Nasal valve implant and method of implanting the same

Abstract

An implant delivery system includes: a handle having a proximal end and a distal end, wherein a longitudinal axis extends in a direction between the proximal end and the distal end; a needle extending from the distal end of the handle, wherein the needle is movable relative to the handle along the longitudinal axis; a pusher member disposed within a cavity of the needle, the pusher member being configured to move an implant disposed within the cavity of the needle; a movable needle shuttle disposed within the handle and coupled to the needle; one or more springs coupled to the movable needle shuttle, configured to apply a proximal tensioning force to the movable needle shuttle; and an actuator configured to releasably engage the movable needle shuttle; wherein the actuator is configured to be actuated to release the movable needle shuttle from the actuator so that the movable needle shuttle moves the needle proximally to at least partially retract the needle into the handle and deploy the implant from the distal tip of the needle.

Description

[0001] This application is a divisional application of the invention patent application with the application date of April 28, 2017, application number 201780027098.1, and invention name “Nasal valve implant and implantation method thereof”.

[0002] Related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 330,439, filed May 2, 2016, U.S. Provisional Patent Application No. 62 / 378,577, filed August 23, 2016, U.S. Provisional Patent Application No. 62 / 417,210, filed November 3, 2016, and U.S. Provisional Patent Application No. 62 / 456,427, filed February 8, 2017, which are incorporated herein by reference in their entireties. Priority is claimed under 35 U.S.C. §119 and any other applicable statutes. Technical Field

[0004] The technical field generally relates to nasal valve implants and methods of implanting the same in mammals. Background Art

[0005] The nasal valve area of a mammal is the narrow portion of the nasal passage that creates most of the resistance to flow during breathing. It is generally the area located between the nasal septum and the outside or mobile side of the nasal cartilage. During inhalation of air through the nasal valve area, negative pressure is created and the valve area tends to collapse, resulting in a condition medically known as vestibular stenosis. The collapse of the nasal valve area can be dynamic (e.g., during exercise), or it can be fixed or permanent. There are several causes of nasal valve collapse including, for example, aging, trauma, or congenital conditions. Surgical intervention can be performed to alter the nasal valve area whereby a expander graft is placed between the septum and the cartilage. Alternatively, a repair splint can be placed on the outside of the nose (e.g., BREATHE In yet another alternative, a stent-like structure can be placed inside the nose to reinforce and maintain an open nasal valve area. Unfortunately, these less invasive solutions can be uncomfortable to wear and are not generally considered socially acceptable solutions.

[0006] The latest option for solving the collapse of the nasal valve area is to develop a reinforcement implant, which is inserted into the lateral cartilage of the experimenter and engages with or covers the bone tissue in the upper nose area. For example, examples of these types of devices can be seen in U.S. Patent Application Publication Nos. 2011 / 0251634, 2014 / 0243975, 2016 / 0058556 and U.S. Patent No. 7,780,730. The surgery for placing these reinforcement implants involves pushing a sharp tool (e.g., a needle) in the direction toward the eye and other structures. Therefore, it is very important for the physician to have a very detailed understanding of the position and trajectory of the implant and / or tool tip. Existing implant tools use external fixation and measurement tools to determine the position of the tip of the implant and / or delivery system. However, these tools are complicated and cumbersome to use and may only provide the user with an approximation or estimation of the position of the implant and tool tip. Therefore, it is necessary to help the physician safely place the implant in the nasal valve area. Summary of the Invention

[0007] The present invention relates to nasal valve implant systems and devices, as well as methods for implanting the same in mammals. In one embodiment of the present invention, transillumination is used to implant a nasal valve implant. According to one embodiment, a delivery tool equipped with transillumination is advanced through nasal tissue to a desired location for delivery and implantation in the nasal valve region. Transillumination can be provided by the delivery tool, the implant, or both.

[0008] In one embodiment, a method for delivering an implant to a subject's nasal valve region includes the steps of providing a delivery tool having a distal region terminating at a distal tip, wherein at least one of the distal tip and the distal region emits light therefrom. While emitting light from the delivery tool, the delivery tool is advanced through nasal tissue to a desired location in the nasal valve region, wherein the light can be observed through the subject's skin (i.e., transillumination). The delivery tool is then used to deliver the implant to the nasal valve region.

[0009] In another embodiment, a delivery system for delivering an implant to a nasal valve region of a subject includes a delivery tool having a distal region terminating at a distal tip. A light source is disposed within or connected to the delivery tool, wherein at least one of the distal tip and the distal region emits light therefrom. The implant is disposed on or within the distal region of the delivery tool and can be delivered to a desired location in the nasal valve region.

[0010] In another embodiment, a method for delivering an implant to the nasal valve region of a subject includes providing a delivery tool having a handle and a needle extending from a distal end of the handle, wherein the implant is contained within the needle and proximally adjacent to or positioned adjacent to a pusher member, the pusher member being at least partially disposed within the needle and comprising an optical fiber. While emitting light from the needle, the delivery tool is advanced through nasal tissue to a desired location in the nasal valve region, wherein an operator of the delivery tool can observe the light through the subject's skin. The delivery tool is then used to deliver the implant to the nasal valve region of the subject.

[0011] In another embodiment, a delivery system for delivering an implant into the nasal valve region of a subject includes a delivery tool having a handle and a needle extending from a distal end of the handle. The implant is contained within the needle and proximally adjacent or positioned adjacent to a pusher member at least partially disposed within the needle, wherein the needle has a plurality of orifices formed therein. A light source is disposed within the delivery tool and coupled to an optical fiber terminating at an end of the pusher member. The delivery tool includes a slidable button disposed in the handle and configured to proximally retract the needle to release the implant from the needle.

[0012] In another embodiment, a delivery system for delivering an implant to a subject's nasal valve region comprises a delivery tool having a handle and a needle extending from the distal end of the handle, wherein the implant is contained in the needle and adjacent to or configured to be disposed adjacent to a pusher member disposed within the needle. The needle has a plurality of apertures formed therein. A light source is disposed within the delivery tool and is coupled to an optical fiber that terminates at one end of the pusher member. At least one biasing spring is disposed in the handle and is operably coupled to the needle to apply a proximal force on the needle when the spring is in a loaded state. The handle also comprises a release mechanism, which is disposed in the handle and is configured to retract the needle proximally into the handle and release the implant when actuated. The release mechanism may comprise a button-activated latch, a ratchet, or a temporary locking interface (e.g., frictional engagement) that is connected to the needle interface directly or by an indirect sliding member coupled to the needle. In one embodiment, the release mechanism is actuated using a button on the handle. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The drawings illustrate generally by way of example and not limitation, the various embodiments discussed in this document.

[0014] Figure 1A A perspective view of a delivery system according to one embodiment is shown. The arming lever is in a non-arming or shipping position where no tension is placed on the shuttle spring.

[0015] Figure 1B Shown Figure 1A Top view of the delivery system.

[0016] Figure 2A Shown with the arm lever in the arm position Figure 1A and Figure 1B A perspective view of the delivery system of the invention. The needle shuttle is under tension and locked in place via an actuator.

[0017] Figure 2B Shown Figure 2A Top view of the delivery system.

