Nose implants, systems and methods of use

Abstract

To provide nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools.SOLUTION: A nasal implant delivery tool includes: a handle including an implant loading chamber adapted to receive a nasal implant; a needle extending distally from the handle, the needle having a lumen such that a portion of the lumen has a non-circular cross-section, the needle having a sharp distal end; and an actuator adapted to move the nasal implant along the needle lumen and out of an opening at the distal end of the needle.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. patent application Ser. No. 62 / 233,155, filed Sep. 25, 2015, entitled "Nasal Implants and Systems and Method of Use," the disclosure of which is incorporated herein by reference in its entirety. Literature citations

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] The present invention relates to implants for placement within the body, tools for delivering the implants, and systems and methods for using the implants and tools for placement within the body, and in particular to nasal implants, tools for delivering the nasal implants, and systems and methods for using such implants and tools. [Background technology]

[0004] A person's particular nasal structure may cause or contribute to a variety of problems, such as appearance concerns, breathing difficulties, sleep apnea, snoring, etc., that may affect a person's health and reduce their quality of life. For example, the structure of the external or internal nasal valves may provide resistance to airflow from the nose to the lungs, preventing a person from getting enough oxygen into the blood.

[0005] U.S. Patent Nos. 8,133,276, 7,780,730, and U.S. Patent Application Publication No. 2012 / 0109298 describe implants that can be introduced into a person's nose via a non-surgical injection technique to treat a person's nasal valve.

[0006] There is a continuing need for improved solutions to address problems arising from nasal anatomy that are easier to use, longer lasting, less invasive, less expensive to manufacture, and better performing. Summary of the Invention [Problem to be solved by the invention]

[0007] The present invention is intended to solve the problems of the conventional techniques described above. [Means for solving the problem]

[0008] Described herein are implants for placement within the body, tools for delivering the implants, and systems and methods for using the implants and tools for placement within the body, particularly nasal implants, tools for delivering the nasal implants, and systems and methods for using such implants and tools.

[0009] In general, in one embodiment, a nasal implant delivery tool includes a handle including an implant loading chamber adapted to receive a nasal implant, a needle extending distally from the handle, the needle having an internal lumen, a portion of the internal lumen having a non-circular cross-section, the needle having a sharpened distal end, and an actuator adapted to move the nasal implant along the needle lumen and out an opening at the distal end of the needle.

[0010] This and other embodiments may include one or more of the following features: The actuator of the delivery tool may further include a push rod and plunger assembly. The delivery tool may further include a compression element connecting the push rod to the plunger assembly. The delivery tool may further include a push rod locking element proximal to the implant loading chamber configured to prevent the push rod from moving further proximally relative to the handle. The needle may be movable relative to the handle between a plurality of discrete positions, the plurality of discrete positions may correspond to a length of the nasal implant. The delivery tool may further include a needle slider actuator configured to move the needle relative to the handle between a plurality of discrete positions. The length of the actuator may be adjustable between a first position and a second position. The actuator may include a push rod and plunger assembly, the length of the push rod and plunger assembly may be adjustable between a first position and a second position, which is adjustable by engaging the push rod with a first locking surface on the plunger assembly and a second locking surface on the plunger assembly. The delivery tool may further include an implant orientation indicator configured to visually indicate a plane formed by a first arm and a second arm of the nasal implant in a deployed configuration corresponding to an orientation of the implant within the needle lumen. The implant orientation indicator may include a first arm extending from the handle in a first direction and a second arm extending from the handle in a second direction. The first arm and the second arm may define a plane that may be approximately the same as a plane formed by the first arm and the second arm of the nasal implant in a deployed configuration corresponding to an orientation of the implant within the needle lumen. The implant loading chamber may be in communication with the needle lumen and may be adapted to load the nasal implant into the needle lumen. The implant loading chamber may be adapted to transition the nasal implant from the deployed configuration to the delivery configuration as the nasal implant advances into the needle lumen. The implant loading chamber may be in communication with an implant engagement surface disposed between the needle lumen and the implant loading chamber.The implant engaging surface may be adapted to engage the first and second arms of the implant to transition the implant between the deployed and delivery configurations. The implant engaging surface may have a substantially smooth inner surface. The implant loading chamber may be configured to receive any nasal implant in the deployed configuration. The implant loading chamber may include a first recess and a second recess adapted for passage of tweezers engaged with the nasal implant in the deployed configuration. The implant loading chamber may be adapted to receive a cartridge containing the nasal implant. The cartridge may be configured to accommodate two or more nasal implants. The cartridge of the delivery tool may further include an implant engaging ramp adapted to engage the first and second arms of the implant to transition the implant between the deployed and delivery configurations. The cartridge may be adapted to communicate with the needle lumen. The handle may be adapted to receive the cartridge such that the cartridge engages the needle lumen to adjust the length of the needle lumen relative to the handle. The needle may have a low friction coating on an outer surface. The low friction coating may be selected from the group consisting of PTFE, silicone, and poly(p-xylylene). The delivery tool may further include an actuator register adapted to indicate a position of the actuator when the nasal implant may be at the distal end of the needle lumen. The actuator register may include markings on the actuator or on the handle. The delivery tool may further include an actuator register adapted to indicate a position of the actuator when at least a distal portion of the implant may be out of the needle lumen. The actuator register may be a stop element that prevents further movement of the actuator. The needle may include generally striped markings at various locations along the needle. The delivery tool may further include any of the described nasal implants. The delivery tool may further include a cartridge containing the nasal implant. The delivery tool may further include a cartridge containing two or more nasal implants. The system may include any of the described delivery tools or nasal implants.

[0011] In general, in one embodiment, a nasal implant includes a body including a distal end, a proximal end, and a central portion disposed between the proximal and distal ends, a first arm disposed at the distal end, the arm having a proximal end fixed to the body and a distal end not fixed to the body, the distal end of the arm adapted to move away from a central longitudinal axis of the body from a delivery configuration to a deployed configuration, and a second arm having a proximal end fixed to the body and a distal end not fixed to the body, the distal end of the second arm adapted to move away from a central longitudinal axis of the body from a delivery configuration to a deployed configuration.

[0012] This and other embodiments may include one or more of the following features: The first and second arms may be biased toward their respective deployed configurations. The first and second arms may be configured to self-deploy toward the deployed configurations. The central portion may include a plurality of small protrusions. The implant may further include a blunt proximal end. The implant may further include a plurality of barbs at the proximal end. The implant may include a degradable inner portion and an outer coating including a hydrophobic material. The hydrophobic material may be poly(caprolactone). The hydrophobic material may be Parylene™. The hydrophobic material may be a bioabsorbable material. The hydrophobic material may not be a bioabsorbable material. The hydrophobic material may cover the entire outer surface of the degradable inner portion. The hydrophobic material may cover a portion of the outer surface of the degradable inner portion. The portion of the outer surface may include a central portion of the implant. The portion of the outer surface may include a central portion and a distal end of the implant. The hydrophobic material may have a discontinuous pattern on the outer surface of the degradable inner portion. The hydrophobic material may be about 0.1 microns to about 10 microns thick. The hydrophobic material may be about 0.1 microns to about 5 microns thick. The hydrophobic material may be about 0.1 microns to about 1 micron thick. The hydrophobic material may be less than about 10 microns thick. The hydrophobic material may be less than about 5 microns thick. The hydrophobic material may be less than about 1 micron thick. The outer coating may include a hydrophobic material of a thickness selected to achieve a predetermined degradation characteristic. The implant may further include a drug within the hydrophobic material or a drug disposed between the degradable inner portion and the outer coating including the hydrophobic material. The agent may be selected from the group consisting of an antibiotic, another antibacterial agent, an antifungal agent, an antihistamine, an anti-inflammatory agent, a cartilage growth inducer, a decongestant, a drug, a growth factor, a microparticle, a mucolytic agent, a radiopaque material, a radiopaque drug, a radiolabel, a steroid, and a vitamin.The drug may be a bioactive agent, and the hydrophobic material may be configured to elute one or more bioactive agents selected from the group consisting of thrombolytic agents, corticosteroids, vasodilators, antihypertensives, antibacterials or antibiotics, antimitotics, antiproliferatives, antisecretory agents, nonsteroidal anti-inflammatory agents, immunosuppressants, growth factors, growth factor antagonists, anticancer and / or chemotherapeutic agents, antipolymerase agents, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, free radical scavengers, antioxidants, biological agents, and radiotherapeutic agents. The central portion may have a bending stiffness of about 9-130 N-mm2.

[0013] In general, in one embodiment, a method of supporting a tissue compartment in a patient's nose includes inserting a needle of a delivery tool into the nasal tissue, the delivery tool including a handle portion, the needle extending distally from the handle, the needle including a needle lumen, the handle including an implant loading chamber adapted to receive an implant, and the delivery tool including an actuator adapted to move the implant along the needle lumen and out of an opening at a distal end of the needle; advancing the implant distally out of the needle lumen to position a distal end of the implant within the nasal tissue, the implant including a first arm at a distal end and a second arm at its distal end; advancing the implant distally out of the needle lumen to position a distal end of the implant within the nasal tissue, the implant including a first arm at a distal end and a second arm at a distal end thereof; advancing the first arm away from a central longitudinal axis of the implant during the advancing step; and advancing the delivery tool to position a central portion of the implant within the nasal tissue; and supporting the tissue compartment with the implant.

[0014] This and other embodiments may include one or more of the following features: Advancing the implant may include pushing the implant distally away from a central longitudinal axis of the implant by engaging the first and second arms, respectively, with tissue. The actuator may include a push rod, a plunger assembly, and a compression element connecting the push rod to the plunger assembly, and advancing the implant may include pushing the implant distally with the push rod. The method may further include maintaining a distal axial force on the implant by the push rod and the compression element during initial withdrawal of the delivery tool. The method may further include loading the implant into an implant loading chamber of the delivery tool. The method may further include loading the implant into the implant loading chamber using tweezers. The method may further include loading a cartridge containing the implant into the implant loading chamber. The method may further include retracting the push rod of the actuator to a proximal locking point before loading the implant into the implant loading chamber. The method may further include adjusting a length of the needle extending from the handle prior to loading the implant. Sliding the needle relative to the handle may include moving a slider on the handle in communication with the needle to move the needle relative to the handle between a plurality of discrete positions. The actuator may include a push rod and plunger assembly, and the method may further include adjusting a length of the push rod and plunger assembly prior to loading the implant. The method may further include advancing the implant from the implant loading chamber into the needle lumen. The delivery tool may have an implant engaging surface disposed between the needle lumen and the implant loading chamber, and the method may further include advancing the implant from the implant loading chamber through the implant engaging surface and into the needle lumen.The loading step may include loading the implant into the proximal end of the needle and advancing the implant to the distal end of the needle before the inserting step. The loading step may include folding a first arm and a second arm of the implant before the implant enters the proximal end of the needle. The advancing step may include advancing the actuator to a locking point, followed by unlocking the actuator and then advancing the implant distally out of the needle lumen to position the distal end of the implant in the nasal tissue. The inserting step may include inserting the distal end of the needle into the nasal tissue. The method may further include maintaining a known orientation between the implant and the needle during the inserting step. Maintaining a known orientation between the implant and the needle may include engaging the implant with a portion of the needle lumen having a non-circular cross-section. The implant may include a degradable inner portion and an outer coating including a hydrophobic material. The hydrophobic material may be poly(caprolactone). The hydrophobic material may be Parylene™. The hydrophobic material may be a bioabsorbable material. The hydrophobic material may not be a bioabsorbable material. The hydrophobic material may cover the entire outer surface of the degradable inner portion. The hydrophobic material may cover a portion of the outer surface of the degradable inner portion. The portion of the outer surface may include a central portion of the implant. The portion of the outer surface may include a central portion and a distal end of the implant. The hydrophobic material may have a discontinuous pattern on the outer surface of the degradable inner portion. The hydrophobic material may be about 0.1 microns to about 10 microns in thickness. The hydrophobic material may be about 0.1 microns to about 5 microns in thickness. The hydrophobic material may be about 0.1 microns to about 1 micron in thickness. The hydrophobic material may be less than about 10 microns in thickness. The hydrophobic material may be less than about 5 microns in thickness. The hydrophobic material may be less than about 1 micron in thickness. The method may further include the step of selecting an implant based on a degradation characteristic of the implant. The degradable characteristics of the implant may be based on a degradable inner portion and an outer coating that includes a hydrophobic material.The method may further include selecting a conformality and thickness of the outer coating based on desired degradation characteristics of the implant. The method may further include degrading the degradable inner portion of the implant. The duration of the degrading of the degradable inner portion of the implant may be less than about 48 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 36 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 24 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 18 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 12 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 9 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 6 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 3 months. The duration of the degrading of the degradable inner portion of the implant may be less than about 1 month. The method may further include the step of the implant eluting a drug into the nasal tissue. The drug may be selected from the group consisting of an antibiotic, another antibacterial agent, an antifungal agent, an antihistamine, an anti-inflammatory agent, a cartilage growth inducer, a decongestant, a drug, a growth factor, a microparticle, a mucolytic agent, a radiopaque substance, a radiopaque drug, a radiolabeled agent, a steroid, and a vitamin. The drug may be a bioactive agent, and the hydrophobic material may be configured to elute one or more bioactive agents selected from the group consisting of a thrombolytic agent, a corticosteroid, a vasodilator, an antihypertensive agent, an antibacterial or antibiotic agent, an antimitotic agent, an antiproliferative agent, an antisecretory agent, a nonsteroidal anti-inflammatory agent, an immunosuppressant, a growth factor, a growth factor antagonist, an anticancer and / or chemotherapeutic agent, an antipolymerase agent, an antiviral agent, a photodynamic therapy agent, an antibody targeted therapy agent, a prodrug, a free radical scavenger, an antioxidant, a biological agent, and a radiotherapeutic agent. The implant may have the drug contained within the hydrophobic material of the implant or disposed between a degradable inner portion and an outer coating that includes the hydrophobic material of the implant. The delivery tool may be any of the delivery tools previously described.The implant may be any of the nasal implants already described.

[0015] Generally, in one embodiment, a method of making a nasal implant includes the steps of providing a biodegradable inner portion of the nasal implant, selecting desired biodegradable characteristics, and applying a hydrophobic material having a preselected pattern and thickness that corresponds to the desired biodegradable characteristics of the biodegradable inner portion of the nasal implant.

[0016] This and other embodiments may include one or more of the following features: The hydrophobic material may be poly(caprolactone). The hydrophobic material may be Parylene™. The hydrophobic material may be a bioabsorbable material. The hydrophobic material may not be a bioabsorbable material. The hydrophobic material may cover the entire outer surface of the degradable inner portion. The hydrophobic material may cover a portion of the outer surface of the degradable inner portion. The portion of the outer surface may include a central portion of the implant. The portion of the outer surface may include a central portion and a distal end of the implant. The hydrophobic material may have a discontinuous pattern on the outer surface of the degradable inner portion. The hydrophobic material may be about 0.1 microns to about 10 microns in thickness. The hydrophobic material may be about 0.1 microns to about 5 microns in thickness. The hydrophobic material may be about 0.1 microns to about 1 micron in thickness. The hydrophobic material may be less than about 10 microns in thickness. The hydrophobic material may be less than about 5 microns in thickness. The hydrophobic material may have a thickness of less than about 1 micron. The desired biodegradation characteristics may include a period of less than about 48 months. The desired biodegradation characteristics may include a period of less than about 36 months. The desired biodegradation characteristics may include a period of less than about 24 months. The desired biodegradation characteristics may include a period of less than about 18 months. The desired biodegradation characteristics may include a period of less than about 12 months. The desired biodegradation characteristics may include a period of less than about 9 months. The desired biodegradation characteristics may include a period of less than about 6 months. The desired biodegradation characteristics may include a period of less than about 3 months. The desired biodegradation characteristics may include a period of less than about 1 month.

