Nasal delivery tools, systems, and methods of use

Abstract

A tool for delivering an implant, a system including the delivery tool and a nasal implant, and a method for using the delivery tool to place the implant in the body are provided. The nasal implant delivery tool (200) includes an inner handle (208), an outer handle (202), a needle (206), and a push rod. The inner handle includes a loading chamber configured to receive a nasal implant. The outer handle is configured to move axially relative to the inner handle. The needle extends distally from the inner handle and has a central lumen and a distal opening. The push rod is configured to move the nasal implant from the loading chamber, through the central lumen, and out the distal opening of the needle. The push rod is coupled to the outer handle such that it moves axially relative to the inner handle when the outer handle moves axially relative to the inner handle.

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application was filed on March 28, 2017, and is entitled "Nasal Delivery Tools, Systems, and Methods of Use." This application claims priority to U.S. Provisional Application No. 62 / 477,829, filed on Dec. 13, 2003, which is hereby incorporated by reference in its entirety. The entire contents of which are incorporated herein by reference.

[0002] [Incorporated by reference] All publications and patent applications mentioned in this specification are to be construed as if each individual publication or patent application were individually incorporated by reference. All such claims are hereby incorporated by reference to the same extent as if specifically and individually incorporated by reference. Accordingly, they are hereby incorporated in their entirety.

[0003] [Field of the Invention] Implants for placement in the body, tools for delivering the implants, and methods for using the implants and tools Described herein are systems and methods for performing nasal implants. More particularly, nasal implants, nasal transplants Tools for delivering implants and systems for using such implants and tools The methods are described herein. [Background technology]

[0004] A person's particular nasal anatomy can present a variety of problems, e.g., cosmetic concerns, breathing difficulties, sleep problems, etc. Inducing or causing apnea or snoring, or damaging or causing injury to a person's health For example, the external or internal nasal valves may block airflow from the nose to the lungs. This can make it harder for blood to flow and can prevent a person from getting enough oxygen into their blood.

[0005] Typically, support from the lateral nasal cartilages is observed in rhinoplasty, nasal trauma, or aging. Nasal valve collapse, characterized by loss of airway pressure, is a frequent cause of nasal airway narrowing. The outer cartilages function to keep the nasal passages open. If the outer cartilages weaken, These outer cartilages tend to collapse inward due to the negative pressure on the airflow when a person breathes. This problem is exacerbated by the fact that currently most patients are elderly or have a history of nasal surgery. Combined with the complexity and highly variable results associated with current restorative techniques, most treatments It hasn't been done yet.

[0006] Generally, nasal valve collapse is the result of numerous complex surgeries performed by a very small number of surgeons. It is often an untreated problem due to inconsistent results from There is a need for an endoscopic method of repairing the nasal valve with a method that is both easy to use and It is a long-lasting, minimally invasive, cost-effective and effective nasal anatomy. There is a need for improvements that address the problems caused by nasal implants. There is a need for improved delivery tools for delivering implants. Summary of the Invention

[0007] A tool for delivering an implant, a system including a delivery tool and a nasal implant, and a method for delivering the implant Methods of using the delivery tools for placement within the body are described herein. The present invention relates to a nasal implant, a tool for delivering the nasal implant, and a method for using such an implant and tool. A system and method for performing a nasal implant positioning guide is described herein. Also described herein.

[0008] Generally, in one embodiment, the nasal implant delivery tool includes an inner handle, an outer handle, a knee. The inner handle is adapted to receive the nasal implant. The outer handle is axially spaced apart from the inner handle. The needle extends distally from the inner handle and is adapted to move within the central The push rod is adapted to push the nasal implant from the loading chamber to the central lumen. The push rod is configured to move through the distal opening of the needle and out of the distal opening of the needle. When the outer handle moves axially relative to the inner handle, the outer handle moves axially relative to the inner handle. The outer handle is connected to the outer handle for movement.

[0009] This and other embodiments may include one or more of the following features: The distal end of the needle may have a flat bevel tip. The distal end of the needle may have a sharp tip. The sharp tip may have two or more surfaces with a bevel of 50° or less. The outer handle may be movable between a plurality of different locking positions relative to the inner handle. The locked positions may include a distal deployed position, a ready position, and a proximal The push rod may correspond to a distal graft loading position. When in position, the nasal implant is advanced partially or completely beyond the distal opening of the needle. The central lumen of the needle may be adapted to be advanced distally by the outer handle. The loading chamber may be configured to hold the nose when in the ready position. The delivery tool may be adapted to be exposed when the barrel is in the proximal implant loading position. The device may further include a first button and a second button on the outer handle. The outer handle moves from the ready position to the distal deployed position when the first button is depressed. The first button may be configured to enable the handle to move. To prevent the first button from being depressed while in the graft loading position, the inner handle a first locking feature configured to engage with a second locking feature on the The second button is configured to move the outer handle from the ready position to the proximal position when the second button is depressed. The first button may be configured to allow the first button to be moved to a side graft loading position. The inner hand grip or the second button is pressed when the first or second button is not depressed. The first or second lever may have an engagement surface configured to engage a corresponding engagement surface of the lever. The second button is configured such that when the first or second button is pressed down, the engagement surface engages with the inner handle. to disengage from corresponding engagement surfaces to allow relative movement between the inner and outer handles. The delivery tool may be configured to move the engagement surface to accommodate a nasal transition within the delivery tool. The implant may further include a graft orientation indicator configured to indicate the orientation of the implant. The explant orientation indicator includes a first arm extending in a first direction from the delivery tool; and a second arm protruding from the first arm in a second direction. The arm is formed by a first arm and a second arm of the nasal implant in a deployed configuration. The needle may define a surface substantially similar to the surface of the needle. The low friction coating may be PTFE, silicone, or poly(p-xylylene). The needle may include band-like markings at various locations along the needle. The central lumen of the needle may include a portion having a non-circular cross-section. The outer handle may be configured to completely cover the proximal end of the inner handle. The handle may include a grip configured to be held in a user's hand.

[0010] Generally, in one embodiment, a method for delivering a nasal implant to nasal tissue includes: (1) kneading a delivery tool. The delivery tool includes an inner handle that contains the nasal implant. (2) delivering the graft distally through the needle of the delivery tool into the nasal tissue. While holding the inner handle in place, move the outer handle of the delivery tool forward to the side. (3) advancing the delivery tool distally relative to the inner handle; and (4) withdrawing the delivery tool from the nasal tissue. and issuing a step of:

[0011] This and other embodiments may include one or more of the following features: The implant comprises: a first arm at a distal end of the implant and a second arm at the distal end of the implant; During the advancement step, the first arm moves away from the central longitudinal axis of the graft and the second arm The implant may be adapted to move away from a central longitudinal axis of the implant. The step of moving the implant includes moving the implant such that the first arm and the second arm each engage tissue. The method may include withdrawing the delivery tool from the nasal tissue. The method may further include advancing the outer handle to a distal locking position before the insertion of the outer handle. The method includes: exposing the graft loading chamber of the inner handle prior to needle insertion. , further comprising sliding the outer handle proximally relative to the inner handle. The method further comprises: inserting the implant into the implant loading chamber of the delivery tool after the implant loading chamber is exposed. The method may further include loading the implant into the implant loading chamber. Remove the outer handle from the inner handle before sliding the outer handle proximally to release the The method may further include pressing a button on the outer handle to release the device. The method further comprises: advancing the outer handle of the delivery tool distally before advancing the outer handle distally. The method may further include depressing a button on the outer handle to release the device from the dollar. The method includes maintaining a known orientation between the graft and the needle during the insertion step. The step of maintaining a known orientation between the graft and the needle may further include: The method may include engaging the graft with a portion of the needle lumen having a non-circular cross-section. This method involves using a nasal graft guide to position and orient the nasal graft prior to inserting the needle. It may further include planning.

[0012] Generally, in one embodiment, a nasal implant guide includes a nasal implant guide portion and a handle. The nasal implant guide portion includes a proximal opening, a plurality of markings, a distal opening, and a fork. The proximal opening is adapted to allow for marking of the patient's lateral nasal wall. The plurality of markings correspond to the proximal features of the nasal implant. and a ruler for estimating the distance between the pterygoid rim edge. The distal opening is configured to allow for marking on the patient's outer nasal wall, The fork feature corresponds to the base of the distal fork of the explant. The fork feature is located distally from the distal opening. The handle protrudes outwards and corresponds to the extension of the distal fork feature of the nasal implant. The nasal implant guide portion is engaged with the nasal implant guide portion to position the nasal implant guide portion against the outer nasal wall. It is configured so that it can be easily held by hand.

[0013] This and other embodiments may include one or more of the following features: The guide portion may further include a shape that looks like a portion of the shape of the nasal implant. The needle is engaged with the nasal graft guide portion at approximately 90° to the major axis of the nasal graft guide portion. The forked feature may include a first prong and a second prong.