[0018] Figure 3A Shown after actuation of the delivery tool Figure 1A and Figure 1B A perspective view of the delivery system. The needle shuttle and needle have been retracted proximally to extract the implant.

[0019] Figure 3B Shown Figure 3A Top view of the delivery system.

[0020] Figure 4A Shown is a perspective view of a removable needle and cannula according to one embodiment.

[0021] Figure 4B Another perspective view of the removable needle and cannula is shown.

[0022] Figure 4C A cross-sectional view of the removable needle and cannula is shown, taken along the longitudinal axis of the needle. The implant can be seen within the needle.

[0023] Figure 4D Another perspective view of the removable needle and hub is shown, illustrating the top surface of the needle.

[0024] Figure 4E Another perspective view of the removable needle and hub is shown, illustrating the bottom surface of the needle.

[0025] Figure 5 A perspective view of an implant according to one embodiment is shown.

[0026] Figure 6 A perspective view of an implant according to another embodiment is shown.

[0027] Figure 7 Shown is a perspective view of a needle shuttle according to one embodiment. In this embodiment, the needle shuttle is fixed to a needle hub for installing / removing a removable needle.

[0028] Figure 8 Another embodiment of a delivery tool is schematically shown.

[0029] Figure 9AOne embodiment of an implant coupled to the distal end of a pusher member via a locking joint is shown.

[0030] Figure 9B A cross-sectional end view of an implant according to one embodiment is shown.

[0031] Figure 10A A top view of another embodiment of a nasal implant delivery tool is shown.

[0032] Figure 10B Shown Figure 10A Side view of a nasal implant delivery tool.

[0033] Figure 10C A partial cross-sectional view of a nasal implant loaded onto a pusher member and contained within a shaft or needle of an implant delivery tool is shown.

[0034] Figure 11A Shown are snap-fit or interference features for temporarily locking the implant in place within the needle of the delivery system.

[0035] Figure 11B Another embodiment of a snap-fit or interference feature for temporarily locking an implant having a spring-like shape (eg, an S-shape or curved shape) in place within a needle of a delivery system is shown.

[0036] Figure 11C A cross-sectional view of a needle having multiple tabs for retaining an implant is shown according to one embodiment.

[0037] Figure 11D Shown is a cross-sectional view of a needle having an opening or aperture that receives a spring-biased tab or arm of an implant.

[0038] Figure 11E Shown is a cross-sectional view of a needle with an implant therein interfacing with a tab from the needle to temporarily retain the implant in the needle.

[0039] Figure 12 One embodiment of a nasal wall implant loading / reloading tool is shown.

[0040] Figure 13A Another embodiment of an implant loading / reloading tool is shown. The implant loading tool is pre-loaded with an implant loaded therein.

[0041] Figure 13B A side view of the actuating lever is shown.

[0042] Figure 13C An enlarged view is shown showing the implant positioned in the cartridge.The delivery system is loaded into the recess of the implant loading / reloading tool.

[0043] Figure 14A A perspective view of another embodiment of an implant loading / reloading tool is shown. The needle of the delivery tool has not yet been inserted into the tool.

[0044] Figure 14B Shown Figure 14A A perspective view of an implant loading / reloading tool with the needle of a delivery tool inserted into the tool.

[0045] Figure 15 One example of a kit including a delivery tool and a plurality of needles containing implants therein is shown.

[0046] Figure 16A A bottom view of a subject's nose is shown, illustrating the nasal wall and the possible location of a hypothetical needle for insertion into a delivery tool.

[0047] Figure 16B A side view of a subject's nose is shown, illustrating the implant deployed in the nasal valve area within the nasal mucosal tissue.

[0048] Figure 16C Shown is light emitted through an orifice or hole located along the top side of the delivery tool needle. This light can be observed through the subject's skin. DETAILED DESCRIPTION

[0049] The present invention generally relates to nasal valve implants and methods of implanting the same in mammals.

[0050] Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B A method for inserting an implant 10 (in Figure 5 1 (best seen in FIG) is an exemplary embodiment of a delivery system 2 for delivering an implant to the nasal valve region of a subject. In this embodiment, the delivery system 2 includes a delivery tool 12 that is manipulated by a user to deliver the implant to the nasal valve region of the subject. The delivery tool 12 includes a housing 14 having a proximal end 16 and a distal end 18. The outer body of the housing 14 defines a handle 20 that is held or grasped by the user of the delivery tool 12, as explained herein. The handle 20 can be ergonomically designed to accommodate being held by a single hand of a user or operator. This can include various surface features (such as ridges, depressions, curves) that assist the user in holding or manipulating the delivery tool 12 with a single hand. As explained herein, the housing 14 also includes an operating component of the delivery tool 12 that is used to guide placement of the delivery tool 12 in the appropriate anatomical position and delivery of the implant 10 to the target tissue of the nasal valve.

[0051] The distal end 18 of the handle 20 includes a needle 22 extending distally from the distal end 18 of the handle 20. As explained herein, the needle 22 includes a hollow lumen 21, wherein the hollow lumen is sized to receive the implant 10 (at Figure 4B and Figure 4C In one embodiment, needle 22 is movable relative to handle 20 in a direction along the long axis of handle 20 and can be in an extended state (e.g., as shown in FIG. Figure 1A and Figure 1B As shown) and retracted state (as shown Figure 3A and Figure 3B In the extended state, the needle 22 contains the implant 10 in the hollow lumen, as shown. Figure 4C . With the needle 22 in an extended state and containing the implant 10, the delivery tool 12 is manipulated by a user to insert the needle 22 into the nasal mucosal tissue of the subject near the nasal valve area. As explained in more detail below, an actuator 24 located on the delivery tool 12 is triggered by the operator (e.g., using a finger or thumb) to deploy the implant 10 from the lumen of the needle 22 in response to proximal movement of the needle 22 relative to the fixation implant 10. In this regard, the actuator 24 initiates proximal retraction of the needle 22 to at least partially enter the handle 20, and thereby deploy the implant 10 from the lumen of the needle 22 in a withdrawal movement.

[0052] In a preferred embodiment, the distal tip 26 of pin 22 is sharpened to assist tissue penetration or tissue dissection. Pin 22 can be light-tight (for example, being made of stainless steel etc.). Alternatively, pin or shaft can be made of optically transparent or translucent material. If pin or shaft are not optically transparent or translucent, then when implant 10 is loaded in pin 22 fully, the part extending to implant 10 distal ends of pin 22 or shaft can keep relatively short for safety purposes.

[0053] The needle 22 can be formed using a hollow shaft of rigid material (e.g., a hypotube) terminating at a tip 26, which in some embodiments can be sharpened or beveled to assist in tissue penetration. In one embodiment, the needle 22 is 18XT gauge; although it should be understood that other gauges can be used. Figure 4D and Figure 16CAs seen in FIG. 1 , in one embodiment, the needle 22 has a hole or orifice 28 in the needle body so that the implant 10 can be visualized during the implantation procedure using transillumination of light originating from a light source 56 located within the housing 14 (or in other embodiments, passing through the housing 14) and into the optically transparent or translucent implant 10. In a preferred embodiment, a plurality of orifices 28 are positioned along the top surface of the needle 22 (which corresponds to the top surface of the handle 20) to provide visual feedback through the outside of the nose; thereby showing the location of the implant 10 and / or the needle tip 26 and the trajectory of the implant 10. Figure 4E As seen in FIG, light may also be emitted through the bottom surface of needle 22 via one or more apertures 28, thereby allowing the user to visually see whether the proximal end of implant 10 is fully positioned beneath the nasal mucosal lining.

