Nasal implant delivery system

Abstract

To provide nasal implant delivery systems that pierce a nasal tissue of a patient to enable an implant to be placed accurately in the nose of the patient.SOLUTION: A nasal implant delivery system comprises: a grippable housing (110); a hollow needle (102) extending from the grippable housing and defining a delivery conduit extending from a proximal end to a distal end of the needle (102), the distal end being a piercing end (112) configured to pierce nasal tissue; a first control mechanism (114) configured to advance an implant (104) from a proximal position, in which the needle is loaded with the implant, to a distal position of the needle; and a second control mechanism (106) configured to retract the needle away from the implant at the distal position and toward the grippable housing so as to deliver the implant to an implantation position in the nasal tissue.SELECTED DRAWING: Figure 7B-C

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 61 / 770,008, filed on February 27, 2013, and U.S. Provisional Patent Application No. 61 / 785,816, filed on March 14, 2013, the entire disclosures of which are incorporated herein by reference under 35 U.S.C. § 119.

[0002] Incorporation by Reference All publications and patent applications mentioned in this specification are hereby incorporated by reference into this specification, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] The present invention relates to implants for placement within the body, instruments for delivering the implants, and systems and methods for using the implants and instruments placed within the body, and more particularly, to nasal implants, instruments for delivering the nasal implants, and systems and methods for using such implants and instruments.

Background Art

[0004] The specific nasal anatomical structure of an individual can cause or contribute to various problems such as concerns about appearance, breathing difficulties, sleep apnea, or snoring, and can affect an individual's health or reduce the quality of life. For example, the structure of the internal or external nasal valve can create resistance to airflow from the nose to the lungs, and an individual may not be able to deliver sufficient oxygen to the blood.

[0005] Non - surgical injection methods can be used to introduce into an individual's nasal region for treating the individual's nasal valve. The implants described in (Patent Document 1), (Patent Document 2), and (Patent Document 3) exist.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0007] To address problems caused by the nasal structure, continuous improvements such as ease of use, durability, low invasiveness, low manufacturing cost are highly desired.

Means for Solving the Problems

[0008] Implants to be placed in the body, instruments for delivering these implants, and systems and methods for using the implants and instruments placed in the body. Specifically, nasal implants, instruments for delivering nasal implants, and systems and methods for using such implants and instruments are described herein. These can be useful for minimally invasive procedures, including the treatment of outpatient patients, and can result in minimal pain and rapid recovery. These systems assemblies, and methods can be used, for example, in hospitals or clinics, and in some cases may require only appropriate local anesthesia. These implants, assemblies, systems, and methods can be useful for minimally invasive procedures, including the treatment of outpatient patients, and can result in minimal pain and rapid recovery. These systems assemblies, and methods can be used, for example, in hospitals or clinics, and in some cases may require only appropriate local anesthesia. These implants, assemblies, systems, and The method can be particularly useful for the support and repair of nasal tissue, such as the internal nasal valve or the external nasal valve. Some implants can provide long-term solutions for improving nasal function and rhinoplasty: semi-permanent implants that degrade over a long period can only support nasal tissue for a short period, but this implant can remain intact, reinforce nasal tissue, and initiate a body response (e.g., a fibrotic response) that supports nasal tissue over a long period. The nasal treatment system can utilize a preformed or moldable nasal implant that includes a bioabsorbable material that structurally supports the surrounding nasal tissue. The assembly and system can penetrate the patient's nasal tissue to enable accurate placement of the implant into the patient's nose. One aspect of the present invention provides a nasal implant delivery system that includes a delivery device and an implant. In some embodiments, the system includes a graspable housing that includes an implant delivery conduit having a piercing end configured to pierce nasal tissue. In some embodiments, the conduit includes an internal alignment portion having a cross-sectional shape configured to align the implant with the conduit. In some embodiments, the system includes a longitudinally elastic deformable portion configured to have a first contracted shape and a second expanded shape and includes a longitudinally implant. In some such embodiments, the first shape includes a non-circular cross-section configured to align the orientation of the implant with the conduit by the conduit alignment portion when the implant is disposed within the conduit. In some embodiments, the second shape includes an expanded shape configured to fix the implant to the nasal tissue when the implant is disposed within the nasal tissue.

[0009]

[0010] In some embodiments, the delivery device is adapted to receive the implant when the implant is placed in the conduit. In some embodiments, the catheter is configured to hold the catheter near the distal end of the conduit. holds the implant near the distal end of the conduit when the implant is placed in the conduit. In some embodiments, the conduit is configured to be 14 gauge, 16 gauge, or includes an 18 gauge needle, and the implant is configured to be received within the needle. In some embodiments, the delivery device is configured to receive the implant within the conduit. In some embodiments, the delivery device includes an implantable catheter, a catheter-like catheter, and a window along the length of the delivery device. When the implant is in the conduit, it is held proximal to the bevel at the distal end of the conduit. In some embodiments, the cross-sectional shape of the conduit comprises an ellipse. In an embodiment, the conduit and the implant are in a vascular endothelial cell when the implant is in the conduit. configured to form a friction fit with the implant is.

[0011] In some embodiments, the elastically deformable portion comprises teeth configured to have a contracted first shape and an expanded second shape. In some embodiments, the elastically deformable portion comprises teeth at an end of the implant. In some embodiments, the length of the implant includes a plurality of repeating features. In some embodiments, the implant comprises a plurality of ribs having alternating raised regions and recessed regions. In some embodiments, the implant has a first end feature and a second end feature different from the first end feature. In some embodiments, the first end feature includes a rounded end. In some embodiments, the implant includes a biodegradable material. In some embodiments, the implant includes a biocompatible biodegradable poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA). In some embodiments, the implant is configured to have an implant bending stiffness of 2.5e-6 to 1.5e-5.

[0012] Some embodiments include a stylet having a proximal gripping portion and a distal pushing portion configured to fit within a conduit. In some such embodiments, the stylet is configured such that when the implant and the pushing portion are disposed within the conduit and the pushing portion is moved within the conduit, the implant is moved through the conduit into tissue.

[0013] Another aspect of the invention provides a biodegradable longitudinal implant having a first end with an elastically deformable portion configured to have a contracted first shape and an expanded second shape. In some embodiments, the first shape includes a non-circular cross-section configured to orient the implant with respect to a delivery conduit of a nasal implant delivery device. In some embodiments, the second shape includes an expanded shape configured to fix the implant to nasal tissue when the implant is disposed within the nasal tissue. Some embodiments have a first feature and It includes a second end portion having a different second feature. Some embodiments comprise a length between the first end portion and the second end portion, which has a plurality of repeating features. In some embodiments, the implant has an outer diameter of less than 1.5 mm or less than 1.2 mm when in a shrunk first shape. .

[0014] In some embodiments, the implant is configured to have an implant bending stiffness of 2.5e-6 to 1.5e-5. In some embodiments, the length of the implant is less than 30 mm or less than 25 mm. In some embodiments, the elastically deformable portion has teeth at the ends of the implant. In some embodiments, this length includes a plurality of repeating features. In some embodiments, this length includes a plurality of ribs having alternating raised regions and recessed regions. In some embodiments, the feature of the first end portion includes a rounded end. In some embodiments, the implant comprises biocompatible biodegradable poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA).

[0015] Another aspect of the present invention provides a system for placing an implant into a patient's nasal tissue. This system includes an assembly comprising a grippable housing, a delivery conduit control mechanism, and an implant delivery conduit. In some embodiments, the implant delivery conduit has a piercing end configured to pierce body tissue. In some embodiments, the conduit is configured to hold the implant and place this implant into body tissue. In some such embodiments, the movement of the delivery conduit is controllable by the delivery conduit control mechanism. In some embodiments, the delivery conduit control mechanism is configured to move the delivery conduit away from the implant and towards the housing without moving the implant.

[0016] In some embodiments, it is configured to be connected to the end of the implant within the delivery conduit and includes an implant pushing member. In some such embodiments, the implant pushing member is configured to control the position of the implant when the implant is disposed within the conduit . In some embodiments, the delivery conduit control mechanism is further configured to move the conduit in a direction away from the implant pushing member.

[0017] Some embodiments include a first trigger member external to the housing. In some such embodiments, the first trigger member is configured to be actuated by a user's finger . In some such embodiments, this actuation moves the delivery conduit from a first position to a second position . In some such embodiments, the first trigger member is configured to move the delivery conduit into the housing when actuated. In some embodiments, the trigger member is configured to be actuated by a user's finger pulling on the trigger member. In some such embodiments, a handgrip is included proximal to the first trigger member. In some such embodiments, the handgrip is configured to be partially covered by the user's hand when the user's finger is positioned on the first trigger member . In some embodiments, the trigger configuration and handgrip are further configured to be usable by either a left-handed or right-handed person . Some embodiments include a second trigger member generally opposite the first trigger member, and the first trigger member and the second trigger member are configured to be simultaneously pulled by the fingers of the user's hand . In some embodiments, the trigger configuration and handgrip are further configured to be usable by either a left-handed or right-handed person . Some embodiments include a second trigger member generally opposite the first trigger member, and the first trigger member and the second trigger member are configured to be simultaneously pulled by the fingers of the user's hand .

[0018] ​In some embodiments, the implant pushing member is configured to hold the implant in place as the delivery conduit moves away from the implant. In some embodiments, the user-controllable safety feature is configured to hold the delivery conduit in a position advanced relative to the housing. In some embodiments, the implant further includes, for example, a biodegradable material. Some such embodiments include an implant pushing member, and the implant pushing member

[0019] and the implant have mating ends. Some embodiments further include a support member connected to the graspable housing, wherein the support member is configured to contact the patient's face, for example, when the delivery conduit is retracted from the implant during use of the assembly.

[0020] Another aspect of the present invention provides a method of implanting an implant into a patient's nasal tissue. Some embodiments include the step of mounting the implant within a graspable housing, the housing comprising a delivery conduit control mechanism for controlling movement of the delivery conduit;

[0021] attaching the implant delivery conduit to the housing; advancing the implant within the conduit until the implant is proximate the distal end of the conduit; and advancing the implant delivery conduit into the nasal tissue to penetrate the nasal tissue with the piercing end of the implant delivery conduit; using the delivery conduit control mechanism to retract the delivery conduit into the graspable housing from the implant, thereby leaving the implant in place within the nasal tissue. ​​​​​Steps; and removing the implant delivery conduit from the patient. In some embodiments the movement of the conduit is controllable by an implant delivery control mechanism.

[0022] Some embodiments release a safety mechanism controlled by the user, thereby enabling the movement of the delivery conduit; and further advancing the implant to the tip of the end of the conduit Steps. Some embodiments juxtapose the proximal end of the implant against an implant pushing member thereby preventing movement of the implant relative to the delivery conduit during the step of pulling back the delivery conduit. Some embodiments the housing is followed by a support member, and the method further includes contacting the support member against the patient's face during the step of pulling back the delivery conduit, thereby holding the housing in place on the patient's face. including the step of contacting the support member against the patient's face during the step of pulling back the delivery conduit, thereby holding the housing in place on the patient's face. Another aspect of the present invention provides a method of delivering an implant to nasal tissue. Some embodiments

[0023] include disposing a hollow delivery conduit holding an elastically deformable implant having a first shape within nasal tissue; and removing the hollow delivery conduit in a direction away from the implant, thereby deforming the implant into a second shape. Another aspect of the present invention includes a system for shaping an implant in body tissue, the system including a graspable housing having a delivery conduit control mechanism, an implant delivery conduit, and an energy delivery element. Some embodiments include a graspable housing having a delivery conduit control mechanism configured to control the movement of the delivery conduit. Some embodiments include an implant delivery conduit having a piercing end, i.e., connected to the delivery conduit control mechanism and piercing body tissue at the piercing end including the step of

[0024] Another aspect of the present invention includes a system for shaping an implant in body tissue, the system including a graspable housing having a delivery conduit control mechanism, an implant delivery conduit, and an energy delivery element. Some embodiments include a graspable housing having a delivery conduit control mechanism configured to control the movement of the delivery conduit. Some embodiments include an implant delivery conduit having a piercing end, i.e., connected to the delivery conduit control mechanism and piercing body tissue at the piercing end configured to control the movement of the delivery conduit. Some embodiments include an implant delivery conduit having a piercing end, i.e., connected to the delivery conduit control mechanism and piercing body tissue at the piercing end configured to control the movement of the delivery conduit. Some embodiments include an implant delivery conduit having a piercing end, i.e., connected to the delivery conduit control mechanism and piercing body tissue at the piercing end having a piercing end, i.e., connected to the delivery conduit control mechanism and piercing body tissue at the piercing end It includes a conduit configured to be inserted to place an implant within tissue. Some embodiments include an energy delivery element configured to deliver energy to the implant when the implant and the energy delivery element are placed within tissue. Some embodiments include an energy source for delivering energy to the energy delivery element. Some embodiments include an energy source control device configured to control the energy delivered from the energy source to the energy delivery device.

[0025] Some embodiments further include an energy-responsive implant disposed within the implant delivery conduit and configured to deform from a first shape to a second shape in response to energy delivered from the energy delivery element. In some such embodiments, the energy -responsive implant is configured to deform from the first shape to the second shape by conforming to the shape of a structure within body tissue. In some embodiments, the energy-responsive implant includes a heat-responsive biodegradable material. In some embodiments, the energy-responsive implant includes at least one of poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA). In some embodiments, the energy-responsive implant includes an internal cavity configured to receive the energy delivery element. In some embodiments, the energy delivery element is configured to deliver heat to the implant. In some embodiments, the delivery conduit control mechanism is configured to move the implant delivery conduit away from the energy-responsive implant, thereby placing the implant in contact with nasal tissue.

[0026] ​​​​​​​​​ Some embodiments further include a display configured to indicate whether an energy source is ready to deliver energy to an energy delivery element.

[0027] In some embodiments, the energy delivery element includes a flexible material configured to conform to the shape of the implant. In some embodiments, the energy delivery element comprises a resistive wire configured to fit inside the implant. In some embodiments, the energy delivery element is configured to at least partially surround the implant when the element is in use. In some embodiments, the energy delivery element further comprises a ribbon.

[0028] Some embodiments include an insulating material configured to separate the energy delivery element from nasal tissue when the energy delivery element is used to deliver energy to the implant.

[0029] In some embodiments, the implant delivery tube is configured to be at least partially retracted within a graspable housing. In some such embodiments, the energy delivery element is configured to move along the outside of the implant delivery conduit from the housing when the conduit is at least partially retracted within the graspable housing. In some such embodiments, the implant delivery conduit is further configured to move beyond the piercing end of the implant delivery conduit so as to at least partially cover the implant. In some other embodiments, the energy delivery element further comprises a clamping element configured to hold the energy delivery device outside the implant delivery conduit. In an embodiment, the energy delivery element further comprises an insulating material configured to separate the energy delivery element from tissue when used to deliver energy to the implant. Some embodiments include an energy delivery control mechanism connected to the housing and configured to move the energy delivery element relative to body tissue or the implant. In some such embodiments, the energy delivery control mechanism is further configured to move the energy delivery element relative to the housing. Some such embodiments include a pulley mechanism configured to retract the energy delivery element into the housing. Some embodiments include a user interface element external to the housing configured to control the operation of the energy delivery control mechanism in response to the user, thereby controlling the energy delivery element.

[0030] In some embodiments, the implant delivery conduit is configured to hold the implant within 10 mm of the piercing end during placement of the implant into tissue. Another aspect of the present invention provides a method of altering the shape of the nose. Such a method includes inserting an energy-responsive implant having a first shape into nasal tissue; inserting an energy delivery element into the nasal tissue; delivering energy from the energy delivery element to the energy-responsive implant, thereby increasing the flexibility of the energy-responsive implant; shaping the energy-responsive implant into a second shape; and removing energy from the energy-responsive implant, thereby

[0031]

[0032] a step of holding the implant in a second shape; an energy-responsive implant having the second shape removing an energy delivery element juxtaposed to nasal tissue from the nasal tissue; and applying a force from the energy-responsive implant to the nasal tissue, thereby changing the shape of the nose may include.