[0014] Generally, in one embodiment, the system includes some of the delivery tools described above and the nasal implant described above. The system may further comprise any of the nasal implant guides described above.

[0015] The novel features of the invention are set forth with particularity in the following claims. The following detailed description and the following detailed description set forth illustrative embodiments in which the principles of the invention are utilized. This will be better understood with reference to the drawings. [Brief description of the drawings]

[0016] [Figure 1A] FIG. 1 illustrates the anatomy and tissue of the underlying nose with the overlying skin or tissue omitted. [Figure 1B-1D] FIG. 1 illustrates an exemplary nasal implant. [Fig.1E.1F] FIG. 1 illustrates the placement of a nasal implant within the nasal anatomy. [Fig. 2A.2B] FIG. 2A shows a delivery tool containing nasal implants in multiple positions (FIGS. 2A and 2B are perspective views of needles containing implants). [Fig. 2C.2D] A diagram showing a delivery tool containing a nasal graft in multiple positions (Figures 2C and 2D show the end of the nasal graft extending from the needle and the remainder of the nasal graft hidden within the needle). [Figure 3A-3C] 3A and 3B are perspective views of a needle containing a graft, and FIG. 3C shows the end of the nasal graft extending from the needle with the remainder of the nasal graft hidden within the needle. [Figure 3D.3E] Figure 3D is a cross-sectional view of the outer handle of the device of Figures 3A-3C taken along the long axis, and Figure 3E is a cross-sectional view of the device of Figures 3A-3C taken along a direction perpendicular to the long axis. [Figure 3F] FIG. 3D is a cross-sectional view of the central portion of the entire device of FIGS. 3A-3C taken along the long axis. [Figure 4A.4B] 3D-3E are side and cross-sectional views illustrating delivery of the delivery tool of FIGS. 3A-3C. FIG. [Figure 4C] FIG. 13 illustrates the use of a proximal button to allow proximal retraction of the outer handle relative to the inner handle. [Fig.4D.4E] FIG. 13 illustrates the use of a proximal button to allow proximal retraction of the outer handle relative to the inner handle. [Figure 5A] FIG. 3D is a cross-sectional view of the delivery tool of FIGS. 3A-3C in an implant-loaded configuration. [Figure 5B-5D] Figure 5B is a top view of the delivery tool in an implant loading configuration, Figure 5C is a close-up of the latching mechanism in an implant loading configuration, and Figure 5D is a diagram showing the locking mechanism in an implant loading configuration. [Figure 5E] FIG. 13 shows the quick stop in the implant loading configuration. [Figure 6A.6B] FIG. 3D shows the delivery tool of FIGS. 3A-3C after the deployment button has been pressed to deploy the nasal implant. [Figure 6C.6D] FIG. 3D illustrates the advancement of the outer handle of the delivery tool of FIGS. 3A-3C to deploy the implant. [Figure 7A] FIG. 3D illustrates the position of the outer handle of the delivery tool of FIGS. 3A-3C after delivery of the implant. [Figure 7B] FIG. 4 illustrates a portion of the handle of the delivery tool of FIGS. 3A-3C with a retraction lock. [Figure 8A.8B]3A-3C illustrating the operation of the deployment button, the inner latch mechanism, and the reset mechanism. FIG. [Figure 8C] 3A-3C illustrating the operation of the deployment button, the inner latch mechanism, and the reset mechanism. FIG. [Figure 9A-9C] 1A-1D are various views of an exemplary tip of a needle of a delivery tool. [Fig. 9D-9F] 11A-11C are various views of another exemplary tip of a needle of a delivery tool; [Figure 10A.10B] 13A-13D illustrate a portion of a handle of another exemplary delivery tool. [Figure 10C] 13A-13D illustrate a portion of a handle of another exemplary delivery tool. [Figure 11A.11B] 1 illustrates a portion of another exemplary delivery tool. [Figure 12A.12B] 13A-13C show a portion of another example delivery tool with a portion of the outer handle broken away for clarity. [Figure 13A] 13A-13D illustrate a portion of a handle of another exemplary delivery tool. [Figure 13B] 13A-13D illustrate a portion of a handle of another exemplary delivery tool. [Figure 13C] 13A-13D illustrate a portion of a handle of another exemplary delivery tool. [Figure 13D] 13A-13D illustrate a portion of a handle of another exemplary delivery tool. [Fig. 14A.14B] FIG. 16 is a cross-sectional view of a delivery tool similar to the delivery tool of FIGS. 13A-13D. [Fig. 14C.14D] 13A-13D are cross-sectional views of another delivery tool similar to the delivery tool of FIGS. [Fig. 15A and 15B] 1A-1C illustrate various embodiments of exemplary external nasal guides that can be used by medical personnel to plan the position and orientation of a nasal implant relative to the nasal anatomy. [Fig. 15C.15D] 1A-1C illustrate various embodiments of exemplary external nasal guides that can be used by medical personnel to plan the position and orientation of a nasal implant relative to the nasal anatomy. [Figure 15E] 1A-1C illustrate various embodiments of exemplary external nasal guides that can be used by medical personnel to plan the position and orientation of a nasal implant relative to the nasal anatomy. [Figure 16A.16B] 13A-13C illustrate the use of an exemplary nasal guide to position the implant. [Fig. 17A and 17B] 13A-13C illustrate the use of another exemplary nasal guide for positioning an implant. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Nose graft, delivery tool for delivering nose graft, method for using graft, nose using tool Methods for delivering implants and external nasal guides to assist in the placement of nasal implants are described herein. The delivery tools, devices, systems, and methods described herein provide a variety of advantages. For example, the delivery tool may provide improved ergonomics and Improved one-handed use can be achieved. Improved ergonomics can be achieved. This can reduce the likelihood of inaccurate nasal graft deployment and / or inaccurate positioning of the nasal graft. The improved ergonomic design also makes it easier to position and maintain the needle's orientation. This can result in graft migration as the tool retracts and changes in graft orientation. You can reduce the possibility.

[0018] Embodiments of a nasal implant delivery tool are described herein. In some embodiments, The nasal implant delivery tool includes an implant loading chamber configured to receive the nasal implant. and a hand-held inner handle configured to move axially relative to the inner handle portion. and an outer handle configured to be held by the nasal implant delivery tool. A needle may be provided extending distally from a portion of the handle. In some embodiments, the needle may have a non-circular cross-section. The non-circular cross-section may be associated with a graft orientation feature. This acts as a guide for the nasal graft to move within the lumen at a constant, known rotational orientation. The device has an opening between the graft loading chamber and the proximal end of the needle. The opening or passage may allow the implant to pass from the implant loading chamber to the In one example, the needle is adapted to allow the needle to move to a position within the needle. The loading ramp may be associated with a loading chamber and a loading ramp. This allows the graft arms to be compressed for insertion into the lumen of the nose. The implant tool may include an ejection element / actuator (e.g., a push rod). The ejection element / actuator ejects the nasal implant from the loading chamber through the needle lumen. The ejection element / actuator is configured to move the ejection element out of the opening at the distal end of the needle. The actuator is engaged or coupled to the outer handle and follows axial movement of the outer handle portion. The outer handle may be adapted to move axially relative to the inner handle. , e.g., by using one or more buttons to provide multiple different locking positions relative to the inner handle. The device may be adapted to move between the

[0019] In some embodiments, the nasal implant delivery tool is (corresponding to) the surface formed by the first arm and the second arm of the nasal implant in the deployed configuration The implant may include an implant orientation indicator configured to provide a visual indication of The inner handle portion is in a deployed configuration (corresponding to the orientation of the graft within the needle lumen). To provide a visual representation of the plane formed by the first and second arms of the implant. The implant may include a graft orientation indicator configured as follows: The tool operator orients the tool and the nasal graft arm in the deployed configuration. The implant may be designed to allow rapid observation of the corresponding orientation of the implanted surface. The orientation indicator is designed to prevent the tool operator from covering the graft orientation indicator while using the device. It may extend from a portion of the handle to avoid obscuring or obscuring the The graft orientation indicator includes a first arm and a hand that protrude from the handle in a first direction. The first arm and the second arm may be provided so as to protrude in a second direction from the first arm. The arm of the first nasal graft is in a deployed configuration that corresponds to the orientation of the graft within the needle lumen. and may define a surface substantially similar to a surface defined by the arm and the second arm. .

[0020] In some embodiments, the implant loading chamber receives the nasal implant in a deployed configuration. Further, the implant loading chamber is configured to allow the nasal implant to be pre-inserted into the needle lumen. The catheter is configured to transition from the expanded configuration to a compressed delivery or ready configuration when the catheter is advanced. A ramp between the graft loading chamber and the needle may be provided to guide the arms of the graft to the needle. The device may be configured to transition to a compressed delivery configuration within the lumen.