[0054] The apertures 28 can be spaced equidistant from one another, or they can have varying inter-aperture distances along the length of the needle 22. The size of the apertures 28 can be the same along the length of the needle 22, or they can vary. For example, because light enters from one side of the needle 22, the apertures 28 located closest to that end tend to emit the brightest light. With this in mind, the spacing and / or size of the apertures 28 can be adjusted to provide generally uniform illumination along the entire length of the needle 22. For example, the size of the apertures 28 can increase as the apertures 28 travel in the distal direction along the needle 22. The increasing size of the apertures 28 along the needle 22 creates a transillumination pattern that the user perceives as being constant along the length of the needle 22. Additionally or alternatively, the needle 22 can optionally include a slot near the distal tip to create a brighter area at the tip of the needle 22.

[0055] Reference Figure 4A In one embodiment, the sides of the needle 22 include localized apertures or openings formed or created by respective tabs 30 formed in the body of the needle 22 (e.g., on opposing sides or surfaces of the needle 22) for frictionally engaging the implant 10 to retain the implant 10 within the needle 22 until deployment. The tabs 30 can be bent inwardly toward the lumen of the needle 22 so that the tabs 30 frictionally engage the outer surface of the implant 10 to prevent the implant 10 from prematurely moving or dislodging from the needle 22 until the operator intentionally deploys the implant 10. In some embodiments, the needle 22 includes one, two, three, four, five, six, or more than six localized apertures or openings formed by such tabs 30.

[0056] like Figure 4A and Figure 4CAs seen in the drawings, in one embodiment, the tip 26 of the needle 22 is beveled so that the distal-most portion of the needle 22 terminates at the top surface of the needle 22 containing the plurality of apertures 28. In this configuration, the plurality of apertures 28 on the top surface and the beveled tip 26 face upward, toward the exterior surface of the nose. As shown, having the beveled tip 26 facing the exterior of the nose allows for easier insertion into tissue (e.g., the needle 22 is less likely to slip over the interior nostril surface) and is also intended to provide improved tactile feedback of contact with the skull, thereby helping the user prevent undesired contact of the tip 26 of the needle 22 with bone tissue.

[0057] Figure 5 An implant 10 according to one embodiment is shown. The implant 10 can have various lengths, but typically the length is within the range of about 1.5 cm to about 2.5 cm. Depending on the patient's anatomy, etc., implants 10 of different lengths may be required. The diameter of the implant 10 can also vary and depend on the size of the needle 22 used. The maximum outer diameter of the implant 10 should be less than the ID (inner diameter) of the needle 22 so that the implant 10 does not bind to the needle 22 during loading or deployment. A typical diameter of the implant 10 can include 0.040 inches or 1 mm. In some embodiments of the present invention, the implant 10 can be at least partially optically translucent or optically transparent so that light is emitted from the implant 10. This provides the user with direct feedback on the orientation and positioning of the implant 10. This light can be emitted from all surfaces of the implant 10 or less than all surfaces of the implant 10. For example, in an optional embodiment, one or more outer surfaces of the implant 10 can be designed to emit directional light emissions to provide better information about the specific orientation of the implant 10 in the underlying tissue. In some embodiments, light is emitted only from the delivery tool 12. For example, light can be emitted from the distal tip 26 of the needle 22. Alternatively, or in addition to the distal tip 26 of the needle 22, light can be emitted along the length of the distal region of the needle 22 in a stripe or notch (not shown) located on the side of the needle 22 or in a series of apertures 28 located in a line. In other embodiments, light is emitted from both the delivery tool 12 and the implant 10. In yet another embodiment, light is emitted only from the implant 10.

[0058] In some embodiments, implant 10 can be provided with a plurality of implants 10 and / or delivery instruments 12. The various surfaces of implant 10 and / or delivery instruments 12 can be patterned or textured to provide different light effects. In addition, delivery instruments 12 or implant 10 can have scale marks illuminated by light, etc. to reduce the washout (washout) from the light emitted from a larger area. In certain embodiments, implant 10 can be used for transmitted light (for example, waveguide or light transmission member). In certain embodiments, one or two tips of implant 10 can be beveled, angled or faceted to guide light in a directional manner. In addition, in some embodiments, implant 10 can have stripes along the outer surface for directional orientation.

[0059] Using the implant 10 as a light transmitting member provides certain benefits. For example, if the tip of the implant 10 (or an area near the tip) and / or stripes along the implant 10, or a series of apertures 28 facing the patient's skin, were to emit light, the physician could visualize where the implant 10 is located within the patient's anatomy. The illuminated tip would provide an accurate understanding of the implant tip's location, and the stripes would provide an accurate understanding of the implant's trajectory and orientation. The light is of sufficient intensity so that it passes through the subject's skin or other tissue and can be visualized by an operator of the delivery tool 12 (e.g., a physician). In this regard, transcutaneous light illumination or visualization through the skin is used to track and monitor the positioning and / or trajectory of the delivery tool 12 and / or implant 10. In some embodiments, it may be necessary to turn down or reduce the ambient light so that the emitted light can be observed, however, depending on the brightness of the light used, this may not be necessary. Although Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B Light source 56 is shown located within delivery tool 12, but it should be understood that in other embodiments, an external light source (not shown) can be coupled to delivery tool 12 (via a light port located in handle 20, etc.) to provide light source 56. The light emitted by light source 56 is visible light, preferably red light, which is better transmitted through the subject's skin.

[0060] In one embodiment, the implant 10 is made of an optically transparent or translucent biocompatible polymer material. The implant 10 can be made of a resorbable polymer that decomposes over an extended period of time (e.g., more than 12 months). An example of a resorbable translucent polymer is a blend of poly (l-lactic acid) (PLLA) and poly (ε-caprolactone) (PCL) (e.g., a blend of 90-95% PLLA and 10-5% PCL). The implant 10 is typically rigid or semi-rigid in construction so that it resists or prevents collapse of the nasal valve region. The implant 10 can be decorated or have various optional surface features that allow the implant 10 to be securely held in place in the nasal valve region. These surface features include ribs, hooks, barbs, retaining members, etc. Optionally, the implant 10 can be loaded with one or more biological agents or pharmaceutical preparations (e.g., anti-inflammatory agents, antibiotics, or other active agents).

[0061] In one embodiment, Figure 6As seen in FIG. 1 , the implant 10 may include a distal tip 32 that is beveled similar to the beveled tip 26 of the needle 22 to facilitate insertion of the implant 10 into tissue. However, in other embodiments, the implant 10 does not include any type of beveled tip 26 and may be longitudinally and / or axially symmetrical (e.g., as shown in FIG. 1 ). Figure 5 Another optional feature of the implant 10 includes indentations 34 positioned along the outer surface of the implant 10. For example, the indentations 34 can be circular in shape and add texture to hold the implant 10 in place after release. Additionally, the indentations 34 help to diffuse light out of the aperture 28 included in the needle 22. In other embodiments, the indentations 34 can be omitted entirely. Figure 5 In yet another alternative embodiment shown, the implant 10 includes a plurality of circumferential ribs 36 positioned along the outer surface of the implant 10. The ribs 36 advantageously interface with the tabs 30 of the needle 22 to help secure the implant 10 within the needle 22 prior to delivery. Additionally, the ribs 36 serve to retain the implant 10 within the tissue of the nasal valve area after deployment.