[0017] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 illustrates the anatomy and tissues underlying the nose on the face with the overlying skin or tissue omitted. [Diagram 2] 2A-2B are diagrams illustrating the placement of an implant in a patient's nose. [Diagram 3] 3A-3B show an implant having arms. [Figure 4] 4A-4B show multiple implants placed in a patient's nose. [Diagram 5] FIG. 1 illustrates an implant delivery device for placing an implant into body tissue. [Figure 6] 1 is a cross-sectional view of an implant delivery device for placing an implant into body tissue. [Figure 7] FIG. 1 illustrates an implant positioned in an implant loading chamber of an implant delivery apparatus. [Figure 8] 8A-8B are diagrams illustrating an implant delivery device and an implant delivery device with an implant in a loading chamber, respectively, according to some embodiments. [Figure 9] 9A-9B show an implant delivery device with different actuator positions. [Figure 10] 10A-10B are cross-sectional views of an implant delivery device with different actuator positions. [Figure 11] FIG. 1 illustrates an implant positioned in an implant loading chamber of an implant delivery apparatus. [Figure 12] FIG. 1 illustrates an implant positioned in an implant loading chamber of an implant delivery apparatus. [Figure 13] FIG. 13 shows an implant within a needle lumen of an implant delivery device. [Figure 14] FIG. 13 shows an implant extending distally from a needle lumen of an implant delivery device. [Figure 15] 1 is a cross-sectional view of an implant delivery device for placing an implant into body tissue. [Figure 16] FIG. 1 illustrates an actuator of an implant delivery device. [Figure 17] FIG. 13 shows a portion of a push rod of an implant delivery device. [Figure 18] 18A-18B show a portion of an actuator of an implant delivery device. [Figure 19] FIG. 13 shows a portion of an actuator of an implant delivery device. [Figure 20] FIG. 13 shows a handle with a slider of an implant delivery device. [Figure 21] FIG. 1 shows the handle and cassette with the implant of an implant delivery device. [Figure 22-1] 1(A)-(C) show a portion of the actuator of an implant delivery device. [Figure 22-2] (D) and (E) show a portion of the actuator of the implant delivery device. [Diagram 23] 23A-23B show an implant. [Figure 24] 24A-24F show an implant. [Diagram 25] 1 illustrates an implant according to some embodiments. [Figure 26] 1A-1C show examples of implant cores with varying coating thicknesses, according to some embodiments. [Figure 27-1] 1A and 1B show embodiments of nasal implants having various coating configurations. [Figure 27-2](C) and (D) show embodiments of nasal implants having various coating configurations. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Described herein are implants, devices, and systems for altering, strengthening, repairing, and supporting body tissue, as well as methods of using the implants, devices, and systems. Such systems and methods may be used to support or alter any tissue in the body, but may be particularly advantageous for use in nasal tissue in a patient's nose, for example to aid in nasal breathing or to modify the cosmetic appearance of the nose. The systems described herein broadly include an implant to be placed in the patient's body, an implant delivery tool to deliver the implant to the patient, and an actuator adapted to move the nasal implant through the delivery tool, although these system components may be used independently of one another. The implant delivery tool may include a handle and a piercing end (needle) to pierce the body tissue. The implant may have sufficient strength to support tissue or change tissue shape when the implant is in place in the body. The implant may also be sufficiently flexible to change shape during delivery of the implant or to allow tissue to move when the implant is in place within the body. The implant delivery tool may be a handheld delivery tool and may be configured to place the implant relatively close to a body surface, for example, under or in cartilage or other connective tissue, muscle, or skin. The implant delivery tool may have a small piercing end (needle) to create a small, relatively unnoticeable opening through the body surface (e.g., through skin, mucus, or epithelium) and pass through the underlying tissue to deliver the implant to the patient. The implant delivery tool may deliver the implant minimally invasively through the body opening to the tissue, minimizing trauma. In addition to minimizing pain, infection, and swelling, such minimally invasive systems and methods described herein may also eliminate the need for large dressings to cover the skin and tissue openings after implant delivery, which may otherwise cause patient discomfort or draw undue attention.This may be especially important when the patient receives the implant in a highly visible location and a dressing is applied to the patient's face, such as receiving a nasal implant in the nose. In some cases, implant delivery can be performed very quickly, in just a few seconds or minutes. The systems and methods described herein can be very safe and require little to no surgery. The systems and methods can be performed in hospitals, but generally can also be performed in clinics or outpatient facilities or other non-hospital care facilities. The delivery tool that delivers the implant into the patient's body can create a small hole that is easy to heal by using a relatively small needle (approximately the same size as a needle used to draw blood or place an IV (intravenous) line in a patient) to place the implant in the body.

[0020] The implant may be placed near the surface of the skin or may be placed deep within body tissue. The implant may be shaped to have a low profile in at least one dimension (e.g., height) so that it lies relatively flat against the tissue when implanted. If the nasal implant is placed near the surface of the patient's nose, the implant can be low profile so that the presence of the implant is not obvious when viewing the patient.

[0021] The implant may be capable of having different configurations or shapes, for example, a delivery configuration when the implant is delivered, a deployed configuration when fully deployed, and other configurations before, during, or after delivery or deployment. The implant may have a collapsed configuration and an expanded configuration. The implant may be collapsible or configured to collapse to fit into an implant delivery tool and to fit through a small deployment hole formed by the delivery tool. The implant may be configured to expand in body tissue to perform its support or tissue shaping function when deployed in a patient. The expanded implant may better support or change body structures or tissues or help hold the implant in place. The implant may have an implant body and protrusions, which may be capable of moving independently or relative to the implant body. The protrusions can move from an outward orientation toward the central longitudinal axis of the implant, thereby reducing the overall profile of the implant so that an implant with a relatively large cross-sectional profile can (temporarily) fit into a relatively small area of ​​the delivery device before assuming a deployed configuration in the body tissue. The end can be forked, with two or more implant protrusions (e.g., arms at the end of the fork) able to move toward each other to reduce the overall implant profile, or diverge (e.g., away from each other) to expand the overall implant profile. The implant can include an elastomeric or other flexible material such that the implant body or protrusions (arms) can change shape without breaking. The implant or a portion of the implant (e.g., arms) can be curved or arc-shaped over part or all of the implant or portion of the implant. The implant, and in particular the implant protrusions (arms), can include one or more features (e.g., bevels) that may be useful for guiding the implant into an implant delivery tool or for guiding the implant into tissue. The bevels can be on the ends of the protrusions.

[0022] The implants, devices, systems, and methods described herein may be used in any body tissue, but will be particularly useful for supporting or altering the internal nasal valve or other nasal tissue. The internal nasal valve is a complex three-dimensional structure that controls breathing and how air (oxygen) moves in and out of the body. Dysfunction of the internal nasal valve can dramatically and adversely affect a person's ability to breathe.

[0023] FIG. 1 shows the underlying anatomy and tissues of the face. The overlying outer layer of skin and muscle has been omitted to better reveal the underlying cartilage and bone that gives structure. The nose is located in the center of the face and plays an important role in olfaction (smelling) and breathing control. The nose controls breathing by restricting airflow. There are two air passages in the nose (originating from each nasal cavity), one on each side, that combine to form a single air passage into the body. Air from the nose flows through the trachea into the lungs, where it spreads into the lung lobules and absorbs oxygen for use throughout the body. Each of the two air passages in the nose has several segments along each air passage, including two types of nasal valves (called the external and internal nasal valves), that act to control the airflow through the nose, and together the external and internal nasal valves control the airflow in and out of the body. The amount of airflow resistance caused by these valves needs to be "just right"; too much or too little resistance can result in breathing problems and other issues. These valves are tissues that surround the airflow, and the amount of resistance they offer to the airflow is largely determined by their shape and size (their internal cross-sectional area). The internal nasal valves on each passage are the narrowest segments of the nasal passages and generally generate most of the resistance. Besides their important function of controlling airflow, the internal nasal valves also contribute to giving the nose its characteristic shape. The nasal valves are shaped and supported by various structures in the nose and face, with the external nasal cartilages playing a key role in their shape and function. Any significant (or even minor) changes in the structure of the internal nasal valves can impair nasal breathing as well as alter the cosmetic appearance of the nose. These changes generally act to reduce the cross-sectional area of ​​the internal nasal valves and can be caused by surgery, other medical procedures, or facial trauma. Furthermore, nasal valve structure varies from person to person, and in some individuals, the valves can be significantly narrowed due to softening or malformation of the cartilage, which is usually referred to as nasal obstruction. As the valve area narrows, the acceleration of the airflow increases with a concomitant decrease in intraluminal pressure, causing the valve to collapse.While normal nasal valves can collapse under great respiratory pressures, dysfunctional internal nasal valves can collapse even during normal breathing, with the undesirable consequences of reduced oxygen flow, snoring, and mouth breathing.

[0024] The nose includes the external nose, which protrudes from the face, and the nasal cavity, which is located below the external nose. From top to bottom, the external nose has the root, bridge, dorsum, free tip, and columella. The external nose is connected to the pyriform orifice, which is the continuous free edge of the pyriform opening of the nasal cavity in the skull, and is formed by the nasal bones and maxilla. As shown in FIG. 1, the nose is located in the center of the face and framed by the bones of the head, with the frontal bone 2 above the nose, the lateral frontal process of the maxilla 6 on the outside of the nose, and the anterior nasal spine of the maxilla 20 below the nose (another lateral frontal process of the maxilla on the other side of the nose is not visible in this view). The external nose can be roughly divided into three layers from outside to inside, which are the overlying skin and muscle layer (not shown in this view), the middle cartilage and skeletal layer, and the inner mucous layer (not visible in this view).

[0025] The intermediate cartilage and skeletal layers form, structure, and support the nose while also being configured to allow the nose to be flexible and swing and bend in various directions. The nose can also be roughly divided into three sections from top to bottom: the bony upper (upper) third, the cartilaginous middle third, and the cartilaginous lower (lower) third. The upper third includes the paired left nasal bone 4a and right nasal bone 4b, which join in the middle of the nose to form the upper (or upper) part of the bridge of the nose. The nasal bone 4a (along with the lateral maxillary frontal process 6) joins superiorly to the frontal bone 2 to form the frontonasal (naso-nasal) suture 5. The nasal bone 4a joins the maxilla at the lateral maxillary frontal process 6 to form a fibrous connection at the maxillonasal suture 7 (or naso-maxillary suture). The cartilage and skeletal layers of the middle third include the septal cartilage 10, which forms part of the nasal septum and separates the nasal cavities and the two air passages inside the nose. The lateral process 8 of the septal cartilage 10 blends upward into the upper lateral cartilage 11 (not visible in this view is another lateral process on the far side of the nose that blends into the upper lateral cartilage). FIG. 1 also shows the alar cartilage 24, which is one of several accessory cartilages that provide support and mobility for the nose and influence its complex three-dimensional shape. The upper lateral cartilage 11 is usually fairly stiff and is responsible for most of the support of the sides of the nose. The upper lateral cartilage 11, along with the septal cartilage tissue, contribute to the formation of the internal nasal valve, which is located on the inside of the nose below the upper lateral cartilage and is not well visible in this view. As mentioned above, there are two internal nasal valves (one on each side of the nose). Each internal nasal valve is bounded on the medial side by the septal cartilage 10, the caudal edge 13 of the upper lateral cartilage, and the tip of the inferior turbinate, with the medial border formed by the septal cartilage 10, the lateral border formed by the caudal edge 13 of the upper lateral cartilage, and the inferior border formed by the tip of the inferior turbinate (not visible in this view), and each internal nasal valve surrounds an opening through which air flows. The connection of the upper lateral cartilage to the septum (septal cartilage) forms an angle that defines the internal nasal valve angle (also simply called the "valve angle"). The internal nasal valve angle is the narrowest part of the nasal airway and creates the resistance that controls the flow of air therethrough.There is some natural variation in the nasal valve angle among individuals, and the valve angle may change over time as a natural result of aging. The valve angle is determined in part by genetics, and each ethnic group has an average valve angle that is specific to that ethnic group. Additionally, there is variation in the valve angle among individuals within a particular ethnic group, and between the left and right valves of the same individual. The nasal valve angle may also change as a result of surgery, trauma, or other intervention. If the valve angle of a valve is below about 10 degrees, the valve may be considered to be collapsed, causing the side walls of the nose to collapse upon inhalation and closing off the nasal airway, and the valve may benefit from treatment as described herein. If the valve angle is above about 10 degrees, some airway obstruction, cosmetic problems, or other problems may occur and may also benefit from treatment, but the valve dysfunction is generally not as severe as a collapsed valve. Valves in need of treatment may be subject to treatment using the implants, devices, systems, and methods described herein.

[0026] The cartilage and skeletal layers of the lower third include the greater alar cartilage (also called the lower lateral cartilage or lower lateral cartilage because of its location and to distinguish it from the upper lateral cartilage), which contributes to the shape of the nostril and the tip of the nose. This cartilage is softer and more mobile than the upper lateral cartilage, allowing the tip of the nose to move. The greater alar cartilage 14 is U-shaped and includes a lateral crus 16 and a medial crus 18. The greater alar cartilage 14 forms part of the external nasal valve around the nostril 17, but does not reach the bone laterally at all. The cartilage and skeletal layers of the lower third also include the alar fibroadipose tissue 26 of the alar, which fills the gap between the lateral crus 16 and the bone. Figure 1 also shows the minor alar cartilage 12, which connects the greater alar cartilage to the lateral cartilage 8 of the cartilage and skeletal layers.

[0027] As previously mentioned, the nose is a complex three-dimensional structure. It may be desirable to change the shape of the nose or to provide additional support to the nasal structure to improve or maintain the function or appearance (aesthetics), but it may be difficult to change one aspect of the nose without adversely affecting another. Indeed, previous surgical interventions have contributed to changes in nasal valve function that may be treated with the systems and methods described herein. Described herein are implants, devices, systems, and methods that function to change or support one aspect of the body structure or shape, including the nose. FIGS. 2A and 2B are front and side views, respectively, of an implant 32 implanted in a patient's nose to support one tissue compartment of the patient's nose. The implant 32 may be useful in maintaining or improving the function or appearance of the nose. The implant 32 is underneath the skin and muscle, which are omitted to better illustrate the implant and the underlying nasal structure and implant. FIGS. 2A-2B show the implant 32 in place to support or change the internal nasal valve. The implant 32 apposes a number of structures that lie in the cartilage and skeletal layers beneath the skin and muscle. The body of the implant 32 has a proximal end 34, a distal end 36, and a central portion 38 between the proximal and distal ends. The central portion 38 is positioned between the nasal cartilage and the patient's skin or muscle. The central portion 38 apposes the upper lateral cartilage 11 and the lower lateral crura 16 of the lower lateral cartilage. As described above, the caudal end of the upper lateral cartilage defines the internal nasal valve angle with the septal cartilage, and the central portion 38 of the implant 32 further apposes the caudal end 48 of the upper lateral cartilage 11, thereby overlying or acting on the internal nasal valve wall to support or change the shape of the internal nasal valve. The distal end 36 of the implant 32 apposes a number of structures that lie above the cartilage and skeletal layers. 2A-2B, the distal end 36 of the implant 32 is fork-shaped with a first arm 40 and a second arm 42 forming the tines of the fork. Each arm is fixed to the implant body at a proximal end and is not fixed to the implant body at a distal end. In this example, the arms juxtapose the nasal bone 4a, the frontal process of the maxilla 6, and the maxillonasal suture 7 (nasomaxillary suture).In some variations, the distal end of the implant may be apposed to or adjacent to one or more structures in the upper layer or any structure or tissue in the middle or lower cartilage and skeletal layers (e.g., accessory cartilage, greater alar cartilage, lesser alar cartilage, septal cartilage, maxilla, etc.).