[0021] In some embodiments, the needle includes a low friction coating on an outer surface of the needle. In some examples, the low friction coating is made of polytetrafluoroethylene (PTFE), silicone, In some embodiments, the needle may be poly(p-xylylene). The needle is provided with substantially stripe-like markings at various locations along the needle. King provides the surgeon with information regarding the depth and location of the needle within the nasal tissue. This can be done.

[0022] In some embodiments, the nasal implant delivery tool is capable of housing the nasal implant. The implant may be any of the nasal implants described herein. In one example, a loading tool and The nasal implant used in conjunction with the nasal implant comprises a distal end, a proximal end, and a middle part disposed between the proximal end and the distal end. The implant further comprises a body having a first arm and a second arm. The first arm is disposed at the distal end. The first arm is fixed to the body. The arm has a proximal end secured to the body and a distal end that is not fixed to the body. configured to move away from a central longitudinal axis of the body to transition from the deployed configuration to the deployed configuration. The second arm has a proximal end fixed to the body and a distal end not fixed to the body. The distal end of the second arm is adapted to be connected to the body so as to transition from the delivery configuration to the deployed configuration. The first arm and the second arm are configured to move away from the central longitudinal axis. When these arms are in a deployed configuration in which they have moved away from the central longitudinal axis of the body, The surface is defined by a first plane.

[0023] A method of supporting a tissue section of a patient's nose is also presented in the present embodiment. In one embodiment, the method includes inserting a needle of a delivery tool described herein into nasal tissue. The method includes the step of advancing an outer handle, thereby advancing the graft. distally out of 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 a distal end of the implant. The method may include a first arm and a second arm. During the advancement step, the second arm is moved away from the long axis of the graft. The method may include moving the delivery tool toward the nasal tissue. and supporting the tissue section with the implant.

[0024] In some embodiments, the method includes removing the outer hand prior to withdrawing the delivery tool from the nasal tissue. The method may further include advancing the catheter to a distal locking position. This prevents premature advancement of the outer handle by the surgeon. Because if the distal locking position is not reached, the outer handle will slide during retraction, This is because it informs the surgeon that the graft has not fully deployed. Slide the handle proximally to expose the graft loading chamber in the inner handle portion. The method may further include a step of: Before sliding the outer handle proximally, press the outer handle button and The method may further include disengaging the implant from the inner handle. The step of loading the piece into an implant loading chamber of the delivery tool may include: The tip folds the first and second arms of the graft before inserting it into the needle. The method may include the steps of: The graft is removed from the graft loading chamber by advancing the actuator relative to the inner handle portion. The method may further include advancing the graft from the needle into the needle lumen. The tip advances the graft distally out of the needle lumen and positions the distal end of the graft within the nasal tissue. Before placing the outer handle, advance it to the locking point and then unlock the outer handle. The method may further include inserting the needle and the inner halo into the nasal anatomy. Unlocks the outer handle independently from the inner handle while preventing the handle from moving The step of unlocking the outer handle may include the step of advancing the outer handle. Press the button on the outer handle to release the outer handle from the locking surface of the inner handle. The method may include causing the

[0025] Also described herein is a system. The system includes the delivery tool described herein. and a nasal implant. The nasal implant may comprise any of the nasal implants described herein. The nasal implant may be placed in the needle or delivered. The system may also be provided with a nasal implant guide as described herein. The present invention may include one or more of the following:

[0026] FIG. 1A shows the anatomy and tissues of the inner face. The figure shows the inner cartilage and structures. The outer layer of skin and muscles have been omitted to more clearly show the bone structure. , located in the center of the face, and responsible for olfaction (ability to smell) and respiratory control (e.g. restricting airflow) The nose has two airflow pathways. One airflow pathway ( These airflow pathways are located on either side of the nose (starting at the nostrils) and combine to form a single airflow into the body. Air from the nose flows through the trachea into the lungs, where it is packed into the lobules. The two airways in the nose are connected to the nasal passages, which absorb oxygen for use throughout the body. Along each side of the airflow pathway there are two types of nasal valves (called the external and internal nasal valves) that control the airflow through the nose. The external and internal nasal valves work together to allow air into and out of the body. These nasal valves are tissues that surround the airflow and provide pressure to the airflow. The amount of resistance depends on the shape and size of these nasal valves (e.g., the cross-sectional area of ​​the inside of these nasal valves). The internal nasal valves on each airway are the narrowest areas of the nasal airway. This is the region where airflow is controlled and generally provides most of the resistance. The internal nasal valve gives the nose its characteristic shape. The nasal valve is shaped by various structures in the nose and face. The upper lateral nasal cartilages play a significant role in the shape and function of the valve. Additionally, large or small changes in internal nasal valve structure can impair nasal breathing and / or or may change the cosmetic appearance of the nose. Such changes generally involve the cross-sectional area of ​​the internal nasal valve. It acts to reduce the amount of creatinine in the skin, which may result from surgical / medical procedures or facial trauma. In addition, there are individual differences in the structure of the nasal valve, and some people may experience nasal congestion (commonly seen as nasal congestion). They may have valves that are significantly narrowed by weakened or malformed cartilage (presumably due to As the valve area narrows, the acceleration of the airflow increases and there is a concomitant decrease in luminal pressure, which Even normal nasal valves can collapse under high breathing pressure. However, a dysfunctional internal nasal valve can collapse during normal breathing, resulting in , oxygen flow is reduced, resulting in snoring and / or mouth breathing.

[0027] The nose consists of the external nostrils that protrude from the face and the nasal cavity below the external nostrils. The nose has the root, bridge, nasal dorsum, free tip, and columella. , which is attached to the pyriform aperture, the continuous free edge of the pyriform opening of the nasal cavity in the skull, and As shown in Figure 1A, the nose is located in the center of the face and is formed by the maxilla and maxilla. The skull is surrounded by the bones of the head, and the frontal bone 2 is located above the nose, and the superior vertebrae are located outside of it. The jaw bone has a frontal process 6 and an anterior nasal spine 20 of the maxilla located below it (in this figure, (The other lateral maxillary condyle on the other side of the nose is not visible.) The exoskeleton extends from lateral to medial. Three layers: an outer skin and muscle layer (omitted from this diagram), and an intermediate soft It is broadly divided into a bone and skeletal layer and an inner mucosal layer (barely visible in this view).

[0028] The central cartilage and skeletal layer provides shape, structure and support to the nose, while the It provides flexibility and sway, allowing the nose to bend in various directions. From top to bottom, the skeletal layer is divided into three regions: the upper third of the bone; It is roughly divided into the upper third, the middle third, which is the cartilaginous region, and the lower third, which is the cartilaginous region. The upper third area includes a pair of left nasal bones 4a and a pair of right nasal bones 4b. a and 4b join in the center of the nose and form the upper (or upper) part of the bridge of the nose. Bone 4a (with the lateral frontal process 6) joins superiorly to the frontal bone 2 and forms the frontonasal bone ( ) suture 5. Laterally, the nasal bone 4a is attached to the maxilla at the frontal process 6. It connects to the nasal suture 7 (or nasomaxillary suture) and forms a fibrous junction. The middle third of the cartilage and skeletal layer comprises the septal cartilage 10. It forms part of the nasal septum, which separates the nasal cavities and the two airways inside the nose. The lateral process 8 of the central cartilage 10 merges upward with the upper lateral cartilage 11 (in this figure (The other lateral protuberance on the other side of the nose, which merges with the upper lateral cartilage on the other side of the nose, is not visible.) FIG. 1A also shows the alar cartilage 24, which is the structure that supports and moves the nose. It is one of several accessory cartilages (which control the size of the nose and affect its complex three-dimensional shape). The lateral cartilages 11 are usually fairly stiff and are responsible for most of the support of the sides of the nose. The lateral cartilage 11 contributes to the formation of the internal nasal valve together with the septal cartilage tissue. The valve is located inside the nose below the upper lateral cartilage and is not well visible in this view.

[0029] As mentioned above, there are two internal nasal valves, one on each side of the nose. The border is defined by the septal cartilage 10 and its lateral border is defined by the caudal edge 13 of the upper lateral cartilage. its inferior border is defined by the tip of the inferior turbinate (not visible in this view) The attachment of the upper lateral cartilage to the septum (also called the "valve angle") An angle is formed that defines the internal nasal valve angle. The point at which the internal nasal valve angle is formed is the narrowest point of the nasal airway. It is the part of the nasal valve that creates the resistance that controls the airflow through the nasal airway. There is natural variation. The valve angle also changes over time as a natural result of aging. Valve angle It may be genetically determined, and ethnic groups have their own average valve angles. Furthermore, even within a particular ethnic group, there are variations in valve angle between people, and the angle between the left and right valves Also, the nasal valve angle may change as a result of surgery, trauma, or other interventions. Valves having a valve angle of less than about 10° are generally considered to be collapsed. This may result in narrowing of the nasal airway due to collapse of the nasal wall during inspiration. Such valves are believed to be candidates for treatment as described herein. Needles greater than approximately 10° may also cause some airway narrowing and / or cosmetic problems. In this case, the valve function may be impaired and the treatment described above should be performed. The damage is generally less severe than that of a collapsed valve. The subject is a candidate for treatment using the implants, devices, systems, and methods described herein.