[0062] The size of the implant 10 can vary depending on the point of application and the anatomy of the subject. In one example, the implant 10 is cylindrical in shape and has a diameter of approximately 0.038 inches (-0.97 mm) and a length of approximately 0.79 inches (-20.07 mm). It should be understood that other diameters and lengths of the implant 10 can be used. In one embodiment, the implant 10 is pre-loaded within the needle 22. As explained herein, in one embodiment, the needle 22 can be removed relative to the delivery tool 12. In this regard, a kit or the like (e.g., as described herein) can be provided to the user. Figure 15 ), which includes a single delivery tool 12 and a plurality of different needles 22 pre-loaded with the implant 10. For example, implants 10 and needles 22 of different lengths can be included as part of a kit. In another embodiment, the user loads the implant 10 into the needle 22. Such loading of the needle 22 may require a dedicated needle loading device as described in more detail herein.

[0063] refer to Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B and Figure 7, the proximal end of the needle 22 is coupled to a needle shuttle 40. As explained herein, the needle shuttle 40 is used to pull the needle 22 proximally upon actuation of the delivery tool 12. The needle shuttle 40, disposed in the handle 20, straddles a longitudinal track located within the interior of the housing 14. The needle shuttle 40 includes a plurality of proximal and distal pin or boss elements 42. The proximally positioned pin or boss elements 42 secure the needle shuttle 40 to a pair of springs 66, as described in more detail below. The distally positioned pin or boss elements 42 secure the needle hub 45 (at Figure 7 40. The pin or boss member 42 is also used to releasably connect the shuttle actuator 24 to the needle shuttle 40. The needle hub 45 allows the needle 22 to be removably mounted via the hub 23 located on the needle 22. The hub 23 includes a boss or tooth 25 (in the center) that engages a groove 46 contained in the needle hub 45. Figure 4B ). Groove 46 enables the hub 23 to be pushed onto the needle hub 45 and rotated about a quarter turn to lock the hub 23 relative to the needle shuttle 40. The needle 22 is rotated in the opposite direction to remove the needle hub 23 from the needle hub 45. In some embodiments, the pin or boss element 42, the needle hub 45, and / or the needle shuttle 40 are formed from a unitary portion of material rather than from separate pieces or components.

[0064] The needle shuttle 40 allows the needle 22 to move longitudinally in the direction of the main longitudinal axis of the handle 20. That is, the needle shuttle 40 and the needle 22 can move distally during certain loading and equipment operations of the delivery tool 12. When the actuator 24 is actuated by the user to deploy the implant 10, the needle shuttle 40 and the needle 22 can move proximally. In one embodiment, the needle 22 is permanently mounted to the needle shuttle 40. In an alternative embodiment, as described above, the sleeve 23 can be used to remove the needle 22 from the needle shuttle 40. In this final configuration, different needles 22 (e.g., needles 22 of different lengths or needles containing different implants 10) can be selectively attached to the needle shuttle 40.

[0065] refer to Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A and Figure 3B The pusher member or anchor 48 is disposed within the housing 14 and includes a proximal base 50 anchored or fixed relative to the housing 14 and a tubular element 52 extending distally from the base 50 in a longitudinal direction. The needle shuttle 40 includes an aperture or channel 41 through which the tubular element 52 extends (see FIG. Figure 7). The needle shuttle 40 thus rides on a portion of the pusher member or anchor 48. Specifically, the tubular element 52 is arranged in a coaxial arrangement with the needle 22, wherein the tubular element 52 is at least partially located within the lumen of the needle 22, so that proximal retraction of the needle 22 causes the needle 22 to move proximally above the fixed tubular element 52. Therefore, the outer diameter of the tubular element 52 is smaller than the inner diameter of the needle 22, so that the needle 22 can move freely relative to the tubular element 52 as needed. The tubular element 52 may include a hypotube section fixed to the base 50. The pusher member or anchor 48 is used during the deployment of the implant 10 and prevents the implant 10 from moving proximally when the needle 22 is retracted in the proximal direction. Therefore, the pusher member or anchor 48 serves as a proximal support that physically contacts the proximal end of the implant 10 when the implant 10 is removed by withdrawing the needle 22 proximally.

[0066] In one embodiment, at least one optical fiber 54 is located within the lumen of the pusher member or anchor 48 and extends along the length of the tubular element 52 and terminates at the distal end at the distal-most end of the tubular element 52 (e.g., a flush arrangement between the distal end of the optical fiber 54 and the distal end of the tubular element 52). The diameter of the optical fiber 54 used can vary depending on the size of the device and the pusher member or anchor 48, but is typically about 0.75 mm (-0.03 inches) in diameter or less. Of course, the optical fiber 54 can also be smaller or larger. As an example, the diameter of the optical fiber 54 is about 0.5 mm (-0.02 inches) or about 0.75 mm (-0.03 inches). The pusher member or anchor 48 can also have a variety of sizes and can be made of, for example, 19.5 gauge hypotube (0.039 inches OD x 0.027 inches ID; 0.99 mm OD x 0.69 mm ID). In the case where a 0.75 mm (0.03 in) optical fiber 54 is used for improved percutaneous illumination, the pusher member or anchor 48 can be made of 19 TW hypotube (0.042 in OD x 0.032 in ID; 1.07 mm OD x 0.81 mm ID). In yet another alternative embodiment, the optical fiber 54 can be omitted entirely, and the light source can be incorporated into the pusher member or anchor 48.

[0067] At least one optical fiber 54 extends proximally and is optically coupled via a bezel 57 to a red light source 56 (e.g., a red light emitting diode (LED)) mounted on an LED star board 58, which is powered by a drive circuit 60 contained in the handle 20 and one or more batteries 62 that power the electronics and the light source 56. The red light emitted by the light source 56 is transmitted down the length of the tubular element 52 through the at least one optical fiber 54, where the light end is coupled to the implant 10. The light is transmitted through the body of the implant 10 and exits via the cylindrical surface of the implant 10 and / or the distal tip of the implant. The transmitted light then passes through an orifice 28 contained in the needle 22, which enables an operator of the delivery tool 12 to visualize the implant 10. In some embodiments, the light source 56 is a laser or a laser diode.