[0033] In some embodiments, the step of shaping the implant into a second shape includes the step of matching the implant to the shape of a portion of the nasal tissue. Some embodiments include, for example, applying a force to a portion of the nasal tissue to obtain a desired shape, and the step of shaping the implant includes the step of matching the implant to the desired shape of a portion of the nasal tissue. In some embodiments, the step of changing the shape of the nose includes the step of changing the shape of the nasal valve.

[0034] Another aspect of the present invention provides a method of shaping a nasal implant within nasal tissue. The method includes implanting an energy-responsive implant having a first shape into the nasal tissue; inserting an energy delivery element into an individual's nose; delivering energy from the energy delivery element to the implant, thereby increasing the flexibility of the implant; shaping the implant into a second shape; removing the energy from the implant, thereby holding the implant in the second shape. may include.

[0035] In some embodiments, the shaping step includes matching the implant to the shape within the body. In some embodiments, the step of removing the energy includes reducing the flexibility of the implant. In some embodiments, the step of delivering the energy includes It includes the step of heating the implant. In some such embodiments, the step of delivering energy includes heating the implant material to a temperature higher than the glass transition temperature (Tg) of the material. Some embodiments include the step of moving the energy delivery element to contact the implant before the step of delivering energy from the energy delivery element. Some embodiments include the step of inserting the energy delivery element into a housing equipped with a monitoring element, and this method may further include the step of monitoring at least one of the intensity of energy from the energy delivery element, the temperature of the implant, and the temperature of the nasal tissue. In some embodiments, the step of monitoring includes the step of using an open control loop process in the monitoring element. In some embodiments, the step of monitoring includes the step of using a closed control loop process in the monitoring element. Some embodiments further include the step of contacting and placing the implant on the nasal tissue before the step of delivering energy from the energy delivery element. Some embodiments further include the step of contacting and placing the implant on the nasal tissue after the step of delivering energy from the energy delivery element. In some embodiments, the step of delivering energy and the step of shaping the implant include performing these steps simultaneously using one instrument. Some embodiments include repeating the step of delivering energy from the energy delivery element, and this method further includes the step of shaping the implant into a third shape. In some such embodiments, energy is removed from the implant, thereby

[0036] Some embodiments further include the step of contacting and placing the implant on the nasal tissue before the step of delivering energy from the energy delivery element. Some embodiments further include the step of contacting and placing the implant on the nasal tissue after the step of delivering energy from the energy delivery element. In some embodiments, the step of delivering energy and the step of shaping the implant include performing these steps simultaneously using one instrument. Some embodiments include repeating the step of delivering energy from the energy delivery element, and this method further includes the step of shaping the implant into a third shape. In some such embodiments, energy is removed from the implant, thereby Some embodiments include repeating the step of delivering energy from the energy delivery element, and this method further includes the step of shaping the implant into a third shape. Some embodiments include repeating the step of delivering energy from the energy delivery element, and this method further includes the step of shaping the implant into a third shape. In some such embodiments, energy is removed from the implant, thereby including the step of holding the implant in a third shape.

[0037] Some embodiments include the step of implanting a second energy-responsive implant into nasal tissue and repeatedly delivering energy from an energy delivery element to the implant thereby increasing the flexibility of the implant. Some such embodiments further include the step of shaping the implant into a second shape. Some such embodiments further include removing energy from the implant, thereby holding the implant in a second shape of the second implant shape.

[0038] In some embodiments, the energy delivery element includes a flexible energy delivery element disposed along the length of the implant, and the shaping step further includes simultaneously shaping the energy delivery element and shaping the implant into a second shape, and the step of delivering energy includes delivering energy during the shaping step.

[0039] In some embodiments, the shaping step includes applying pressure to the implant using a shaping instrument attached to at least one of the inside and the outside of the nose. In some embodiments the shaping step includes applying pressure to the implant before and during the step of removing energy from the implant. Some embodiments include the step of leaving the implant partially within the needle during the step of shaping the implant. Some embodiments include repeating the step of delivering energy from the energy delivery element to the implant after the removing step, and the method includes holding the implant in a third Further comprising the step of forming into a shape.

[0040] In some embodiments, the step of implanting comprises the step of: Inserting the tip of the needle containing the material into the nose; moving the implant pushing member through the nasal tissue; retracting proximally against both of the implants; and an implant pushing member. In some such embodiments, the method further includes the step of retracting the needle away from the implant. In one embodiment, after the step of moving the needle, the implant, and the implant pushing member, moving the energy delivery element relative to the implant; activating; checking the temperature of the energy delivery element; a step of warning the user when the curing period has elapsed; removing the energy source from the implant; maintaining pressure on the implant during implant placement to maintain the implant shape; removing pressure from the implant; verifying the shape of the implant; and The method further includes removing the heating element from the implant without changing the position of the implant. In some embodiments, during the step of removing the energy delivery element, the implant pushing member Some such embodiments include a step of attaching the shaping device to the nosepiece. The step of shaping includes the step of placing the molded article in a fabric, the step of shaping including shaping the molded article using a shaping tool. Some embodiments include a step of verifying the shape of the implant after the molding step. Includes

[0041] Another aspect of the present invention provides another method of shaping an implant within nasal tissue, for example, by heating a delivery conduit. Some embodiments include the steps of: placing an implant delivery conduit containing an implant having a first shape into nasal tissue; heating a portion of the delivery conduit, thereby heating the implant; and after this heating step, shaping the implant into a second shape. Some embodiments further include, after the shaping step, withdrawing the implant delivery conduit from the nasal tissue and the implant, thereby placing the implant in contact with the nasal tissue. In some embodiments, the implant delivery conduit includes a cannula and a needle external to and generally concentric with the cannula, the cannula includes an energy delivery element, and the method further includes partially retracting the needle away from the implant prior to the step of heating a portion of the delivery conduit. Some such embodiments include partially retracting the cannula prior to the step of shaping the implant. In some embodiments where the implant delivery conduit includes a beveled needle, the method further includes heating nasal tissue in the vicinity of the delivery conduit with the heated delivery conduit. In some embodiments where the implant delivery conduit includes a heated inner portion, the method further includes insulating the nasal tissue from the heated inner portion. In some embodiments, the heating step includes heating the implant to a temperature at or above the glass transition temperature (Tg) of the implant material. In some embodiments, the heating step is at a temperature higher than body temperature.

[0042]

[0043] ​​​​​​​​​​​​​​​High, but heat the implant to a temperature lower than the glass transition temperature (Tg) of the implant material. It includes a step of heating.

[0044] Another aspect of the present invention includes a system for shaping an implant within tissue in the body, and this system includes a first grippable housing having an implant delivery conduit control mechanism; an energy delivery element control mechanism having a second grippable housing; and an energy delivery element. In some embodiments, the first grippable housing is connected to an implant delivery conduit and has an implant delivery conduit control mechanism configured to move this implant delivery conduit relative to an energy-responsive implant, and this grippable housing is configured to receive the implant delivery conduit and is connectable to a joining element. In some embodiments, the implant delivery conduit is connected to a joining element and is configured to hold the implant. Some embodiments include a second grippable housing having an energy delivery element control mechanism, and this energy delivery element control mechanism is connected to an energy delivery element and is configured to move this energy delivery element relative to the implant and is further configured to deliver energy to the energy delivery element, and the second housing is connectable by a joining element. Some embodiments include a joining element connectable to an energy delivery element, a first grippable housing, and a second grippable housing. Some embodiments include an energy delivery element configured to deliver energy to the implant when the energy delivery element and the energy-responsive implant are arranged. In some embodiments, the connector is always connected to the first housing or the second housing or both. Some embodiments include a second grippable housing having an energy delivery element control mechanism, and this energy delivery element control mechanism is connected to an energy delivery element and is configured to move this energy delivery element relative to the implant and is further configured to deliver energy to the energy delivery element, and the second housing is connectable by a joining element. Some embodiments include a joining element connectable to an energy delivery element, a first grippable housing, and a second grippable housing. Some embodiments include an energy delivery element configured to deliver energy to the implant when the energy delivery element and the energy-responsive implant are arranged. In some embodiments, the connector is always connected to the first housing or the second housing or both. Some embodiments include an energy delivery element configured to deliver energy to the implant when the energy delivery element and the energy-responsive implant are arranged. In some embodiments, the connector is always connected to the first housing or the second housing or both. Some embodiments include a joining element connectable to an energy delivery element, a first grippable housing, and a second grippable housing. Some embodiments include an energy delivery element and an energy-responsive implant arranged such that when the energy delivery element and the energy-responsive implant are arranged, energy is delivered to the implant. Some embodiments include an energy delivery element configured to deliver energy to the implant when the energy delivery element and the energy-responsive implant are arranged. In some embodiments, the connector is always connected to the first housing or the second housing configured to be connected to only one of them.

[0045] Some embodiments include an energy-responsive implant. Some embodiments include a power source connected to a grippable housing. configured to be connected to a grippable housing.

[0046] Yet another aspect of the present invention provides a method of shaping a nasal implant, including at least partially covering the nasal implant with a flexible energy delivery device and delivering energy from the energy delivery element to the implant. Some embodiments include placing an energy-responsive implant in nasal tissue; at least partially covering the implant with a flexible energy delivery element configured to deliver energy to the implant; delivering energy from the energy delivery element to the implant; and after the delivering step, shaping the implant into a desired shape. covering the implant with a flexible energy delivery element configured to deliver energy to the implant; and delivering energy from the energy delivery element to the implant. Some embodiments include placing an energy-responsive implant in nasal tissue; at least partially covering the implant with a flexible energy delivery element configured to deliver energy to the implant; delivering energy from the energy delivery element to the implant; and after the delivering step, shaping the implant into a desired shape. placing an energy-responsive implant in nasal tissue; at least partially covering the implant with a flexible energy delivery element configured to deliver energy to the implant; delivering energy from the energy delivery element to the implant; and after the delivering step, shaping the implant into a desired shape. covering the implant at least partially with a flexible energy delivery element configured to deliver energy to the implant; delivering energy from the energy delivery element to the implant; and after the delivering step, shaping the implant into a desired shape. and after the delivering step, shaping the implant into a desired shape.

[0047] In some embodiments, the flexible energy delivery element comprises a flat strip, and the step of at least partially covering comprises placing the flat strip along the outside of the implant. In some embodiments, the implant comprises an internal hollow region, and the step of at least partially covering comprises placing a resistive material within this hollow region. In some embodiments, the step of at least partially covering comprises placing a resistive wire within the internal hollow region, the resistive wire being configured to deliver heat to the implant. Some embodiments include an insulating element, and the method includes insulating nasal tissue from energy coming from at least one of the implant and the energy delivery element. covering the implant at least partially with a flexible energy delivery element configured to deliver energy to the implant; In some embodiments, the implant comprises an internal hollow region, and the step of at least partially covering comprises placing a resistive material within this hollow region. covering the implant at least partially with a flexible energy delivery element configured to deliver energy to the implant; In some embodiments, the step of at least partially covering comprises placing a resistive wire within the internal hollow region, the resistive wire being configured to deliver heat to the implant. covering the implant at least partially with a flexible energy delivery element configured to deliver energy to the implant; In some embodiments, the step of at least partially covering comprises placing a resistive wire within the internal hollow region, the resistive wire being configured to deliver heat to the implant. Some embodiments include an insulating element, and the method includes insulating nasal tissue from energy coming from at least one of the implant and the energy delivery element. In some embodiments, the step of at least partially covering comprises placing a resistive wire within the internal hollow region, the resistive wire being configured to deliver heat to the implant. Some embodiments include an insulating element, and the method includes insulating nasal tissue from energy coming from at least one of the implant and the energy delivery element. Further includes a flap. Some embodiments remove the flexible energy delivery element from the nasal region. Including steps.

[0048] Yet another aspect of the present invention is to insert an energy delivery conduit for holding an implant into nasal tissue. Step, and pulling back this conduit to expose the implant outside the conduit. Steps, and delivering energy to the implant, including a method of shaping a nasal implant within nasal tissue. This method includes inserting an energy delivery conduit into nasal tissue. Step, wherein the conduit holds an energy-responsive implant having a first shape and has an energy delivery element disposed along the outer surface; pulling back the conduit relative to the implant and the energy delivery element, thereby exposing a portion of the energy-responsive implant outside the conduit; positioning the energy delivery element in proximity to the energy-responsive implant, wherein the conduit holds a portion of the implant; delivering energy from the energy delivery element to the energy-responsive implant, thereby enhancing the flexibility of the implant; applying a force to the implant, thereby deforming the implant from the first shape to the second shape; and removing energy from the implant, thereby holding the implant in the second shape. Step, wherein the conduit holds an energy-responsive implant having a first shape and has an energy delivery element disposed along the outer surface; pulling back the conduit relative to the implant and the energy delivery element, thereby exposing a portion of the energy-responsive implant outside the conduit; positioning the energy delivery element in proximity to the energy-responsive implant, wherein the conduit holds a portion of the implant; delivering energy from the energy delivery element to the energy-responsive implant, thereby enhancing the flexibility of the implant; applying a force to the implant, thereby deforming the implant from the first shape to the second shape; and removing energy from the implant, thereby holding the implant in the second shape. Step, and delivering energy to the implant, including a method of shaping a nasal implant within nasal tissue. This method includes inserting an energy delivery conduit into nasal tissue. Step, and pulling back this conduit to expose the implant outside the conduit. Steps, and delivering energy to the implant, including a method of shaping a nasal implant within nasal tissue. This method includes inserting an energy delivery conduit into nasal tissue. Step, wherein the conduit holds an energy-responsive implant having a first shape and has an energy delivery element disposed along the outer surface; pulling back the conduit relative to the implant and the energy delivery element, thereby exposing a portion of the energy-responsive implant outside the conduit; positioning the energy delivery element in proximity to the energy-responsive implant, wherein the conduit holds a portion of the implant; delivering energy from the energy delivery element to the energy-responsive implant, thereby enhancing the flexibility of the implant; applying a force to the implant, thereby deforming the implant from the first shape to the second shape; and removing energy from the implant, thereby holding the implant in the second shape. Step, and delivering energy to the implant, including a method of shaping a nasal implant within nasal tissue. This method includes inserting an energy delivery conduit into nasal tissue. Step, and delivering energy to the implant, including a method of shaping a nasal implant within nasal tissue. This method includes inserting an energy delivery conduit into nasal tissue. Step, and delivering energy to the implant, including a method of shaping a nasal implant within nasal tissue. This method includes inserting an energy delivery conduit into nasal tissue. Step, and delivering energy to the implant, including a method of shaping a nasal implant within nasal tissue. This method includes inserting an energy delivery conduit into nasal tissue. Steps may be included.

[0049] The novel features of the present invention are particularly set forth in the appended claims. Referring to the following detailed description and the accompanying drawings, which illustrate exemplary embodiments in which the principles of the present invention are utilized, the features and advantages of the present invention will be better understood. Referring to the following detailed description and the accompanying drawings, which illustrate exemplary embodiments in which the principles of the present invention are utilized, the features and advantages of the present invention will be better understood. The features and advantages of the present invention will be better understood.

Brief Description of the Drawings

[0050]

Figure 1A

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DETAILED DESCRIPTION OF THE INVENTION

[0051] Various regions of the airway tissue can affect the airflow leading to the lungs. One of the major influences on the airflow is the nasal ventilation resistance. The most resistant structures in the nose are the narrowest regions, such as , the external nasal valve and the internal nasal valve. During normal inhalation, the nasal valve cartilage around these valves prevents or reduces the collapse of the valves and contributes to maintaining the patency of the airway. Incomplete internal and / or external valves can collapse during inhalation and impede the airflow. For example, aging, hypoplasia or weak cartilage, external surgical procedures (e.g., rhinoplasty, septoplasty), and / or problems with the nasal septum, turbinates, lateral cartilage, or other structures due to trauma can lead to problems with the nasal valves and affect the airflow.

