on multiple regions of the target nasal tissue. In some variations, the method may be configured to utilize more than one tensioning element to act on multiple regions of the target nasal tissue. In some variations, the method may be configured to alter the shape of multiple nasal tissues. In some variations, the method may be configured to alter the shape of multiple nasal tissues in multiple regions.

[0234] Delivery Device The tension elements described herein may be delivered using a variety of delivery devices. The delivery device may be configured to access various tissues in an atraumatic manner and may aid in the passage of the tension element through tissue in its insertion (low profile) configuration. In general, the delivery device may include a cannula with a proximal end, a distal end, and an atraumatic tip. The cannula may further include a lumen extending from the proximal end through the atraumatic tip and within which the tension element may be stored. The tension element may include a distal anchor configured to pivot at a pivot point from an insertion configuration to a deployed configuration in response to the application of force to the tension element, as described herein above. In some variations, the delivery device may include a component that mechanically, electronically, or visually indicates the tension level of the tension element. In other variations, a tension level measurement component may be provided on the tension element itself.

[0235] The tension element and anchor delivery element may be preloaded into the delivery device or loaded into the delivery device immediately prior to the procedure. A handle is coupled to the cannula proximal end and an actuator is disposed on the handle. In one variation, the actuator may be concentrically disposed about the handle. In another variation, the actuator may include a pair of tabs that may be advanced and retracted relative to the handle. The actuator may be coupled to the anchor delivery element and the tension element coupled thereto to advance the tension element and anchor delivery element out of the lumen of the cannula.

[0236] In some variations, the cannula of the delivery device is made from a transparent material, such as a clear plastic selected from the group consisting of acrylic, polycarbonate, polyethylene terephthalate, polyvinyl chloride, polyethylene, polypropylene, and polystyrene. In other variations, the cannula may be made from stainless steel or other suitable metals. The cannula may also have a variety of cross-sectional shapes. For example, the cross-sectional shape of the cannula may be circular, non-circular, semi-circular, or ovoid. A non-circular cannula cross-sectional shape may aid in orienting the cannula relative to the plane of the cartilage or other tissue. The cannula length may range from about 50 mm to about 70 mm, including all values ​​and subranges therein. For example, the cannula length may be about 50 mm, about 55 mm, about 60 mm, about 65 mm, or about 70 mm. In some variations, one or more portions along the cannula length may be flexible or malleable. In other variations, one or more markers may be provided along the cannula to aid in visualizing the distal end of the cannula and / or determining the length of the cannula inserted into the nasal cavity or tissue. A light element may also be included within the delivery device to aid in visualization. In some variations, the light element may be a light wire configured to slide within the cannula lumen or a second lumen concentrically disposed within the cannula lumen or a lumen provided within the delivery device handle.

[0237] Some variations of the cannula may include an internal deflector within the cannula distal end that deflects or angles the anchor delivery element as it is advanced out of the cannula. The internal deflector may be a flat rigid surface within the cannula distal end that is angled at about 30 degrees to about 70 degrees relative to the longitudinal axis of the cannula. In other variations, the cannula distal tip may be pre-shaped to have an angle of about 30 degrees to about 70 degrees relative to the longitudinal axis of the cannula.

[0238] One or more ports in fluid communication with the lumen may be provided in the cannula for delivery of tension elements from the lumen into the tissue. The one or more ports may be provided at any suitable location on the cannula, for example, at the distal tip of the cannula or at the distal sidewall of the cannula. The one or more ports may also have any suitable shape. For example, the one or more ports may be circular, semicircular, or oval. When the port is provided at the distal tip of the cannula, the port may have a length and depth. The length of the port may range from about 3.0 mm to about 6.0 mm. For example, the port length may be about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, about 5.5 mm, or about 6.0 mm. The depth of the port may range from about 1.0 mm to about 2.0 mm. For example, the port depth may be about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, or about 2.0 mm. In some variations, the port may have a depth that is about 30% to about 70% of the cannula outer diameter. The port may also have curved and flat portions when viewed from the side.

[0239] The delivery device may also include a handle with a grip. The handle length may range from about 13 cm to about 25 cm, including all values ​​and subranges therein. The grip may include multiple ridges to improve a user's grip on the handle. The handle and grip may be made from the same material or different materials. For example, the handle and grip may be made from materials such as, but not limited to, nylon, silicone, polycarbonate, polyethylene, polypropylene, polyetheretherketone, polyetherimide, polyetherimide, Delrin, acrylic, polybenzimidazole, polyester, styrene acrylonitrile, or acrylonitrile butadiene styrene (ABS). Additionally, one or more directional indicators for orienting the port relative to the anchoring location within the target tissue may also be provided.