[0068] refer to Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A 、 Figure 3B , the needle shuttle 40 is fixed to the end of one or more springs 66 by a proximal pin or boss 42. Figure 1B 、 Figure 2B and Figure 3B Two such springs are shown in FIG. The opposite ends of spring 66 are fixed to an equipment shuttle 67, which is coupled to a rod 68 via a pair of pins 69. Equipment shuttle 67 includes an orifice of a tubular element 52 in which a pusher member or anchor 48 is accommodated. Thus, during the equipment operation, equipment shuttle 67 slides coaxially over tubular element 52. Rod 68 is fixed to equipment shuttle 67 via pins 69 at two side arms 71 and can rotate around pins 69 and relative to handle 20. Rod 68 extends proximally and terminates in a pair of finger-like tabs 70 (other configurations are also contemplated) used by the operator during the equipment of delivery tool 12. Equipment rod 68 is used to provide tension on needle shuttle 40 when in the equipped state, so that actuation of actuator 24 will result in proximal retraction of needle 22 and deployment of implant 10. In one embodiment, equipment rod 68 can be locked in place to place delivery tool 12 in the equipped state, whereby spring 66 is in a tensioned state. For example, the rod 68 may rest within a recess 72 formed in the proximal end 16 of the housing 20 that receives a cross member of the rod 68, such as Figure 1A and Figure 1B This locks the rod 68 in place and prevents the rod 68 from moving distally in response to the tension of the spring 66. In an alternative embodiment, one or more locking tabs (not shown) provided on the outer surface of the rod 68 may be used to engage with the housing 14 to lock the arming rod 68 in place.

[0069] In one embodiment, the delivery system 2 of the present invention is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient. The device 2 is a device that can be used to deliver the implant 10 to the patient.

[0070] like Figure 1B 、 Figure 2B and Figure 3B As best seen in FIG, one of the arms 71 of the rod 68 includes a boss or tab 74 that extends inwardly and is positioned to actuate a switch 76 disposed in the housing 14 or on a board containing the light source driver circuit 60, which turns on the red light source 56 when the arm 68 is pulled sufficiently proximally relative to the handle 20 and placed in the recess 72. In one embodiment, the driver circuit 60 drives a red LED used as the light source 56, but if any alternative light source 56 is used, the light source 56 may also include a red laser or a red laser diode. In one embodiment, after the implant 10 has been deployed, the red LED of the light source 56 is turned off by removing the rod 68 from the recess 72. In another embodiment, the LED of the light source 56 remains on after being triggered and continues to operate until the battery 62 is depleted. In some embodiments, the light source 56 can be actuated using a pull tab (not shown) strategically positioned during manufacturing. The presence of the pull tab prevents current from powering the light source 56. The user removes the pull tab from the delivery system, thereby turning on the light source 56, which continues to illuminate until the battery is depleted.

[0071] In one embodiment, the switch 76 is also coupled to a light source driver circuit 60 that operates a white LED light 78 disposed at the distal end of the housing 14. The white light 78 assists the physician in selecting the intranasal location where the needle is to be inserted. The white light 78 or "headlight," also located in the handle, can be provided by a conventional light bulb, an LED, or multiple LEDs driven by the same control board 58 used to power the red light source 56. Alternatively, a separate control board or driver circuit located in the handle can be used to drive the white light 78. The white light 78 (e.g., an LED or light bulb) can be mounted at or near the distal end of the handle 20, as shown. Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A and Figure 3B The white light 78 can illuminate the target area directly, or one or more lenses (not shown) can be included in a lens assembly or the like that is also located in the distal end of the handle 20. Alternatively, the white light 78 can be located in the handle 20 (e.g., with the red LED located on a common base or circuit board) and a light pipe, optical fiber, or fiber bundle is used to transmit the white light out of the distal end of the handle.

[0072] refer to Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A and Figure 3B The actuator 24 includes a button 80 that is exposed along the surface of the handle 20 and is connected to an actuator body 82 that is spring-biased against the handle 20 using a spring 84. The actuator body 82 includes a recess 86 therein (at Figure 3A ), the notches 86 are sized to receive the pair of distal pins or bosses 42 when the needle shuttle 40 is fully advanced in the distal direction. The notches 86 hold the needle shuttle 40 in the distally advanced position until the button 80 is used to fire the delivery tool 12. Depression of the button 80 (e.g., using the thumb or finger of the same hand holding the handle 20) moves the actuator body 82 and the notches 86, so that the needle shuttle 40 then disengages the actuator body 82 and retracts proximally into the handle 20 via the tensioning spring 66. While notches 86 are described, it should also be understood that a detent, latch, or the like may be used as an alternative.

[0073] Figure 3A and Figure 3B The delivery tool 12 is shown in a fired state, wherein the needle 22 is at least partially proximally withdrawn into the handle 20 via the needle shuttle 40. The implant 10 contained within the lumen of the needle 22 is withdrawn and deployed into the nasal valve region of the subject by proximally retracting the needle 22. The pusher member 48 (i.e., the tubular element 52 of the pusher member 48) prevents the implant 10 from retracting proximally with the needle 22.

[0074] exist Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A and Figure 3BIn an embodiment of the present invention, there is no mechanical interlock between the pusher member or anchor and the implant, which greatly reduces the possibility of the implant being displaced during removal of the delivery system. Retracting the needle 22 (rather than pushing the implant 10 beyond the distal end of the needle 22) also helps prevent the implant 10 from being displaced or misplaced during delivery. In an alternative to using a pair of springs 66, the needle 22 can be actuated by other energy storage mechanisms. For example, a single spring may be sufficient to apply the desired tensioning force. A cylinder containing compressed air can also be used to move the needle 22 in the proximal direction. In another example, an electric actuator can move the needle 22 in the proximal direction. Additionally, although Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A and Figure 3B An embodiment is shown in which the implant 10 is deployed by withdrawing the implant 10 through proximal withdrawal of the needle 22 and use of a pusher member or anchor 48, but in alternative embodiments, a different delivery mechanism is employed. For example, referring to Figure 8 Another embodiment of the delivery tool 12 uses an actuator, such as a slider or knob 90, that is movable (e.g., in the direction of arrow A) or depressible and coupled to the needle 22. The slider or knob 90 can be slid rearward to release the implant 10 from the needle 22. The slider or knob 90 can be directed proximally relative to the handle 20, thereby retracting the needle 22 into the handle 20, while the pusher member 92 remains stationary and holds the implant 10 static relative to the handle 20. Alternatively, the implant 10 can be unlocked from a releasable locking joint, etc.

[0075] Figure 9A One embodiment of an implant 10 is shown coupled to the distal end of a pusher member 92 via a locking joint 94. The locking joint 94 can be unlocked to release the implant 10 for deployment. The locking joint 94 can include a mechanical connection such as a snap ring, an interference fit, etc. As explained herein, light can be transmitted through the pusher member 92 and into the implant 10. Figure 9B As seen in the figure, the implant 10 can optionally have a flat surface on one side for directional emission of light. The implant 10 can have a polished surface for light emission and texture on the rest of the implant 10, or alternatively be coated to contain internal reflection and light emission. Alternatively, light can be emitted from all of the implants 10. It should be noted that the distal tip of the implant 10 can optionally be sharpened or beveled to serve as a dissecting tip. Figure 8 An embodiment of the implant 10 is shown loaded or positioned in the needle 22 of the delivery tool 12. The implant 10 in this embodiment can be held in a static position by the pushing member 92 when the needle 22 is retracted.