[0052] Surgical procedures (e.g., submucous resection of the turbinate, septoplasty) have heretofore been used to reduce the size of the turbinate, or correct a deviated septum, or repair the nasal wall to improve the nasal valve and airflow. These surgical treatments are invasive, uncomfortable, and require a significant amount of time to recover. Furthermore, these surgical treatments cannot easily address problems with the lateral cartilage wall. The lateral cartilage wall has been repaired, for example, by cartilage grafting using additional material (cartilage) from the nose or ear. In addition to the limitations described above, these techniques are expensive (e.g., thousands of dollars), highly invasive, require a high level of surgical experience, have a long painful recovery period (e.g., a three-week downtime), are not always successful, and require a second surgically invasive site (the nasal region or ear to harvest cartilage). Invasive nasal surgery is difficult due to the need to continuously use the surgical site for breathing. Thus, the invasive surgical approach is far from ideal. Non-surgical approaches when the nasal valve collapses include strips or stent-like materials placed in or around the nose (e.g., "BreathRight", Breathe with EEZ, Nozovent). These temporary sub-optimal approaches have limited effectiveness and are of low cosmetic level.

[0053] This specification describes implants, assemblies, systems, and methods of using implants, assemblies, and systems that can be used to maintain and repair body tissue. These can be useful for minimally invasive procedures, including the treatment of outpatient patients, and can result in minimal pain and rapid recovery. These systems, assemblies, and methods can be used, for example, in a hospital or clinic. These can be used in a wide range of settings, and in some cases may require only adequate local anesthesia. The implants, assemblies, systems, and methods are particularly useful for treating nasal tissue, such as the internal nasal valve or the external nasal valve. Some implants may be useful for supporting and restoring the distal nasal valve. Could offer a long-term solution for improvement: semi-permanent implants that degrade over time The implant can only support the nasal tissue for a short period of time, but the implant remains intact. This is a response of the body (e.g., fibrosis) that reinforces the nasal tissue and supports it over time. The nasal treatment system is made of a biocompatible material that provides structural support to the surrounding nasal tissue. Preformed or moldable nasal implants may be utilized, including any of the following: The system is capable of penetrating the patient's nasal tissue and precisely positioning the implant within the patient's nose. This makes it possible.

[0054] FIG. 1A shows the underlying anatomy and tissues of the face with muscle and skin removed. The nasal bone and the remaining bones of the face are shown. The implant is not attached to any nasal or surrounding tissue. It can be juxtaposed, interposed, or attached or connected. In some embodiments, the implant is placed in the nasal tissue. It is partially inserted into the tissue and partially into the surrounding tissue (eg, the maxilla).

[0055] One aspect of the present invention provides a nasal implant for nasal valve repair. The graft may be used to augment a flap that may have already been treated with cartilage grafting or to provide other 1B and 1C show a conventional method used for repairing an internal valve. An implant is shown. Figure 1B shows an extended graft implanted in a patient's nose. . Figure 1C shows a alar batten graft implanted in a patient's nose. Figure 1D shows four implants according to one embodiment of the present invention implanted in a patient's nose to reinforce the nasal valve in these same areas. Any type of implant, for example, the implants described herein or any of the implants described in (Patent Document 1), (Patent Document 2), and (Patent Document 3) can be used. The method of using an implant can include the steps of passing the implant through the mucosa, passing the implant through the nasal area inside the lateral cartilage, and moving the implant along the maxilla. The implant can be additionally or alternatively placed submucosally to treat the expanded area between the lateral cartilage and the septal cartilage. In some embodiments, the implant is formed from an absorbable material. These implants are implanted in a position that supports the lateral wall cartilage and helps to resist or reduce the movement of the cartilage during inhalation, thereby maintaining the patency of the patient's airway. As shown, the implant is positioned such that its most distal point is in close contact with the maxilla. The implant can be disposed between the maxilla and the overlying soft tissue (shown in Figures 1F and 1G). Figure 1F shows the internal anatomy of the nose and the positions where the implant can be implanted (see the ellipse in Figure 1F). Note that the implant traverses (or is adjacent to) one area that is 4836, lesser alar cartilage 4838, and fibroadipose tissue 4840 shows an implant disposed within nasal tissue at a location such as shown in FIG. 1F with respect thereto. In FIG. 1F, a portion of the nasal tissue is cut away to illustrate the relationship of the implant to the nasal tissue in the region of the maxilla Specifically, the implant acts between the maxilla 4844 below the implant and the soft tissue above the implant. Soft tissue above the bone (e.g., periosteum, muscle, dermis 4842, etc.) may be located adjacent to the bone. The soft tissue and bone wrap around the implant, thereby holding the implant in place . The implant so held acts on other portions of the implant (e.g., portions passing through or near the lateral cartilage) to hold the implant in place and support the cartilage and nasal valve. By this efficacy, the implant supports the lateral cartilage so that the lateral cartilage does not collapse. The implant can substantially prevent rotational and / or longitudinal movement thereof. The implant can prevent inward movement of the lateral cartilage during inhalation without providing cosmetic changes . Alternatively, the distal surface of the implant can be simply placed in contact with the edge of the surface of the maxilla . In either case, the proximal end of the implant can extend to a position below the lateral wall

[0056] cartilage, such as in a deep alar graft . In either case, the proximal end of the implant can extend to a position below the lateral wall cartilage, such as in a deep alar graft

[0057] The implant can also be placed in the same position as the conventional spread graft shown in FIG. 1B, i.e., between the upper edge of the septal cartilage and the lateral wall cartilage, such that the implant extends from the base of the nose The angle of the lateral cartilage can be increased when the implant is placed. 1I and 1J show a view of the patient's nostrils. Two implants were inserted and pressed between the lateral cartilage and the nasal septum, increasing the internal nasal angle. This shows the point.

[0058] As mentioned above, the nose is a complex three-dimensional structure with a relatively narrow range of different tissue types. The three-dimensional shape of the blood vessels allows them to carry out various functions, such as transporting air (especially oxygen) to the lungs. function of heating the air, humidifying the air, and providing a pleasant smell to food and other items. These structures (and the structures shown in these drawings) serve the function of detecting both unpleasant and unpleasant odors. Nasal implants placed in the nose are not tolerated. Improve (or maintain) nasal function and / or improve nasal function without causing any adverse side effects Therefore, the complex 3-dimensional structure of the right tissue should be improved (or maintained) in order to improve (or maintain) the appearance of the The placement of the right implant can provide these benefits. Control of short-term and long-term effects on tissues may also affect the success of nasal implants. The size and shape of the implant are optimized to fit the specific nasal anatomy to achieve the desired effect. Implants can be remarkably successful. Implants that conform or even match the shape of a particular nasal anatomy are sometimes The present invention relates to implants, assemblies, systems, and Methods for using such implants, assemblies, and systems are provided, as well as methods for using the same. may be used to control the initial placement of the implant into the desired tissue area or to improve nasal function and / or Or can provide an implant that is particularly suitable for short - or long - term success in improving (or maintaining) the appearance of the nose. An implant can be provided.

[0059] Figures 2A - 2B, 3A - 3B, 4A - 4B, 5A - 5B, and 6A - 6E show a simple nasal implant system and modified configurations for inserting the implant into nasal tissue. are shown.

[0060] Figures 2A - 2B and 3A - 3B show the nasal implant system used. Figure 2A (perspective view) and Figure 2B (longitudinal cross - sectional view) show the nasal implant system ready to place the implant in nasal tissue or in the process of passing through nasal tissue (nasal tissue is not shown in this figure). Figure 3A (perspective view) and Figure 3 (longitudinal cross - sectional view) show the same nasal implant system as it appears after the implant has been placed in nasal tissue. The nasal implant system can include a delivery needle, a stylet, and an implant. are shown. Figure 2A (perspective view) and Figure 2B (longitudinal cross - sectional view) show the nasal implant system ready to place the implant in nasal tissue or in the process of passing through nasal tissue (nasal tissue is not shown in this figure). Figure 3A (perspective view) and Figure 3 (longitudinal cross - sectional view) show the same nasal implant system as it appears after the implant has been placed in nasal tissue. The nasal implant system can include a delivery needle, a stylet, and an implant. The nasal implant system can include a delivery needle, a stylet, and an implant. The nasal implant system can include a delivery needle, a stylet, and an implant. The nasal implant system can include a delivery needle, a stylet, and an implant.

[0061] Figures 2A - 2B show a system 150 that includes a hollow delivery needle 152 for placing implant 104 into nasal tissue. The hollow delivery needle 152 has a piercing end 162 that penetrates tissue for placement. The hollow needle 152 can be held or moved using the needle knob 156. For example, by pushing the needle knob 156, the needle 152 can be inserted into nasal tissue, or by pulling the knob 156, the needle 152 can be removed from the nasal tissue and separated from the implant. System 150 can include implant 104. Implant 104 can be pre - attached to the needle 152 by a physician or other user before use, or during treatment (e.g., minimally invasive procedure The hollow delivery needle 152 has a piercing end 162 that penetrates tissue for placement. The hollow delivery needle 152 has a piercing end 162 that penetrates tissue for placement. The hollow delivery needle 152 has a piercing end 162 that penetrates tissue for placement. The hollow delivery needle 152 has a piercing end 162 that penetrates tissue for placement. 50 can include implant 104. Implant 104 can be pre - attached to the needle 152 by a physician or other user before use, or during treatment (e.g., minimally invasive procedure procedure) the implant 104 can be loaded into the needle 152 by the physician or other user. The physician or other user may attach it to the needle 152, for example, during an invasive or non-invasive procedure. The system 150 may also include a stylet 158 configured to fit within the needle 152. The stylet 158 can hold the implant 104 within the hollow needle 152, or, for example, hold the implant 104 in a first position relative to the nasal tissue when the needle 152 is withdrawn from the implant 104. The stylet 158 can push the implant 104 into the needle 152 to adjust the position of the implant 104. For example, the stylet 158 can first push or reposition the implant 104 into the needle 152 before, for example, placing the needle 152 and the implant 104 into the nasal tissue. The stylet 158 can push the implant 104 to the implant insertion position such that the distal end 168 of the implant 104 is close to the piercing end 162 of the needle 104. Specifically, the distal end 168 can be proximal to the bevel of the piercing end. Move the needle 156 through the nasal tissue to the implant position. The depth of insertion of the needle into the tissue can be indicated by a mark 164 that can be verified by the physician or other user. Such a mark can be graduated, for example, in 1 mm increments up to a maximum of 30 mm. Since the depth of the needle in the tissue is indicated by the mark and the needle is withdrawn from the implant, the mark can accurately indicate the depth at which the implant is to be placed. The physician or other user can receive tactile feedback from the body tissue to determine when the needle has reached the appropriate position. For example, the physician or other user can feel when the needle contacts a hard object ( For example, it is possible to "feel" when hitting the bone) or to "feel" a change in the behavior of the needle. Or when the needle contains a radiopaque material, the physician can "confirm" the position of the needle using an imaging device.

[0062] After the needle 156 has been moved through the nasal tissue to the implant position, but before releasing the implant from the needle, the stylet 158 can be used to push the implant 104 to the implant implantation position so that the distal end 168 of the implant 104 can be located at the most distal side of the bevel of the piercing end. From the proximal side to the distal side of the bevel of the distal end of the implant the movement can be a movement of 0 mm to 10 mm, 1 mm to 7 mm, or 2 mm to 4 mm. The hollow delivery needle 152 that holds the implant 104 can be placed within the nasal tissue.

[0063] Figures 3A - 3B show the nasal implant system of FIGS. 2A - 2B that appears after the implant has been placed within the nasal tissue. The structure changed with respect to the positions of FIGS. 2A - 2B at the positions of FIGS. 3A - 3B is indicated by adding lowercase letters ( "a", "b", etc.) after the corresponding reference numerals (e.g., 152a). Specifically, ( while still within the hollow needle 152) the implant 104 is placed at the desired nasal tissue position, and after the stylet 158 abuts against the proximal end 166 of the implant 104 (e.g., the end closest to the physician or other user), the needle 152b is pulled back by moving the needle knob 156b in a direction away from the implant 104 (e.g., pulling), whereby the implant 104 is placed in the tissue at the same position as when this implant 104 was within the needle. ​​​​​​​​​​Leave it inside. In the next step, the stylet knob 160 and the needle knob 156b are used to pull (either together or separately) the stylet and the needle out of the tissue, leaving the implant in the proper position in the tissue to improve (or maintain) the function of the nose and / or improve (or maintain) the appearance of the nose. In another embodiment, the needle 152 can still hold with respect to the implant 104. In this case, the implant 104 can be pushed out of the needle by pressing the proximal end 166 of the stylet 158 against the implant 104. In yet another embodiment, the implant 104 can be placed in the nasal tissue (e.g., removed from the needle) using both operations: pulling the needle back from the implant and pushing the implant out of the needle using the stylet. Leave it in the proper position in the tissue to improve (or maintain) the function of the nose and / or improve (or maintain) the appearance of the nose.

[0064] In another embodiment, the needle 152 can still hold with respect to the implant 104. In this case, the implant 104 can be pushed out of the needle by pressing the proximal end 166 of the stylet 158 against the implant 104. In yet another embodiment, the implant 104 can be placed in the nasal tissue (e.g., removed from the needle) using both operations: pulling the needle back from the implant and pushing the implant out of the needle using the stylet. In yet another embodiment, the implant 104 can be placed in the nasal tissue (e.g., removed from the needle) using both operations: pulling the needle back from the implant and pushing the implant out of the needle using the stylet. In yet another embodiment, the implant 104 can be placed in the nasal tissue (e.g., removed from the needle) using both operations: pulling the needle back from the implant and pushing the implant out of the needle using the stylet. In yet another embodiment, the implant 104 can be placed in the nasal tissue (e.g., removed from the needle) using both operations: pulling the needle back from the implant and pushing the implant out of the needle using the stylet. In yet another embodiment, the implant 104 can be placed in the nasal tissue (e.g., removed from the needle) using both operations: pulling the needle back from the implant and pushing the implant out of the needle using the stylet.

[0065] Figures 4A - 4B show another embodiment of a nasal implant system for placing an implant in nasal tissue, similar to the nasal implant systems shown in Figures 2A - 2B and Figures 3A - 3B with different control mechanisms. The needle knobs 176a - 176b are provided with enlarged knobs and can be gripped or held by the user's hand or finger and thumb to insert and retract the needle 172 against the nasal tissue as described above. See also cross - sectional view 186. The stylet or pusher 178 can be gripped or held by the user's hand (e.g., the opposite hand) or the user's finger and thumb when the stylet is disposed within the needle 172 to maintain the implant 104 in the proper position and retract the needle 172 to place the implant 104 in the nasal tissue. In yet another embodiment, the implant 104 can be placed in the nasal tissue (e.g., removed from the needle) using both operations: pulling the needle back from the implant and pushing the implant out of the needle using the stylet. The needle knobs 176a - 176b are provided with enlarged knobs and can be gripped or held by the user's hand or finger and thumb to insert and retract the needle 172 against the nasal tissue as described above. The needle knobs 176a - 176b are provided with enlarged knobs and can be gripped or held by the user's hand or finger and thumb to insert and retract the needle 172 against the nasal tissue as described above. The stylet or pusher 178 can be gripped or held by the user's hand (e.g., the opposite hand) or the user's finger and thumb when the stylet is disposed within the needle 172 to maintain the implant 104 in the proper position and retract the needle 172 to place the implant 104 in the nasal tissue. The stylet or pusher 178 can be gripped or held by the user's hand (e.g., the opposite hand) or the user's finger and thumb when the stylet is disposed within the needle 172 to maintain the implant 104 in the proper position and retract the needle 172 to place the implant 104 in the nasal tissue. The stylet or pusher 178 can be gripped or held by the user's hand (e.g., the opposite hand) or the user's finger and thumb when the stylet is disposed within the needle 172 to maintain the implant 104 in the proper position and retract the needle 172 to place the implant 104 in the nasal tissue. The stylet or pusher 178 can be gripped or held by the user's hand (e.g., the opposite hand) or the user's finger and thumb when the stylet is disposed within the needle 172 to maintain the implant 104 in the proper position and retract the needle 172 to place the implant 104 in the nasal tissue. The stylet or pusher 178 can be gripped or held by the user's hand (e.g., the opposite hand) or the user's finger and thumb when the stylet is disposed within the needle 172 to maintain the implant 104 in the proper position and retract the needle 172 to place the implant 104 in the nasal tissue.