[0028] The delivery tools disclosed herein deliver the implant configurations disclosed herein to a target location within a patient. An example of a delivery tool is a nasal implant delivery tool.

[0029] Further examples of nasal implants and delivery tools are disclosed in U.S. Patent Application No. 62 / 042,209, filed August 26, 2014, and U.S. Patent Application No. 14 / 836,841, filed August 2, 2015, the entire disclosures of each of which are incorporated herein by reference. Any of the nasal implants disclosed in U.S. Patent Application No. 62 / 042,209 and U.S. Patent Application No. 14 / 836,841 may be used with the delivery tools disclosed herein.

[0030] The delivery tool may include a handle including an implant loading chamber adapted to receive the nasal implant, a needle extending distally from the handle, the needle having an internal lumen, a portion of the internal lumen having a non-circular cross-section and having a sharpened distal end, and an actuator adapted to move the nasal implant along the needle lumen and out of an opening at the distal end of the needle.

[0031] 5 shows an implant delivery device 100 for placing an implant into body tissue. The delivery device 100 includes a handle 102, a needle 104 having a needle lumen, and an actuator 106 including a push rod 108 and a plunger assembly 110. The handle 102 includes an implant loading chamber 112 adapted to receive a nasal implant.

[0032] The implant loading chamber 112 includes a recess 114 that may be adapted to allow for the use of tweezers to place an implant within the implant loading chamber 112. The recess 114 may include a first recess and a second recess adapted to receive the tweezers engaged with the nasal implant in the deployed configuration.

[0033] 6 is a cross-sectional view of the tool 100. The implant loading chamber 112 is in communication with the needle lumen 124 and is adapted to load a nasal implant into the needle lumen 124. For example, the implant loading chamber 112 may be adapted to transition the nasal implant from a deployed configuration to a delivery configuration as the nasal implant advances from the implant loading chamber 112 into the needle lumen 124. The needle lumen 124 may have a sufficiently smooth inner surface to facilitate easy delivery of the implant as well as withdrawal / retraction of the needle lumen from the implant after the implant is delivered to the target location within the patient.

[0034] The implant loading chamber 112 may be in communication with an implant engaging surface 120 disposed between the needle lumen 124 and the implant loading chamber 112. The implant engaging surface 120 may be adapted to engage a first arm and a second arm of the implant 32 to transition the implant from the deployment configuration to the delivery configuration. In some embodiments, the implant engaging surface has a substantially smooth inner surface. A smooth inner surface can reduce the likelihood that a portion of the implant will catch on the implant engaging surface as the implant is advanced into the needle lumen.

[0035] The handle 102 includes an implant orientation indicator 116 that is configured to visually indicate the plane formed by the first and second arms of the nasal implant in the deployed configuration that corresponds to the orientation of the implant within the needle lumen. The implant orientation indicator is designed to allow the tool operator to visually determine the orientation of the tool and the corresponding orientation of the plane formed by the arms of the nasal implant in the deployed configuration at a glance. The implant orientation indicator extends from a portion of the handle such that the implant orientation indicator is not hidden or obscured by the operator's hand during use of the device. For example, the implant orientation indicator 116 may be located toward the distal end of the handle as shown in FIG. 5. The implant orientation indicator may include a first arm that protrudes from the handle in a first direction and a second arm that protrudes from the handle in a second direction. The first and second arms define approximately the same plane as the plane formed by the first and second arms of the nasal implant in the deployed configuration that corresponds to the orientation of the implant within the needle lumen.

[0036] In some embodiments, the delivery tool includes a push rod locking element proximal to the implant loading chamber configured to prevent the push rod from moving further proximally relative to the handle. The push rod locking element may be configured to prevent the push rod from slipping outside of the interior portion of the handle. FIG. 6 shows a push rod locking element 122. The illustrated push rod locking element 122 is configured to engage a notch 132 (FIG. 17) on the push rod 108 to prevent the push rod 108 from retracting further relative to the handle 102.

[0037] The delivery tool actuator may include a push rod and plunger assembly. In some embodiments, a compression element may connect the push rod and plunger assembly. In FIG. 16, a compression element 130 is shown connecting the push rod 108 and the plunger assembly 110. The compression element 130 may apply additional axial force in the distal direction to the implant to prevent the implant from backing out or sliding out as the tool is removed or withdrawn from the patient.

[0038] 7 shows the implant 32 positioned within the implant loading chamber 112 of the implant delivery apparatus 100. The implant loading chamber 112 is configured to receive the implant 32 in a deployed configuration (e.g., with the arms of the implant spread apart).

[0039] Figure 8A shows the delivery tool 100 with the push rod 108 and plunger assembly 110 in the retracted position and the implant loading chamber 112 unobstructed by the push rod 108. In Figure 8B, an implant 32 is positioned in the implant loading chamber.

[0040] The delivery tool 100 is shown in Figure 9A with the plunger assembly 110 and push rod 108 advanced to push the implant from the implant loading chamber and into the needle lumen, where the implant is at the pre-deployment stop and the implant is contained within the needle lumen.

[0041] In Figure 9B, the push rod 108 and plunger assembly 110 have been advanced from the configuration shown in Figure 9A and the implant is about to be pushed distally out of the needle lumen 124. Figure 15 is a cross-sectional view of the implant delivery apparatus with the push rod 108 and plunger assembly 110 in the distally advanced position.

[0042] Figure 10A is a cross-sectional view of the tool 100 with the push rod 108 and plunger assembly 110 in a distally advanced position. Figure 10B shows the cross-sectional view of the tool 100 with the push rod 108 and plunger assembly 110 in a retracted position, the push rod 108 engaged with the push rod locking element 122, and the implant loading chamber 112 ready to receive an implant.

[0043] 11-12 show the implant 32 after it has been placed into the implant loading chamber 112. FIG. 13 shows the implant 32 within the needle lumen 124. The implant 32 is in a compressed delivery configuration while in the needle lumen 124. The push rod 108 is shown advancing the implant 32 distally within the needle lumen 124. FIG. 14 shows the implant 32 extending distally past the distal end of the needle 104. The arms 78a, 78b of the implant 32 are allowed to transition to a deployed configuration as the implant 32 exits the needle lumen 124.

[0044] 16 is a close-up view of the actuator 106 showing the push rod 108 engaging the plunger assembly 110 via a compression element 130. The compression element 130 is capable of exerting a distal axial force on the push rod 108 when the push rod 108 is initially retracted after the implant has been deployed into body tissue to reduce the likelihood of the implant migrating from its deployed location and position.

[0045] 17 is a close-up view of a portion of the handle 102 showing the push rod 108 engaging the push rod locking element 122. The push rod locking element 122 can prevent the push rod 108 from further retracting relative to the handle 102 by engaging the push rod 108 at a notch 132.

[0046] The delivery tool may be adapted for use with implants of various sizes and shapes. For example, the delivery tool is adjustable to accommodate implants of various lengths and configurations. The implant loading chamber is adjustable to allow implants of various sizes and shapes to pass through the implant loading chamber and into the handle of the delivery tool. One or more parts of the delivery tool are adjustable between multiple positions to accommodate different lengths of implants. In one example, the needle may be movable relative to the handle. The needle may be movable relative to the handle between multiple discrete positions. The multiple discrete positions may correspond to the length of the nasal implant. For example, if the implant is short, the needle may be retracted proximally to substantially shorten the length of the needle extending out of the handle. In one example, a needle slider actuator is configured to move the needle relative to the handle between multiple discrete positions. FIG. 20 shows an implant delivery device handle 230 having a needle slider actuator 232. The needle slider actuator 232 is capable of axially sliding the needle 234 between multiple positions to accommodate the length of the implant. In some cases, the slider may also move the implant engaging surface 236 and the needle 234 .

[0047] In another example, the actuator can be adjusted relative to the tool to accommodate different lengths of the implant. For example, the length of the actuator can be adjustable between a first position and a second position. The length of the push rod and plunger assembly can be adjustable between a first position and a second position by engaging the push rod with a first locking surface on the plunger assembly and a second locking surface on the plunger assembly. FIGS. 18A-18B show the actuator 200 in two discrete positions. The push rod 202 can be engaged with the plunger assembly 204 in two different positions 206, 208. The knob 205 of the plunger assembly 204 can be slid between the two positions 206, 208 by turning. The plunger assembly 204 can be locked or engaged such that the length of the push rod 202 and plunger assembly 204 is fixed during use. FIG. 19 illustrates an alternative configuration of actuator 220 in which a torsion spring 222 is used to secure a plunger assembly 224 between discrete positions 226, 228.

[0048] In some embodiments, the delivery tool may be adapted to receive a cartridge containing one or more nasal implants in the implant loading chamber. The implant loading chamber may be adapted to receive a cartridge containing the nasal implants. FIG. 21 shows an implant delivery device 240 having a handle 241 and a cassette / cartridge 242 having an implant 244. The cassette or cartridge 242 may include one or more nasal implants 244. The handle 241 may be configured to receive the cartridge 242 such that the nasal implant 244 can be advanced from the cartridge 242 into the needle lumen by being pushed by a push rod. In some cases, the cartridge 242 may be configured to accommodate two or more nasal implants.

[0049] The cartridge may be adapted to communicate with the needle lumen. The implant may move from within the cartridge directly into the needle lumen. In some cases, the delivery device may have an implant-engaging surface disposed between the cartridge and the needle lumen. The cartridge may include an implant-engaging ramp adapted to engage a first arm and a second arm of the implant to transition the implant between a deployment configuration and a delivery configuration. For example, the implant-engaging ramp may cause the first arm and the second arm of the implant to be in a compressed configuration such that the implant can be advanced from the implant-engaging ramp into the needle lumen.

[0050] In some embodiments, the handle may be adapted to receive the cartridge such that the cartridge engages the needle to adjust the length of the needle relative to the handle. The delivery tool may be adapted to receive cartridges of various sizes housing implants of various sizes. The cartridge size may be designed such that the cartridge engages the handle to adjust the length of the needle lumen to fit the nasal implant housed in the cartridge. In another alternative, the cartridge may be configured to adjust the relative distance between the actuator and the needle lumen by adjusting the length of the actuator.

[0051] The delivery tool may include an indicator configured to output a signal regarding a status of the implant or the delivery tool. In some embodiments, the needle may include generally striped markings at various locations along the needle.

[0052] In some embodiments, the needle of the delivery tool has a low-friction coating on its outer surface. In some cases, it may be difficult to penetrate some nasal tissue. The low-friction coating can facilitate the needle's penetration and movement relative to some nasal tissue. The low-friction coating can reduce drag forces between the tissue and the needle during insertion and retraction of the needle through the body tissue. In general, the low-friction coating can be made of a biocompatible and lubricious material that can adhere to the needle. Examples of materials that can be used for the low-friction coating include PTFE, silicone, and poly(p-xylylene)-based polymers. One example of a suitable poly(p-xylylene)-based polymer is available under the trade name Parlyene.

[0053] The delivery tool may include an actuator register adapted to indicate a position of the actuator when the nasal implant is at the distal end of the needle lumen. The actuator register may include markings on the actuator or on the handle. The actuator register may be adapted to indicate a position of the actuator when at least a distal portion of the implant is out of the needle lumen.

[0054] In some embodiments, the actuator resistor is a stop element that prevents further movement of the actuator. FIGS. 22-1A-C and 22-2D-E show a portion of an actuator of an implant delivery device in various configurations. FIG. 22-1A shows a plunger 300 before insertion into a delivery tool 302. The delivery tool 302 includes a tail sheath 304. The plunger 300 is received within the delivery tool 302 and engages with the tail sheath 304. The delivery tool 302 includes a stopper 306 that prevents the advancement of the plunger 300 when the delivery tool 302 is in the implant loading mode of FIG. 22-1B. FIG. 22-1B shows the plunger 300 in a first configuration relative to the tail sheath 304, with the stopper 306 allowing the implant to be loaded. The plunger 300 may be stopped against a natural spring (FIG. 22-1(C)) or other stop. The plunger 300 may be turned or twisted (or the tail sheath 304 may be adjusted) to move from the loading mode (FIGS. 22-1(B)-(C)) to the deployment mode (FIGS. 22-2(D)-(E)). Once twisted into the deployment mode, a spring mechanism or stop may be moved or forced open by a feature 308 on the handle or other part of the device, allowing the plunger 300 to advance past the stop 306. In the deployment mode, the plunger 300 may be allowed to advance further to deploy the implant.

[0055] In some embodiments, the delivery tool may include a snap mechanism or a mating pocket. When the snap mechanism is moved or snapped into the mating pocket, an audible "click," "snap," or other sound may be generated. The snap mechanism may be locked or held in association with the mating pocket. The mating mechanism may enter the mating pocket when the implant is in a particular position in the delivery tool or when the implant is partially or fully deployed. Some embodiments include providing an indicator of the implant's position (e.g., distal position, deployed position), etc. The mating mechanism may be removed or unlocked from the handle by, for example, manually depressing the snap mechanism in the pocket of the handle. This may be useful, for example, when loosening the plunger to reload the delivery tool with additional (second, third, etc.) implants. The indicator may output a signal that the implant is loaded (in place within the delivery tool), that a portion of the implant is out of the needle (e.g., a distal portion of the implant is out of the needle), or that the entire implant can be out of the needle. The signal may be, for example, an audible signal (e.g., a beep, buzzer, voice, etc.), a tactile signal (e.g., a vibration signal), a visual signal (e.g., a colored or white light, a flashing or solid light), etc.

[0056] In some embodiments, the distal end of the needle may be sharp enough to puncture nasal or facial tissue (e.g., any of those described herein). A sharp distal end can minimize tearing of the nose. The needle may be any size, such as hypodermic needle sizes known in the art, such as 8 gauge, 10 gauge, 12 gauge, 14 gauge, 16 gauge, 18 gauge, 20 gauge, etc., outside diameter. The needle may be sized to fit between the mucosa, epithelium, muscle capsule, and cartilage or bone of the nose and face. In some embodiments, the needle may fit between the mucosa / skin and cartilage of the nose. The needle may be long enough to penetrate the tissue to place the implant (e.g., at least 50 mm, at least 75 mm, at least 100 mm, at least 115 mm, at least 125 mm, or at least 150 mm). The distal end of the needle may include an opening adapted to fit the implant inside. The needle has a lumen that may be adapted to accommodate or hold an implant. The lumen may have any cross-sectional profile, for example, circular, non-circular, oval or oval, elliptical, triangular, square, rectangular, hexagonal, etc. In some variations, different regions of the lumen may have different cross-sectional profiles. The orientation of the lumen, which is non-circular in cross-section, may be determined relative to the handle of the delivery tool, allowing the handle of the delivery tool to control the orientation of the lumen (as well as the orientation of the implant determined within the lumen). The handle may control the orientation of the implant during implant delivery. The lumen may have one, two, or two, three, four, five, or more than two, three, four, or more than five different cross-sectional profiles. For example, the proximal portion may be circular and the distal portion may be non-circular. In some embodiments, the proximal lumen region may be circular, the intermediate lumen region may be non-circular (e.g., oval, oval, elliptical, or any other shape including those described above), and the distal lumen region may be circular. A lumen that is non-circular in cross section may have a major axis and a minor axis. The implant may be configured to or may engage with a lumen of a needle or a lumen of a handle.An implant disposed in the handle or needle lumen may have first and second arms at its distal end, each of which may be fixed at a proximal end to the implant and free at a distal end to the implant, the distal end of each arm may be biased to transition away from a central longitudinal axis of the implant from a delivery configuration within the needle lumen to a deployed configuration outside the needle lumen, and each of the first and second arms includes a bevel surface (e.g., an outer bevel surface) that engages an inner surface of the needle lumen at opposite ends of the longitudinal axis. In some embodiments, a step of maintaining a known orientation between the implant and the lumen (needle) during the inserting step is included.