[0076] Figures 10A-10C Another embodiment of a delivery tool 12 for delivering an implant 10 into the nasal valve area of a subject is shown. In this embodiment, the delivery tool 12 has a distal region 100 and a proximal region 102. The distal region 100 can include a shaft or needle 104 (e.g., a hypotube) terminating in a tip 106, which in some embodiments can be sharpened or beveled to assist in tissue penetration. In this embodiment, the beveled tip 106 is oriented relative to the delivery tool 12 such that the beveled tip 106 faces the outer surface of the nose during use. The proximal region 102 includes a handle 108 that is grasped by a user (e.g., a physician) during use. Figures 10A-10C In an embodiment, the implant 10 is located within the needle 104. That is, the implant 10 is contained within the lumen of a shaft or needle 104 that extends distally from the handle 108. The shaft or needle 104 can include an 18UTS gauge needle having an outer diameter (OD) of 0.050 inches (1.27 mm) and an inner diameter (ID) of 0.044 inches (1.12 mm). Of course, other sizes of shaft or needle 104 can be used. For example, an 18XX size hypotube can also be used. In another example, the hypotube is an 18XT, having an OD of 0.050 inches (1.27 mm) and an ID of 0.042 inches (1.07 mm). Either needle size can accommodate an implant 10 having a diameter of 0.040 inches or 1 mm. In addition, as Figure 10A As seen in FIG, a hole or aperture 110 is formed in one side (eg, the top side) of the shaft or needle 104. The aperture 110 is formed on the top side of the shaft or needle 104 so that the outer surface of the nose can be illuminated as explained herein.

[0077] Still refer to Figures 10A-10C , the delivery tool 12 includes a pusher member 112 that extends partially into the lumen of the shaft or needle 104 and provides pushing support for the implant 10. Figures 10A-10C In the embodiment of the present invention, the pusher member 112 is stationary relative to the delivery tool 12, and the shaft or needle 104 is movable in the proximal direction (ie, toward the handle 108), as shown in FIG. Figure 10BAs shown by arrow A in , the implant 10 loaded into the lumen of the shaft or needle 104 is withdrawn and released into the appropriate position. The pusher member 112 serves as a proximally positioned stop that prevents proximal movement of the implant 10 when the shaft or needle 104 is retracted proximally during deployment. In one embodiment of the present invention, the pusher member 112 is a 19.5 gauge hypotube segment (0.039 inch OD×0.027 inch ID; 0.991 mm OD×0.686 mm ID) that extends partially into the lumen of the shaft or needle 104, although other sizes are also contemplated. A pusher member 112 of this size can accommodate a 0.5 mm (0.02 inch) optical fiber 114. The distal end of the pusher member 112 terminates in a clasp or locking member 116 (at Figure 10C The proximal end of the implant 10 includes a mating clasp or locking member 116. When rotationally and longitudinally engaged, the two clasps or locking members 116 lock the implant 10 in place until the implant 10 is released. The pusher member 112 includes an inner lumen (at Figure 10C ). Fiber optics 114 are used to transmit light into implant 10 for transillumination from light source 122.

[0078] The implant 10 can be deployed from the needle 104 of the delivery tool 12. For example, an actuator 118 (such as a movable or slidable slide, knob, or button) can be used to release the implant 10 from the delivery tool 12. Figures 10A-10C In the embodiment of the present invention, the implant 10 can be released from the needle 104 by a slidable button 118, which is pressed downward to first unlock and then slide along Figure 10B 10 is pulled back in the proximal direction of arrow B in FIG. 10 to retract the needle 104 over the implant 10. The implant 10 is prevented from moving in the proximal direction by the pusher member 112, and the implant 10 is released after the needle 104 is proximally retracted over the implant 10. In an alternative configuration, the actuator 118 can be connected to the pusher member 112 such that distal advancement of the actuator 118 pushes the implant 10 out of the stationary needle 104.

[0079] refer to Figures 10A-10C , the optical fiber 114 extends through the lumen of the pusher member 112 and terminates at or near the proximal end of the implant 10. The light transmitted through the optical fiber 114 then enters the implant 10, where it radially exits the implant 10, which may include the optional indentation feature 34 (e.g., Figure 610 and reaches out of the orifice 110 of the shaft or needle 104. The proximal end of the optical fiber 114 is coupled to a light source 122, such as a light emitting diode (LED) or a laser diode. The light source 122 is powered by a driver circuit 124 and powered by one or more batteries 126. In an optional aspect of the present invention, the light source 122 is turned off when the button 118 is retracted. Preferably, the light source 122 emits red light to better penetrate tissue.

[0080] In order to use Figures 10A-10C The delivery tool 12 of the embodiment of the present invention is advanced through nasal tissue to a desired location in the nasal valve region while emitting light from the needle 104, wherein the light can be observed through the subject's skin via transillumination. The implant 10 is then delivered to the nasal valve region by, for example, pushing and sliding the button 118 in a proximal direction to deploy the implant 10.

[0081] Figures 11A-11E Various embodiments of the needle 22 and implant 10 are shown in which the needle 22 and / or implant 10 have one or more features for temporarily engaging the implant 10 with the needle 22 until deployment. Figure 11A The implant 10 is shown with a protrusion or boss 13 that interfaces with a hole or aperture 28 contained in the needle. The implant 10 can be "snapped" into place at a desired internal position within the needle 22. The snap-fit arrangement can provide rotational alignment and hold the implant 10 in place. Figure 11B Another embodiment of a needle 22 and implant 10 is shown whereby the implant 10 includes a protrusion or boss 13 (similar to Figure 11A ), which interfaces with an aperture 28 or slot in the needle 22 to temporarily secure the implant relative to the needle (e.g., a snap fit). The implant 10 can have a curved shape to provide a spring-type bias for forming a temporary mechanical lock between the needle 22 and the implant 10. Figure 11C An embodiment of a needle 22 design is shown that includes a plurality of tabs 128 (e.g., opposing tabs) formed in the needle 22 and bent inward such that the implant 10 can be loaded from the distal end of the needle 22 by pushing it into and frictionally engaging the tabs 128 to maintain the implant 10 stationary relative to the needle 22 until deployed. Figure 11D Another alternative embodiment of an implant 10 is shown having a spring-biased portion or region 130 that interfaces with a hole or opening 28 contained in the wall of a needle 22. In yet another embodiment (not shown), a portion of the implant 10 may be oversized to create a friction fit inside the needle.

[0082] Figure 11EAnother embodiment of temporarily locking the implant 10 to the needle 22 is shown. In this embodiment, a tab 30 located on the needle 22 engages with a feature 132 located on the implant 10. The tab 30 can be formed by laser cutting the needle 22 and then bending the tab 30 inward. The corresponding features 132 (e.g., barbs, ribs, etc.) on the tab 30 and the implant 10 can be optimized for loading, needle retraction, and implant retention in the tissue. An advantage of this embodiment is that it reduces the complexity of the implant 10 and allows rotational symmetry around the long axis of the implant 10; thereby greatly simplifying the design, production, and positioning of the implant 10 in the device. In other embodiments (not shown), one or more tabs can be used.

[0083] The position of the interference fit or snap / tab fit along the length of the needle 22 can be adjusted. For example, it may be desirable to keep the implant 10 stable and attached to the delivery system until the needle 22 is fully or mostly withdrawn. Therefore, in some embodiments, it may be advantageous to position the feature near the distal end of the needle 22. Regardless of whether the needle / implant interface is a friction fit, snap fit, tab fit, etc., when the actuator 24, 118 is triggered, the temporary connection formed is overcome by the rapid proximal withdrawal of the needle 22. Such an embodiment requires lower manufacturing accuracy, is always released from the implant 10, and can be easily reinstalled.