[0030] The lower third of the cartilage and skeletal layer contains the alar cartilage that forms the nostrils and tip of the nose. (The greater alar cartilage is called the lower lateral cartilage based on its location and to distinguish it from the upper lateral cartilage.) This cartilage is softer and less mobile than the upper lateral cartilage. The alar cartilage 14 is U-shaped and the lateral crura 1 6 and medial crus 18. The greater alar cartilage 14 is located at the base of the nostril 17 (also called the external nares). It forms part of the external nasal valve around it, but does not reach the bone laterally at all. The lower third of the skeletal layer is made up of fibrous tissue from the lateral legs 16 and the tail wing, which fills the gap between the bone. FIG. 1A also shows the alar cartilage and lateral cartilage of the cartilage and skeletal layers. 8. The small alar sinus cartilage 12 connecting the nasal cavity to the nose 8 is shown.

[0031] As mentioned above, the nose is a complex three-dimensional structure. In order to maintain the shape of the nose, it is desirable to change the shape of the nose or to strengthen the support of the nasal structure. However, it is difficult to change one aspect of the nose without adversely affecting another. Previous surgical interventions have contributed to alterations in nasal valve function. The present invention may be treated using the systems and methods described herein. is an implant, device, or device that functions to modify or support an aspect of the structure or shape of the body, including the nose. , systems, and methods.

[0032] An exemplary nasal implant 32 (for use, for example, with the delivery tools described herein) is 1B and 1C. The implant 32 has a first arm 76a and a second arm 76b. The central body has arms 76a and 76b. These arms 76a and 76b each have a graft. 32 has a first arm outer bevel 78a and a second arm outer bevel 78b on the radially outer surface of the distal end of the The outer bevels 78a, 78b may be used, for example, to guide the implant into the delivery device. To achieve this, the implant is oriented within the delivery device to contract the implant into a contracted configuration. The first and second are useful for guiding the implant through a delivery device. The arms 76a, 76b are additionally provided with inner bevels 80a, 80b. In this embodiment, the inner bevels 80a, 80b and the outer bevels 78a, 78b are double bevels. The inner bevels 80a, 80b and the outer bevels 78a, 78b may be formed as follows. They may share a common edge (e.g., two inclined surfaces may intersect each other at any angle other than 90°). In some instances, the ridges may be spaced apart (intersecting) or flared out from one another. The inner bevels 80a, 80b and the outer bevels 78a, 78b may be at any angle other than 90°. They may intersect and not share edges (e.g., a bevel may be formed from different edges). The bevels 78a, 78b and 80a, 80b are formed at the ends or protrusions of the arms. It may be located along the side of the protrusion or projection.

[0033] The implant 32 further includes a proximal feature 74 at the proximal end. The end may be rounded, atraumatic, blunt, sharp, or flat (as shown in FIG. 1). The traumatic proximal feature 74 prevents the proximal end of the implant from being damaged or cut off, or Once 74 is in place within tissue, e.g., nasal tissue, it is prevented from retracting from the tissue. The proximal features 74 may also be used to anchor or otherwise secure the implant in place within the tissue. This helps to maintain the shape.

[0034] The implant 32 also includes a strain relief region 82 immediately distal to the proximal feature 74. As such, the strain relief regions 82 have a relatively smaller cross-sectional area (e.g., In some embodiments, the strain relief zone 82 has a diameter greater than the other regions. In this case, it is possible to provide strain relaxation by having a different morphology or different materials. It would be good if it could drip.

[0035] The implant 32 has a central spanning region 4 between the distal arms 76a, 76b and the proximal feature 74. 2. The central spanning region 42 provides support between the structures at both ends. They are particularly useful for bridging areas that may be weakened or crushed. The central spanning region 42 is adapted to span a weak or collapsed nasal valve in the nose. The central region 42 includes one or more ribs 60 (also called ridges). The ribs 60 may, for example, aid in the transfer of tissue by trapping tissue in the ribs 60 or in the valleys between the ribs 60. As shown in FIG. 1B, the first rib 60 , has a first rib width W1 and the second rib 60 has a second rib width W2. W1 and W2 may be the same size or different sizes. The first rib 60 may have a first rib diameter and the second rib 60 may have a second rib diameter. The first and second rib diameters may be the same or different. Piece 32 may additionally include another central body feature, such as a bevel, a shell, or a wing. It is also possible to do so.

[0036] A similar implant to implant 32 is described in U.S. Patent Application Publication No. 2016 / 0058556. This document is incorporated herein in its entirety by reference. .

[0037] FIG. 1D shows another embodiment of a nasal implant 62. The implant 62 includes a central body 58, The distal end 56 has two fork-like arms 50, 52, and an atraumatic proximal end 54. The graft 62 has two barbs at the portion of the graft where the arms 50, 52 join the central body 58. The barbs 65 extend across the plane defined by the fork arms 52, 50. The barbs 65 extend from two opposing sides of the implant. In addition, the central body 58 has a series of ribs 55 formed therearound. 5. A graft similar to Graft 62 was published in the journal "Nose Graft and The present invention is described in International Patent Application No. PCT / US17 / 68419, entitled "Methods of Use and Compositions of the Invention and Their Applications," which is hereby incorporated by reference in its entirety. This document is incorporated herein in its entirety by reference. .

[0038] 1E and 1F respectively show (e.g., by a delivery tool described herein) The implant is implanted in the patient's nose to support a section of tissue in the patient's nose (e.g., implant 32 or 62). 7A and 7B are front and side views of an implant 732 (which may be the same). and are useful for maintaining or improving the function or appearance of the nasal cavity (including medially located nasal structures and implants). The implant should be placed underneath the skin and muscle (omitted in the figure to better illustrate the implant). 1E and 1F show the internal nasal valve in place to support or alter it. The implant 732 is shown. Thus, the implant 732 is formed by placing cartilage and skeletal tissue under the skin and muscle. The implant 732 has a proximal end 734, a distal end 736, and a proximal end 738. and a distal end. The central portion 738 is disposed between the nasal cartilage. The central portion 738 is located between the upper lateral cartilage 711 and the lower lateral cartilage 720. It is further juxtaposed with the lower lateral crura 721 of the medial lateral cartilage 723. As previously mentioned, the septal cartilage Together, the caudal end of the upper lateral cartilage defines the medial flap angle. The cardiac portion 738 is juxtaposed with the caudal end 748 of the upper lateral cartilage 711 and covers or forms the inner valve wall. It acts on the valve wall, thereby supporting the inner valve or changing the shape of the inner valve. The distal end 736 of the implant 732 is juxtaposed with the cartilage and skeletal structure of the upper portion. 740, 742 are the nasal bone 704, the frontal process of the maxilla 706, and the maxillo-nasal suture 707 (nasal bone In some variations, the distal end of the implant is apposed to the upper layer of the It may be juxtaposed or adjacent to one of the many structures, or it may have a central or lower soft Structure of bones and skeletal layers (e.g., accessory cartilages, greater alar cartilage, lesser alar cartilage, septal cartilage, maxilla, etc.) The implant may be apposed to or placed adjacent to either the structure or tissue.

[0039] In some embodiments, the implant (e.g., implant 32, 62, 732) is placed into the nasal tissue. For delivery, a special tool may be used.

[0040] Referring to FIGS. 2A-2C, a graft (which may be any of the implants described herein) is ) The delivery tool 100 can be used to deliver the implant 132. The needle 106 extends from a handle 102 that can be held by hand. , and a plunger 104 attached to a push rod 109. The needle 106 is configured to advance the nasal implant 132 within the needle 106. In some embodiments, the needle 106 is configured to hold the implant within the needle 106. The implant 132 has a non-circular cross-section that allows for proper alignment (e.g., To be oriented within the needle 106, the arms of the graft are oriented outwardly of the main axis. Additionally, the handle 102 includes an implant orientation feature 110. Once the graft 132 is properly positioned within the needle 106, the graft orientation feature The portions 110 are aligned along the same longitudinal axis as the arms or forks of the implant 132 in its expanded configuration. Thus, the orientation feature 110 allows the user to move the device in the extended configuration. It will be helpful to visualize the plane defined by the arms of the explant 132. In this embodiment, the handle 102 includes an implant loading window 108. 08, when the device 10 is in the ready position, the graft 1 is inserted through the handle 102. 32. Additionally, in some embodiments, the delivery tool 100 The plunger 104 may include an O-ring. The O-ring may be used to prevent the plunger 104 from deploying. to provide constant low friction throughout (i.e. to keep deployment smooth), and However, if the tool 100 is moved, the plunger 104 is held from unintentional movement. It is structured as follows.