[0057] Although the guide can guide the implant, the guide typically guides the actuator. The guide and actuator may be complementary shapes. For example, the guide may be a trough and the actuator may be a rod that fits partway into the trough. Typically, when the actuator is in place in the guide, a portion of the actuator is located above the guide such that the actuator can act on the implant (move the implant) through the delivery tool.

[0058] The actuator may include one or more markings. The markings may indicate the relative position of the actuator with respect to the delivery tool or implant. For example, the markings may be configured to indicate that the implant is at a desired location for implant deployment within the tissue, that the distal end of the implant is at the distal end of the delivery tool, that the implant is in a partially deployed position, that the implant has been fully delivered (deployed) into the tissue, etc. The markings may be useful to indicate that the implant is in a position, about to be deployed (in a position just before deployment), partially deployed, or fully deployed. For example, the markers may indicate when the arms (fork regions) of the implant have been deployed and unfolded and the remainder of the implant is within the delivery tool. The markings may be any type of marking that indicates the position of the actuator or implant (e.g., relative to the delivery tool), such as a line, multiple lines, a bold line, a protrusion, a ring, a color, a fluorescent marker, etc. To complete deployment of the implant (e.g., to move the non-arm-containing portion of the implant (e.g., the implant body) out of the tissue), the delivery tool can be withdrawn from the tissue, such as by withdrawing the needle while the actuator holds the implant in place (within the tissue). The actuator may include one, two, three, four, five, six or more markings for any reason, such as those just mentioned. Additionally, the actuator may have different markings corresponding to implants of different lengths. The actuator may also include a stop mechanism that prevents the actuator from moving further within the delivery tool.

[0059] Also provided is a system including a delivery tool as described herein and one or more nasal implants. Also provided is a system including a delivery tool as described herein and a cartridge containing the nasal implants. The cartridge can contain two or more nasal implants. In some embodiments, the cartridge can include an implant-engaging surface configured to transition the implant to a delivery configuration.

[0060] As described above, placement of the implant may be performed in a minimally invasive manner utilizing a small opening in the body to minimize pain and scarring. However, it may be advantageous to have the implant larger than the small opening, for example, when the area of ​​tissue to be treated is larger than the small opening in the body. In such cases, the implant may be placed through the opening in a contracted configuration and may be deployed during or after placement in the body. Additionally, the deployed implant may exert a force on the tissue during insertion (e.g., this force may help to hold the implant in place). In some variations, the delivery tool may be configured to receive the implant in the deployed configuration and contract to fit through the small opening in the body before delivering it to the body tissue. The implant may be delivered in the contracted configuration. The implant may be delivered in the deployed configuration or may be deployed during delivery. The delivery tool may include a loading chamber for loading the implant into the delivery tool in the deployed configuration and one or more shaping chambers for changing the shape of the implant. The delivery tool may include an implant loading chamber in communication with the needle lumen and adapted to load the nasal implant into the needle lumen.

[0061] The loading chamber may be generally rectangular in shape, but may also be oval or another shape, so long as it is capable of receiving an implant (e.g., in a deployed configuration) and allowing the implant to be moved through the loading chamber (e.g., by a plunger / actuator). The loading chamber may be closed at the top (may have a roof), but is generally open at the top to allow insertion of the implant. The loading chamber has a floor and generally has first and second lateral walls (sides) and proximal and distal walls (ends), each of which is joined (e.g., at one end) to the first and second lateral walls. The proximal and distal walls may each have an opening, the opening in the proximal wall configured to allow a plunger / actuator to enter the loading chamber, and the opening in the distal wall in open communication with the needle lumen. The proximal wall of the loading chamber may have an opening configured to allow an implant, or a plunger of an actuator, to pass through. The implant may be placed (dropped) into the loading chamber from the top so that it rests on the floor of the loading chamber.

[0062] Shaping the implant as described above using the loading chamber, shaping chamber / implant engagement surface, and needle may be performed in other ways, as long as the implant moves from the deployed configuration to the contracted configuration within the delivery tool. For example, the implant delivery tool may have only a loading chamber, which may shape the implant as described above without the use of a shaping chamber, and the implant may move directly from the loading chamber to the needle. The implant delivery tool may have multiple shaping chambers, each of which may provide a slight change in the implant configuration. The shaping chambers may be oval, rectangular, or other shapes.

[0063] The implant may assume various shapes or configurations upon implantation (during the implantation action where the implant exits the needle and enters the body tissue). The implant 32 may transition from a delivery configuration to a deployed configuration during implantation in tissue. The implant may transition from a contracted or compressed configuration to an expanded configuration by one or more distal arms moving away from the central longitudinal axis of the implant. The arms (e.g., the distal ends of the arms) may be biased away from the central longitudinal axis. The arms may be straight out, but typically diverge such that the distal ends of the arms bend and move away from the central longitudinal axis. Tissue may be captured between the arms. Bifurcating the arms may help distribute the force over a larger area of ​​tissue. In nasal tissue, tenting or distal migration may be prevented or minimized. Bifurcating the arms may also hold the implant in place upon withdrawal of the needle or delivery device. A bevel may assist in the bifurcating of the arms. As the arms move through the tissue, their movement can be assisted by a bevel on the radially inner surface of the distal end of the arm. The bevel can cut through the tissue to guide the arms into the tissue. Although an implant with two beveled arms is shown, the implant may have zero, one, one, one bevel on each arm, two bevels on each arm, etc., and may have zero, one, two, three, four, five or more arms. The implant is advanced into the body tissue by an actuator / plunger. (It's okay to be pushed.)

[0064] The implant in the collapsed position may be deployed in tissue as is and then transition from the collapsed configuration to the delivery configuration, but typically may be oriented prior to deployment. The implant may be oriented in the delivery tool handle, but typically is oriented in the needle. The implant may be oriented by a non-circular lumen (in the delivery tool handle or in the needle). A non-circular lumen having a major axis and a minor axis may allow the arms of the implant to diverge (slightly) outwardly of the major axis (and away from the central longitudinal axis), which may allow the implant to be oriented (via the arms) in the direction of the major axis. This may occur, for example, when the plunger is moving the implant in the implant tool handle, but typically occurs when the implant is moving in the needle. In some embodiments, the needle may assume a circular cross-sectional area after the implant is oriented, and the implant may move within the circular cross-sectional area while maintaining its orientation. For example, the distance traveled within the circular cross-sectional area may be relatively short.

[0065] The implant can transition from a delivery configuration within the needle lumen to a deployment configuration outside the needle lumen. As the implant exits the distal end of the needle, the arms can move away from each other (diverge). The implant can be fully deployed before the implant tool is withdrawn from the implant, or the implant can be partially deployed (e.g., the arms can be deployed while other portions of the implant are disposed within the needle of the delivery tool, at which point the needle can be withdrawn from the implant and away from the tissue, leaving the implant in place). In some embodiments, the actuator can push the implant further into the tissue (an inner bevel on the arms can assist in moving the arms into the tissue). In another example, the actuator can hold the implant in place as the delivery tool is withdrawn from the implant and the actuator, and then the actuator is withdrawn, leaving the implant in place within the tissue. The implant can move through the tissue with the aid of the inner bevel cutting through the tissue and / or with the aid of the biased arms trying to return to an unbiased configuration. The implant can transition from the deployed configuration to the delivered configuration as it exits the distal end of the delivery device.

[0066] In some embodiments, advancing the implant includes pushing the implant distally such that the first and second arms of the implant each engage tissue and move away from the central longitudinal axis of the implant. In some embodiments, advancing the implant may include retracting a portion of the delivery tool (e.g., a needle) to allow the first and second arms of the implant to self-deploy and move away from the central longitudinal axis of the implant. In some cases, advancing may include a combination of pushing and retracting. For example, advancing the implant may include pushing the implant distally and retracting a portion of the delivery tool such that the first and second arms each engage tissue and move away from the central longitudinal axis of the implant. When the implant engages tissue, the first and second arms of the implant each can form a dissection path. For example, advancing the implant may include the first arm forming a first arm dissection path, the first arm dissection path having a longitudinal axis that is offset from the longitudinal axis of the delivery tool. The advancing step may also include the second arm forming a second arm incision path, the second arm incision path also having a longitudinal axis offset from the longitudinal axis of the delivery tool. The longitudinal axis formed by the first arm incision path and the second arm incision path may include a curved or arc shape. The first arm incision path and the second arm incision path may form an angle of less than 180 degrees. The advancing step may also include the first arm and the second arm each engaging a tissue portion located between the first arm and the second arm.

[0067] Also provided is a method of delivering the implants disclosed herein using a delivery tool. A method of supporting a nasal tissue compartment of a patient may include inserting a needle of the delivery tool into the nasal tissue. The delivery tool may include a handle portion, and the needle may extend distally from the handle. The needle may include a needle lumen. The handle may include an implant loading chamber adapted to receive the implant. The delivery tool may also include an actuator adapted to move the implant along the needle lumen and out of an opening at the distal end of the needle. The method may include advancing the implant distally from the needle lumen to position the distal end of the implant within the nasal tissue. The implant may include a first arm at a distal end of the implant and a second arm at the same distal end of the implant. Advancing the implant distally may include moving the first arm away from a central longitudinal axis of the implant and the second arm away from a central longitudinal axis of the implant during the advancing step. The method may include withdrawing the delivery tool to position a central portion of the implant within the nasal tissue and supporting the tissue compartment with the implant.

[0068] Advancing the implant may include pushing the implant distally away from a central longitudinal axis of the implant such that the first and second arms each engage tissue.

[0069] The method may include loading an implant into an implant loading chamber of a delivery tool. The method may include loading the implant into the implant loading chamber using tweezers. The method may include loading a cartridge containing the implant into the implant loading chamber.

[0070] The method may include retracting a push rod of the actuator to a proximal locking point before loading the implant into the implant loading chamber.

[0071] The method may include adjusting a length of the needle extending from the handle prior to loading the implant. The method may include sliding the needle relative to the handle by moving a slider on the handle that is in communication with the needle to move the needle relative to the handle between a plurality of discrete positions. The method may include adjusting a length of the push rod and plunger assembly prior to loading the implant.

[0072] The method may include advancing the implant from the implant loading chamber into the needle lumen. The delivery tool may have an implant engaging surface disposed between the needle lumen and the implant loading chamber, and the method includes advancing the implant from the implant loading chamber, through the implant engaging surface, and into the needle lumen. The loading step may include loading the implant into a proximal end of the needle and advancing the implant to a distal end of the needle before the inserting step. The loading step may include folding a first arm and a second arm of the implant before the implant enters the proximal end of the needle.

[0073] The method may include the steps of advancing the actuator to a locking point, followed by unlocking the actuator and then advancing the implant distally out of the needle lumen to position a distal end of the implant within the nasal tissue.

[0074] The inserting step may include inserting a distal end of the needle into nasal tissue. The method may further include maintaining a known orientation between the implant and the needle during the inserting step. Maintaining a known orientation between the implant and the needle may include engaging the implant with a portion of a lumen of the needle having a non-circular cross-section.

[0075] The method may include maintaining a distal axial force on the implant by the push rod and compression element during initial withdrawal of the delivery tool.

[0076] When the implant is in place within a body tissue, for example within the nasal tissue or any other type of body tissue, bone or other structures can support the implant in a cantilever manner. For example, an implant supporting a nasal valve can be cantilevered by extending beyond the end of the maxilla. The implant 32 can provide a force to change or support a tissue that needs to be changed or supported by applying one or more forces between various portions of the implant. The implant 32 can apply a force from one or more underlying structures (e.g., bony structures such as the maxilla or nasal bone, the accessory cartilage, the upper cartilage, or the lower cartilage) to a structure that needs support (e.g., the accessory cartilage, the upper cartilage, or the lower cartilage (e.g., the caudal region of the upper lateral cartilage)). Connecting the upper and lower cartilages can support or strengthen the nasal valve, improving the appearance or breathing of the nose or reducing problems such as snoring. As mentioned above, the upper lateral cartilage 11 and the lower lateral cartilage 16 together with the nasal septum and the inferior turbinate define the boundaries of the internal nasal valve. The implant 32 acts to support or change the nasal valve. In one embodiment, a force can be applied by the implant to change or support the caudal (lower) region of the upper lateral cartilage, thereby changing or supporting the internal nasal valve and the internal nasal valve angle. The valve angle may increase, decrease, or remain unchanged in response, but typically remains unchanged or increases. Although the skin and tissues over the nose are omitted in this illustration, they can apply a force and hold the implant against the underlying tissue at any location along the length of the implant, for example by holding the implant against the maxilla or nasal bone, or over the entire length of the implant. The nasal bone 4 can apply a force to the implant 32. The implant can act as a lever to support the structure. Structures, such as body structures such as bone (e.g., nasal or facial bones), cartilage, etc., can apply force to the implant to support the implant longitudinally and support body structures, such as the nasal valve.For example, the nasal bone or maxilla can exert forces on the upper lateral cartilage 8 and the lower lateral cartilage 16 .