[0084] The feature on the needle 22 and / or implant 10 is used to form a temporary lock between the implant 10 and the needle 22 to allow easy loading and reloading of the delivery system by the distal end of the needle 22. In order to load or reload the device, in one embodiment, the needle 22 is advanced distally relative to the handle 20 and locked in place. Then, the implant 10 is inserted into the tip of the needle 22 and placed in the needle 22. As discussed below, a loading tool or fixture can be used to assist the process. Tool or fixture are particularly useful for loading an implant 10 that does not have rotational symmetry. Tool or fixture provide an additional safety benefit of reducing needle stick injuries during the loading / reloading process.

[0085] Figure 12One embodiment of an implant loading / reloading tool 140 is shown. The tool 140 is used to encapsulate an implant 10, which can then be loaded into the distal end of the needle 22. In one embodiment, the tool 140 or fixture can be preloaded with an implant 10 that can then be loaded into the delivery tool 12 by the user. Alternatively, the delivery tool 12 can be preloaded with an implant 10, and the tool 140 or fixture is preloaded with a second implant 10 that can be quickly loaded into the delivery tool 12 by the user as needed. In yet another alternative, each implant 10 is preloaded in the tool 140 (or multiple tools) (or the user loads the tool 140 with an implant 10), and the physician loads the needle 22 with the implant 10 from the tool 140. As Figure 12 Shown, instrument 140 comprises the implant 10 that is arranged in groove or cavity 142 before facing.The support 144 that is positioned at instrument 140 is used as distal stopper, and during loading / reloading operation, prevents the distal movement of implant 10.In order to load pin 22 with implant 10, user inserts pin 22 in groove or cavity 142, and described groove or cavity 142 guide pin 22 above implant 10.Pin 22 further advances until implant 10 is fixed in place (for example, by snap fit, tab mating arrangement).Alternatively, the size of groove is configured to make always push pin 22 until pin 22 can not further advance.

[0086] Figures 13A-13C Another embodiment of an implant loading / reloading tool 150 is shown, wherein the implant loading tool 150 is preloaded with the implant 10 loaded therein. The implant 10 is secured to the loading tool via a collet 152. The implant loading tool 150 includes a recess 154 into which the delivery tool 12 is placed to load the implant ( Figure 13A and Figure 13C ). Specifically, the delivery tool 12 with the needle in the retracted position (and the spring 66 relaxed) is inserted into the groove 154 of the implant loading tool 150. To load the implant 10 into the delivery tool 12, Figure 13A Pulling back the rod 156 in the direction of arrow A in FIG. 1 automatically extends the needle 22 distally relative to the handle 20 and locks the needle 22 in the forward position and loads the implant 10 in the needle 22 . Figure 13B Shown is a rod 156 comprising an extension 158 terminating in a pair of pins 161. These pins 161 engage a needle shuttle 40 located within the delivery tool. As explained herein, movement of the needle shuttle 40 results in a corresponding movement of the needle 22.

[0087] Reference Figure 13A and Figure 13C, pin 162 is disposed in loading tool 150 along the axial path defined by implant 10 and needle 22 and prevents axial movement of implant 10 as needle 22 is advanced over implant 10 by actuation of rod 156. Delivery tool 12 is then removed from the implant loading tool and is ready for use.

[0088] Figure 14A and Figure 14B Another embodiment of an implant loading tool 160 is shown. In this embodiment, the tool 160 includes two implant clamps 163, 164 rotatably mounted on a fastener 167, which are spring-biased to clamp the opposite side of the implant 10 by corresponding springs 166. An alignment track 165 is formed in the implant loading tool 160 and is sized and aligned to receive the pin 22 of the delivery tool 12. A pin 168 is positioned in the implant loading tool 160 and abuts one end of the implant 10 to hold the implant 10 in place. In order to load the implant 10, the user inserts the pin 22 of the delivery tool 12 into the alignment track 165 and advances it. The alignment track 165 is coaxially aligned relative to the implant 10 so that the advancement of the pin 22 in the alignment track 165 advances the pin 22 above the stationary implant 10. The pin 22 advances until the implant 10 "locks" to the pin 22, which is one of temporary fixing measures (e.g., snap fit, tab fit, etc.) described herein. The two implant grips 163, 164 separate as the needle 22 advances over the implant 10. The implant 10 is prevented from moving with the needle 22 by the pin 168. Once the implant 10 is locked in place, the needle 22 (with the implant 10) can be removed from the implant loading tool 160.

[0089] It should be understood that the implant loading tools 140, 150, 160 described herein are optional. Figure 15 In another embodiment shown, a kit 200 can be supplied that includes a delivery tool 12 as explained herein and a plurality of needles 22 that have been preloaded with an implant 10. For example, needles 22 of different lengths can be provided with the same or different implants 10. Alternatively, needles 22 of the same length can be provided with different implants 10. For example, implants 10 having different lengths or physical configurations can be provided in the needles 22. In this way, a practitioner can use a specific needle 22 / implant 10 combination that best suits the needs of a particular patient.

[0090] To use the delivery system 2 described herein (such as Figure 1A 、 Figure 1B 、 Figure 2A 、 Figure 2B 、 Figure 3A and Figure 3B), anesthesia is administered to the patient or subject prior to the implantation procedure. If the procedure is performed as an outpatient procedure in an office setting, a combination of a local anesthetic and an injectable anesthetic may be administered to the patient. In addition, prior to the procedure, the patient may take an antianxiety medication before arriving at the office. Of course, the procedure may also be performed in a hospital or other clinical setting (such as an operating room). In such cases, a general anesthetic may be administered to the patient instead of a local anesthetic. During the procedure, if under general anesthesia, the patient typically lies supine and in a flat or slightly elevated position. If the patient is awake, he / she may be in an upright or reclining sitting position.

[0091] When the patient is ready for implantation, the physician plans the position of the implant in the patient's nose. As part of the process, the physician can mark the outer surface of the nose with one or more markers (e.g., using a surgical pen) to assist in planning the target implant position and trajectory. If not yet completed, the physician then loads the needle 22 (e.g., from the kit 200) containing the implant 10 onto the delivery device 12. Then, as described herein, the delivery device 12 is armed by pulling the arming rod 68 proximally. This arming operation turns on the red light source 56 and the white light 78. If the delivery device 12 includes a pull tab, the physician or assistant can remove it to actuate the light sources 56, 78 or other electrical components of the device 12.