[0041] 2A-2C show the stages in proper deployment of the implant 132 from the tool 100. FIG. During phase 1 of deployment (FIG. 2A), the force (F PRESS ) is the minimum friction (F IMPLANT ) and friction within the tool 100, i.e., the push rod 109 along the O-ring (F O-R ING ) as the implant 132 exits the needle 106 and interacts with the nasal tissue. When starting to use, the plunger force is kept low and constant. Stage 2 of Deployment (FIG. 2B) During this procedure, the forked arms of the implant 132 exit the distal end of the needle 106 and penetrate the adjacent nasal tissue. This causes the force to be transmitted directly to the plunger 104. Force (F PIERCE ) occurs. As a result, F PRESS The fork of the graft 232 During stage 3 (Figure 2C), when fully deployed, the plunger For example, the plunger 104 is held in the proximal position of the handle 102 until the plunger 104 reaches the end of its travel. A large force (F PRESS ) to continuously push the plunger 104 In some embodiments, the forked arms of the implant 132 are positioned at the distal end of the needle 106. The tool 100 is held stationary relative to the tissue while it penetrates approximately 4 mm beyond the tip into the tissue. can be.

[0042] FIG. 2D illustrates improper deployment of the implant 232 from the tool 100. PRESS In order to provide a counter-traction force while applying the force, the user may optionally 1. Support the device 100 by grasping the housing of the device, e.g., the main handle body 102. By supporting the device 100, the user is subjected to a reaction force F GRIP Receive. This is because the user pulls the handle 102 proximally, generating a force F PRESS Therefore, during proximal retraction of the tool 100 from the tissue, The implant 132 is maintained in a quiescent state, so that the implant 132 does not lose its desired or intended shape. However, the target position is not reached and the target position remains approximately 4 to 6 mm behind (in front of) the desired position. Without training, this reaction would go undetected during deployment and would be considered a correct deployment. However, this incorrect deployment may require removal of the implant 132 or may result in the implant 132 failing to deploy as desired. As a result, the nasal tissue cannot be adequately supported through the delivery system. The tool is configured to prevent or minimize the possibility of inadvertent retraction during deployment. It needs to be done.

[0043] 3A-3F are schematic diagrams showing a method for preventing or minimizing the possibility of inadvertent recoil during deployment. 1 illustrates an embodiment of a delivery tool 200 that can be handheld. 1 and 2. A removable outer handle 202 and an inner handle 208 (e.g., with respect to the delivery tool 100). and a needle 206 (having a portion having a non-circular cross section as described above). The side huddle 202 is slidable relative to the inner handle 208 and the distal button 204a and The inner handle 208 includes a flange 252 and a distal button 204b. The distal end has an orientation feature 210, and in some embodiments, a graft loading window. As shown in FIGS. 3D and 3E, between the inner handle 208 and the outer handle 202 In order to cause sliding in the The rails 222a to 222d on the inner surface of the holder 222 are slidable along the rails 222a to 222d. 222d is 50-80%, for example, approximately 60%, of the length of the outer handle 202, and supports The gripping surfaces 238a-238d extend substantially the entire length of the inner handle 2308. Similar to tool 200, implant orientation features 210 of tool 200 may be used to The arm of the implant 232 (which may be a graft) is aligned longitudinally with the arm of the implant 232. It has been decided.

[0044] The nasal implant 232 advances the outer handle 202 distally relative to the needle 206. The outer handle 202 can be advanced through the needle 206 by The outer handle 202 is rigidly connected to the push rod 214 (see FIG. 3F). When moved distally around the handle 208, the push rod 214 pushes the graft 23 2, thereby moving the graft 232 distally through the needle 206. The distal button 204a is depressed to release the inner handle 20 8. The outer handle 202 is configured to permit distal movement of the outer handle 202 relative to the Additionally, the proximal button 204b can be depressed to move the outer handle 202 toward the inner handle. 298, thereby connecting the outer handle 202 to the inner handle 208. 232. The implant 232 is configured to move proximally relative to the distal end of the implant 232 to allow loading of the implant 232.

[0045] 3A-3C show stages in the deployment of an implant 232 with the tool 200. Now, the implant 232 is loaded into the needle 206 and is ready for deployment. The implant 232 will not deploy until the user depresses the distal button 204a. The tool 200 causes partial deployment of the implant 232. The distal button 204a is depressed. 2, whereby the inner handle 208 is disengaged from the outer handle 202. Similar to device 100, the implant 232 is inserted into the tissue until the fork arms of the implant begin to engage the tissue. At this point, the outer handle 208 and the implant 232 are deployed with low force. The thrust is increased until the fork arms penetrate into the soft tissue. The deployed configuration of the delivery tool 200 within tissue is shown in FIG. When the handle 202 moves forward relative to the inner handle 208, the fork-shaped portion of the implant 232 The arms are pushed distally out of the needle 206 and into the tissue. When the outer handle 202 is fully extended around the inner handle 208, the outer handle 202 comes to a sudden stop. That is, it comes to a sudden stop when it abuts against the flange 252 and is locked in the stopped position. When the handle 202 is fully advanced, the handle is locked in place and can then be adjusted by the user. If the outer handle 202 is not in the emergency stop position, a detectable audible and tactile click is generated. and if not advanced sufficiently to the associated locking position, retract the device 200, so that However, the outer handle 202 slides proximally and full deployment of the nasal implant 232 is not achieved. The user is alerted that

[0046] Advantageously, the user holds only the outer handle 202 of the device 200 and the inner handle 2 08, the user does not need to apply a counter load ( That is, F in FIG. GRIP As a result, the tool 200 does not add any In addition, the user can easily grasp the outer handle 202 by gripping the mechanism and the planar Because it serves as both a food processor and a jar, the user is free to change hand grip or orientation during use. This allows the orientation of the tool 200, and therefore the implant 232, to remain constant during deployment. This will ensure that the system is maintained at a high level.

[0047] 4A-4C show a delivery device in a preloaded configuration (i.e., without an implant contained therein). The cross-sectional view of FIG. 4B shows the delivery device 200 engaging the latch 212 of the inner handle 208. 1 shows distal button 204a engaged (note that distal button 204a is depressed). In this position, the proximal button 204b is not depressed either. The cantilevered portion 205b of the proximal button 204b has a spring-like characteristic that biases the proximal button 204b upward. The cantilever portion 205b is heat caulked to the inner surface of the distal side of the outer handle 202. The proximal button is supported by a rib feature 251 on the proximal side of the proximal button. Then, the backstop tang 216 of the inner handle 208 engages the distal teeth 228 of the outer handle 202. This engagement provides an outer relative to inner handle 208 in the preload configuration. Proximal retraction of the side handle 202 is prevented. Referring to Figures 4D and 4E, To load into device 200, proximal button 204b is depressed and retraction stop tang 2 16 is pushed away from distal teeth 228. Proximal button 204b is held down. Then, the outer handle 202 is rotated proximally relative to the inner handle 208, specifically, the distal teeth. 228 and the proximal teeth 229, allowing loading of the implant. It becomes possible.

[0048] 5A-5E show the delivery tool 200 in a loading configuration in preparation for loading an implant. To expose the implant loading chamber 218, the outer handle 202 is inserted into the inner handle 204. In this retracted position, the inner handle 208 is proximally retracted relative to the inner handle 208. And to prevent the outer handle 202 from completely separating, the rear of the inner handle 208 The stop tongue 216 abuts against the stop tooth 239, and at the same time (connected to the stop tongue 216) The tongue latch 220 abuts against the stop rib 220b. Retraction of the inner push rod 214 exposes the implant loading chamber 219 and moves the inner push rod 214 closer to the implant loading chamber 219. The implant is pulled distally enough to free the implant loading chamber 218 and allow the implant to be loaded. In one embodiment, the delivery tool is in the loaded configuration (where the device is in the ready configuration). (to prevent accidental deployment of the graft during transfer to the distal end) by pressing the distal button 204a. As shown in FIG. 5D, in the loaded configuration, the latch 212 rides up onto rails 221 on the inner handle 208; This prevents the distal button 204a from being pressed downward. 221 is a portion of the length of the inner handle 208 (e.g., 40 to 80%, specifically, 60 %) and the position of the t-slot feature 219 in the ready or preloaded configuration. (This disengages the t-slot feature 210 and releases the button 2 (This allows downward pressure on 04a).

[0049] After the nasal implant is loaded into the loading chamber 219, the outer hand is The handle 202 is rotated distally until it reaches the ready position stop 262 of the inner handle 208. This allows the device 200 to return to the ready configuration shown in FIG. In this position, the t-slot feature maintains the distal button 204a in an undepressed state. The portion 219 is disengaged from the rail 221 of the inner handle 208. The button can be depressed to prepare for deployment.