[0077] In some variations, the implant is a biocompatible implant suitable for repairing a nasal valve. The implant may be used to strengthen the nasal valve of a patient's nose. The implant may support the cartilage and may help to keep the patient's airway open by resisting or reducing the movement of the cartilage during inhalation. Although the implant 32 of FIGS. 2A-2B is apposed or adjacent to a number of specific structures of the cartilage and skeletal layers of the patient's nose, as well as the overlying muscle / skin, the entire implant, or one or more regions of the implant, may be apposed or adjacent to any cavity, structure, or tissue within the patient's body. For example, the protrusions (arms) or other protrusions, or portions of the arms or other protrusions, the central region, portions of the central region, the distal end, the proximal end, the strain relief portion, the features, the ridges, etc., may be apposed or adjacent to any cavity, structure, or tissue within the patient's body. In some variations, the implant, or a region of the implant, may be juxtaposed or adjacent to any one or more cavities, structures, or tissues, such as facial or nasal bones, cartilage, connective tissue, fascia, fat, airway epithelium, squamous epithelium, nasal squamous epithelium, ligament, muscle, mucus, skin, (ala) fibroadipose tissue, blood vessels, mucous membrane, nasal mucosa, frontal bone, lacrimal bone, maxilla (e.g., anterior nasal spine, frontal process), nasal bone, vomer, nasomaxillary suture, nasofrontal suture, paranasal cartilage, upper lateral cartilage (including the cranial border, caudal border, or central region of the upper lateral cartilage), lower lateral cartilage, greater alar cartilage (e.g., lateral crus, medial crus), lesser cartilage, septal cartilage (e.g., lateral process, nasal septum cartilage), etc. The implant may be juxtaposed or adjacent to one or more other implants or synthetic structures. An implant placed apposed or adjacent to a cavity, structure, or tissue may act on it (e.g., support it, exert forces on it, resist forces therefrom, act as a fulcrum for forces therefrom), or may not act on it. For example, a portion of the implant may span the entirety of a tissue but have no substantial interaction or influence on that tissue. The implant may be placed above or below one or more of the aforementioned tissues.The implant may be positioned in any orientation relative to these tissues, and may be positioned approximately parallel, perpendicular, or oblique to the major or minor axis of the cavity, structure, tissue, or another implant. In some examples, the implant is positioned within the nasal tissue. In some embodiments, the implant is positioned partially within the nasal tissue and partially within the surrounding tissue (e.g., the maxilla). The implant may be attached (e.g., by adhesives, sutures, screws, etc.) to the structure, tissue, or another implant (e.g., as described herein), or may be adjacent to or in contact with the structure, tissue, or another implant (e.g., as described herein). The implant may be positioned such that there is sufficient clearance between the proximal tip of the implant and the rim of the nostril to insert the implant through the mucosal tissue. The implant may be held in place by a force (e.g., a compressive force) between the implant and the structure, tissue, or another implant. The implant may be held in place (at least in part) by a force exerted on the implant from above. In certain embodiments, the distal end of the nasal implant (at least a portion of it) rests against the maxillary bone and / or nasal bone and / or naso-maxillary suture and is held in place by the stiffness of the overlying skin and muscle which presses the implant against those bones or sutures.

[0078] 3A shows an implant acting on body tissue having a generally longitudinal body having a first end 70, a second end 72, and a central portion disposed between the first and second ends. The implant defines a central longitudinal axis 71. In some embodiments, the first end of the implant is located proximal to an insertion site within the tissue. A second (distal) end 70 of the implant 32 has a first arm 76a and a second arm 76b, each of which is fixed to the body at a proximal end and is free from a distal end.

[0079] In some variations, the implant is adapted to have or assume various configurations. For example, the implant may have a collapsed configuration and an expanded configuration. The implant may be capable of assuming a range of configurations intermediate (continuous) between the collapsed and expanded configurations. In some cases, the implant may be capable of being held in any of these configurations. The collapsed configuration may be a delivery configuration and may be useful for delivery of the implant, for example, for moving the implant within an implant delivery device and positioning it within body tissue. The collapsed implant may be small enough to easily fit within a relatively small delivery device. The expanded configuration of the implant may be a deployed configuration and may be useful, for example, for retaining the implant within body tissue after it is in place within the body. The expanded configuration may also or instead aid in bioabsorption of a bioabsorbable implant, for example, by providing a pathway for the implant for bodily fluids involved in bioabsorption. A range of configurations intermediate between the delivery and deployed configurations may be useful, for example, for guiding the implant to a desired location during deployment.

[0080] In some variations, the arms of the implant may be adapted to move relative to the implant body. The arms may be adapted to move away from, around, or towards a central axis of the implant body. The arms, or portions of the arms, may include a material adapted to move the arms from a first position to a second position. The material that moves the arms may be, for example, an elastically deformable material or a shape memory material. The arms may include a first It may be biased to move to position 2.

[0081] Two or more arms may be adapted to be capable of being moved (e.g., pushed or pulled) toward or away from one another without breaking or cracking. The arms may be sufficiently movable (e.g., deformable, flexible) to move up to 10°, up to 20°, up to 30°, up to 40°, up to 45°, up to 50°, up to 60°, up to 70°, up to 80°, up to 90°, up to 145°, or up to 180° relative to a central longitudinal axis of the implant body from a first position to a second position without breaking or cracking, or may move between any of these ranges (e.g., from 30° to 70°, from 10° to 50°). In some embodiments, the arm in a first position on the implant may be oriented parallel (or nearly parallel) to a central longitudinal axis of the implant and then may be moved to a second position such that the arm is oriented obliquely (e.g., up to 10°, up to 20°, etc., as described above) relative to its first position and the central axis of the implant body.

[0082] In some embodiments, the implant has first and second arms, the distal ends of which are adapted to move away from a central longitudinal axis of the body. The first and second arms may move from a delivery configuration to a deployed configuration, i.e., from a collapsed configuration to an expanded configuration. In some embodiments, the first and second arms are biased toward their respective deployed configurations. In some embodiments, the biased arms are capable of moving from the delivery configuration to the deployed configuration when the force from the delivery device is removed (e.g., by withdrawing the implant from the delivery device).

[0083] The arms of the implant, e.g., first and second arms 76a and 76b, may be of different shapes or configurations or may be the same. The arms may be mirror images of each other. The distal end may have a protrusion instead of or in addition to the distal arm. The arms or protrusions may be useful to perform a function of the implant or implant arm and may act alone, together, or with another structure to perform the function. Such functions may include, for example, guiding the implant within the delivery tool, orienting the implant within the delivery tool, orienting the implant relative to the actuator (push rod), delivery tool, or patient tissue, holding the implant within the delivery tool, orienting the implant relative to the patient, cutting patient tissue or enabling arm movement within the patient tissue, compressing or moving patient tissue, holding the implant within the patient tissue, exerting a force on the patient tissue, etc. The arms or protrusions may be or have barbs, bumps, cilia or cilia-like, generally elongated rods, hairs, hooks, loops, prongs, rods, spikes, screws, teeth, etc. The arms or protrusions may be relatively rigid or relatively flexible. The arms or protrusions may be more flexible or rigid than another part of the implant or all remaining parts. The arms or protrusions may exert a force on another part of the implant, or another implant, or body tissue. The arms or protrusions may provide or cause friction (e.g., static friction) between the arms or protrusions and another part of the implant, or another implant, or body tissue. The implant may have one or more arms, protrusions, or protrusions, for example, 2, 3, 4, 5, 6, more than 6, more than 10, more than 20, more than 100, more than 1000, etc. arms, protrusions, or protrusions.The arms or protrusions may be relatively flexible in a first dimension (e.g., in the depth direction or as they extend away from the central longitudinal axis of the implant) and relatively less flexible or inflexible in a second axial direction (e.g., in the width direction, or side-to-side direction, or length direction). The arms may be configured to be capable of being pulled or pushed inward (e.g., toward the central longitudinal axis of the implant) and pushed or deployed outward (e.g., away from the central longitudinal axis of the implant).

[0084] 3A and 3B also show that the first arm 76a and the second arm 76b have a first arm inner bevel 80a and a second arm inner bevel 80b, respectively, on a radially inner surface of the distal end 72 of the implant 32. The bevels (e.g., an inclined surface that meets another bevel at any angle other than 90°), particularly the inner bevels, can be useful, for example, to guide the implant or implant arms through body tissue. The first arm inner bevel 80a has a first sharpened end 81a, and the second arm inner bevel 80b has a second sharpened end 81b. The sharpened ends of the inner bevels can be particularly useful for cutting through tissue during implant deployment as well as providing a path through the body tissue for the implant arms to travel. For example, the sharpened ends of the inner bevels can cut through or move through tissue without causing undue tearing or excessive damage. In some embodiments of implants having a body and arms, the cross-sectional area of ​​the arms is smaller than the cross-sectional area of ​​the body. In general, making small, sharp incisions through tissue is less painful and results in faster healing than tearing or making large cuts through tissue. As described in more detail below, during implant deployment, the sharp end of the bevel can cut through tissue, and as the sharp end moves through tissue, the angled end portion of the bevel and the rest of the arms can follow. The cross-sectional area of ​​the cut, incision, or path in tissue where the distal end meets can be smaller than the cross-sectional area of ​​the implant body or the cross-sectional area of ​​the tissue contacting portion of the implant delivery device. Because the bevel acts at the beginning of the delivery device to guide the arms through tissue, and the arms are smaller than the distal end of the delivery device that houses the implant, the incision made by the bevel and the insertion path formed by the bevel and the arms may be large enough to allow passage of the arms, but not the delivery device or implant body, as the case may be.During implant deployment, an implant having arms that are flexible or otherwise movable (e.g., relative to the implant body) may be pushed or otherwise advanced through body tissue, with the inner beveled surface (or angled portion) pushing against the body tissue to move the arms away from the central longitudinal axis of the implant body (away toward the deployed configuration). Alternatively, or in addition, the implant arms may be biased toward the deployed configuration, and the bevels can assist in moving the biased implant arms toward the deployed configuration and the deployed implant position within the body tissue.

[0085] FIG. 3A also shows that each of the first arm 76a or second arm 76b has a first arm outer bevel 78a and a second arm outer bevel 78b, respectively, on a radially outer surface of the distal end 72 of the implant 32. The outer bevels may be useful, for example, for guiding the implant into a delivery device, for collapsing the implant into a collapsed configuration, for orienting the implant within a delivery device, for guiding the implant through a delivery device, etc. The inner bevel 80a and the outer bevel 78a on the first arm 76a form a double bevel, where the bevels or inclined surfaces may share an end (e.g., the two inclined surfaces meet each other at any angle other than 90°) or may flare relative to each other. In some embodiments, the first and second or inner and outer bevels or inclined surfaces meet one another at any angle other than 90° and do not share an end (e.g., the bevels are formed from separate ends). An implant or arm or protrusion may have one or more bevels or angled surfaces or ends that meet another bevel or angled surface or end at any angle other than 90°. The bevels may be located at the ends of the arms or protrusions or may be located along the sides of the protrusions or projections.

[0086] 23A-23B show drawings of a molded implant 1800 with beveled ends, including a retention element 1802 used during manufacture. After the device is molded, it may be cut along lines 1804 and 1806 to form the beveled ends of arms 1808 and 1810, respectively, creating, for example, the 63 degree trim angle shown.

[0087] 24A-24C show drawings of a molded implant with beveled ends. As shown, the overall length of the device 1900 can range from 0.74 inches to 1.04 inches. The arms 1902 and 1904 have a flare at their tips of 0.166 inches to 0.206 inches when inactive. These drawings illustrate the dimensions available for the implants of the present invention, as detailed above. Detail A in FIG. 24C shows the intersection of the arms 1902 and 1904 at point 1906. The intersection of the arms 1902 and 1904 at point 1906 forms an angle. The angle shown in FIG. 24C is an acute angle of less than 90 degrees. In some embodiments, the arms 1902 and 1904 can engage tissue such that the arms 1902, 1904 form an angle of less than 90 degrees. In some embodiments, the angle between the arms 1902, 1904 is less than 180° when the implant is implanted in tissue.

[0088] The implant may include one or more barbs, forks, or spread shapes at the proximal end. The forks, barbs, or spread shapes at the proximal end of the implant may prevent the implant from backing out of the insertion site. The proximal tip of the implant 432 shown in FIG. 25 may spread out after exiting the needle to prevent migration of the implant after deployment and withdrawal of the delivery tool / needle. The implant 432 has a proximal feature 474 at its proximal end. As shown, the proximal feature 474 is a blunt end. The second end (distal end) of the implant 432 has a first arm 476a and a second arm 476b, each of which is fixed to the body at a proximal end and is not fixed to the body at a distal end. The first arm 476a and the second arm 476b may each have one or more outer bevels 478a and 478b, respectively, on a radially outer surface of the distal end of the implant. The outer bevels 478a, 478b can allow each arm 476a, 476b, respectively, to engage with surrounding tissue. The implant 432 also includes a strain relief section 482. As shown, the strain relief section 482 has a relatively smaller cross-sectional area (e.g., diameter) than other portions of the implant. The implant 432 shows the proximal feature 474 in a compressed (undeployed) configuration and a deployed configuration. In the deployed configuration, the proximal feature deploys barbs / arms 474a, 474b. The barbs, fork shape, or deployed shape at the proximal end can be smaller than the arms (476a, 476b) at the distal end because the barbs, fork shape, or deployed shape at the proximal end are sized to prevent the implant from shifting or slipping relative to the surrounding and adjacent tissue at the proximal end of the implant.

[0089] The implants disclosed herein may include multiple materials to adjust the stiffness, outer hardness / softness, biocompatibility, and absorption characteristics of the implant. In some embodiments, the implant may include a degradable inner structure and a hydrophobic outer coating. The degradable material is degradable by hydrolysis in the body. Coatings on the degradable material can slow down the degradation, for example, hydrophobic coatings can control or adjust the degradation of the implant. The hydrophobic coating can retard the ingress of water and slow the hydrolysis of the degradable portion of the implant. One example of a hydrophobic material that can be used is polycaprolactone, which is a resorbable material that is suitable for coating because it is hydrophobic, crystalline, and highly elastic. The coating may be applied with a solvent blend specifically selected to minimize the effect on the underlying polymer structure. In some embodiments, non-resorbable biocompatible coatings, such as silicone, epoxy acrylate, or Parylene™, may be used to reduce the rate at which water is absorbed into the underlying polymer.

[0090] The rate, characteristics, and / or duration of biodegradation of the implant can be tailored. For example, a number of coatings, both absorbable and non-absorbable, may be applied to the underlying implant structure, which already has the necessary mechanical properties to support the upper and lower lateral nasal cartilages. There are a number of possible coatings, including polycaprolactone, silicone, fluoropolymers, vinyl alcohol, acrylates, and the like. In some embodiments, the coating may be Parylene™. Parylene™ (poly(dichloro-para-xylylene)), an exemplary hydrophobic coating compound, has the following form:

number

[0091] The Parylene™ conformal coating process is established, allowing control of the thickness of the coating on the implant substrate. To facilitate some water penetration through the Parylene™ coating to cause hydrolysis, the implant may be coated to a thickness ranging from about 0.1 microns to about 10 microns, preferably 0.1 microns to 5 microns, allowing for a semi-permeable design. By designing a semi-permeable coating, selective tuning of the implant's absorption rate is achieved, with the degree of permeation being determined by the thickness and conformality of the coating.

[0092] By selecting the thickness of the hydrophobic coating, it is possible to modify the absorption characteristics of the implant. In some embodiments, the thickness of the hydrophobic coating may range from about 0.1 microns to about 10 microns. In some embodiments, the thickness of the hydrophobic coating may range from about 0.1 microns to about 5 microns. In some embodiments, the thickness of the hydrophobic coating may range from about 0.1 microns to about 1 micron. In some embodiments, the thickness of the hydrophobic coating is less than 10 microns. In some embodiments, the thickness of the hydrophobic coating is less than 5 microns. In some embodiments, the thickness of the hydrophobic coating is less than 1 micron. By selecting the thickness of the coating, it is possible to control the rate of ingress of water through the coating and into the core of the implant.

[0093] The hydrophobic coating may be applied to the entire exterior surface of the implant or to a portion of the exterior surface of the implant. In some embodiments, the hydrophobic coating may be applied to the central rod of the implant. In other embodiments, the hydrophobic coating may be applied to portions other than the ends of the implant. For example, the proximal or distal ends may not be coated to act as a point of ingress for water.

[0094] The conformality of the hydrophobic coating can also be selected to modify the absorption characteristics of the implant. In some embodiments, the conformality of the hydrophobic coating is selected to control the rate of water ingress through the hydrophobic coating and into the core of the implant. In some embodiments, the hydrophobic coating has a patterned conformality having coated and open compartments. The patterned hydrophobic coating may be applied to the entire exterior surface of the implant or to a portion of the implant. In some embodiments, the hydrophobic coating may have a porous structure.