[0092] Delivery device 12 is then used to create a passage within the nasal tissue for implant 10. Typically, needle 22 is advanced near the nostril into the nasal mucosa of the side wall of the nasal cavity. Figure 16A The general position (I) for inserting the needle 22 into the nasal mucosa is shown. The needle 22 is carefully advanced through the mid-thickness of the side wall to avoid puncturing the nasal mucosa or the outer skin of the nose. It should be noted that during this procedure, transillumination can be used to monitor the progress of inserting the needle 22 into the nasal side wall. The penetration depth of the needle 22 can vary, but the implant 10 is typically placed across the upper lateral cartilage and the lower lateral (Alar) cartilage, as shown in FIG. Figure 16B The delivery device 12 is oriented to position the hole or orifice 28 outwardly on the top surface of the needle 22 so that Figure 16CAs seen in the nasal area, the physician can observe the light emitted by the transmitted illumination to confirm the correct trajectory and advancement of the needle 22. In addition, the physician will use a single orifice 28 located on the bottom surface of the needle 22 to view the inside of the patient's nostril to confirm the position. Once the needle 22 (and implant 10) is confirmed to be in the desired position, the physician will activate the actuator 24 (e.g., by pressing the button 80 with the thumb), which will cause a rapid proximal retraction of the needle 22, thereby leaving the implant 10 in the proper position. The delivery tool 12 can then be removed from the nasal area. Optionally, a second or more implants 10 can be placed into the anatomical structure before the delivery tool 12 is removed from the nasal area or after the delivery tool 12 is reinserted into the nasal area.

[0093] Depending on the procedure, the delivery tool 12 can then be used again to perform the same procedure in the patient's other nasal passage. The same delivery tool 12 can be used, whereby another needle 22 containing an implant 10 is loaded onto the delivery tool 12 and the same procedure described above is repeated for the other side of the patient's nose. Of course, in some cases, only a single implant 10 is placed in one nasal passage of the patient. Furthermore, the above-described procedure can be performed in conjunction with other nasal surgeries. For example, these procedures include inferior turbinate reduction, septoplasty, balloon dilatation of the sinus ostia or sinus passages, and the like.

[0094] Although the present invention has been described herein as using a delivery tool 12 for preparing tissue for implantation and performing the implantation, another approach is to use the delivery tool 12 to first prepare a "pocket" in the tissue surrounding the desired implantation site and then deliver the implant 10. The pocket preparation can be accomplished by blunt dissection of the tissue plane, needle insertion, or excision of a tissue core. Once the pocket has been prepared, a separate delivery tool can be used to place the implant into the prepared pocket. In addition, although the present invention is primarily described in the context of delivering the implant 10 to the nasal valve area of a subject, tools with light-emitting tips and / or stripes can be used for other surgical techniques. For example, blunt dissection instruments used in cosmetic surgery, liposuction tools, and the like can be made easier to use by adding a light guide.

[0095] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. After reviewing the above description, for example, a person of ordinary skill in the art may use other embodiments. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. It should be understood that the submitted abstract is not used to interpret or limit the scope or meaning of the claims. Moreover, in the above detailed description, various features can be combined together to simplify the present disclosure. This should not be interpreted as intending that unclaimed disclosed features are essential to any claim. On the contrary, the subject matter of the invention may be established with less than all the features of a particular disclosed embodiment. Therefore, the following claims are hereby incorporated into the specific embodiments as examples or embodiments, wherein each claim itself is a separate embodiment, and it is expected that such embodiments may be combined with each other in various combinations or arrangements. The scope of the present invention should be determined with reference to the appended claims and the full scope of equivalents to which such claims are entitled.

Claims

1. An implant delivery system for delivering an implant into the nasal valve region, the implant delivery system comprising: a handle having a proximal end and a distal end, wherein a longitudinal axis extends in a direction between the proximal and distal ends; a needle extending from a distal end of the handle, wherein the needle is movable relative to the handle along the longitudinal axis of the handle; a pusher member partially disposed within the lumen of the needle, wherein the pusher member is configured to move an implant disposed within the lumen of the needle; a movable needle shuttle disposed within the handle and coupled to the needle; one or more springs coupled to the movable needle shuttle, wherein the one or more springs are configured to apply a proximal tensioning force to the movable needle shuttle; as well as an actuator configured to releasably engage the movable needle shuttle; wherein the actuator is configured to be actuated to release the movable needle shuttle from the actuator such that the movable needle shuttle moves the needle proximally to cause: the needle to be at least partially retracted into the handle and the implant to be deployed from the distal tip of the needle.

2. The implant delivery system of claim 1 , further comprising an arming rod disposed in the handle and coupled to the one or more springs; in, The arming rod is configured to move proximally relative to the handle to cause the one or more springs to even and apply a proximal tensioning force to the movable needle shuttle.

3. The implant delivery system of claim 1, wherein: The movable needle shuttle is configured to move along a plurality of longitudinal tracks inside the handle.

4. The implant delivery system of claim 1, wherein: The movable needle shuttle includes one or more pins coupled to the one or more springs.

5. The implant delivery system of claim 4, wherein: The pins include a first pin located on a first side of the movable needle shuttle and a second pin located on a second side of the movable needle shuttle; and The spring includes a first spring fixed to the first pin and a second spring fixed to the second pin.

6. The implant delivery system of claim 5, further comprising an arming shuttle, wherein the first spring is further secured to the arming shuttle, and the second spring is further secured to the arming shuttle.

7. The implant delivery system of claim 6, further comprising an arming rod coupled to the arming shuttle, wherein the arming rod is configured to be locked in an armed position in which the spring applies a proximal tensioning force to the movable needle shuttle.

8. The implant delivery system of claim 7, wherein: The equipment bar includes a plurality of finger-like tabs extending laterally therefrom.

9. The implant delivery system of claim 7, wherein: The arming lever is configured to couple to a notch on the handle to lock the arming lever in an arming position.

10. The implant delivery system of claim 1, wherein: the actuator including a notch configured to receive at least one of a pin or a boss of the movable needle shuttle when the movable needle shuttle is in a distal position relative to the handle; and wherein the actuator is configured such that actuation of the actuator releases at least one of the pin or boss from the recess to allow the movable needle shuttle to move in response to the proximal tensioning force exerted on the movable needle shuttle by the one or more springs.

11. The implant delivery system of claim 1 , wherein: The needle is movable between an extended state and a retracted state; wherein, in the extended state, the needle receives the implant; and wherein, in the retracted state, the implant is deployed from the needle.

12. The implant delivery system of claim 11, wherein: The needle includes a plurality of tabs configured to frictionally engage the implant and retain the implant within the needle until the needle is moved to a retracted state.

13. The implant delivery system of claim 12, wherein: The implant includes a plurality of ribs circumferentially arranged on the implant.

14. The implant delivery system of claim 1, wherein: The distal tip of the needle is beveled.

15. The implant delivery system of claim 1, wherein: The actuator is coupled to the movable needle shuttle via a pin; and wherein actuation of the actuator releases a pin to move the movable needle shuttle under the proximal tension of the spring, thereby retracting the needle proximally into the handle and deploying the implant.

16. The implant delivery system of claim 1, wherein: The pusher member is fixedly and non-movably coupled to the handle.

17. The implant delivery system of claim 1, wherein: The actuator includes a button located on the handle.

18. The implant delivery system of claim 1, wherein: The needle is removably coupled to the movable needle shuttle.

19. The implant delivery system of claim 18, wherein: The needle includes a proximal hub secured to the movable needle shuttle via a needle hub.

20. The implant delivery system of claim 1, wherein: The movable needle shuttle includes an aperture defining a passageway therethrough; and wherein the pusher member comprises a tubular element extending through the passage in the movable needle shuttle such that the movable needle shuttle rides on a portion of the pusher member.

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