[0066] ​ Figures 5A - 5B are similar to the nasal implant systems shown in Figures 2A - 2B, 3A - 3B, and 4A - 4B, but show another embodiment of a nasal implant system for placing an implant into nasal tissue, with a needle formed to fit the body and a different control mechanism. Such a body - conforming needle can be useful for placing an implant in areas difficult to reach with, for example, a straight needle, or for forming an implant that fits the body for insertion into tissue to place the implant into nasal tissue (e.g., to place an implant into tissue to support the tissue properly). A body - conforming implant can appropriately match the shape of the tissue and support the tissue. A pre - formed body - conforming implant can be more effective, for example, during re - shaping of a part of the nasal tissue from a first shape to a second shape by applying a greater force by the tissue. A body - conforming implant can provide superior support (compared to, for example, an implant with a circular cross - section). Figure 5A also shows an elliptical cross - section 181 of the implant and the needle. Figures 6A - 6E show another embodiment of a nasal implant system similar to the above - described nasal implant system. The interior of the implant and the needle can have a (matching) elliptical cross - sectional shape. However, the implants shown in Figures 6C - 6E are pre - formed to have a certain curvature. Some

[0067] implants can include an elastic material. Some implants are temporarily held within the needle for a short time while the needle places the implant into the nasal tissue. ​​​It can be deformed (for example, a curved implant can be placed in a straight needle). Some embodiments provide a method of placing an implant in tissue, the method comprising applying a force to an implant having a pre-delivery shape (or a first shape) to hold it within a needle and retain the implant in a delivery shape (or a second shape); placing the implant having the needle and the delivery shape into nasal tissue; and removing the needle from the implant, thereby allowing the implant to return to its pre-delivery shape (first shape) without applying force to the implant. The implant may comprise a soft engagement portion to prevent movement, as described in detail below. The orientation of the implant is determined by the cross-section or shape of the needle. Another aspect of the invention includes a system for placing an implant in a patient's nasal tissue. Such a system can include an assembly including a grippable housing and a delivery conduit control mechanism, and a needle (or other implant delivery conduit, such as a hollow implant delivery conduit) having a piercing end configured to pierce body tissue, the conduit being configured to hold an implant and place the implant in body tissue, and the movement of the delivery conduit being controlled by the delivery conduit control mechanism. In such a system, once the implant is placed in the appropriate position within the tissue, the implant can be removed from the needle. By removing the implant from the needle in this way, the implant can be placed in a specific nasal tissue region with a high degree of accuracy and manipulation.

[0068]

[0069] FIG. 7A shows an assembly 101 and a hollow delivery ​​​​​​​​​​​​Shows the configuration of a nasal implant system 100 with a needle 102 (or other hollow delivery conduit) Figure 7A shows an implant mounted within the needle. Figures 7B and 7C show other configurations of the same system in use for placing the implant within nasal tissue Figure 7B shows the implant mounted within the needle and the advanced needle just prior to withdrawing the needle to position the implant properly Figure 7C shows the needle withdrawn from the implant and the implant placed within nasal tissue. Between related drawings (e.g between Figures 7A, 7B, and 7C), structures at different positions are indicated by adding a letter (such as "a", "b", etc.) after the corresponding reference numeral (e.g., 101a, 101b ). Figure 7A shows the attachment of the implant to the nasal implant assembly and the movement of the implant distally toward the distal end of the needle . Figure 7B shows the insertion of the needle into nasal tissue and the advancement of the implant distally beyond the distal end of the needle . Figure 7C shows the withdrawal of the needle and the placement (release) of the implant into the tissue .

[0070] Figure 7A shows a hollow delivery needle with a proximal end (closest to the physician or other user) and a distal end (closest to the patient ), the distal end having a piercing tip 112 that can penetrate nasal tissue when force is applied to the needle to move to the desired implant location. Needle 102a is hollow and is attached via a Luer fitting 130 to a Luer connection of the body 111 of the assembly (not shown in this figure). Prior to attachment to the body 111, the nasal implant was mounted to the proximal end of the needle. The system for placing the implant within nasal tissue is A stylet (or other implant insertion member) for placing the implant may be further included. To move the implant 104 to the needle implantation position (e.g., to the distal end of the needle), a physician (or other user) moves the stylet control lever 114a from the proximal position to the distal position, whereby the stylet moves towards the proximal end of the implant and the implant is pushed near the distal end of the needle. Compare the position of the stylet control lever 114a in FIG. 7A with the forward (distal) position of the stylet control lever 114b in FIG. 7B. The implant is placed at the bottom of the bevel (the short side of the bevel) of the piercing end 112 (distal end) of the needle. In other embodiments, the implant can be placed along the bevel in the middle thereof. Generally, the end of the implant is the bottom of the bevel, or less than 1 mm, less than 2 mm, less than 3 mm, or less than 6 mm from the bottom of the bevel. Here, the implant is in the moving position within the needle 102a, and the implant 10 4 moves to the implantation position through the nasal tissue. The needle 102 also has a piercing end 112 at its distal end. The body 111 is held by a physician or other user's hand, and guides the needle 102a holding the implant 104 through the piercing end 112 through the body tissue to the desired implant position within the nasal tissue. In some embodiments, the implant near the end of the needle blocks at least partially the opening of the needle, reducing or preventing core removal of the tissue (the core of the tissue comes out or is collected within the needle). By preventing or minimizing core removal of the tissue, the pain of the patient is reduced and the recovery time is shortened. By placing the implant at the bottom of the bevel without substantially protruding from the opening of the needle, when the needle advances into the tissue, the bevel far can be compared with the forward (distal) position of the stylet control lever 114b in FIG. 7B. The implant is placed at the bottom of the bevel (the short side of the bevel) of the piercing end 112 (distal end) of the needle. In other embodiments, the implant can be placed along the bevel in the middle thereof. Generally, the end of the implant is the bottom of the bevel, or less than 1 mm, less than 2 mm, less than 3 mm, or less than 6 mm from the bottom of the bevel. Here, the implant is in the moving position within the needle 102a, and the implant 10 is placed at the bottom of the bevel of the piercing end 112 (distal end) of the needle. In other embodiments, the implant can be placed along the bevel in the middle thereof. Generally, the end of the implant is the bottom of the bevel, or less than 1 mm, less than 2 mm, less than 3 mm, or less than 6 mm from the bottom of the bevel. Here, the implant is in the moving position within the needle 102a, and the implant 10 4 moves to the implantation position through the nasal tissue. The needle 102 also has a piercing end 112 at its distal end. The body 111 is held by a physician or other user's hand, and guides the needle 102a holding the implant 104 through the piercing end 112 through the body tissue to the desired implant position within the nasal tissue. In some embodiments, the implant near the end of the needle blocks at least partially the opening of the needle, reducing or preventing core removal of the tissue (the core of the tissue comes out or is collected within the needle). By preventing or minimizing core removal of the tissue, the pain of the patient can be the bottom of the bevel, or less than 1 mm, less than 2 mm, less than 3 mm, or less than 6 mm from the bottom of the bevel. Here, the implant is in the moving position within the needle 102a, and the implant 10 4 moves to the implantation position through the nasal tissue. The needle 102 also has a piercing end 112 at its distal end. The body 111 is held by a physician or other user's hand, and guides the needle 102a holding the implant 104 through the piercing end 112 through the body tissue to the desired implant position within the nasal tissue. In some embodiments, the implant near the end of the needle blocks at least partially the opening of the needle, reducing or preventing core removal of the tissue (the core of the tissue comes out or is collected within the needle). By preventing or minimizing core removal of the tissue, the pain of the patient 4 is in the moving position within the needle 102a, and the implant 10 4 moves to the implantation position through the nasal tissue. The needle 102 also has a piercing end 112 at its distal end. The body 111 is held by a physician or other user's hand, and guides the needle 102a holding the implant 104 through the piercing end 112 through the body tissue to the desired implant position within the nasal tissue. In some embodiments, the implant near the end of the needle blocks at least partially the opening of the needle, reducing or preventing core removal of the tissue (the core of the tissue comes out or is collected within the needle). By preventing or minimizing core removal of the tissue, the pain of the patient is reduced and the recovery time is shortened. By placing the implant at the bottom of the bevel without substantially protruding from the opening of the needle, when the needle advances into the tissue, the bevel far is reduced and the recovery time is shortened. By placing the implant at the bottom of the bevel without substantially protruding from the opening of the needle, when the needle advances into the tissue, the bevel far is reduced and the recovery time is shortened. By placing the implant at the bottom of the bevel without substantially protruding from the opening of the needle, when the needle advances into the tissue, the bevel far end of the implant at least partially blocks the opening of the needle to reduce or prevent core removal of the tissue (the core of the tissue comes out or is collected within the needle). By preventing or minimizing core removal of the tissue, the pain of the patient is reduced and the recovery time is shortened. By placing the implant at the bottom of the bevel without substantially protruding from the opening of the needle, when the needle advances into the tissue, the bevel far is reduced and the recovery time is shortened. By placing the implant at the bottom of the bevel without substantially protruding from the opening of the needle, when the needle advances into the tissue, the bevel far end of the implant at least partially blocks the opening of the needle to reduce or prevent core removal of the tissue (the core of the tissue comes out or is collected within the needle). By preventing or minimizing core removal of the tissue, the pain of the patient The distal tip can perform a cutting function.

[0071] After the needle 102a has moved through the nasal tissue to the implantation position, but before the implant is released from the needle the physician (or other user) moves the stylet control lever 114a from the proximal position to the distal position, whereby the implant 104 is further pushed slightly beyond the distal end of the needle (e.g., to the distal side of the bevel of the piercing end). This movement can be 0 mm to 1 0 mm, 1 mm to 7 mm, or 2 mm to 4 mm. By this additional movement the implant is positioned near or beyond the point where the distal end of the needle is inserted into the nasal tissue.

[0072] The system may also include a needle control mechanism 108a (e.g., a delivery guide control mechanism) for controlling the movement of the needle 102a. The needle control mechanism 106a moves from the first position shown in FIG. 7B to the second position shown in FIG. 7C and back to the needle control mechanism 106b, whereby the control mechanism pulls the needle 102a from the first position shown in FIG. 7B proximal to the implant 104 to the second position within the graspable housing 110 shown by the needle 102b in FIG. 7C. When the needle is retracted, the implant 104 disposed within the nasal tissue remains in the desired position. The needle control mechanism may include a lever 108a configured for use by a physician or other user to control the movement of the needle. The lever 108a can move from the first position (shown in FIG. 7B) to the second position (shown in FIG. 7C). The stylet (not shown in this figure) can extend distally between the graspable housings 110 and can be disposed at least partially within the hollow needle 102a or 102b ​ It can be cut. The stylet can be connected to the proximal end of the implant and can control the movement of the implant relative to the needle. Specifically, the stylet can prevent the implant from moving proximally when the needle is retracted. Moreover, the stylet can maintain the implant in a desired position when the implant is withdrawn from the needle (e.g., when the needle is retracted from the implant). In some embodiments, such means for withdrawing from the needle is a needle designed such that the needle, particularly the piercing tip of the needle, enters the tissue with minimal tissue damage and contributes to the penetration of all tissues. The implant does not have to be pushed or inserted to a predetermined position against the nasal tissue. All of tissue damage, patient pain, and healing time are reduced. In addition, the control mechanism and the needle can move relative to the housing; that is, the housing is maintained in its position when the needle control mechanism and the needle are retracted toward the housing, or pass through the housing, or partially pass through the housing. Specifically, the assembly is configured such that the housing and the stylet - and the implant - are securely held by a physician or other user when the needle moves, thereby placing the implant in a desired position within the nasal tissue. In some embodiments, the assembly allows a physician or other user to readjust the needle after the needle has been placed in the tissue. In some embodiments, the implant can be attached to the distal end of the needle.

[0073]

[0074]

[0075] ​​​​​​​​​​​​​​In an embodiment, the needle can be pre-mounted with an implant, for example, by itself or as part of a kit, before being used by a physician or other user. In some embodiments, the implant can be mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). In some embodiments, the needle can be larger than 10 gauge (e.g., 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32 gauge, or less than 32 gauge). The implant can be sized to fit (e.g., fit tightly to the needle). In some embodiments, using a thinner needle can reduce tissue damage. In some embodiments, the thinner needle can fit (better) into narrow regions of the nasal tissue (e.g., between the skin / mucosa and cartilage of the nose). Figures 8A - 8C show another embodiment of a system for placing an implant within a patient's nasal tissue, related to the embodiment of Figures 7A - 7C. Figure 8A shows the configuration of a nasal implant system 130 comprising an assembly 131 and a hollow delivery needle 102 (or other hollow delivery conduit) for implanting implant 104 into the nasal tissue. Figure 8A shows the implant mounted on the needle. Figures 8B and 8C show other configurations of the same system when used to place the implant within the nasal tissue. Figure 8B shows the implant being mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly).

[0076] In some embodiments, the needle can be larger than 10 gauge (e.g., 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32 gauge, or less than 32 gauge). The implant can be sized to fit (e.g., fit tightly to the needle). In some embodiments, using a thinner needle can reduce tissue damage. In some embodiments, the thinner needle can fit (better) into narrow regions of the nasal tissue (e.g., between the skin / mucosa and cartilage of the nose). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly).

[0077] Figures 8A - 8C show another embodiment of a system for placing an implant within a patient's nasal tissue, related to the embodiment of Figures 7A - 7C. Figure 8A shows the configuration of a nasal implant system 130 comprising an assembly 131 and a hollow delivery needle 102 (or other hollow delivery conduit) for implanting implant 104 into the nasal tissue. Figure 8A shows the implant mounted on the needle. Figures 8B and 8C show other configurations of the same system when used to place the implant within the nasal tissue. Figure 8B shows the implant being mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). mounted on the needle by a physician or other user before performing a nasal implant procedure, such as a non-invasive or minimally invasive procedure. In some embodiments, the implant can be mounted within the stylet passage via a side port (e.g., of the body of the assembly). Shown are the implant mounted on the needle and the advancing needle, just before retracting the needle for placement at the appropriate location. FIG. 8C shows the needle retracted from the implant and the implant placed within the nasal tissue. FIG. 8A shows the attachment of the implant to the nasal implant assembly and the movement of the implant near the distal end of the distal end of the needle. FIG. 8B shows the insertion of the needle into the nasal tissue and the movement of the implant distally of the distal end of the needle. FIG. 8C shows the retraction of the needle and the placement (release) of the implant into the tissue. The detailed description of the attachment of the implant, the advancement of the implant to the distal end of the needle, the placement of the needle and implant into the nasal tissue, and the retraction of the needle to place the implant in the nasal tissue and contact the nasal tissue is as described above for FIGS. 7A - 7C. The changes to FIGS. 7A - 7C include the shape and orientation of the stylet control levers 144a, 144b and the shape and orientation of the needle control mechanisms 137a, 137b.

[0078] FIGS. 9A - 9C show a system for placing an implant within a patient's nasal tissue. FIGS. 9A - 9C show another embodiment of a system for placing an implant within a patient's nasal tissue, related to the embodiments of FIGS. 7A - 7C and FIGS. 8A - 8C. FIG. 9A shows the configuration of a nasal implant system 130 comprising an assembly 131 and a hollow delivery needle 102 (or other hollow delivery conduit) for implanting an implant 104 into nasal tissue. FIG. 9A shows the implant mounted on the needle. FIGS. 9B and 9C show other configurations of the same system when used to place the implant within the nasal tissue. B shows the implant attached to the needle and the advanced needle just before retracting the needle to place the implant in the proper position. Figure 9C shows the needle retracted from the implant and the implant placed within the nasal tissue. Figure 9A shows the attachment of the implant to the nasal implant assembly and the movement of the implant near the distal end of the distal end of the needle. Figure 9B shows the configuration of the system when inserting the needle into the nasal tissue and advancing the implant distally to the distal side of the distal end of the needle. Figure 8C shows the configuration of the system when retracting the needle to place (release) the implant within the tissue. The detailed description of the attachment of the implant, the advancement of the implant to the distal end of the needle, the placement of the needle and implant into the nasal tissue, and the retraction of the needle to place the implant within the nasal tissue and bring it into contact with the nasal tissue is as described above in FIGS. 7A-7C. Changes to FIGS. 7A-7C include the shape and orientation of the stylet control levers 184a, 184b and the shape and orientation of the needle control mechanisms 177a, 177b.