[0095] In some embodiments, the hydrophobic coating may have a layered structure made of multiple materials, for example, in some embodiments, a combination of bioabsorbable and non-bioabsorbable layers may be used to tailor the degradation rate or properties of the implant after implantation in the nasal tissue.

[0096] Coating may be done by a variety of processes, for example, vapor deposition, dip coating, stripping, etc. This is done by spray coating, sputter coating, brush layering, etc. stomach.

[0097] In some embodiments, the hydrophobic coating is bioabsorbable. In the case of polycaprolactone, the coating itself is hydrophobic and bioabsorbable, allowing it to be completely absorbed over time. In the case of dip coating, a coating thickness of 0.1 to 10 microns will achieve the desired results. Furthermore, the same effect can be achieved by depositing 0.001 to 20 weight percent of polycaprolactone on the implant substrate. Polycaprolactone is readily soluble in a mixture of various solvents, including but not limited to cycloalkanes, organic esters, chloroform, and other such organic solvents.

[0098] The degradation characteristics and degradation rates can be selectively tailored such that the lifespan of the polymer matrix of the implant core or base can be increased by up to 20 times.

[0099] FIG. 26 shows examples of implant cores with various coating thicknesses. The baseline shows the implant cores before exposure to accelerated physiological conditions for comparison with other implant configurations shown in FIG. 26. The accelerated physiological conditions included hot saline conditioning to accelerate the effects of water penetration. The accelerated physiological conditions can simulate extended exposure to physiological conditions. The coatings on the implant cores are 0.0μ, 0.1μ, 1.0μ, and 10μ. FIG. 26 shows that the thicker the coating, the less the implant degrades when the illustrated implants are exposed to accelerated physiological conditions. The uncoated core degrades the most and the 10μ coated core degrades the least. By selecting the thickness, conformality, and patterning of the coating, it is possible to tailor the degradation of the implant under physiological conditions.

[0100] 27-1(A)-(B) and 27-2(C)-(D) show embodiments of nasal implants having various coating configurations. The implant 32 shown in FIG. 27-1(A) has a coating 500 on or nearly on the entire outer surface of the implant 32. The coating 500 can slow down the degradation of the implant 32 after it is embedded in tissue by slowing or preventing the ingress of water. The implant 32 shown in FIG. 27-1(B) has a coating 500 on the longitudinal center of the implant between lines 501 and 502. The absence of the coating 500 on the proximal and distal ends allows water to ingress into the implant 32 through the uncoated sections, thereby accelerating the degradation of the implant 32. The implant 32 shown in FIG. 27-2(C) has a coating 500 on the outer surface of the implant, including the longitudinal center of the implant 32 and the arms 76a, 76b of the implant. The proximal features 74 are not covered with the coating 500 in order to allow water to ingress into the implant from the proximal features 74, facilitating degradation of the implant 32. The implant 32 shown in FIG. 27-2(D) has a discontinuous coating 520 over, or nearly over, the entire exterior surface of the implant 32. The discontinuous coating 520 can slow down degradation of the implant 32 after it is embedded in tissue by slowing or preventing water ingress into the coated portions, while at the same time allowing water to ingress through the discontinuous portions to promote degradation of the uncoated portions of the implant 32.

[0101] The implant, arms, or prongs may have other or additional features, such as gripping portions, prongs, teeth, etc. Features may be angled relative to the implant, arms, or prongs to hold the implant, arms, or prongs in place within the delivery device or tissue. Features on the arms or prongs may limit or prevent substantial proximal and / or distal movement of the implant, or side-to-side (lateral) movement. Figure 3A shows an implant 32 having multiple segments.

[0102] The implant may include one or more of the proximal end features, distal end features, or body features as described herein, or as described in U.S. Patent Application Publication No. 2011 / 0251634 (Gonzales et al.), U.S. Patent Application Publication No. 2012 / 0109298 (Iyad Saidi), and / or U.S. Pat. Saidi), or any of the features shown in U.S. Patent Application Serial No. 14 / 192,365, filed February 27, 2014. The implant 32 shown in FIGS. 3A-3B has a proximal feature 74 at its proximal end. As shown, the proximal feature 74 is a blunt end. The proximal feature may be sharp or flat, but is generally rounded or has an atraumatic shape. The atraumatic end can prevent the proximal end of the implant from damaging or cutting the tissue or exiting the tissue when in place within the tissue (e.g., within nasal tissue). The proximal feature can help to anchor or otherwise hold the implant in place within the tissue in which it is implanted. As will be described in more detail below, the proximal feature can also be configured to receive or mate with a plunger or actuator to assist in orienting the implant within the delivery device or moving the implant within the delivery device to implant into the tissue. The proximal mechanism and the actuator or plunger can interact in some way to allow the actuator to move the implant. For example, the implant can have a concave end and the plunger or actuator can have a convex end. The implant 32 also has a strain relief section 82. As shown, the strain relief section 82 has a relatively smaller cross-sectional area (e.g., diameter) than other portions of the implant. The strain relief section can be larger than other areas, but can be of a different configuration or material to provide strain relief. The strain relief section can be more flexible or have a lower bending stiffness than other areas of the implant. The strain relief section can be useful in absorbing movement of tissue, such as the nose, to allow the nose to bend. An implant for use in nasal or facial tissue can be configured such that the strain relief section is adjacent to the mucosa to absorb movement of the nose when the implant is in place in the nasal tissue.The strain relief section can work in conjunction with a proximal feature, such as a blunt end, to retain the implant within tissue (e.g., the tissue can form a collar around the waist portion so that the proximal end prevents movement through the collar).

[0103] The implant 32 also has a central bridge region. The central bridge region may be particularly useful for bridging the structures at both ends where support is needed, such as weak or collapsed areas. Such areas may be considered to be particularly weak areas or areas of particularly high overall stress where support is needed. The central bridge region may bridge a weakened or collapsed nasal valve in the nose. The bridge region may be supported by areas of the implant near the bridge region. The central region may include one or more ribs (also called ridges). The implant 32 has multiple ribs 80a, 80b (or ridges), which may be the central bridge region. Body features such as ribs may help secure the implant in place, such as by gripping tissue with a rib, valley, or otherwise. The implant may have one or more ribs or other body features, such as bevels, scallops, wings, etc. The implant may have 0 to 50 body features (e.g., ribs), or may have 0 body features (e.g., ribs), 1 body feature (e.g., ribs), 2 body features (e.g., ribs), 3 body features (e.g., ribs), 4 body features (e.g., ribs), 5 body features (e.g., ribs), 5 body features (e.g., ribs) to 10 body features (e.g., ribs), 10 body features (e.g., ribs) to 20 body features (e.g., ribs), 20 body features (e.g., ribs) to 30 body features (e.g., ribs), 30 body features (e.g., ribs) to 50 body features (e.g., ribs), etc., or any number of body features (e.g., ribs) between any of these numbers. As shown in FIG. 3A, the first rib has a first rib width W1 and the second rib has a second rib width W2. The rib widths W1 and W2 may be the same size or may be different. The first rib can have a first rib diameter and the second rib can have a second rib diameter. The first and second rib diameters can be the same size or can be different. For example, the ribs along one end, e.g., the distal end, can be thicker or larger to provide more leverage (e.g., against the maxilla) and the ribs along the proximal end can be thinner or smaller so that the implant is more flexible.Also, in some cases, features along the distal end may be thinner or smaller in diameter, for example to reduce or eliminate an objectionable rib profile that may be visible on the outer surface of the nose. Features such as ribs may be thinner, for example to allow the nose to move during breathing (inhalation and exhalation). Ribs may increase the relative surface area of ​​the implant, which may contribute to the rate or uniformity of biodegradation of a biodegradable implant. Ribs may contribute to the flexibility of the implant; that is, having more ribs or larger valleys between ribs may increase the flexibility of the implant.

[0104] In some variations, the implant may be relatively low profile (e.g., low height) in at least one dimension (length, width, height). The height of the implant may be, for example, less than 1 mm, less than 2 mm, less than 3 mm, less than 4 mm, less than 5 mm, less than 10 mm, less than 20 mm, or any size therebetween, such as 1 mm to 2 mm, 1 mm to 5 mm, 2 mm to 4 mm, etc. It may be particularly advantageous for the implant to be low profile, for example, because it can be inserted into a relatively small implant hole that heals easily, or because it can be of a desirable shape that fits the anatomy of the space in which it is implanted, or because it can be less noticeable when implanted. The height of the implant may be selected based on the implant environment and the desired implant effect. For example, in the face and nose, the underlying cartilage and bone largely determine the shape of the face and nose, but the muscles and skin also play a role. The muscles, skin, and associated tissues that cover the underlying cartilage and bone tend to take on the shape of the underlying structures they cover. The thickness of the skin and flesh varies from person to person. Some people have thicker skin and muscles, while others have thinner. If a relatively tall implant is placed on cartilage or bone, the overlying muscle and skin may have a noticeable ridge or protrusion that may be noticeable at first glance to the person, who may feel uncomfortable or self-conscious about the attention, whereas a person with thicker muscle and skin may have a less noticeable ridge or protrusion and may be better able to contain or mask the implant. A relatively low profile implant may have a relatively low profile so that it is not noticeable through the skin when the implant is in place in the nose. Even low profile implants may have a small ridge or protrusion that may be noticeable when viewed or touched up close. The body of the implant may be curved or bent (and may have various shapes that are not straight), but is generally relatively straight and capable of being curved or bent. For example, the implant may be bent to a minimum bending radius of 15mm±0.5mm.

[0105] Different regions of the implant may have material properties such as strength, flexibility, stiffness, bending stiffness, etc. The material properties of the implant can be selected to approximate the material properties of the body structure. For example, the bending stiffness of a nasal implant can be made to be equal to or close to the bending stiffness of nasal tissue such as cartilage. As described below, some nasal cartilage has measured elastic moduli ranging from 5 MPa to 32 MPa. The implant, or a portion of the implant, such as the central region, end region, arm region, proximal feature, distal feature, projection, ridge, or other portion of the implant described herein, may have an elastic modulus of 5 MPa to 32 MPa, or may be greater than 2, 4, 5, 10, 15, 20, 25, 30, 32, 35, 40, or 50 MPa, or may be less than 2, 4, 5, 10, 15, 20, 25, 30, 32, 35, 40, or 50 MPa, or any value therebetween, such as between 2 MPa and 50 MPa, 10 MPa and 30 MPa, etc. The bending stiffness of some Batten grafts made of septal cartilage has been measured to be 50-130 N-mm2, or 50-140 N-mm2, and the bending stiffness of the implant, or portion of the implant, may be within this range. The bending stiffness of the implant may be greater or less than this. For example, other supporting structures of the body may work with the implant to provide additional support and therefore less support from the implant is needed, or more support from the implant may be needed due to weaker tissue support. The implant, or portions of the implant, such as the central region, end regions, arm regions, proximal features, distal features, protrusions, ridges, or other portions of the implants described herein, may have a bending stiffness of greater than 10, greater than 30, greater than 50, greater than 75, greater than 100, greater than 150, greater than 200, greater than 300, greater than 400, or less than 600, less than 500, less than 420, less than 400, less than 300, less than 200, less than 130, less than 100, less than 50. For example, the implant, or portions of the implant, may have a bending stiffness of 10-590 N-mm2, 30-450 N-mm2, 60-250 N-mm2, 75-200 N-mm2, 50-130 N-mm2, or 9-130 N-mm2. In some embodiments, a central portion of the implant has a bending stiffness of less than about 130 N-mm2.In some embodiments, the central portion of the implant has a bending stiffness of about 10-130 N-mm2. In some embodiments, the central portion of the implant has a bending stiffness of about 50-130 N-mm2. Because the material properties of the bioabsorbable implant change over time, the bioabsorbable implant may be configured to have any material property, such as any of the material properties described above, after a period of time in the body or exposed to bodily fluids.

[0106] The implant may be made of any biocompatible material that provides the desired support and shaping properties of the implant. The implant may be made partially or entirely of a non-biodegradable material known in the art, such as any polymer, metal, or shape memory material. The implant may be made of organic and / or inorganic materials. The implant material may be solid (e.g., titanium, Nitinol, or Gore-Tex®) that is knitted or woven from a single material (e.g., titanium, or polyethylene terephthalate, or a combination of materials). Woven materials may have pores that allow for tissue ingrowth after implantation. Representative synthetic polymers include alkylcelluloses, cellulose esters, cellulose ethers, hydroxyalkylcelluloses, nitrocelluloses, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyalkylenes, polyamides, polyanhydrides, polycarbonates, polyesters, polyglycolides, polymers of acrylic and methacrylic acid esters, polyacrylamides, polyorthoesters, polyphenylenes, polysiloxanes, polyurethanes, polyvinyl alcohols, polyvinyl esters, polyvinyl ethers, polyvinyl halides, polyvinylpyrrolidones, poly(ether ketones), silicone-based polymers, mixtures and copolymers thereof.

[0107] Specific examples of these broad classes of polymers include poly(methyl methacrylate), poly(ethyl methacrylate), poly(butyl methacrylate), poly(isobutyl methacrylate), poly(hexyl methacrylate), poly(isodecyl methacrylate), poly(lauryl methacrylate), poly(phenyl methacrylate), poly(methyl acrylate), poly(isopropyl acrylate), poly(isobutyl acrylate), poly(octadecyl acrylate), polyethylene, polypropylene, poly(ethylene glycol), poly(ethylene oxide), poly(ethylene terephthalate), poly(vinyl alcohol), poly(vinyl acetate), poly(vinyl chloride), polystyrene, polyurethanes, poly(lactic acid), poly(butyric acid), poly(valeric acid), poly[lactide-co-glycolide], poly(fumaric acid), poly(maleic acid), copolymers of poly(caprolactone) or poly(lactic acid) with polyethylene glycol, and mixtures thereof.

[0108] The polymers used in the implant may be non-biodegradable. Examples of non-biodegradable polymers that may be used include ethylene vinyl acetate (EVA), poly(meth)acrylic acid, polyamides, silicone-based polymers and copolymers, and mixtures thereof.

[0109] In some embodiments, the implant may include a combination of one or more bioabsorbable materials and non-absorbable materials. For example, in some cases, at least one of the distal end, proximal end, or central portion is comprised of a core made of a non-absorbable or absorbable material. The implant may then include an outer layer made of a different non-absorbable or absorbable material than the core. In some embodiments, the core and outer layer are fixedly laminated to one another. In some embodiments, the core and outer layer are slidably engaged to one another.

[0110] In some embodiments, the first and second arms of the implant are configured to self-deploy towards the deployed configuration. In some embodiments, the first and second arms of the implant are configured to transition to the deployed configuration by engaging tissue or a portion of a delivery tool.