[0050] The user (e.g., surgeon) then uses the delivery tool to deliver the nasal implant to the target area. The user delivers the delivery device in a prepared form (with the implant in place) to the tissue. The needle 206 of the device 200 can be inserted into the patient's nasal wall. While maneuvering along the anatomy, the device 200 overcomes tension and pressure due to friction and resistance of the target tissue. Although both are subjected to a compression load, the handles 208, 202 do not move relative to each other.

[0051] 6A-6D, once the user has placed the device 200 in place within the body, When the implant is ready to be deployed, the distal button tab 204a is depressed. When button 204a is depressed, it pushes latch 212 downward (i.e., 2, pushing toward the gap 268 (as shown in the state change from FIG. 6A to FIG. 6B ). The latch 212 is captured under a lip 269 of the outer handle 202. In this state, actuation provides an auditory and / or tactile feedback mechanism to prepare the implant for deployment. indicates to the user that the deployment is ready (i.e., the deployment lock has been removed) Once latched, the user may press distal Button 2 (without releasing the button) 04a can be released because the distal button 204a (when the latch 212 The distal end of the distal end of the stent is held depressed by the lip 269. After pressing the tab 204a, the user can press the button 204b as shown in the state change of FIGS. 6C and 6D. The outer handle 202 can then be slid forward (because the latch 212 is (Because it is no longer engaged with the lip 262 of the inner handle 108). As the push rod 202 moves forward, the push rod 214 moves distally, pushing the graft into the loading chamber. The implant is then pushed out of chamber 218, and deployed. Thus, the user must rotate the outer handle 202 until it comes to a sudden stop against the flange 252. The side handle 202 can be advanced forward.

[0052] Once the outer handle 202 is attached to the flange 252, as shown in FIGS. 7A and 7B, On the other hand, when the device is stopped suddenly, the handle 202 locks into place to allow for retraction of the device 200. 7B, in this position, the retraction stop tang 216 contacts the proximal stop tang 216. The outer handle 226 moves proximally to the proximal tooth 229 and comes to rest against the proximal tooth 229, thereby 202 is prevented from moving proximally relative to the inner handle 208. The surgeon then sheathes the device 200 by unsheathing the outer handle 202 from the inner handle 208. This latching action allows the device to be retracted from the soft tissue without causing hearing loss and / or A tactile feedback mechanism is provided to indicate when the implant is fully deployed or fully open and when the device is fully deployed. The outer handle 202 must be latched in the open position (i.e., the outer handle 202 must be pulled away from the inner handle 202 before it is fully opened). 208, so that the graft is properly or fully opened. This allows for the provision of an indication that the device has not been

[0053] After the nasal implant is delivered, button 204a is pressed as described above with respect to Figures 4A-4D. In addition, the implant may be reloaded with another implant by inserting another implant into the implant cavity. In contrast, when the outer handle 202 is pulled proximally, the deployment button 204a extends the implant. 2 and engages the proximal end of the loading chamber 218, disengaging the latch 212 from the lip 269. 2, which causes the latch 212 and button 204a to spring upward. (e.g., button 204a and / or latch 212 are biased toward the upper position) When the button 204a is activated, the button 204a moves upward as shown in the state change from FIG. 8A to FIG. 8C. (moves).

[0054] 9A-9F, the tip of a needle (e.g., needle 206 of device 200) Using the tip, the delivery needle 206 can be positioned to deliver the nasal implant 232. This can facilitate tissue penetration and / or tissue separation during the determination. For example, FIG. 9A and FIG. Referring to FIG. 9B, chip 996a has three distinct faces 997a-997c. These three bevel cut surfaces are inclined at (i.e., inclined at 45° from the main bevel perpendicular plane). , and has a principal angle α in the range of about 11 to 15°. In another example, see FIGS. 9C and 9D. Then, the tip 996b may be designed as a flat bevel surface without a cut surface. The tip 006b may have a principal angle α in the range of 15 to 20°. Chip 996b has fewer faces (e.g., than chip 996a) and the following features: Identification of layers (i.e., dermis, upper and lower outer cartilage, mucosa) for improved surface detection, Identification of forces occurring in different tissue types and cannula movement vectors to improve resection of soft tissue surfaces. 9E and 9F, the chip 9 96C is a cross-sectional view of two beveled surfaces 99 (e.g., inclined at 45°) that intersect at a sharp point 998. The tip 996c has a principal angle α of 11 to 20°. The beveled configuration of tips 996a, 996b, and 996c allows easy access to the mid-thickness surface of the nasal valve wall. In addition, the bevel design of the tips 996a, 996b, and 996c facilitates implantation. When placed over the upper jaw for unilateral deployment, it provides increased resistance to cephalad movement. The bevel grinding angle is a balance between the strength of the tip geometry and the sharpness of the tip. This maintains the implant's natural elasticity and influences the interaction of the implant arms (forks) during soft tissue engagement.

[0055] In the delivery tools described herein, for example, a button on the handle and a quick stop Numerous alternative embodiments may be used for the locking structure within the inner handle portion of the delivery tool. It's okay to stay there.

[0056] In some embodiments, a button with a magnetic latching design may be used. 10A-10C show a portion of the handle of an exemplary delivery tool 300. 00 is a wrapper with a magnetic stopper 333 attached when the distal button 304a is depressed. The delivery tool is similar to the delivery tool 200, except that the delivery tool operates by pressing a button 304a. 10A to 10B. When the button 304a is depressed, it rotates about a pivot 331. The magnet 339 on the bottom of the latch 312 is magnetic. The air is sucked into the air stopper 333, which disengages the latch 312 and allows the delivery tool 200 to As shown in FIG. 10C, the outer handle 3 When the graft loading port 318 is retracted, the proximal edge 330 of the graft loading port 318 comes into contact with the reset angled boss 334. The magnet 339 interacts with the stopper 333, pulling it upwards, thereby causing the button 30 4a will return upward due to the spring force.

[0057] In some embodiments, one or more of the locking mechanisms of the delivery tool may be spring-based. 11A and 11B show a device similar to device 200, except that it includes a spring locking mechanism. 4 shows a delivery tool 400. The spring lock mechanism engages the distal button 404a, which A spring 444 (like a leaf spring) presses the button 404a to reset the button 404b. 11A to 11B. When button 404a is depressed (as shown in FIG. 1), spring 444 is flattened. In an embodiment, the button 404a does not provide a locking state when pressed, but rather provides a locking state during deployment. The distal button is held down by the user during proximal retraction. The tongue 404 a is reset by a spring 444 .

[0058] In some embodiments, the button and latch are combined on an exterior portion of the delivery device. For example, FIGS. 12A and 12B show a distal button 504a positioned at a central pivot point 55. 5. The device is similar to device 200, except that it functions as a spring-loaded latch having a small A spring (e.g., a die-cut spring) biases button 504a to the up position. The user holds button 504a in the depressed state. The latch is in the ready position (FIG. 12A) or the extended position (FIG. 12B). From the ready position, the user can Disengage the distal portion (raised portion) of the bar 555 from the proximal locking position of the inner handle 508. To do this, the distal portion (raised portion) of this lever 555 is pressed and held in that state. Then, when the lever 555 reaches the locking position 554 of the inner handle (as shown in FIG. 5B), Move the outer handle 502 distally until the implant is in position. It will be possible.

[0059] In some embodiments, a spring and a spring with a snap-fit ​​detent are used. 13A-13D show that the distal button 604a is a spring and snap-fit ​​detent. A delivery tool 600 is shown, which is similar to device 200, except that it includes an insert. 13A shows the device 600 in the ready position. In this position, the distal button 604a is in the "up" position, and the button latch 666 also abuts against the emergency stop 662 on the inner handle. In the ready configuration, the spring 664 lifts the button latch 666. 200, preventing backing out of the outer handle 602 relative to the inner handle 208. FIG. 13B shows the button 604a being depressed. At this time, the button latch 666 is pushed down against the spring 664. This compresses the spring 664 and causes the button latch 666 to engage the inner handle 60. 8 quick stop 662. In some embodiments, the button 604a , produces a clicking sound and / or provides a tactile response. An exemplary embodiment for reducing the upward bounce and subsequent disengagement of the (See FIG. 14D for more details.) The outer handle 602 then For deployment, the device 6 is advanced distally around the handle 208. The outer handle 602 is connected to the inner handle 608 in the final deployed state. In this position, the backstop tang on the inner handle engages the device 20. 0, the outer handle is spring biased to a second, locked position at the proximal end thereof. FIG. 13D shows the reset mechanism for button 604a, allowing the device to be reloaded. To do this, the user depresses the retract button as previously described with respect to tool 200. As the handle 602 is retracted relative to the inner handle 608, the load port ramp 67 3 engages with a central rib 671 on the deployment button 604a. The beveled design of features 673, 671 pushes up distal button 604a. , a return that depresses distal button 604a (as described with respect to FIGS. 14A-14D). This overcomes the restraint of the stop, causing the deployment button 604a and button latch 666 to spring back. It will go up.