[0240] As shown in FIG. 64A, an exemplary delivery device may include a cannula (42) with a proximal end (43), a distal end (44), and an atraumatic tip (45). The cannula (42) may further include a lumen (46) extending from the proximal end (43) through the atraumatic tip (45) within which a tension element (47) may be stored. The tension element (47) may include a distal anchor (48) configured to pivot at a pivot point from an insertion configuration to a deployed configuration upon application of force to the tension element, as described above. Within the cannula lumen (46), the tension element (47) may be coupled to an anchor delivery element (49) along with a cutting tip for use in puncturing or penetrating tissue. A handle (50) may be coupled to the cannula proximal end (43), and an actuator (51) may be concentrically disposed about the handle (50). The actuator (51) may be advanced to deploy the tension element (47) from the distal port (52) of the cannula (42). As shown in further detail in FIG. 65, the actuator (51) may be advanced in the direction of arrow U to advance the tension element (47) and the anchor delivery element (49) from the cannula distal port (52). After disengagement of the tension element from the anchor delivery element (49) and deployment of the distal anchor (58), the actuator (51) may be retracted in the direction of arrow D and the delivery device may be withdrawn, deploying the full length of the tension element (47). As shown in the cross-sectional view of FIG. 64E, the actuator (51) may be coupled to the anchor delivery element (49) via a screw (66). Referring back to FIG. 64A, a directional line indicator (53) may be provided on the handle (50) to aid in aligning the distal port with the tissue of interest. Grip-enhancing ridges (54) may improve a user's hold on the handle (50). Anti-rolling features (55), which may be thickened portions of the handle, may help stabilize the delivery device during delivery of the tension element (47). As shown in FIG. 64B, the distal port (52) of the cannula (42) may have an oval shape. In the close-up view provided in FIG. 64C, the atraumatic tip (45) may have a rounded portion (63). The rounded portion (63) may have a radius of curvature of approximately 1.19 mm.In addition, the port (52) may have a length (L) and a depth (D). The port length may range from about 3.0 mm to about 6.0 mm, as described above, and the port depth may range from about 1.0 mm to about 2.0 mm. The port may also have a curved portion (64) and a flat portion (65), as shown in the side view of FIG. 64D. This configuration of the cannula tip may aid in atraumatically accessing various tissues.

[0241] In another variation, as shown in Fig. 66, the handle (59) may include a number of grip-enhancing ridges (60) and a directional indicator (61) similar to the handle provided in Fig. 64A. However, instead of being concentrically disposed about the handle, the actuator includes two tabs (62). Advancement of the tabs toward tissue may cause the tension element to be deployed from the delivery device, while retraction of the tabs (62) may uncouple and uncouple the anchor delivery element from the tension element.

[0242] The foregoing description uses specific terminology for purposes of explanation to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required to practice the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations are possible in light of the above teachings. The embodiments have been chosen and described in order to explain the principles of the invention and its practical application, thereby enabling those skilled in the art to utilize the invention and its various embodiments with various modifications as may be suitable for the particular use contemplated.

Claims

1. A device for manipulating tissue within a target, A tension element, the tension element comprising an elongate body having a proximal end and a distal end, A distal anchor at the distal end of the tension element, the distal anchor comprising an anchor body and a pivot point, and having an insertion configuration and a deployed configuration, Comprising, The distal anchor is configured to pivot from the insertion configuration to the deployed configuration at the pivot point in response to the application of a force to the elongate body.

2. The tension element has a tensile strength ranging from about 100 MPa to about 600 MPa, the device according to claim 1.

3. The tension element comprises a biodegradable material, the device according to claim 1.

4. The biodegradable material comprises a biodegradable polymer, the device according to claim 3.

5. The biodegradable polymer is selected from the group consisting of LPLA (poly(L-lactic acid)), DLPLA (poly(DL-lactic acid)), LDLPLA (poly(DL-lactic acid-co-L-lactic acid)), LPLA-HA (poly(L-lactic acid) with hydroxyapatite), PGA (poly(glycolide)), PGA-TMC (poly(glycolide-co-trimethylene carbonate) or polyglyconate), PDO (poly(dioxanone)), LPLG (poly(L-lactic acid-co-glycolide)), DLPLG (poly(DL-lactic acid-co-glycolide)), and copolymers and blends thereof, the device according to claim 4.