[0111] For example, the implant, or the arms or features of the implant, may include a shape memory material. In some variations, the implant includes a biocompatible and bioabsorbable material, such as a bioabsorbable polymer. A bioabsorbable or biodegradable implant can provide structure and support to a body tissue, such as nasal tissue, for a temporary period of time and can induce or cause the formation of scar tissue or other tissue that provides structure and support to the body tissue for an extended period of time, including after the implant has degraded. Biologically formed scar tissue or other tissue can be advantageous because it can be more comfortable, provide longer term support, remain more stable in place, etc., compared to an implant. A portion or the entire implant may be biodegradable (also referred to as biodegradable) and bioabsorbable. The implant or implant body may be essentially composed of a bioabsorbable material. The implant or implant body may include two or more types of bioabsorbable materials. A method described herein may include biodegrading and bioabsorbing the implant, or only a portion of the implant, if the implant includes both bioabsorbable and non-bioabsorbable portions. Bioabsorption can be driven by tissues and organs. Bioabsorbent tissues and organs may include bodily fluids such as blood, lymph, mucus, saliva, etc. Bacteria can also contribute to the bioabsorption of materials. The implant may be made partially or entirely of one or more biocompatible and biodegradable materials, which may be, for example, naturally derived or synthetic polymers.Biodegradable implants include poly(lactide), poly(glycolide), poly(lactide-co-glycolide), poly(lactic acid), poly(glycolic acid), poly(lactic acid-co-glycolic acid), poly(lactide) / poly(ethylene glycol) copolymer, poly(glycolide) / poly(ethylene glycol) copolymer, poly(lactide-co-glycolide) / poly(ethylene glycol) copolymer, poly(lactic acid) / poly(ethylene glycol) copolymer, poly(glycolic acid) / poly(ethylene glycol) copolymer, poly(lactic acid-co-glycolic acid) / poly(ethylene glycol) copolymer, poly(caprolactone), ... The implant may be made of poly(ethylene glycol) / poly(ethylene glycol) copolymers, poly(orthoesters), poly(phosphazenes), poly(hydroxybutyrates) or copolymers containing poly(hydroxybutyrate), poly(lactide-co-caprolactone), polycarbonates, polyesteramides, polyanhydrides, poly(dioxanones), poly(alkylene alkylates), copolymers of polyethylene glycol and polyorthoesters, biodegradable polyurethanes, poly(amino acids), polyetheresters, polyacetals, polycyanoacrylates, poly(oxyethylene) / poly(oxypropylene) copolymers, or mixtures or copolymers thereof. In some embodiments, the implant contains poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA), or both. In some embodiments, the implant has a PLLA / PDLA copolymer ratio of 90:10, 80:20, 70:30, 60:40, 50:50, or between any of these values. In some embodiments, the implant has a PLLA / PDLA copolymer ratio of 70:30±10%.

[0112] The implant may have various sections, each made of a different bioabsorbable material based on the desired properties of each section and based on the type of tissue each section will engage and the typical properties of that tissue type. It may be desirable for the arms and center of the implant to provide more structural support than the proximal end. For example, the arms and center may be made of a first bioabsorbable material having a first bioabsorbable profile, and the proximal end may be made of a second bioabsorbable material having a second bioabsorbable profile. The second bioabsorbable profile may be shorter than the first bioabsorbable profile.

[0113] The biodegradable implants or portions of the implants described herein may be configured or adjusted to biodegrade (to be absorbed) within 60 months, 36 months, 24 months, 18 months, 12 months, 9 months, 6 months, 3 months, or 1 month, or any time between any of these time periods. For example, the implants may be configured to degrade between 9 and 12 months, between 3 and 12 months, between 1 and 12 months, etc. If the entire implant is composed of a biodegradable material, the entire implant or nearly the entire implant may degrade during these time periods. For example, the biodegradable implants may degrade such that the material properties are significantly altered. Since the material properties of the bioresorbable implants change over time, the bioresorbable implants may be configured to have any of the material properties, such as those described elsewhere herein, after any of the above-mentioned time periods in the body or exposed to body fluids. In some embodiments, the bioabsorbable implant has (or is configured to have) a bending stiffness of less than 15 N-mm2, less than 10 N-mm2, less than 5 N-mm2, less than 4.2 N-mm2, less than 4 N-mm2, less than 3 N-mm2, less than 2 N-mm2, or less than 1 N-mm2 after 3 months, 6 months, 9 months, or 12 months in the body. If the implant includes both biodegradable and non-biodegradable materials, the biodegradable portion may degrade in any of these time periods, and the non-biodegradable material may not degrade. An implant implanted in the body may be exposed to body tissues and fluids, which may cause biodegradation. An implant may be selected or configured to biodegrade within the times listed above for a variety of reasons. For example, an implant with desired material properties (e.g., flexibility, strength, etc.) may degrade in a different time frame when exposed to mucus than an implant that is not exposed to mucus. A slower degradation of the implant may allow more time for desired scar or other tissue to form before degradation.

[0114] The implant may contain additional materials, such as antibiotics, other antibacterial agents, antifungals, antihistamines, anti-inflammatory agents, cartilage growth inducers, decongestants, drugs, growth factors, microparticles, mucolytic agents, radiopaque materials, steroids, vitamins, etc. Such materials may be affixed, glued, painted, or kneaded onto the implant. Such materials may be inserted into the body tissue along with the implant. Such materials may be needed at different times, may be time-sensitive, or may be of sustained release. For example, anti-inflammatory agents may be effective immediately after implantation to suppress premature inflammation and pain, but may not be desirable during later scarring and healing stages, since they may interfere with the healing process that provides new tissue to support the tissue after removal of the implant. For example, the implant may be configured to release a cartilage growth inducer, such as a fibroblast growth factor (FGF, e.g., basic fibroblast growth factor (FBF2)) or a transforming growth factor (TGF, e.g., TGFβ1), over a period of days or weeks to prevent early inappropriate or unwanted responses.

[0115] Additionally, these coatings may be configured to elute thrombolytic agents, vasodilators, corticosteroids, antihypertensives, antibacterial or antibiotic agents, antimitotic agents, antiproliferative agents, antisecretory agents, nonsteroidal anti-inflammatory agents, immunosuppressants, growth factors and growth factor antagonists, anticancer and / or chemotherapeutic agents, antipolymerase agents, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, free radical scavengers, antioxidants, biological agents, radiotherapeutic agents, radiopaque agents, and radiolabeled agents, thereby allowing the contemplated coatings to act as controlled release agents for biopharmaceuticals or bioactive agents coated onto the (implant) bioresorbable substrate layer.

[0116] In some embodiments, the coating may be used to act as a tie layer between the substrate-based implant material and the drug coating, as well as coatings that are used to extend the degradation period.

[0117] As for further details related to the present invention, materials and manufacturing techniques within the level of ordinary skill in the art may be used. The same may be considered to hold true for method-based aspects of the present invention in view of additional acts commonly or necessarily used. It is also considered that any optional features of the described inventive variations may be described and claimed independently or in combination with any one or more of the features described herein. Similarly, reference to a singular item encompasses the possibility of a plurality of the same items. More specifically, in this specification and the appended claims, the singular forms "a," "an," "said," and "the" shall encompass the plural unless the context clearly contradicts otherwise. Furthermore, the claims may be written to exclude all optional elements. Thus, this specification shall act as a predicate for the use of exclusive terminology such as "solely," "only," and the like in connection with the description of elements of the claims or the use of "negative" limitations. Unless otherwise defined herein, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. The breadth of the present invention is not limited by this specification, but rather only by the plain meaning of the terms used in the claims.