[0079] As previously described at different times, the implant 104 may be moved within the assembly 101 or into the needle 102, or held in a suitable position within the assembly 101 or the needle 102. The end of the implant 104 can be held by the stylet. The needle 102 can be further configured internally, for example, to hold the implant 104 by a tight fit with the implant. A tight fit holds the implant firmly enough within the needle, but the force from the stylet or other pusher when retracting the needle to place the implant within the nasal tissue moves the implant to the proper position. ​ It can be a loose friction fit that can be maintained. In such an embodiment, no mechanism for holding the implant or for releasing the implant from the needle or cutting instrument is required to place the implant into the nasal tissue by pulling the delivery needle back from the implant. A "just right" friction fit can also be useful for holding the implant in a needle, e.g., in a kit. FIGS. 10A - 10J illustrate some embodiments of the implant. Any of these implants can be used with any of the systems, assemblies, and devices, and any of the methods described herein, or the implant can be used with other stems, assemblies, or devices described elsewhere. It can be a loose friction fit that can be maintained. In such an embodiment, no mechanism for holding the implant or for releasing the implant from the needle or cutting instrument is required to place the implant into the nasal tissue by pulling the delivery needle back from the implant. A "just right" friction fit can also be useful for holding the implant in a needle, e.g., in a kit.

[0080] FIGS. 10A - 10J illustrate some embodiments of the implant. Any of these implants can be used with any of the systems, assemblies, and devices, and any of the methods described herein, or the implant can be used with other stems, assemblies, or devices described elsewhere. FIGS. 10A - 10J illustrate some embodiments of the implant. Any of these implants can be used with any of the systems, assemblies, and devices, and any of the methods described herein, or the implant can be used with other stems, assemblies, or devices described elsewhere. It can be a loose friction fit that can be maintained. In such an embodiment, no mechanism for holding the implant or for releasing the implant from the needle or cutting instrument is required to place the implant into the nasal tissue by pulling the delivery needle back from the implant. A "just right" friction fit can also be useful for holding the implant in a needle, e.g., in a kit.

[0081] Such implants may be useful for placement in body tissue, such as nasal tissue. One aspect of the present invention provides an implant that is generally longitudinally elastic and has a first end, a second end, and a length therebetween, the implant comprising surface features along this length. In some embodiments, the implant is configured to have an implant bending stiffness of from 2.5e-6 to 1.5e-5. In some embodiments, the implant is configured to have an implant bending stiffness of from 2.5e-6 to 1.5e-5 after contacting body tissue for at least 3 months, at least 6 months, at least 9 months, or at least 1 year. Some embodiments of the implant include one or more surface features (such as fins, notches, ribs, or scallops). Some embodiments of the implant include resorbable features (such as PLLA-PDLA in a ratio of 90:10 to 50:50). Some embodiments include implants having a curvature at an angle greater than 0 degrees and less than 45 degrees, less than 35 degrees, less than 25 degrees, or less than 15 degrees. Some embodiments include implants less than 30 mm, less than 25 mm, less than 20 mm, or less than 15 mm. Some embodiments include implants having a diameter (such as an outer diameter) configured to form a tight fit within a 16-gauge needle. Some embodiments have an outer diameter of less than 1.5 mm, less than 1.2 mm, less than 1.0 mm, or from 0.8 to 1.2 mm. In some embodiments, the implant includes a color that is not easily visible through the skin (such as skin color, tan, brown, etc.). In some embodiments, the implant includes a radiopaque material. The implant may maintain its shape; be strong yet flexible; such properties may be similar to cartilage.

[0082] Another aspect of the present invention includes a longitudinally extending implant having a first end, a second end, and a length therebetween, the first end having end features. In some embodiments the second end has end features. In some embodiments, the first end features and the second end features are the same. In some embodiments, the first end features and the second end The end features may have the same structure. In some embodiments, the first end feature and the second end feature may have different structures. In some embodiments, the end structure is configured to couple to a pusher instrument . In some embodiments, the end feature includes an ellipse. In some embodiments, the end feature includes an extension feature, such as teeth or fins. The extension feature, when inserted into the nasal tissue , may be useful for preventing movement of the implant, such as movement into the path or space remaining after removal of the needle that placed the implant into the tissue . The extension feature may be useful for fixing the implant to bone or cartilage. In some embodiments, an implant with a distal end of an ellipse may enable attachment of the implant to bone at any angle of the implant .

[0083] The end features may be useful for fixing the implant together with the tissue. One or more surface features may be useful for fixing the implant together with the tissue .

[0084] Another aspect of the invention provides an adjustable (e.g., adjustable for an individual patient) implant . In some embodiments, the shape of the implant conforms in situ to the shape of the nasal tissue . In some embodiments, a specific length of the implant can be selected based on the size of an individual's nasal structure .

[0085] FIG. 10A shows an implant that includes scallops, such as a series of circular segments or angular protrusions . Such scallops, segments, or protrusions can provide additional surface area to reduce or prevent movement of the implant (e.g., such as retraction of the implant into the incision or needle insertion site) for (e.g., for interaction with the tissue) . Such scallops, segments, or protrusions can be used to indicate length and can provide stability during resection of the implant.

[0086] Figure 10B shows an implant having an elliptical first end and an elliptical second end. The elliptical ends can provide a larger surface area to be supported by tissue at any angle.

[0087] Figure 10C shows an implant having an elliptical first end (semi-elliptical). The elliptical end can provide a larger surface area to be supported by tissue at any angle.

[0088] Figure 10D shows an implant having a plurality of ribs and a conical first end and a conical second end. The implant can have one rib or two or more ribs. Such ribs can have alternating raised regions and recessed regions (valleys) with a smooth transition between the rib and the recess (valley). The conical ends can provide a larger surface area to be supported by tissue at any angle when the implant is placed within the tissue. The ribs along the axis can provide additional surface area for tissue attachment. The valleys of the ribs can provide stability when cutting the implant.

[0089] Figure 10E shows an implant having a plurality of fins (as described above) and conical ends. One or two or more fins can provide additional surface area for tissue attachment to the implant. The valleys of the fins can provide stability during cutting of the implant.

[0090] Figure 10F shows an implant having a first semi-elliptical end and a second end with a concave end feature. It shows a plant. The concave end feature enables tissue to enter into the implant obtainable. The concave end feature can be coupled to a matching shape ( e.g., elliptical) of an insertion instrument (e.g., stylet, pusher).

[0091] Figure 10G shows an implant having a first semi-elliptical end and a plurality of notches (e.g., along one side or one region of the implant ). One or more notches can provide an effect for reducing or preventing the movement of the implant (e.g., retraction of the implant to the incision or needle insertion site, or retraction through the incision or needle insertion site). One or more notches can provide stability during cutting of the implant and indication of length (e.g., for cutting of the implant ).

[0092] Figure 10H shows an implant having a first semi-elliptical end and a second end with an expansion feature. The concave expansion feature can enable tissue to enter into the implant obtainable. The concave end feature can be coupled to a matching shape (e.g., elliptical) of an insertion instrument (e.g., stylet, pusher). The flare shape can be compressed within an insertion instrument (e.g., a needle) and can be expanded or expand after being placed in the tissue. Such an expansion feature can provide an effect for reducing or preventing the movement of the implant (e.g., retraction of the implant to the incision or needle insertion site or retraction through the incision or needle insertion site).

[0093] Figure 10I shows an implant having a first semi-elliptical end and a second end with a plurality of teeth. is shown. One or more teeth at the implant end can be compressed within the insertion instrument (needle). When placed in tissue, one or more teeth can expand to impart effectiveness to the implant. Such expansion features can impart effectiveness to reduce or prevent movement of the implant (e.g., retraction of the implant into the incision or needle insertion site, or retraction through the incision or needle insertion site). When placed in tissue, one or more teeth can expand to impart effectiveness to the implant. Such expansion features can impart effectiveness to reduce or prevent movement of the implant (e.g., retraction of the implant into the incision or needle insertion site, or retraction through the incision or needle insertion site). When placed in tissue, one or more teeth can expand to impart effectiveness to the implant. Such expansion features can impart effectiveness to reduce or prevent movement of the implant (e.g., retraction of the implant into the incision or needle insertion site, or retraction through the incision or needle insertion site). When placed in tissue, one or more teeth can expand to impart effectiveness to the implant. Such expansion features can impart effectiveness to reduce or prevent movement of the implant (e.g., retraction of the implant into the incision or needle insertion site, or retraction through the incision or needle insertion site). When placed in tissue, one or more teeth can expand to impart effectiveness to the implant. Such expansion features can impart effectiveness to reduce or prevent movement of the implant (e.g., retraction of the implant into the incision or needle insertion site, or retraction through the incision or needle insertion site).

[0094] Figure 10J shows an implant with a first conical end and a second conical end and a plurality of modified fins along the axis. The modified fins show a (continuous) progression from a short length to a long length from a first region (which can be the first end region) to a second region (which can be the second end region). Such modified fins can provide additional surface area for tissue attachment. The valleys of the fins can impart stability when cutting the implant and can indicate the length of the implant (e.g., for cutting the implant). Figure 10J shows an implant with a first conical end and a second conical end and a plurality of modified fins along the axis. The modified fins show a (continuous) progression from a short length to a long length from a first region (which can be the first end region) to a second region (which can be the second end region). Such modified fins can provide additional surface area for tissue attachment. The valleys of the fins can impart stability when cutting the implant and can indicate the length of the implant (e.g., for cutting the implant). Figure 10J shows an implant with a first conical end and a second conical end and a plurality of modified fins along the axis. The modified fins show a (continuous) progression from a short length to a long length from a first region (which can be the first end region) to a second region (which can be the second end region). Such modified fins can provide additional surface area for tissue attachment. The valleys of the fins can impart stability when cutting the implant and can indicate the length of the implant (e.g., for cutting the implant). Figure 10J shows an implant with a first conical end and a second conical end and a plurality of modified fins along the axis. The modified fins show a (continuous) progression from a short length to a long length from a first region (which can be the first end region) to a second region (which can be the second end region). Such modified fins can provide additional surface area for tissue attachment. The valleys of the fins can impart stability when cutting the implant and can indicate the length of the implant (e.g., for cutting the implant). Figure 10J shows an implant with a first conical end and a second conical end and a plurality of modified fins along the axis. The modified fins show a (continuous) progression from a short length to a long length from a first region (which can be the first end region) to a second region (which can be the second end region). Such modified fins can provide additional surface area for tissue attachment. The valleys of the fins can impart stability when cutting the implant and can indicate the length of the implant (e.g., for cutting the implant). Figure 10J shows an implant with a first conical end and a second conical end and a plurality of modified fins along the axis. The modified fins show a (continuous) progression from a short length to a long length from a first region (which can be the first end region) to a second region (which can be the second end region). Such modified fins can provide additional surface area for tissue attachment. The valleys of the fins can impart stability when cutting the implant and can indicate the length of the implant (e.g., for cutting the implant). Figure 10J shows an implant with a first conical end and a second conical end and a plurality of modified fins along the axis. The modified fins show a (continuous) progression from a short length to a long length from a first region (which can be the first end region) to a second region (which can be the second end region). Such modified fins can provide additional surface area for tissue attachment. The valleys of the fins can impart stability when cutting the implant and can indicate the length of the implant (e.g., for cutting the implant).

[0095] An implant with ribs or an implant with a regular repeating pattern that includes a biodegradable material can form a controlled degradation pathway. An implant with ribs or an implant with a regular repeating pattern that includes a biodegradable material can form a controlled degradation pathway.

[0096] Figures 10K - 10N show cross - sectional views of various embodiments of the implant.

[0097] Figures 11 and 12A - 12C show another system for placing an implant into a patient's nasal tissue. Such a system includes an assembly with a grippable housing and a delivery guide control mechanism, and an implant holder for holding and placing the implant into the nasal tissue Figures 11 and 12A - 12C show another system for placing an implant into a patient's nasal tissue. Such a system includes an assembly with a grippable housing and a delivery guide control mechanism, and an implant holder for holding and placing the implant into the nasal tissue Figures 11 and 12A - 12C show another system for placing an implant into a patient's nasal tissue. Such a system includes an assembly with a grippable housing and a delivery guide control mechanism, and an implant holder for holding and placing the implant into the nasal tissue can include a needle (or other hollow implant delivery conduit) configured as such, the needle further having a piercing end for piercing body tissue to move the needle through the body tissue.

[0098] Figure 11 shows another configuration of a nasal implant system 500 with a hollow delivery needle 102 (or other hollow delivery conduit) for implanting the assembly 501 and the implant 104 into nasal tissue. Figure 12A - Figure 12C show a similar nasal implant system 520 with a modified form of a stylet (e.g., the proximal end of the needle) control knob that can be used to push the implant into the needle before attachment to the needle assembly. The nasal implant system 500 or the nasal implant system 520 can have the option to withdraw the implant, thereby allowing the implant to be more accurately positioned within a particular nasal tissue. In summary, Figures 11 and 12A - Figure 12C show the configuration of the system during the steps in the placement of the implant into nasal tissue. Figure 11 shows a nasal implant system with a delivery needle 102 ready for placement to place the implant (not shown) into nasal tissue. Referring to Figures 12A - Figure 12B, the implant 104 has a proximal end 168 (closest to the physician or other user; not easily visible in this figure) and a distal end. The implant 104 is already attached to the proximal end of the delivery needle 102, and the proximal end of this delivery needle 102 is connected to a graspable housing 510. The implant 104 is pushed distally through the needle 102 under the control of the implant control knob 508 by a stylet (e.g., rotation of the implant control knob 508 by the physician or other user) and the proximal end of the delivery needle 102 is connected to a graspable housing 510. The Advance it towards the distal side, place it close to the piercing end 112 of the needle 102, and hold it in close contact with the piercing end 112 of the needle. The delivery needle 102 with the implant 104 held in the vicinity of the piercing end 112 is placed into the body tissue (e.g., nasal tissue), and then advanced through the body tissue (e.g., through the nasal tissue or surrounding tissue), and the piercing end 112 of the needle 102 is placed at the most distal end of the desired implantation position. Once the piercing end 112 of the needle 102 is properly positioned, advance the implant 104 further distally to the sufficiently distal end of the needle 102 (e.g., the distal end of the bevel). At this point, the implant is ready to be placed within the nasal tissue and can be withdrawn from the needle. The user grasps or holds the handgrip 512. The user places the first finger on the (distal portion) of the first trigger member 502 and the second finger on the (distal portion) of the second trigger member 504. The user presses the safety button 514 to enable movement of the needle 102. The user pulls the first trigger member and the second trigger member, thereby pulling the needle into the housing 510 where it can be gripped and withdrawing the implant 104 at the appropriate position within the tissue. Then, the assembly 501 is pulled back from the nasal tissue, leaving the implant in place.

[0099] Figures 13A - 13C show the technical diagrams of an embodiment of an apparatus similar to the apparatus shown in Figures 11 and 12A - 12C. Figures 14 and 15 show the side view and internal structure of an embodiment of an assembly similar to the assembly shown in Figures 11, 12A - 12C, and Figures 13A - 13C. Figures 14 - 21 show single trigger, double trigger, "pe ​​​​​​A grippable housing including embodiments of a "cylindrical grip" and embodiments of a pistol grip shows various embodiments of rings, handgrips, and triggers. In some embodiments , a double trigger and a pistol grip are combined. In some embodiments, the assembly / ha ndle grip is configured such that a single person can perform various operations (e.g., inserting a needle and an implant into tissue , unlocking a safety device of the needle, extracting the implant / withdrawing the needle from the tissue , and withdrawing the assembly from nasal tissue). In some embodiments , the assembly / grip is configured such that it can be used by either a right-handed or left-handed person (e.g., without changing the assembly / handgrip at all). In some embodiments , the assembly is configured to place the implant with a force of 10 N or less. In some embodiments, the assembly is configured to pull back with a force of 10 N or less.