[0060] As shown in FIGS. 14A and 14B, in one exemplary embodiment, button 604a is A double-sided connecting ring that engages a discrete location on the double-sided button detent insert. FIG. 14A shows a line passing through button 604a in the ready position (up position). 6 is an exemplary cross-sectional view of device 600 taken along a Detent bumps 669a, 669b on the deployment button arms 669a, 669b prevent preloading of the parts. 63a, 663b are recessed in first recess 664 on detent insert tabs 667a, 667b. a, 664b. Referring to FIG. 14B, when button 604a is depressed, When deployed, the detent bumps 663a, 663b on the deployment button arms 669a, 669b Press the cantilever arms 661a, 661b of the mooring insert tabs 667a, 667b (FIG. 1 4B) until it reaches the position of the second recesses 665a, 665b. Once you have done so, it will snap into place. Snapping it into place will A visual click and / or tactile response occurs, and the detent insert tabs 667a, 667b Button 604a would be held in the down / depressed position.

[0061] 14C and 14D show a button 604a on a double-sided button detent insert. FIG. 13 shows another exemplary embodiment with a two-sided connecting linkage that engages at discrete locations. This embodiment has detent bumps 1463a, 1463b on arms 1469a, 1469b. Except that 463b is angled to reduce the force required to press the button. 14A and 14B. In addition, recesses 1464a, 1464b are provided. b has a dome shape to provide strong retention. Additionally, the detent insert The tabs 1467a and 1467b each have a semicircular or D-shape and, during deployment (FIG. 14D The straight edges of the D-shape are bent outward (as shown by the arrows in FIG. As shown in the embodiment of FIGS. 14A and 14B, detent bumps 1463a, 1463b b is the upper recess 1464 when moving from the preparation configuration (FIG. 14C) to the deployment configuration (FIG. 14D). a, 1464b to the lower escapes 1465a, 1465b. Lower detent 1465 a, 1465b, buttons 604a, 604b are held down until reset during loading. 04a, 604b will be held in the down / pressed configuration.

[0062] The delivery tools described herein provide a number of advantages. The tip allows identification of tissue planes for tissue resection instead of tissue penetration. The blunt tip of a single bevel cannula is similar to the bevel tip of a cutting trocar. It penetrates tissue layers less easily than a sharp tip, facilitating detection of the intended resection plane and allowing for intermediate extension. Minimize opening advancement. For example, in the final development on the maxilla, blunt tips is less likely to advance cephalad during graft deployment than a sharp tip.

[0063] The delivery tools described herein also provide improved ergonomics for the user. Due to the deployment mechanism, where the outer handle is used to advance the implant, there is minimal reaction. Only traction forces need to be applied to the device, or no counter-traction forces need to be applied to the device at all. The use of an external handle to actuate the needle also prevents the needle from moving during graft deployment. The tissue may be pulled out and inadvertently displace the nasal graft from the desired graft position or orientation. The possibility of this happening is reduced.

[0064] The delivery tools described herein also allow for improved one-handed operation of the device. The delivery tools described herein allow the implant to be deployed with minimal manipulation of the tool. While manually grasping and holding the device, the surgeon guides the needle into the soft tissue at the desired location. Once the deployment is ready, the user can operate the grip with little effort. Easily access distal buttons (e.g., deployment actuator buttons) without requiring additional or no access and depress the distal button, then slide the grasped outer handle forward. This allows the nasal graft to be deployed at the target location through the needle. One-handed operation is advantageous because it avoids rotation and deflection of the delivery device during use. Because it is possible.

[0065] Additionally, the actuation and retraction locks of the devices described herein prevent premature deployment. Similarly, to prevent inadvertent deployment of the device while it is in use, A shroud around the button may be used.

[0066] Any one or more features described herein with respect to one embodiment may be used with respect to other embodiments. The present invention may be combined with any one or more of the features described herein with respect to the embodiment. , or may be replaced.

[0067] The delivery tools described herein may alternatively or additionally be incorporated by reference in their entirety as set forth in the "Patent Citations" section of the "Patent Citations" filed on September 23, 2016. U.S. patent application Ser. No. 15 / 274, filed on Nov. 13, 2013, entitled "Nasal Implants and Systems and Methods of Use" The present invention may also include features described in US Pat. No. 5,986, which is incorporated herein by reference. , which are incorporated herein in their entirety.

[0068] In some embodiments, the nasal implant is delivered by any of the delivery tools described herein. When reaching this point, a nasal implant positioning guide may be used.

[0069] 15A-15F are schematic diagrams for planning the position and orientation of the graft relative to the nasal anatomy. The nasal implant guides 1400 each have a handle 14 12 and an implant guide portion 1410 (e.g., one or both sides thereof to indicate the method of deployment). The nose implant guide portion 1410 has a portion of the nose implant that is modeled after the nose implant. The implant guides 1400 each further include a proximal opening 1402 and a distal opening 1406. The nasal implant guide 1400 includes a fork feature 1406 that protrudes distally from a distal opening 1406. 408. In some embodiments, the nasal implant guide 1400 includes a proximal feature and the wing rim edge. A plurality of markings (e.g., six small ones) adapted to provide a ruler to the user These markings 1404 correspond to the proximal opening 1402. They start 4mm from the center of the ball end and are spaced 2mm apart. In some embodiments, the handle 1412 is axially oriented relative to the nasal implant guide portion 1410. In another embodiment, the handle 1412 is aligned at The nasal graft guide portion 1410 is arranged at an angle of approximately 90° to the main axis of the nasal graft guide portion 1410. Engaged to minute 1410.

[0070] FIG. 15A shows a handle 1412a and an implant guide 1412b aligned in the axial direction. FIG. 15B shows an implant 1400a having a handle 1410a. 12b is inclined at an angle of 90° to the guide portion 1410b. Proximal opening 1402b and distal opening 1406b are shown to accommodate a larger marking pen. The openings 1402a and 1406a are larger than the openings 1402a and 1406a to accommodate the tips of the supports. The fork-like feature 408b of the support guide 1410b makes the positioning of the graft fork more clear. For clarity, the device 1400b is configured to have the contours of a graft fork. The markings are not shown. FIG. 15C shows the shape of the 4 mm, 6 mm, and 8 mm protrusions. FIG. 15D shows device 1400c having marking 1404c in a 4m FIG. 1 shows markings 1404d in the form of projections of 1 mm, 8 mm, and 12 mm. 5E has markings 1404e in the form of indentations of 4 mm, 8 mm, and 12 mm. It shows.

[0071] (As shown in FIGS. 15B and 15C) the position of the handle 1412 is adjusted to the guide portion 14 12, in some cases, the user can use this tool around the patient's face, thereby keeping the tool aligned with the intended trajectory. When using a 90° angle, the target anatomical structures can be better visualized. Depending on the design, either left-handed or right-handed users can use the guide 1400 , making it possible to operate on either side of the nasal anatomy.

[0072] The nasal graft guide described herein can be used as a planning / marking aid. The present invention is intended to mimic the implant and provide a schematic depiction of the surgeon's preferred implant location. For example, as shown in Figures 16A and 16B, a nasal implant guide 1600 may include: Guide the placement of an implant 1632 (which may be any implant described herein) Like the guide 1500a, the guide 1600 includes a guide portion 161. 16A. The handle 1612 is axially aligned with the handle 1612 shown in FIG. Thus, the guide 1600 may be configured as follows: 4, by attaching the fork feature 1608 to the distal fork arm 1676 of the implant 1632. a, 1676b) to indicate the desired location of the distal end of the delivery tool needle. 16, the distal opening 1606 is positioned to allow for marking of the nasal wall. Similarly, the user may determine the desired location of the proximal feature 1674 of the implant 1632. A marking 1602 may be drawn on the outer nasal wall through the proximal opening 1602. 4 advantageously measures the distance from the alar rim edge 1660 to the proximal feature 1674 of the implant. The length of the handle 1612 is the length of the plan / mark. The design ensures that the user's hands do not obstruct the visualization of the guide 1600 and anatomical structures while performing the procedure. It is being calculated.

[0073] Positioning the nasal implant 1632 within the nasal anatomy 1665, as shown in FIG. 16B. Specifically, fork-shaped arms 1676a and 1676b are disposed adjacent to the maxilla to and positioned beyond the maxilla to connect the central bridging region 1642 to the upper lateral cartilage and the lower lateral soft tissue. The markings on the guide 1600 can be used to position the guide to support the bone. Cut.

[0074] 17A and 17B, similarly, implant 1732 is attached to nasal anatomy 173. 5, the nasal implant 1700 is placed over the nasal anatomy 1735. is.