6. The tension element comprises PDO (poly(dioxanone)), the device according to claim 5.

7. The tension element is configured to degrade after about 6 months, the device according to claim 3.

8. The tension element has a length ranging from about 10 cm to about 20 cm, the device according to claim 1.

9. The tension element has a length of about 15 cm, the device according to claim 1.

10. The anchor, in its deployed configuration, prevents passage of the distal end of the tension element through tissue rearwardly, the device according to claim 1.

11. The anchor body comprises a plurality of arms, the device according to claim 1.

12. The plurality of arms pivot at the pivot point in response to application of a force to the extension body, the device according to claim 11.

13. The anchor body is rectangular in shape, the device according to claim 1.

14. The anchor body comprises a heel and a toe retainer, the device according to claim 13.

15. The anchor body has a dog bone shape, the device according to claim 1.

16. A plurality of proximal anchors are disposed between the distal anchor and the proximal end of the tension element, the device according to claim 1.

17. The distal anchor and the plurality of proximal anchors are of the same type of anchor, the device according to claim 16.

18. The distal anchor and the plurality of proximal anchors are of different types of anchors, the device according to claim 16.

19. The distal end of the tension element further comprises an enlarged distal tip, the device according to claim 1.

20. The device according to claim 1 further comprises a proximal needle removably attached to the proximal end of the extension body of the tension element. Claim 21 The device according to claim 1, further comprising an anchor delivery element coupled to the distal anchor, the anchor delivery element having a cutting tip and being configured to pass the distal anchor through the tissue in its insertion configuration. Claim 22 The device according to claim 21, wherein the anchor delivery element comprises a keyhole shaped to removably couple the distal anchor to the anchor delivery element. Claim 23 The device according to claim 21, wherein the anchor delivery element comprises a seating region configured to removably secure the anchor to the anchor delivery element. Claim 24 The device according to claim 23, wherein the seating region has a height that is the same as the height of the distal anchor when the distal anchor is seated on the anchor delivery element. Claim 25 The device according to claim 23, wherein the seating region comprises a release tab. Claim 26 The device according to claim 1, wherein the force applied to the tissue by the tension element is a tensile force. Claim 27 The device according to claim 1, wherein the tissue is nasal tissue, laryngeal tissue, or ear tissue. Claim 28 The device according to claim 27, wherein the nasal tissue comprises septal cartilage, lateral nasal cartilage, major alar cartilage, minor alar cartilage, alar fibroadipose tissue, nasal bone, or turbinate. Claim 29 A device for manipulating tissue within a subject, a tension element comprising an elongate body having a proximal end and a distal end, a distal anchor at the distal end of the tension element, the distal anchor comprising an anchor body and a pivot point and having an insertion configuration and a deployed configuration, comprising The distal anchor body comprises a plurality of arms, and the plurality of arms are configured to pivot from the insertion configuration to the deployment configuration at the pivot point in response to the application of a force to the extension body, a device. **Claim 30** A delivery device, A cannula, the cannula comprising a proximal end, a distal end, and a non-traumatic tip, the cannula further comprising a lumen extending from the proximal end through the non-traumatic tip, and configured to store a tension element, a cannula; A handle coupled to the proximal end of the cannula; An actuator disposed concentrically about the handle and comprising; The tension element comprises a distal anchor, and the distal anchor is configured to pivot from an insertion configuration to a deployment configuration at a pivot point in response to the application of a force to the tension element, a delivery device. **Claim 31** The cannula is transparent, the delivery device according to claim 30. **Claim 32** The cross-sectional shape of the cannula is circular or oval, the delivery device according to claim 30. **Claim 33** The handle comprises a grip having a plurality of ridges, the delivery device according to claim 30. **Claim 34** The handle comprises a directional indicator, the delivery device according to claim 30. **Claim 35** A device for manipulating tissue within a subject, A tension element, the tension element comprising an extension body having a proximal end and a distal end, a tension element; A distal anchor at the distal end of the tension element, the distal anchor comprising an anchor body and having a certain surface area, an insertion configuration, and a deployment configuration, a distal anchor and comprising; The device, wherein the distal anchor in the deployed configuration has a surface area for opposing tissue that is greater than the distal anchor in the inserted configuration.

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