[0100] Another aspect of the present invention provides a system, an assembly, and an implant, as well as a method for shaping the implant within tissue in the body . By shaping the implant in vivo, it becomes possible to specifically adapt the shape of the implant to the anatomical structure of the nose (in terms of size and shape) , thereby enabling appropriate handling of the condition corrected by the implant . Shaping the implant in the body (e.g., into a non-linear shape) can also reduce tissue damage, for example, by enabling the use of a thin needle during implant insertion . The use of specially shaped implants can provide advantages , such as obtaining a larger reshaping surface and a level of support for tissue that requires support . The possibility of being pushed out (e.g., the implant being pushed out of the proper position) is reduced, or the possibility of the explant being visible from the outside is reduced. Implants that are specially shaped can offer advantages, but there are numerous problems in generally providing implants that are specially shaped in vivo. One problem is how to supply energy to the implant so that it responds to the shaping. Another problem is how to minimize tissue damage that can occur by the system or device used for shaping or energy delivery. Another problem is how to prevent damage to the nasal tissue by the energy supplied for shaping the implant. Another problem is how to remove any energy delivery element or shaping device while preventing or minimizing damage to the nasal tissue. Another problem is how to reshape an implant placed in the nasal tissue when a physician or other individual does not have easy access to the implant. Another problem is what to do if the implant is initially formed in an undesired shape. The implant can be heated by external heating / conduction heating. After implant insertion, heat can be applied directly to the patient's nose by conduction with a heating device from inside the nostril, from outside the nostril, or both simultaneously. A force can be applied using the heating device to shape the implant. The implant can be heated by external heating / alternating heating that applies heat directly to the patient's nose by a heating device from inside the nostril, from outside the nostril, or both simultaneously. The heat source can be, for example, ultrasound or microwaves. The implant can be preformed as described later with a preformed

[0101] ​​​​​​​​​​​​​​It can be heated by a new heater. After insertion, the tip of the needle is heated. As a result, the implant and the local tissue are heated, and the cooling of the implant is reduced. The needle is removed , and the implant is rapidly formed (free forming). The implant can be heated by an internal heating / cannula heater as described later. After insertion, the needle is retracted to expose the heater at the end of the cannula . As a result, the implant at the end of the cannula is heated . The heater is withdrawn from the implant after the implant is formed. An integrated insertion instrument and heater instrument can be used: forming can be performed simultaneously with insertion. The implant can be heated by a flexible heater / ribbon heater as described later. The flexible heater element wraps around the implant. Both components are inserted together into the patient's body . After the needle is retracted, the flexible heater is heated and the implant is formed. Next , the flexible heater is removed. The heater can be a flexible ribbon heater that wraps around the implant . An insulating material can be provided to protect the internal tissue. The insertion instrument and the heater instrument can be integrated. As a result, the local implant temperature can be made sufficiently higher than the glass transition temperature, which enables simple bending of the implant . The implant can be heated by an internal heating / flexible heater / coil wire as described later. The flexible heating element can be arranged at the center of the implant . The heater can be a resistance heater or a heat conductor. Both components can be inserted together into the patient's body. After the needle is retracted, the flexible heater can be heated to form the implant.

[0102] Any form of energy capable of shaping the implant (e.g., heat, microwave, ultrasonic wave) can be used. Any form of energy delivered to the implant that enables or causes the implant to be deformed can be used. For example, the energy can be delivered from outside the nose (e.g., by conduction, or by ultrasonic or microwave). The energy can be, for example, a heater that heats the end of the implant, a heater that heats the side of the implant, or delivered from inside the nose by heating inside the nose. A system for shaping an implant within body tissue includes a graspable housing with a delivery conduit control mechanism; a hollow implant delivery conduit having a piercing end, connected to the delivery conduit control mechanism, its movement being controlled by this delivery conduit control mechanism, and configured to hold the implant, pierce body tissue with the piercing end, and place the implant within the tissue, the hollow implant delivery conduit; an energy delivery element configured to deliver energy to the implant when the implant and the energy delivery element are disposed within the tissue; an energy source for delivering energy to the energy delivery

[0103] Figure 22 shows a part of a system 188 for shaping an implant within body tissue, and Figures 23A - 23C show the steps in shaping a nasal implant within nasal tissue using such a system. This system and method relate to the relationship A heating element is used between, and this heating element is delivered into nasal tissue using a delivery needle. In the present disclosure, Similar to the other needles and implants described in other parts, FIG. 22 shows that the implant 104 is ready to be withdrawn from the needle by the needle 102 to be placed at an appropriate position within the tissue, and shows an implant disposed within the needle that can be confirmed at an appropriate position within the tissue. The implant 104 includes a heat-responsive material (e.g., an energy-responsive material), by which the implant 104 can become more flexible when exposed to heat. FIG. 22 further shows a heater 190 (energy delivery element) that is between the stylet and the implant and is configured to heat the implant. FIGS. 23A - 23N show the steps in the insertion of the heat-responsive implant into the tissue and the change in the shape of the implant. FIGS. 23A - 23B show the preparation steps. FIG. 23A shows a physician examining the nose to find the optimal position of the implant and anesthetizing the patient near the insertion site. The physician waits for the anesthesia to take effect and disinfects the surface of the insertion site with a disinfectant solution. FIG. 23B shows that the implanting instrument has been taken out of the sterilization package and is ready. FIGS. 23C - FIG. 23I show the insertion steps. FIG. 23C shows that the needle tip of the implanting instrument is being inserted into the patient's nose by the physician. FIG. 23D shows carefully guiding the needle within the nasal tissue so that the path is surely in an appropriate position. The depth of the needle is monitored by a visual cue integrated into the outer shaft. This depth is indicated by the position of the implant relative to the bone. The position of the implanting instrument can still be slightly changed up, down, right, and left. FIG. 23E shows that when at an appropriate depth and position, the needle is released ​ and is shown to be movable relative to the stylet and the implant. FIG. 23F shows that the needle is removed from around the implant while the implant and the stylet remain fixed. FIG. 23G shows that the implant is maintained within the nasal tissue while the heating element faces the implant. FIG. 23H shows that the heater is activated and can reach the correct temperature. FIG. 23I shows that the heater is warming the implant so that the implant can become flexible at the location that needs to be corrected. FIGS. 23 J - FIG. 23N show the shaping of the implant. FIG. 23J shows that when the implant is capable of being shaped, the implant is shaped by applying pressure with a shaping tool. FIG. 23K shows that the power to the heater is turned off and the shape of the implant hardens by cooling of the implant. FIG. 23L shows that the shape of the implant is confirmed and further heating and molding are performed as necessary. FIG. 23M shows that the heating element is removed from around the implant while the stylet remains engaged. FIG. 23N shows that the stylet and the implantation device are removed from the patient. The specially shaped implant remains within the nasal tissue. A method of shaping an implant within tissue includes the steps of placing an energy - responsive implant having a first shape within nasal tissue; inserting an energy delivery element into an individual's nose; delivering energy from the energy delivery element to the implant, thereby increasing the flexibility of the implant; shaping the implant into a second shape; and removing energy from the implant. FIG. 23N shows that the stylet and the implantation device are removed from the patient. The specially shaped implant remains within the nasal tissue. A method of shaping an implant within tissue includes the steps of placing an energy - responsive implant having a first shape within nasal tissue; inserting an energy delivery element into an individual's nose; delivering energy from the energy delivery element to the implant, thereby increasing the flexibility of the implant; shaping the implant into a second shape; and removing energy from the implant. The method of shaping an implant within tissue includes the steps of placing an energy - responsive implant having a first shape within nasal tissue; inserting an energy delivery element into an individual's nose; delivering energy from the energy delivery element to the implant, thereby increasing the flexibility of the implant; shaping the implant into a second shape; and removing energy from the implant. placing an energy - responsive implant having a first shape within nasal tissue; inserting an energy delivery element into an individual's nose; delivering energy from the energy delivery element to the implant, thereby increasing the flexibility of the implant; shaping the implant into a second shape; and removing energy from the implant. delivering energy from the energy delivery element to the implant, thereby increasing the flexibility of the implant; shaping the implant into a second shape; and removing energy from the implant. shaping the implant into a second shape; and removing energy from the implant. - removing it, thereby retaining the implant in a second shape. This By using a system or method such as this, during shaping, the implant can be made to conform to the body tissue, enabling the implant and the body tissue to be accurately fitted together.

[0104] Figures 24A - 24E show another embodiment of a system 200 for shaping an implant within tissue in the body using energy. Figure 24A shows a cannula 198a and a needle 1196a with a heating element, where the implant 104(a) is disposed within the cannula heating element for delivery to a desired implantation tissue location within the nasal tissue for implantation. The cannula heating element is disposed within the needle, as shown. Once the implant 104(a ), cannula 198a, and needle 196b are delivered to the desired position, the needle 196a is withdrawn as shown in Figure 24C, leaving the cannula 198a and the implant 104a contained within this cannula 198a at the desired implantation tissue location. After protecting the nasal tissue with insulation 202 from excessive heat and heating the implant, the cannula 198b is withdrawn, removing the heated (flexible) implant 104(a ) from the desired tissue location and leaving it in place. The implant 104b can be rapidly shaped, for example, by forming a bend 206 in the implant. Any external pressure (e.g., an instrument pressing on the outside of the nose) or internal pressure (e.g., an instrument pressing ) on the inside of the nose) can be used to specifically shape the implant against the nasal tissue. In other embodiments, the needle remains in position around the cannula during the heating step.

[0105] It is possible. In other embodiments, the needle and the cannula can form a single unit .

[0106] Steps in a method of using such a heating element include: placing a hollow delivery conduit containing an implant having a first shape into nasal tissue; heating a portion of the delivery conduit to thereby heat the implant; after this heating step, shaping the implant into a second shape; and retracting the conduit from the nasal tissue and the implant to thereby place the implant in contact with the nasal tissue. In some embodiments, the delivery conduit includes an interior (cannula) that includes insulation, and the method further includes insulating the nasal tissue. ; heating a portion of the delivery conduit to thereby heat the implant ; after this heating step, shaping the implant into a second shape ; and retracting the conduit from the nasal tissue and the implant to thereby place the implant in contact with the nasal tissue. In some embodiments, the delivery conduit includes an interior (cannula) that includes insulation, and the method further includes insulating the nasal tissue. ; and retracting the conduit from the nasal tissue and the implant to thereby place the implant in contact with the nasal tissue. In some embodiments, the delivery conduit includes an interior (cannula) that includes insulation, and the method further includes insulating the nasal tissue.

[0107] Figures 25A - 25C show another embodiment of a system 196 for shaping an implant within tissue in the body using energy. This system is a central axis heater configured to deliver energy to the implant from within the interior (center) of the implant. The energy - responsive implant 198 has a hollow interior for receiving a heating element 204, and this heating element can be, for example, a rod or a wire (e.g., a resistive wire, a heat - conducting rod). The resistive wire can enable the implant to be heated uniformly along its entire length. Figure 25A shows the system 196 when inserting a needle 102a that houses an implant 198a into nasal tissue, and this implant 198a houses a heating element 204 (this system maintains the same configuration as just before being inserted into the nasal tissue). The energy - responsive implant 198 has a hollow interior for receiving a heating element 204, and this heating element can be, for example, a rod or a wire (e.g., a resistive wire, a heat - conducting rod). ; and this heating element can be, for example, a rod or a wire (e.g., a resistive wire, a heat - conducting rod). The resistive wire can enable the implant to be heated uniformly along its entire length. Figure 25A shows the system 196 when inserting a needle 102a that houses an implant 198a into nasal tissue, and this implant 198a houses a heating element 204 (this system maintains the same configuration as just before being inserted into the nasal tissue). ; and this implant 198a houses a heating element 204 (this system maintains the same configuration as just before being inserted into the nasal tissue). (this system maintains the same configuration as just before being inserted into the nasal tissue). . As shown in Figure 25B and described in other parts, insert into the desired position within the tissue After that, the needle 102b is retracted and the implant 198a is withdrawn. The heater is operated until the implant is above Tg. Above Tg, the implant is freely formed. Once the desired shape is obtained, the operation of the heater is stopped and the implant is cooled until it is below Tg (this cooling can be, for example, less than 20 seconds). As shown in FIG. 25C, while holding the rear portion of the implant in place, the heater element within the heater element is retracted. Then, the device is retracted from the implant.

[0108] Figures 26A - 26D illustrate another embodiment of an integrated implantation and heating system 224 with a central axis heater for shaping an implant using energy within tissue in the body. This system integrates an implantation operation function including retraction of the needle and a heating function including retraction of the heater into a single housing. This system can be used with any implant or heating system, but is particularly useful with an implant system having a central axis heater for heating the implant, such as the system shown in FIGS. 25A - 25 C. FIG. 26A shows a perspective view of the system during delivery before heating the implant, and FIG. 26B shows a cross - sectional view of this system. FIG. 26C shows a cross - sectional view of the system after the needle has been retracted but before heating and shaping are complete. FIG. 26D shows a cross - sectional view of the system after heating and shaping are complete. System 224 has a grippable housing 226. System 224 has a heater on / off switch 236 for controlling the heating of the heater, a battery for supplying heat to the heater, . FIG. 26C shows a cross - sectional view of the system after the needle has been retracted but before heating and shaping are complete. FIG. 26D shows a cross - sectional view of the system after heating and shaping are complete.