[0118] As used in the specification and claims, including in the examples, and unless otherwise specified, any numerical value may be read as if it is preceded by the word "about" or "approximately", even if the word is not explicitly present. The words "about" or "approximately", when describing a size and / or location, may be used to indicate that the stated value and / or location falls within a reasonable expected range of values ​​and / or locations. For example, a numerical value may be ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), or other such values. Any numerical range described herein is intended to encompass all subranges subsumed therein. The technical ideas that can be understood from the above-described embodiments will be described below. Aspect 1: a handle including an implant loading chamber adapted to receive a nasal implant; a needle extending distally from the handle, the needle having a lumen, a portion of the lumen having a non-circular cross-section, the needle having a sharpened distal end; an actuator adapted to move the nasal implant along the needle lumen and out an opening at the distal end of the needle; nasal implant delivery tools including Aspect 2: The delivery tool of embodiment 1, wherein the actuator further comprises a push rod and plunger assembly. Aspect 3: The delivery tool of embodiment 2, further comprising a compression element connecting the push rod to the plunger assembly. Aspect 4: 4. The delivery tool of any one of claims 2 to 3, further comprising a push rod locking element proximal to the implant loading chamber configured to prevent the push rod from moving further proximally relative to the handle. Aspect 5: 5. The delivery tool of any one of aspects 1-4, wherein the needle is movable relative to the handle between a plurality of discrete positions, the plurality of discrete positions corresponding to a length of the nasal implant. Aspect 6: 6. The delivery tool of any one of aspects 1-5, further comprising a needle slider actuator configured to move the needle relative to the handle between a plurality of discrete positions. Aspect 7: The delivery tool of any one of aspects 1-6, wherein the length of the actuator is adjustable between a first position and a second position. Aspect 8: The delivery tool of aspect 7, wherein the actuator includes a push rod and plunger assembly, the length of which is adjustable between a first position and a second position, which is adjustable by engaging the push rod with a first locking surface on the plunger assembly and a second locking surface on the plunger assembly. Aspect 9: A delivery tool described in any one of aspects 1 to 8, further comprising an implant orientation indicator configured to visually indicate a plane formed by the first arm and the second arm of the nasal implant in a deployed configuration that corresponds to an orientation of the implant within the needle lumen. Aspect 10: A delivery tool as described in embodiment 9, wherein the implant orientation indicator includes a first arm extending from the handle in a first direction and a second arm extending from the handle in a second direction. Aspect 11: The delivery tool of aspect 10, wherein the first arm and the second arm define approximately the same plane as the plane formed by the first arm and the second arm of the nasal implant in the deployed configuration that corresponds to the orientation of the implant within the needle lumen. Aspect 12: A delivery tool according to any one of the preceding claims, wherein the implant loading chamber is in communication with the needle lumen and adapted to load the nasal implant into the needle lumen. Aspect 13: 13. The delivery tool of embodiment 12, wherein the implant loading chamber is adapted to transition the nasal implant from a deployed configuration to a delivery configuration as the nasal implant advances into the needle lumen. Aspect 14: A delivery tool according to any one of aspects 1-13, wherein the implant loading chamber is in communication with an implant engaging surface disposed between the needle lumen and the implant loading chamber. Aspect 15: A delivery tool as described in aspect 14, wherein the implant engagement surface is adapted to engage with a first arm and a second arm of the implant to transition the implant between a deployment configuration and a delivery configuration. Aspect 16: 16. The delivery tool of any one of aspects 14 or 15, wherein the implant engaging surface has a substantially smooth inner surface. Aspect 17: A delivery tool described in any one of aspects 1-16, wherein the implant loading chamber is configured to receive any of the nasal implants described in aspects 35-61 in a deployed configuration. Aspect 18: A delivery tool according to any one of aspects 1-17, wherein the implant loading chamber includes a first recess and a second recess adapted to pass tweezers engaged with the nasal implant in the deployed configuration. Aspect 19: A delivery tool according to any one of the preceding claims, wherein the implant loading chamber is adapted to receive a cartridge containing the nasal implant. Aspect 20: 20. The delivery tool of embodiment 19, wherein the cartridge is configured to accommodate two or more nasal implants. Aspect 21: A delivery tool as described in aspect 19 or 20, wherein the cartridge further includes an implant engagement ramp adapted to engage with a first arm and a second arm of the implant to transition the implant between a deployment configuration and a delivery configuration. Aspect 22: A delivery tool according to any one of aspects 19 to 21, wherein the cartridge is adapted to communicate with the needle lumen. Aspect 23: A delivery tool described in any one of aspects 19 to 22, wherein the handle is adapted to receive the cartridge such that the cartridge engages the needle lumen to adjust the length of the needle lumen relative to the handle. Aspect 24: A delivery tool according to any one of aspects 1 to 23, wherein the needle has a low-friction coating on its outer surface. Aspect 25: 25. The delivery tool of embodiment 24, wherein the low friction coating is selected from the group consisting of PTFE, silicone, and poly(p-xylylene). Aspect 26: 26. The delivery tool of any one of the preceding aspects, further comprising an actuator register adapted to indicate a position of the actuator when the nasal implant is in the distal end of the needle lumen. Aspect 27: 27. The delivery tool of aspect 26, wherein the actuator register comprises markings on the actuator or on the handle. Aspect 28: 28. The delivery tool of any one of aspects 1-27, further comprising an actuator register adapted to indicate a position of the actuator when at least a distal portion of the implant exits the needle lumen. Aspect 29: 29. The delivery tool of embodiment 28, wherein the actuator resistor is a stop element that prevents the actuator from moving further. Aspect 30: A delivery tool according to any one of the preceding aspects, wherein the needle includes generally striped markings at various locations along the needle. Aspect 31: The delivery tool according to any one of embodiments 1 to 30, further comprising a nasal implant according to any one of embodiments 35 to 61. Aspect 32: The delivery tool of any one of the preceding aspects, further comprising a cartridge housing the nasal implant. Aspect 33: The delivery tool of any one of embodiments 1-32, further comprising a cartridge housing two or more nasal implants. Aspect 34: A delivery tool according to any one of aspects 1 to 33; A nasal implant according to any one of aspects 35 to 61; A system including: Aspect 35: A body, A distal end. A proximal end; the body including a central portion disposed between the proximal end and the distal end; a first arm disposed at the distal end, the arm having a proximal end fixed to the body and a distal end not fixed to the body, the distal end of the arm adapted to move away from a central longitudinal axis of the body from a delivery configuration to a deployed configuration; a second arm having a proximal end fixed to the body and a distal end not fixed to the body, the distal end of the second arm adapted to move away from a central longitudinal axis of the body from a delivery configuration to a deployed configuration; Including nasal implants. Aspect 36: 36. The implant of embodiment 35, wherein the first and second arms are biased toward their respective deployed configurations. Aspect 37: 37. The implant of any one of aspects 35-36, wherein the first and second arms are configured to self-expand towards the deployed configuration. Aspect 38: 38. The implant of any one of embodiments 35-37, wherein the central portion comprises a plurality of small protrusions. Aspect 39: The implant of any one of embodiments 35-38, further comprising a blunt proximal end. Aspect 40: 40. The implant of any one of embodiments 35-39, further comprising a plurality of barbs on the proximal end. Aspect 41: 41. The implant of any one of embodiments 35-40, comprising a degradable inner portion and an outer coating comprising a hydrophobic material. Aspect 42: The implant of embodiment 41, wherein the hydrophobic material is poly(caprolactone). Aspect 43: The implant of embodiment 41, wherein the hydrophobic material is Parylene™. Aspect 44: The implant of embodiment 41, wherein the hydrophobic material is a bioabsorbable material. Aspect 45: The implant of embodiment 41, wherein the hydrophobic material is not a bioabsorbable material. Aspect 46: 46. ​​The implant of any one of aspects 41-45, wherein the hydrophobic material covers the entire outer surface of the degradable inner portion. Aspect 47: 46. ​​The implant of any one of aspects 41-45, wherein the hydrophobic material covers a portion of an outer surface of the degradable inner portion. Aspect 48: 48. The implant of embodiment 47, wherein the portion of the outer surface includes the central portion of the implant. Aspect 49: 48. The implant of embodiment 47, wherein the portion of the outer surface includes the central portion and the distal end of the implant. Aspect 50: Aspect 50. The implant of any one of aspects 41-49, wherein the hydrophobic material has a discontinuous pattern on the outer surface of the degradable inner portion. Aspect 51: 51. The implant of any one of aspects 41-50, wherein the hydrophobic material has a thickness of about 0.1 microns to about 10 microns. Aspect 52: The implant of any one of aspects 41-50, wherein the hydrophobic material has a thickness of about 0.1 microns to about 5 microns. Aspect 53: 51. The implant of any one of aspects 41-50, wherein the hydrophobic material has a thickness of about 0.1 microns to about 1 micron. Aspect 54: The implant of any one of aspects 41-50, wherein the hydrophobic material is less than about 10 microns in thickness. Aspect 55: The implant of any one of aspects 41-50, wherein the hydrophobic material is less than about 5 microns in thickness. Aspect 56: The implant of any one of aspects 41-50, wherein the hydrophobic material is less than about 1 micron in thickness. Aspect 57: The outer coating, which includes the hydrophobic material, is selected to achieve predetermined degradation characteristics. 42. The implant of embodiment 41, having a controlled thickness. Aspect 58: An implant described in any one of aspects 41 to 57, further comprising a drug within the hydrophobic material or disposed between the degradable inner portion and the outer coating comprising the hydrophobic material. Aspect 59: The implant of embodiment 58, wherein the agent is selected from the group consisting of an antibiotic, another antibacterial agent, an antifungal agent, an antihistamine, an anti-inflammatory agent, a cartilage growth inducer, a decongestant, a drug, a growth factor, a microparticle, a mucolytic agent, a radiopaque material, a radiopaque drug, a radioactive label, a steroid, and a vitamin. Aspect 60: 59. The implant of embodiment 58, wherein the drug is a bioactive agent, and the hydrophobic material is configured to elute one or more bioactive agents selected from the group consisting of thrombolytic agents, corticosteroids, vasodilators, antihypertensive agents, antibacterial or antibiotic agents, antimitotic agents, antiproliferative agents, antisecretory agents, nonsteroidal anti-inflammatory agents, immunosuppressants, growth factors, growth factor antagonists, anticancer and / or chemotherapeutic agents, antipolymerase agents, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, free radical scavengers, antioxidants, biological agents, and radiotherapeutic agents. Aspect 61: 61. The implant of any one of aspects 35 to 60, wherein the central portion has a bending stiffness of about 9 to 130 N-mm2. Aspect 62: 1. A method of supporting a nasal tissue compartment of a patient, comprising: inserting a needle of a delivery tool into the nasal tissue, the delivery tool including a handle portion, the needle extending distally from the handle, the needle including a needle lumen, the handle including an implant loading chamber adapted to receive an implant, the delivery tool including an actuator adapted to move the implant along the needle lumen and out of an opening at the distal end of the needle; advancing the implant distally from the needle lumen to position a distal end of the implant within the nasal tissue, the implant including a first arm at a distal end and a second arm at the distal end; the first arm moving away from a central longitudinal axis of the implant during the advancing step, and the second arm moving away from the central longitudinal axis of the implant during the advancing step. withdrawing the delivery tool to position a central portion of the implant within the nasal tissue; supporting the tissue compartment with the implant; The method includes: Aspect 63: The method of aspect 62, wherein the step of advancing the implant includes pushing the implant distally away from the central longitudinal axis of the implant such that the first arm and the second arm each engage the tissue. Aspect 64: A method according to any one of aspects 62 to 63, wherein the actuator includes a push rod, a plunger assembly, and a compression element connecting the push rod to the plunger assembly, and the step of advancing the implant includes the step of pushing the implant distally with the push rod. Aspect 65: 65. The method of embodiment 64, further comprising the step of continuing to apply a distal axial force to the implant by the push rod and the compression element during initial withdrawal of the delivery tool. Aspect 66: Aspect 66. The method of any one of aspects 62-65, further comprising the step of loading the implant into the implant loading chamber of the delivery tool. Aspect 67: 67. The method of embodiment 66, further comprising the step of loading the implant into the implant loading chamber using tweezers. Aspect 68: 67. The method of embodiment 66, further comprising the step of loading a cartridge containing the implant into the implant loading chamber. Aspect 69: Aspect 69. The method of any one of aspects 66-68, further comprising the step of retracting a push rod of the actuator to a proximal locking point before loading the implant into the implant loading chamber. Aspect 70: Aspect 70. The method of any one of aspects 66-69, further comprising adjusting the length of the needle extending from the handle prior to loading the implant. Aspect 71: The method of claim 70, wherein the step of sliding the needle relative to the handle includes moving a slider on the handle and connected to the needle to move the needle relative to the handle between a plurality of discrete positions. Aspect 72: Aspect 70. The method of any one of aspects 66-69, wherein the actuator includes a push rod and plunger assembly, and further comprising the step of adjusting a length of the push rod and plunger assembly prior to loading the implant. Aspect 73: Aspect 73. The method of any one of aspects 66-72, further comprising the step of advancing the implant from the implant loading chamber into the needle lumen. Aspect 74: The method of aspect 73, wherein the delivery tool has an implant engaging surface disposed between the needle lumen and the implant loading chamber, and further comprises a step of advancing the implant from the implant loading chamber, through the implant engaging surface, and into the needle lumen. Aspect 75: A method according to any one of aspects 66 to 74, wherein the loading step includes loading the implant into a proximal end of the needle and advancing the implant to the distal end of the needle prior to the inserting step. Aspect 76: Aspect 76. The method of any one of aspects 73-75, wherein the loading step includes folding the first arm and the second arm of the implant before placing the implant into the proximal end of the needle. Aspect 77: Aspect 77. The method of any one of aspects 73-76, wherein the step of advancing the implant comprises advancing the actuator to a locking point, followed by unlocking the actuator and then advancing the implant distally from the needle lumen to position the distal end of the implant within the nasal tissue. Aspect 78: Aspect 62. The method of any one of aspects 62-77, wherein the inserting step comprises inserting a distal end of the needle into the nasal tissue. Aspect 79: A method according to any one of aspects 62-78, comprising maintaining a known orientation between the implant and the needle during the inserting step. Aspect 80: 80. The method of claim 79, wherein the step of maintaining the known orientation between the implant and the needle includes engaging the implant with a portion of the needle lumen having a non-circular cross-section. Aspect 81: The method of any one of aspects 62-80, wherein the implant comprises a degradable inner portion and an outer coating comprising a hydrophobic material. Aspect 82: 82. The method of embodiment 81, wherein the hydrophobic material is poly(caprolactone). Aspect 83: 82. The method of embodiment 81, wherein the hydrophobic material is Parylene™. Aspect 84: The method of embodiment 81, wherein the hydrophobic material is a bioabsorbable material. Aspect 85: The method of embodiment 81, wherein the hydrophobic material is not a bioabsorbable material. Aspect 86: Aspect 86. The method of any one of aspects 81-85, wherein the hydrophobic material covers the entire exterior surface of the degradable inner portion. Aspect 87: 86. The method of any one of aspects 81-85, wherein the hydrophobic material covers a portion of an exterior surface of the degradable inner portion. Aspect 88: 88. The method of claim 87, wherein the portion of the outer surface includes the central portion of the implant. Aspect 89: 88. The method of claim 87, wherein the portion of the outer surface includes the central portion and the distal end of the implant. Aspect 90: Aspect 89. The method of any one of aspects 81-89, wherein the hydrophobic material has a discontinuous pattern on the outer surface of the degradable inner portion. Aspect 91: Aspects 81-90, wherein the hydrophobic material has a thickness of about 0.1 microns to about 10 microns. Aspect 92: A method according to any one of aspects 81 to 90, wherein the hydrophobic material has a thickness of about 0.1 microns to about 5 microns. Aspect 93: A method according to any one of aspects 81 to 90, wherein the hydrophobic material has a thickness of about 0.1 microns to about 1 micron. Aspect 94: A method according to any one of aspects 81 to 90, wherein the hydrophobic material is less than about 10 microns in thickness. Aspect 95: A method according to any one of aspects 81 to 90, wherein the hydrophobic material is less than about 5 microns in thickness. Aspect 96: A method according to any one of aspects 81 to 90, wherein the hydrophobic material is less than about 1 micron in thickness. Aspect 97: The method of any one of aspects 62-96, further comprising the step of selecting the implant based on degradation characteristics of the implant. Aspect 98: The method of embodiment 97, wherein the degradability characteristics of the implant are based on the degradable inner portion and the outer coating comprising the hydrophobic material. Aspect 99: Aspects 81-98, the method of any one of aspects 81-98, further comprising selecting the conformality and thickness of the outer coating based on desired degradation characteristics of the implant. Aspect 100: Aspect 62-99, the method of any one of aspects 62-99, further comprising the step of degrading the degradable inner portion of the implant. Aspect 101: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about 48 months. Aspect 102: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about 36 months. Aspect 103: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about 24 months. Aspect 104: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about 18 months. Aspect 105: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about 12 months. Aspect 106: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about 9 months. Aspect 107: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about six months. Aspect 108: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about three months. Aspect 109: The method of embodiment 100, wherein the step of degrading the degradable inner portion of the implant takes less than about one month. Aspect 110: The method of any one of aspects 62-109, further comprising the step of the implant eluting an agent into the nasal tissue. Aspect 111: The method of embodiment 110, wherein the agent is selected from the group consisting of an antibiotic, another antibacterial agent, an antifungal agent, an antihistamine, an anti-inflammatory agent, a cartilage growth inducer, a decongestant, a drug, a growth factor, a microparticle, a mucolytic agent, a radiopaque substance, a radiopaque drug, a radioactive labeling agent, a steroid, and a vitamin. Aspect 112: The method of embodiment 110, wherein the drug is a bioactive agent, and the hydrophobic material is configured to elute one or more bioactive agents selected from the group consisting of thrombolytic agents, corticosteroids, vasodilators, antihypertensive agents, antibacterial or antibiotic agents, antimitotic agents, antiproliferative agents, antisecretory agents, nonsteroidal anti-inflammatory agents, immunosuppressants, growth factors, growth factor antagonists, anticancer and / or chemotherapeutic agents, antipolymerase agents, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, free radical scavengers, antioxidants, biological agents, and radiotherapeutic agents. Aspect 113: The method of any one of aspects 110 to 112, wherein the implant comprises the agent contained within a hydrophobic material of the implant or disposed between a degradable inner portion and an outer coating of the implant comprising the hydrophobic material. Aspect 114: The method of any one of aspects 62 to 113, wherein the delivery tool is any one of the delivery tools of aspects 1 to 33. Aspect 115: The method of any one of aspects 62-114, wherein the implant is any one of the nasal implants of aspects 35-61. Aspect 116: 1. A method of making a nasal implant, comprising: providing a biodegradable inner portion of the nasal implant; selecting a desired biodegradation characteristic; applying a hydrophobic material having a preselected pattern and thickness corresponding to the desired biodegradable characteristics of the biodegradable inner portion of the nasal implant; The method includes: Aspect 117: The method of embodiment 116, wherein the hydrophobic material is poly(caprolactone). Aspect 118: The method of embodiment 116, wherein the hydrophobic material is Parylene (trademark). Aspect 119: The method of embodiment 116, wherein the hydrophobic material is a bioabsorbable material. Aspect 120: The method of embodiment 116, wherein the hydrophobic material is not a bioabsorbable material. Aspect 121: 120. The method of claim 116, wherein the hydrophobic material covers the entire exterior surface of the degradable inner portion. 2. The method according to any one of claims 1 to 11. Aspect 122: 122. The method of any one of aspects 116-121, wherein the hydrophobic material covers a portion of an exterior surface of the degradable inner portion. Aspect 123: The method of embodiment 122, wherein the portion of the outer surface includes a central portion of the implant. Aspect 124: The method of embodiment 122, wherein the portion of the outer surface includes a central portion and a distal end of the implant. Aspect 125: Aspects 116-125. The method of any one of aspects 116-124, wherein the hydrophobic material has a discontinuous pattern on the outer surface of the degradable inner portion. Aspect 126: A method according to any one of aspects 116 to 125, wherein the hydrophobic material has a thickness of about 0.1 microns to about 10 microns. Aspect 127: A method according to any one of aspects 116 to 125, wherein the hydrophobic material has a thickness of about 0.1 microns to about 5 microns. Aspect 128: A method according to any one of aspects 116 to 125, wherein the hydrophobic material has a thickness of about 0.1 microns to about 1 micron. Aspect 129: A method according to any one of aspects 116 to 125, wherein the hydrophobic material is less than about 10 microns in thickness. Aspect 130: A method according to any one of aspects 116 to 125, wherein the hydrophobic material is less than about 5 microns in thickness. Aspect 131: A method according to any one of aspects 116 to 125, wherein the hydrophobic material is less than about 1 micron in thickness. Aspect 132: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about 48 months. Aspect 133: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about 36 months. Aspect 134: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about 24 months. Aspect 135: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about 18 months. Aspect 136: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about 12 months. Aspect 137: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about 9 months. Aspect 138: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about six months. Aspect 139: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a time period of less than about 3 months. Aspect 140: 132. The method of any one of aspects 116-131, wherein the desired biodegradation characteristics comprise a period of less than about one month.

Claims

1. a handle including an implant loading chamber adapted to receive a nasal implant; a needle extending distally from the handle, the needle including a needle lumen having an opening at a distal end, the distal end being sharp; an actuator configured to move the nasal implant along the needle lumen and toward the opening at the distal end of the needle; Including, A nasal implant delivery tool, wherein the handle includes an implant orientation indicator configured to visually indicate a plane formed by a first implant arm and a second implant arm of the nasal implant corresponding to an orientation of the nasal implant within the needle lumen.

2. 2. The nasal implant delivery tool of claim 1, wherein the implant orientation indicator includes a first indicator arm extending from the handle in a first direction and a second indicator arm extending from the handle in a second direction.

3. The nasal implant delivery tool of claim 2 , wherein the first direction is different from the second direction.

4. 3. The nasal implant delivery tool of claim 2, wherein the first implant arm and the second implant arm have: (i) a contracted configuration in which the first implant arm and the second implant arm are contracted toward a central longitudinal axis of the nasal implant; and (ii) an expanded configuration in which the first implant arm and the second implant arm extend away from the central longitudinal axis more than when the first implant arm and the second implant arm are in the contracted configuration.

5. the first implant arm and the second implant arm each have an arc shape when the nasal implant is in the deployed configuration; The nasal implant delivery tool of claim 4 , wherein the first indicator arm and the second indicator arm each have the arc shape.

6. the implant loading chamber is configured to receive the nasal implant while the nasal implant is in the deployed configuration; the actuator is configured to move the nasal implant from the implant loading chamber into the needle lumen; the implant loading chamber configured to transition the nasal implant from the deployed configuration to the contracted configuration as the nasal implant moves through the implant loading chamber and into the needle lumen; the first implant arm and the second implant arm are biased toward the deployed configuration; 5. The nasal implant delivery tool of claim 4, wherein while the nasal implant is in the contracted configuration within the needle lumen, the implant orientation indicator is configured to indicate an orientation in which the nasal implant will be placed when delivered from the distal end of the needle and returned to the deployed configuration.

7. The nasal implant delivery tool of claim 1 , wherein the implant orientation indicator is at a distal end of the handle.

8. the actuator includes a push rod, a plunger assembly, and a compression element connecting the push rod to the plunger assembly; The nasal implant delivery tool of claim 1 , wherein the compression element is configured to apply a distal axial force to the nasal implant.

9. 9. The nasal implant delivery tool of claim 8, further comprising a push rod locking element proximal to the implant loading chamber, the push rod locking element configured to prevent the push rod from moving further proximally relative to the handle and to prevent the push rod from slipping outside an interior portion of the handle.

10. The nasal implant delivery tool of claim 1 , further comprising an actuator register configured to indicate a position of the actuator when the nasal implant is at the distal end of the needle.

Images