[0075] As used herein, a feature or element is described as being located "on" another feature or element. When mounted, the feature or element may be located directly on top of another feature or element, or In contrast, one feature or element may be intervening. When described as being located "directly on" a feature or element, any intervening features or elements are not included. There is also no indication that a feature or element is "connected," "attached," or "attached" to another feature or element. or "coupled" to another feature or element. may be connected, attached, or coupled to, or there may be intervening features or elements. In contrast, it should also be understood that a feature or element may be "directly connected" to another feature or element. When a description is made of "directly attached" or "directly connected," any intervening features or Even if only one embodiment is described or illustrated, such Features or elements described or illustrated in may be applied to other embodiments. A reference to a structure or feature located "adjacent to" a feature includes above or below the adjacent feature. It will be understood by one of skill in the art that this includes portions located at

[0076] The terminology used herein is for the purpose of describing particular embodiments only and It is not intended to limit the invention. For example, as used herein, the singular "a" "An" and "the" include the plural unless the context clearly indicates otherwise. As used herein, "comprise" and / or "include" are intended to The term "comprising" refers to the features, steps, operations, elements, and Identifies the presence of one or more other features, steps, operations, elements, or components It should be further understood that the present invention does not preclude the presence or addition of other components, parts, and / or groups thereof. As used herein, the term "and / or" means one or more of the associated listed items. It includes any combination of digits and is sometimes abbreviated as " / ".

[0077] "Under" "Below" "Below" "Under" "On" "Above" etc. Interrelated terms are used herein to refer to one or more elements or features shown in the drawings. is used to facilitate the description of relationships between multiple other elements or features. The terms used herein may refer to alternative orientations of the device in use or operation in addition to the orientation depicted in the drawings. It is to be understood that this is intended to include, for example, when the device is inverted in the drawings. In this case, an element described as being located "below" or "directly beneath" another element or feature is also The element or feature is oriented "above" the element or feature. Hence the exemplary use of "below." The term includes both an up and down orientation. The device may be oriented in other directions. (i.e., rotated 90 degrees or at other orientations), in which case The spatial terms used in calligraphy should be interpreted accordingly. Terms such as "on," "down," "vertical," "horizontal," and the like are used herein to refer to, among other things, Unless otherwise specified, they are used for illustrative purposes only.

[0078] The terms "first" and "second" are used herein to describe various features / elements. These features / elements are used to describe the These terms should not be construed as limiting the scope of the invention. It is used to distinguish from other features / elements. Therefore, it is not necessary to deviate from the teachings of the present invention. Instead, the first feature / element mentioned above may be referred to as a second feature / element, and similarly. Additionally, the second feature / element mentioned above may be referred to as the first feature / element.

[0079] All numbers used in this specification and claims, including all numbers used in the examples Unless expressly indicated otherwise, the terms "about" or "approximately" are used. " may be read as a notation even if the phrase is not explicitly stated. The words "about" or "approximately" mean that the stated values ​​and / or locations are within the limits of those values. When describing the size and / or location of the object, the size and / or location should be within a reasonable range of expectation. For example, numerical values ​​should be used with an accuracy of ±0.1%, ±0.2%, or ±0.4% of the stated value (or range of values). 1%, ±2%, ±5%, ±10%, etc. Any number described herein may have a value. Value ranges are also intended to include all subranges.

[0080] Although various exemplary embodiments have been described above, the present invention as set forth in the claims is Any number of modifications may be made to the various embodiments without departing from the scope of the present invention. For example, the order in which various described method steps are performed may often be varied in alternative implementations. In other alternative embodiments, one or more method steps may be Some optional features of the various device and system embodiments may be omitted altogether. It may be included in some embodiments and not in others. It should be understood that the foregoing description is primarily for purposes of illustration and is intended to provide an understanding of the scope of the invention as defined in the claims. should not be construed as limiting the

[0081] The examples and illustrations included herein are merely illustrative of specific embodiments implementing the subject matter. These are illustrative only and not limiting. As previously mentioned, other embodiments may be utilized. or may be derived therefrom, and structural and logical substitutions and modifications are within the scope of the present disclosure. Such embodiments of the inventive subject matter are set forth herein. are merely conventionally referred to individually or collectively by the term "invention." However, if more than one is actually disclosed, the scope of this application shall not be limited to any single invention or The present invention is not intended to be limited to any single inventive concept. Although the present invention has been described and illustrated herein, the specific embodiments shown are not intended to be limiting in any way in order to achieve the same objectives. This disclosure includes all modifications and variations of the various embodiments. Those of ordinary skill in the art will recognize upon review of the foregoing description and are intended to cover all such modifications and variations. Combinations of the above embodiments and other embodiments not specifically described herein are apparent. It will be.

Claims

1. an inner handle comprising a loading chamber configured to receive a nasal implant; an outer handle configured to move axially between a plurality of different locking positions relative to the inner handle, the plurality of different locking positions including a pre-loading locking position and a proximal graft loading position; a locking structure corresponding to the pre-loading locking position, the locking structure being configured to releasably lock the outer handle at the pre-loading locking position against proximal movement of the outer handle relative to the inner handle from the pre-loading locking position toward the proximal graft loading position; a retraction button provided on the outer handle, the retraction button being configured to release the engagement of an engagement structure provided corresponding to the pre-loading engagement position, thereby moving the outer handle proximally relative to the inner handle, and making the loading chamber for receiving the nasal implant ready for loading; and a needle extending distally from the inner handle, the needle having a central lumen and a distal opening; a push rod configured to move the nasal implant from the loading chamber, through the central lumen, and out the distal opening of the needle, the push rod coupled to the outer handle for axial movement relative to the inner handle when the outer handle moves axially relative to the inner handle; A delivery tool for a nasal implant comprising:

2. Distal movement of the outer handle relative to the inner handle causes the push rod to move the nasal implant from the loading chamber, through the central lumen, and out the distal opening of the needle; the plurality of different locking positions includes a distal locking position; the delivery tool further comprises a locking structure corresponding to the distal locking position, the locking structure configured to releasably lock the outer handle in the distal locking position against proximal movement of the outer handle relative to the inner handle; The delivery tool of claim 1 , wherein a locking structure corresponding to the distal locking position locks the outer handle when the outer handle is moved fully distally relative to the inner handle.

3. the inner handle includes a flange and the outer handle is locked to the flange at the distal locking position; or 3. The delivery tool of claim 2, wherein the locking structure corresponding to the distal locking position includes a stop tang and teeth, the stop tang configured to engage with the teeth to lock the outer handle at the distal locking position.

4. the plurality of different locking positions includes a preparatory locking position; the delivery tool further comprises a locking structure corresponding to the preparatory locking position and locking the outer handle to prevent the outer handle from moving distally relative to the inner handle to cause the push rod to move the nasal implant out of the distal opening of the needle, the locking structure including a latch for releasably locking the outer handle in the preparatory locking position; when the outer handle is in the ready locked position, the central lumen of the needle is configured to hold the nasal implant; the delivery tool further comprising a deployment button; 2. The delivery tool of claim 1, wherein the deployment button is configured to unlock the latch to allow the outer handle to move distally relative to the inner handle and the push rod to move the nasal implant out of the distal opening of the needle.

5. 2. The delivery tool of claim 1, wherein a locking structure corresponding to the pre-loading locking position locks the outer handle so that the outer handle cannot move proximally relative to the inner handle to place the loading chamber in a state in which the nasal implant is available for loading.

6. The locking structure corresponding to the pre-loading locking position includes a stop tongue and a tooth; the stop tang is configured to engage the teeth to lock the outer handle in the pre-loading locked position; The delivery tool of claim 5, wherein the retract button is configured to disengage the stop tang from the teeth, causing the outer handle to move proximally relative to the inner handle such that the loading chamber for receiving the nasal implant is ready for loading of the nasal implant.

7. the plurality of different locking positions includes a preparatory locking position; a deployment button on the outer handle; the delivery tool further comprising a locking structure corresponding to the ready locked position and configured to releasably lock the outer handle to prevent the outer handle from moving distally relative to the inner handle to cause the push rod to move the nasal implant out of the distal opening of the needle; 3. The delivery tool of claim 2, wherein the deployment button is configured to unlock the locking structure provided corresponding to the preparatory locking position, thereby allowing the outer handle to move distally relative to the inner handle so that the push rod can move the nasal implant out of the distal opening of the needle, and is distal to the retraction button on the outer handle.

8. 8. The delivery tool of claim 7, wherein the deployment button includes a first locking feature that engages with a second locking feature on the inner handle to prevent the deployment button from being depressed when the outer handle is moved proximally relative to the inner handle so that the loading chamber that receives the nasal implant is ready for loading of the nasal implant.

9. The delivery tool of claim 1 , wherein the outer handle is configured to completely cover a proximal end of the inner handle.

10. 10. The delivery tool of claim 1, wherein the outer handle is configured to move axially relative to the inner handle via a rail on the outer handle that slides on a support surface of the inner handle.

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