[0109] System 224 has a grippable housing 226. System 224 has a heater on / off switch 236 for controlling the heating of the heater, a battery for supplying heat to the heater, and a temperature sensor for monitoring the temperature of the implant. The system also has a central axis heater 240 disposed within the housing 226. Terry 234 (e.g., an energy source), and an LED indicating when shaping can be performed including an indicator light 238. The system 224 has a slider retraction mechanism 2 32 for coupling to a needle after the implant is placed in the appropriate position within the tissue and pulling the needle back (removing) from the implant. The system 224 further includes a needle retraction button 2 28 for controlling the slider retraction mechanism 232. The system 224 further includes a heater retraction knob 230 connected to a pulley mechanism for retracting the heater. FIGS. 26A and 2 6B illustrate the steps of inserting the needle 102 into the desired position within the nasal tissue; and unlocking the needle retraction button 2 28a. FIG. 26C illustrates the step of sliding the needle retraction button 228 to the moving end to pull back the needle and extract the implant. FIG. 26C also illustrates the steps of turning on the heater on / off button 236, waiting for the LED indicator light 238 to turn on, indicating by the activation of the LED indicator light 238 that the implant is ready to be shaped from the first shape to the second shape, and shaping the implant to the second shape (not easily visible in this figure) . FIG. 26D illustrates that the implant is sufficiently cooled (e.g., to hold the implant in the second shape), and the heater retraction knob 230 is rotated to activate the pulley retraction mechanism 2 40 to pull the heater 204a back from the implant 104. Finally, the assembly is removed from the nasal tissue. FIGS. 27A - 27G and FIG. 28 illustrate another embodiment of a system 242 for shaping an implant using energy within tissue in the body. This system has a first housing

[0110] FIGS. 27A - 27G and FIG. 28 illustrate another embodiment of a system 242 for shaping an implant using energy within tissue in the body. This system has a first housing ​​​​​​An implantation operation function including retracting the needle into the jig, and a second housing of the heating control and the heater Retraction into the jig and retraction into a third housing of the battery and the heating control The heating function is separated. This system can be used with any implant or heating system However, it is particularly useful for an implant system equipped with a central axis heater for heating the implant, for example, the system shown in FIGS. 25A to 25C FIG. 27A shows a perspective view of the needle control housing in use, and FIGS. 27B to 27C Show a cross-sectional view of this needle control housing. FIGS. 27D to 27G show diagrams of the heating and Retraction device in use. FIG. 28 shows a diagram of the battery and the heating control housing FIG. 28 shows a diagram of the battery and the heating control housing FIG. 28 shows a diagram of the battery and the heating control housing

[0111] System 242 includes a first grippable housing 244 for controlling the needle. The system 242 includes a first grippable housing 244, and this first grippable housing 244 is coupled to the needle after the implant is placed in the appropriate position within the tissue to control the slider retraction mechanism 232 for retracting (pulling out) the needle from the implant And includes a needle retraction button 228. System 242 includes a second grippable Housing 246 with a heating and retraction device. System 242 includes a third housing 24 8, a heater on / off switch 236 for controlling the heating to the energy delivery element, a battery 234 for supplying heat to the heater, and an LED display lamp 238 indicating when the forming can be performed and when the implant is sufficiently cooled to maintain its shape 8, a heater on / off switch 236 for controlling the heating to the energy delivery element, a battery 234 for supplying heat to the heater, and an LED display lamp 238 indicating when the forming can be performed and when the implant is sufficiently cooled to maintain its shape 8, a heater on / off switch 236 for controlling the heating to the energy delivery element, a battery 234 for supplying heat to the heater, and an LED display lamp 238 indicating when the forming can be performed and when the implant is sufficiently cooled to maintain its shape 8, a heater on / off switch 236 for controlling the heating to the energy delivery element, a battery 234 for supplying heat to the heater, and an LED display lamp 238 indicating when the forming can be performed and when the implant is sufficiently cooled to maintain its shape

[0112] Figures 27A and 27B illustrate the steps of inserting the needle 102 into the nasal tissue and unlocking the needle retraction button 228. Figure 27C shows the steps of sliding the needle retraction button 228 to the moving end and locking the needle retraction button. Figures 27C and 27D show removing the implantation device by twisting it from the heater and the implant, leaving behind the energy-responsive implant 198 attached to the frame 250, which includes the electrical contact 252 and the screw rod 254 for retracting the heater. Figures 27E and 27F show attaching the heating and retraction device 246a to the implant and the heater 254. Figure 27G shows a cross-sectional view of the implant, the heater, and the retraction device with the heater retracted. The retraction device includes a one-way torque-limiting screw nut 241 and a screw rod 243 connected to the heater. Figure 28 shows a third housing 248 equipped with a heater control device and a battery pack that can be attached to the heating and retraction device 246 by the wire 239. The third housing 248 equipped with the battery pack and the heater control device is turned on using the heater on / off button 236. When the LED indicator light 238 is turned on, the implant 198 is formed (as described in other parts). When the LED indicator light 238 turns off the second grippable housing - implant heater retraction knob, the heating and retraction device 246 rotates to move the screw rod 254 (shown in Figure 27D) and retracts the heater from the implant as shown in Figure 27F.

[0113] ​​​​​​​​​​​​​​Any of the above systems, assemblies, or methods can utilize an energy-responsive implant. The energy source can raise the temperature of the implant to a temperature above its glass transition temperature (Tg) so that the implant can be shaped. When the material is above its Tg, the material can be freely shaped. When the temperature of the material is below its Tg, the material maintains its shape. Any of the above systems, assemblies, or methods can apply force using a heating device to shape the implant. After shaping, the heating device can be removed. Figures 29-31 show an assembly 212 including a housing support member 216 connected to a graspable housing 214, where the distal end 220 of the support member is configured to abut the patient's face during use of the support member. Such a housing support member can help hold the assembly 212 in an appropriate position (e.g., with minimal movement or essentially no movement) relative to the patient's face during use of the assembly when the needle is retracted from the implant; thereby maintaining the implant in the desired implantation position during retraction of the needle. In some embodiments, the housing support member can be an extension from the distal face of the assembly. In some embodiments, the housing support member can be slidable from the body of the delivery device. In some embodiments, the housing support member can be spring-loaded (e.g., including a stiff spring). In some embodiments, steps in using the housing support member include moving the housing support member into contact with the patient's face, and

[0114]

[0115] ​​​​​​​​​​​​​​​It may include the step of locking the housing support member in place. In some embodiments the steps in the use of the housing support member are to move the housing support member to contact the patient's face, and, with the needle inserted into the nasal tissue, may include the step of sliding the housing support member proximally. In some embodiments where a grippable housing is connected to the housing support member, a method of implanting an implant into a patient's nasal tissue may include contacting the housing support member with the patient's face when retracting the delivery conduit during the implanting step, thereby holding the housing in place on the patient's face. To place an implant (not shown in these drawings) into tissue, a physician or other user can pull the trigger 222 to retract the needle 102 from the tissue (e.g., pull the needle 222 proximally). The needle can be retracted relative to the housing 214 and the housing support member 216. The housing 214 and the housing support member 216 can be fixed (e.g., made non-movable relative to each other) during the needle retraction step.

[0116] For example, an assembly for placing an implant into nasal tissue as described herein can further include a support member connected to the housing, the support member being configured to abut a portion of the patient's face when the assembly is used by the patient.

[0117] Figures 32A-32D illustrate a nasal implant system 32 00 according to yet another embodiment of the present invention. The system has a grippable housing 3204 that supports an implant holder 3206. An implant 3202, e.g., FIGS. 10A-10N above​ One of the implants described in connection with is mounted on an implant holder 3206, and a needle 3208 (e.g., a 16-gauge beveled subcutaneous needle) is attached to a housing on the implant by a female thread.

[0118] A piston 3210 is slidably disposed within an insertion bore 3212 of a housing 3204, and a handle 3214 extends from the piston 3210 to the lower side of the housing 3204. A pusher 3216 extends from the piston 3210 into the implant holder 3206. Movement of the handle 3214 toward a fixed handle 3218 of the handle causes the pusher 3216 to advance within the implant holder 3206 and push the implant 3202 distally within the needle 320 8. When the two handles contact, the distal end of the implant 3202 comes to the beveled opening of the needle 3208, as shown in FIG. 32D. In use, when the needle is inserted at a desired location in the patient's nose, the needle 3208 can be retracted from the implant 3202 by moving the needle actuator 3220 proximally to the position shown in FIG. 32B. The pusher holds the implant in place while the needle is retracted. In some embodiments, after the needle has been inserted into the nasal tissue, but before retracting the needle and pushing the implant further distally, e.g., to the distal end of the beveled opening of the needle, the handle 321 4 can be moved further distally. An opening 3222 in the distal portion of the housing allows the user to observe and confirm the retraction of the needle. 4.

[0119] FIGS. 33A - 33C illustrate a nasal implant system 3300 according to another embodiment of the present invention. ​​​​​is shown. This system has a housing 3 that supports an implant holder (not shown). 304. An implant 3302, for example, one of the implants described in FIGS. 10A - 10N above, is attached to the implant holder, and a needle 3308 (for example, a 16 - gauge beveled subcutaneous needle) is attached to the housing above the implant by a female screw of a needle actuator 3320. As shown in FIGS. 33A and 33B, an implant actuator 3310 extends proximally from the housing. A pusher 3316 extends distally from the implant actuator 3310 through the housing to the implant holder. When the implant actuator 3310 moves distally towards the housing, the pusher moves towards the implant, the implant exits the implant holder and enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle. Then, when the needle actuator 3320 moves proximally, as shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. For example, a 16 - gauge beveled subcutaneous needle) is attached to the housing above the implant by a female screw of a needle actuator 3320. is attached to the housing above the implant by a female screw of a needle actuator 3320.

[0120] As shown in FIGS. 33A and 33B, an implant actuator 3310 extends proximally from the housing. A pusher 3316 extends distally from the implant actuator 3310 through the housing to the implant holder. When the implant actuator 3310 moves distally towards the housing, the pusher moves towards the implant, the implant exits the implant holder and enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle. Then, when the needle actuator 3320 moves proximally, as shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. extends proximally from the housing. A pusher 3316 extends distally from the implant actuator 3310 through the housing to the implant holder. When the implant actuator 3310 moves distally towards the housing, the pusher moves towards the implant, the implant exits the implant holder and enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle. Then, when the needle actuator 3320 moves proximally, as shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. extends distally from the implant actuator 3310 through the housing to the implant holder. When the implant actuator 3310 moves distally towards the housing, the pusher moves towards the implant, the implant exits the implant holder and enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle. Then, when the needle actuator 3320 moves proximally, as shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. When the implant actuator 3310 moves distally towards the housing, the pusher moves towards the implant, the implant exits the implant holder and enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle. Then, when the needle actuator 3320 moves proximally, as shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. moves towards the implant, the implant exits the implant holder and enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle. Then, when the needle actuator 3320 moves proximally, as shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle. Then, when the needle actuator 3320 moves proximally, as shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. As shown in FIG. 33C, the needle is retracted from the implant while the pusher holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. holds the implant in place. In some embodiments, the rotation dial 3314 can be rotated after the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. After the needle has been inserted into the nasal tissue but before retracting the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle, the rotation dial 3314 can be rotated. A ring grip 3318 extending from the housing helps to stably hold the housing. to the distal end of the beveled opening of the needle. A ring grip 3318 extending from the housing helps to stably hold the housing. A ring grip 3318 extending from the housing helps to stably hold the housing. helps to stably hold the housing.

[0121] FIGS. 34A - 34C show a nasal implant system 3400 according to yet another embodiment of the present invention. This system has a housing that supports an implant holder (not shown). that supports an implant holder (not shown). It has a syringe 3404. An implant 3402, for example, one of the implants described in connection with FIGS. 10A - 10N above, is mounted on an implant holder, and a needle 3408 ( for example, a 16 - gauge beveled subcutaneous needle) is attached to the housing on top of the implant by a female thread of a needle actuator 3420.

[0122] As shown in FIGS. 34A and 34B, an implant actuator 3410 extends proximally from the housing. The implant actuator can have a ring or a cap at its distal end, as shown in FIGS. 34A and 34B respectively. A pusher 3416 extends distally from the implant actuator 3410 through the housing to the implant holder. When the implant actuator 3410 moves distally towards the housing, the pusher moves towards the implant, the implant exits the implant holder and enters the needle, and the distal end of the implant is positioned at the beveled opening of the needle as shown in FIG. 34C. Then, when the needle actuator 3420 moves proximally, as shown in FIG. 34C, the needle is withdrawn while the pusher holds the implant in place. In some embodiments, the implant actuator can be moved further distally after the needle has been inserted into the nasal tissue but before pulling back the needle to push the implant further distally, for example, to the distal end of the beveled opening of the needle. Handles 3414 and 3418 extend from the housing to help hold the housing stably.

[0123] ​​​​​​​​​​​​​​​Figures 35A - 35C illustrate a nasal implant system 35 according to yet another embodiment of the present invention. This system has a housing 3504 that supports an implant holder (not shown). An implant 3502, for example, one of the implants described in connection with FIGS. 10A - 10N above, is mounted on the implant holder, and a needle 3508 ( for example, a 16 - gauge beveled subcutaneous needle) is attached to the housing above the implant by a female thread of a needle actuator 3520. As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle. Subsequently, upon proximal movement of the needle actuator 3520, as shown in FIG. 35C, the needle is withdrawn while the pusher holds the implant fixed. In some embodiments, after the needle has been inserted into the nasal tissue, but before withdrawing the needle and pushing the implant further distally, for example, to the distal end of the beveled opening of the needle, the implant actuator can be further moved within the track of the housing. A ring or handle 3518 extends from the housing to help stably hold the housing.

[0124] As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle. Subsequently, upon proximal movement of the needle actuator 3520, as shown in FIG. 35C, the needle is withdrawn while the pusher holds the implant fixed. In some embodiments, after the needle has been inserted into the nasal tissue, but before withdrawing the needle and pushing the implant further distally, for example, to the distal end of the beveled opening of the needle, the implant actuator can be further moved within the track of the housing. A ring or handle 3518 extends from the housing to help stably hold the housing. As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle. Subsequently, upon proximal movement of the needle actuator 3520, as shown in FIG. 35C, the needle is withdrawn while the pusher holds the implant fixed. In some embodiments, after the needle has been inserted into the nasal tissue, but before withdrawing the needle and pushing the implant further distally, for example, to the distal end of the beveled opening of the needle, the implant actuator can be further moved within the track of the housing. A ring or handle 3518 extends from the housing to help stably hold the housing. As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle. Subsequently, upon proximal movement of the needle actuator 3520, as shown in FIG. 35C, the needle is withdrawn while the pusher holds the implant fixed. In some embodiments, after the needle has been inserted into the nasal tissue, but before withdrawing the needle and pushing the implant further distally, for example, to the distal end of the beveled opening of the needle, the implant actuator can be further moved within the track of the housing. A ring or handle 3518 extends from the housing to help stably hold the housing. As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle. Subsequently, upon proximal movement of the needle actuator 3520, as shown in FIG. 35C, the needle is withdrawn while the pusher holds the implant fixed. In some embodiments, after the needle has been inserted into the nasal tissue, but before withdrawing the needle and pushing the implant further distally, for example, to the distal end of the beveled opening of the needle, the implant actuator can be further moved within the track of the housing. A ring or handle 3518 extends from the housing to help stably hold the housing. As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle. Subsequently, upon proximal movement of the needle actuator 3520, as shown in FIG. 35C, the needle is withdrawn while the pusher holds the implant fixed. In some embodiments, after the needle has been inserted into the nasal tissue, but before withdrawing the needle and pushing the implant further distally, for example, to the distal end of the beveled opening of the needle, the implant actuator can be further moved within the track of the housing. A ring or handle 3518 extends from the housing to help stably hold the housing. As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle. Subsequently, upon proximal movement of the needle actuator 3520, as shown in FIG. 35C, the needle is withdrawn while the pusher holds the implant fixed. In some embodiments, after the needle has been inserted into the nasal tissue, but before withdrawing the needle and pushing the implant further distally, for example, to the distal end of the beveled opening of the needle, the implant actuator can be further moved within the track of the housing. A ring or handle 3518 extends from the housing to help stably hold the housing. As shown in FIGS. 35A and 35B, an implant actuator 3510 extends proximally from the housing. A pusher 3516 extends distally from the implant actuator 3510 through the housing to the implant holder. The slide movement of the implant actuator 3510 to the position shown in FIG. 35C within the track of the housing causes the pusher to move towards the implant, the implant to exit the implant holder and enter the needle, and the distal end of the implant to be positioned at the beveled opening of the needle.

[0125] Figures 36A - 36F illustrate a nasal implant system 3600 according to another embodiment of the present invention This system includes a housing 3604 that supports an implant holder (not shown), and a pistol grip 3613 having a proximal pistol grip skin 3613 and a distal trigger skin 3623 The implant 3602 is attached to the implant holder, and a needle 3608 (e.g., a 16 - gauge beveled subcutaneous needle) is attached to the housing over the implant by a female thread of a needle actuator 3620, e.g., a Luer 3621 The implant 3602 can be formed from a bioabsorbable material that can include various combinations such as PLA, PDLA, PDS, PLC, PGA, or PLG As shown in Figure 36B, the implant 3602 has a substantially round cross - section and is about 25 mm in length. Convex or concave ring features are present at the proximal end of the rod (e.g., at intervals of 1 mm, 2.5 mm, or 5 mm from the end) to indicate to the user where to cut the rod to obtain a specific length The implant has a hook portion or tooth feature 3631 at the distal end. These features can be formed by making a cut in the implant at an angle of 30 - 45 degrees using a blade and then bending the outer portion of the implant material to the plastic deformation point These hook portions are flexible enough to fall inward (i.e., to their original position before forming the hook portion) when introduced into the needle 3608 and elastic enough to expand when the implant is released from the needle into the nasal tissue The hook portions engage the surrounding nasal tissue to prevent the implant from moving backward along its implantation path ​​​​​​​​​​To prevent this, the implant is maintained in the treatment position and is arranged, for example, on the maxillary contact surface. The implant 3602 also has a proximal length marker 3627 and a proximal cup surface 3625.

[0126] The plunger - type implant actuator 3610 extends proximally from the housing. The pusher 3616 extends distally from the implant actuator 3610 through the housing and (via the proximal handle core 3611) to the implant holder. The distal surface of the pusher 3616 is, for example, a concave surface that conforms to the round proximal end of the implant to align the implant with the center of the pusher. (For example, using the plunger head 3609) As the implant actuator 3610 moves distally from the position shown in FIG. 36A to the position shown in FIG. 36E towards the inside of the housing, the implant exits the implant holder and enters the needle, and the distal end of the implant is placed in the beveled opening of the needle. Then, as the needle actuator 3620 moves proximally, as shown in FIG. 36F, the needle is withdrawn from the implant while the pusher holds the implant in place. The handle 3618 extends from the housing to help hold the housing stably.

[0127] The window 3605 in the housing 3604 allows the engagement portion to remain expanded until the implant is loaded into the needle. This feature allows the implant to be maintained within the system for an extended period (e.g., during packaging, sterilization, transportation, and storage) without adversely affecting the position and elasticity of the engagement portion due to polymer creep. ​

[0128] Figures 37A - 37C illustrate a nasal implant system 37 according to yet another embodiment of the present invention 00. The system includes a substantially cylindrical main body 3704, a slidable ring trigger 3710, a rod - shaped piercing element 3708 extending through an instrument shaft 3709, and a hollow implant 3702. This nasal implant delivery instrument is configured to deliver the hollow rod implant 3702 to the nasal anatomical structure in a manner similar to the above - described system . However, in this embodiment, the piercing element 3708 extends through the hollow implant 3702 and holds the implant in a friction fit. The proximal end of the implant is supported on the distal surface of the instrument shaft . When the implant and the supporting piercing element are inserted into the nasal anatomical structure and, for example, placed in the maxilla, the entire instrument (or alternatively only the internal piercing element) can be withdrawn to position the implant in its target location . The implant 3702 may have the above - described engagement portion that interacts with the nasal tissue to maintain the implant in place when the delivery instrument is withdrawn . In use, the instrument and the implant are inserted into the nasal tissue in the configuration shown in Figure 37A. When in the desired position, the triggering 3710 is withdrawn as shown in Figure 37B, thereby releasing the implant 3702 . Then, as shown in Figure 37C, the instrument shaft and the piercing element are withdrawn from the implant and the nasal tissue . The nasal implant of the present invention can be configured as a large body composed of a plurality of individual implants. For example, as shown in Figure 38, a sheet 3800 has an offset . The implant 3702 may have the above - described engagement portion that interacts with the nasal tissue to maintain the implant in place when the delivery instrument is withdrawn. In use, the instrument and the implant are inserted into the nasal tissue in the configuration shown in Figure 37A. When in the desired position, the triggering 3710 is withdrawn as shown in Figure 37B, thereby releasing the implant 3702. Then, as shown in Figure 37C, the instrument shaft and the piercing element are withdrawn from the implant and the nasal tissue . The nasal implant of the present invention can be configured as a large body composed of a plurality of individual implants. For example, as shown in Figure 38, a sheet 3800 has an offset . When in the desired position, the triggering 3710 is withdrawn as shown in Figure 37B, thereby releasing the implant 3702. Then, as shown in Figure 37C, the instrument shaft and the piercing element are withdrawn from the implant and the nasal tissue . When in the desired position, the triggering 3710 is withdrawn as shown in Figure 37B, thereby releasing the implant 3702. Then, as shown in Figure 37C, the instrument shaft and the piercing element are withdrawn from the implant and the nasal tissue . When in the desired position, the triggering 3710 is withdrawn as shown in Figure 37B, thereby releasing the implant 3702. Then, as shown in Figure 37C, the instrument shaft and the piercing element are withdrawn from the implant and the nasal tissue . When in the desired position, the triggering 3710 is withdrawn as shown in Figure 37B, thereby releasing the implant 3702. Then, as shown in Figure 37C, the instrument shaft and the piercing element are withdrawn from the implant and the nasal tissue

[0129] The nasal implant of the present invention can be configured as a large body composed of a plurality of individual implants . For example, as shown in Figure 38, a sheet 3800 has an offset It is composed of a plurality of implants 3802 connected by a butt bridge 3804. The implant 3802 can be separated from the sheet 3800 by cutting the bridge connecting it to its adjacent implant 3802. The implant material can be PLA, PDLA, PDS, PLC, PGA, PLG, or a similar bioabsorbable material.

[0130] Figures 39A - 39D show a delivery instrument 3900 having features that enable the implants to be separated one by one from a sheet of implants, for example, the sheet 3800 shown in Figure 38. The delivery instrument 3900 has a two - part body, namely, a proximal main body 3904 and a distal trigger body 3906. The opening or window 3908 of the trigger body is sized to receive a sheet 3910 formed from a plurality of implants 3912, as shown in Figures 39B and 39C, such that a first implant segment is aligned with the internal insertion passage of the introducer needle 3914. The cutting element 3916 extends towards the implant sheet and has a sharp blade aligned with the bridge that holds the first implant of the sheet against the rest of the sheet. When the push - rod plunger or actuator 3928 moves distally, the push - rod 3930 moves distally, causing the sheet 3910 to move towards the cutting element 3916. As the sheet 3910 advances, the cutting element severs the bridge that holds the first implant against the rest of the sheet, and the implant advances through the insertion passage of the needle 3914, as shown in Figure 39D. The push - rod 3930 continues to move as described in connection with the other embodiments above. Advance one implant 3912 to the distal end of the needle 3914.

[0131] Figures 40A - 40C show various parts of another embodiment of a delivery instrument having features that enable cutting of an implant from an implant sheet. This instrument can be formed in the same manner as the above - described instrument 3900 with a distal trigger housing 4009. Instead of a fixed cutting instrument extending towards the implant sheet, the pusher 4000 of the embodiment of FIG. 40 has a sharp distal edge 4002. A sheet 4002 of individual implants 4004 connected by a bridge is advanced into the delivery instrument through a window 4006 in the instrument body, aligning the first implant with the insertion passage (needle internal passage 4009) of the introduction needle 4008. Movement of the pusher 4000 and the sharp distal edge 4002 distally shears the first implant from the sheet and moves it within the insertion passage of the needle 4008 as shown in FIG. 40C. In yet another alternative embodiment shown in FIGS. 41A - 41D with a distal trigger housing 4111, the cutting can be made annular, thereby shearing both implants from the sheath and shaving the outer surface of one implant so that the implant fits smoothly within the insertion passage of the needle. The cutting instrument 4102 and the pusher 4104 can be separate elements, and an annular cutting instrument 4102 (e.g., a hypodermic tube) advances relative to the pusher 4104 to perform the shearing and shaving operations to remove the implant 41 08 from the sheet 4012 and the pusher moves distally to move the implant 4106 into the insertion passage of the needle.

[0132] In yet another alternative embodiment shown in FIGS. 41A - 41D with a distal trigger housing 4111, the cutting can be made annular, thereby shearing both implants from the sheath and shaving the outer surface of one implant so that the implant fits smoothly within the insertion passage of the needle. The cutting instrument 4102 and the pusher 4104 can be separate elements, and an annular cutting instrument 4102 (e.g., a hypodermic tube) advances relative to the pusher 4104 to perform the shearing and shaving operations to remove the implant 41 08 from the sheet 4012 and the pusher moves distally to move the implant 4106 into the insertion passage of the needle. from the sheet 4012 and the pusher moves distally to move the implant 4106 Advance it into the needle 4110. The cutting instrument has an implant side window 4106.

[0133] In yet another embodiment illustrated in FIG. 42, the diameter of the cutting instrument 4202 can be, for example, by pressing the button 4204 against the instrument body to apply force to the cutter 4202 formed as a split cylinder. This feature enables the use of a thinner implant introduced through a thinner needle. The cutting instrument 4202 has a main instrument body 4210. A sheet of the implant 4208 is fed into the instrument. The cutting instrument 4202 also includes a delivery needle 4206.

[0134] FIGS. 43A - 43E illustrate a spring - loaded implant clip. In this embodiment, similar to the above - described embodiment, a row of implants 4302 is mounted on the delivery device through the window 4304. The sheet 4300 is mounted within the storage clip 4306. One or more springs 4308 and a lift platform 4309 on the side of the storage clip 4306 press the sheet 4300 inward, such that the innermost implant 4310 within the clip aligns with the insertion path of the guide needle 4312. The pusher 4314 (with an outer surface 4324) advances the implant 4310 into the needle 4312 as described above. The delivery device body 4322 is hand - held and can be controlled by a trigger 4320.

[0135] Alternatively, a sheet of the implant 4311, for example, the sheet described above in connection with FIGS. 38 - 42, can be mounted within the clip 4306. In this case, a shearing element, for example, ​​​Then, the shear element described above in connection with FIGS. 39-42 can be added to the assembly. The delivery instrument body includes a handle distal core 4326.

[0136] FIGS. 44A-44F illustrate yet another method of mounting a plurality of implants to a delivery instrument. The delivery instrument 4400 has a rotatable cylindrical housing 4402 having a plurality of implant chambers in which a single implant 4414 is disposed. The housing 4402 is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412.

[0137] FIGS. 45A-45D illustrate yet another embodiment in which a plurality of implants can be mounted to a delivery instrument and delivered individually. In this embodiment, the ends of a plurality of implants 4502 are connected and mounted to the delivery instrument parallel to the pusher 4504. A cutting button 4506 aligned with the most distal implant segment in the implant line is pressed inward to cut one implant segment from the line and advance it through a delivery instrument chamber aligned with the insertion passages of the pusher and the needle 4508. FIG. 46A is a top view of the sheet 4600 of the nasal implant 4602 connected by a bridge 4604, and FIG. 46B is a perspective view of this sheet 4600. The through hole 4606 is dimensioned to reproduce a Lactosorb (registered trademark) sheet (about 2 mm) to enable suturing. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. is rotated to a position where the implant chambers are aligned (and can also be shown in a return stop) with the insertion passages of the pusher 4406 and the needle 4408. Then, the pusher 4406 advances the implant 4404 through the needle as described above. The delivery instrument can be manually held by the instrument main body 4410. The needle 4408 can be controlled by a trigger 4412. Yes. The slot 4608 serves as a cutting guide for separating individual implants.

[0138] Figure 47A is an end view of the sheet 4700 of the nasal implant 4702 connected by the bridge 4704, and Figure 47B is a perspective view of this sheet 4700. The through-hole 470 6 is dimensioned to reproduce a Lactosorb® sheet (about 2 mm) to enable suturing. The bridge portion is designed to be divided without the need for a surgical scalpel.

[0139] Figures 48A and 48B show the sheet 4800 of the individual nasal implant 4802 connected by the bridge 4804. The opening 4806 in the sheet is larger than the openings in the embodiments of Figures 46 and 47 to allow a needle and suture thread to pass through.

[0140] Figure 49A is a partial end view of the sheet 4900 of the nasal implant 4902 separated by a large sheet portion 4904 in which the hole 4906 is formed, and Figure 49B is a perspective view of the sheet 4 900.

[0141] Figure 50A is a partial end view of the sheet 5000 of the pair of aligned nasal implants 5002, and Figure 50B is a perspective view of the sheet 5000. The hole 5006 is formed in the bridge portion 5004 between the pair of implants.

[0142] Figure 51A is a partial end view of the sheet 5100 of the nasal implant 5102 having a rounded end 5103, and Figure 51B is a perspective view of the sheet 5100. The implant is connected by the bridge 5104 and has an opening 5106 between the bridges 5104. The cutting guide 5104 has an opening 5106 between the bridges 5104. The cutting guide Slot 5108 can be formed in the bridge.

[0143] Figs. 52A - 52H show the details of the sheet 5200 of the nasal implant 5202 connected by the bridge 5204.

Example

[0144] Example 1 Table 1 of the material sample tests shows the material property tests of candidate implants formed in various shapes and sizes with the indicated inner diameter (ID) and outer diameter (OD) from the indicated materials. The elastic modulus (E), the moment of inertia of the sample cross-section (I), and the flexural rigidity (E·I) representing the strength of the sample when bent are shown. The PLLA sample and the PLL A - PGA sample probably had higher flexural strength than other samples due to the strength of PLLA and the rod shape of the PLLA - PGA sample. The PLLA - PDLA sample was probably weak in bending due to its thin wall and tube shape. The PLLA - PCL sample was probably in a glassy state and very bendable because its glass transition temperature was lower than room temperature; overall, it did not behave like a typical solid material.

[0145] Example 2 Table 2 shows the formability and fragility at a certain temperature: tests conducted on material samples. The samples were cut to a length of 15 mm. The samples were tested at room temperature, heated in an oven to several temperatures, and left to reach a constant temperature throughout the sample. Each sample was taken out of the oven and immediately tested by bending it by hand 90 degrees (if possible). Observation of how much force was required, whether the material maintained its shape, the cooling time, Recorded and summarized the vulnerability of the material.

[0146] Example 3 The implantable sheet was cut and tested for compatibility with a 16-gauge syringe. The vial passed through. When a scalpel was placed into the groove of the bridge and positioned accurately, the sheet could be cut relatively easily. Figures 53A and 53B show the results of the cutting of the implantable sheet.

[0147] Example 4 Implant - Dimension Protocol:

[0148] [Table 1]

[0149] Example 5 Implant Bending Rigidity Protocol: Two implant rods were immersed in water and heated at 37°C for 1 hour. Then, these implant rods were bent 180 degrees up to 7 mm. The samples had a bending rigidity of 2 114 N·mm 2 ~105 N·mm. The results are shown in Figures 54A - 54C.

[0150] Example 6 Implant Movement Protocol: The implant was inserted into the tissue sample using a cannula. The implant was placed in a test device and 1000 cycles were performed. The position of the implant was compared before and after. The results were a movement of less than 0.5 mm in both the vertical and horizontal directions in all tests, and this movement of the implant was after manually bending the tissue for 5 minutes. Figures 55A - 55B show the results of the 1000 - cycle test using the test device. In another case, the movement of the implant ​​, the tissue was tested after being manually bent for 5 minutes. No slight movement was observed at all. The results are shown in FIGS. 56A to 56B.

[0151] Various regions of the airway tissue can affect the airflow to the lungs. One major influence on the airflow is from the ventilation resistance from the nose. The highest resistance structures in the nose are the narrowest regions, such as the external nasal valve 5302 and the internal nasal valve 5300 shown in FIGS. 59A to 59B, respectively. During normal inspiration, the nasal valve cartilage around these valves reduces or prevents the valves from collapsing and helps maintain the patency of the airway. Incomplete internal and / or external valves can collapse during inhalation and obstruct the airflow as shown in FIGS. 60A to 60B. FIG. 60A shows the static valve, and FIG. 60B shows the collapse of the valve during inhalation. For example, aging, hypoplasia or weak cartilage, surgery (e.g., rhinoplasty, septoplasty), and / or trauma to the nasal septum, turbinates, lateral cartilage, or other structures can lead to nasal valve problems and affect the airflow, for example, causing dyspnea, snoring, sleep apnea, and a decrease in quality of life. Minimally invasive surgical treatments for nasal valve collapse are described herein. Such treatments can be effective for the treatment of outpatient patients with minimal invasiveness, reduce the patient's pain and shorten the recovery time, and can be a sustainable solution.

[0152] Surgical treatments (e.g., submucous resection of the turbinates, septoplasty) have been used heretofore to reduce the size of the turbinates, correct a displaced septum, or repair the nasal wall to improve the nasal valve and airflow. These surgical treatments are invasive, uncomfortable, and require a significant amount of time to recover. Furthermore, these surgical treatments cannot easily address problems with the lateral cartilage wall. Yes. The outer cartilage wall has been repaired by, for example, cartilage transplantation using additional material (cartilage) derived from the nose or ear. In addition to the above limitations, these techniques are costly (e.g., thousands of dollars ), highly invasive, require a high level of surgical experience, have a long painful recovery period (e.g., a three-week downtime), are not always successful, and require a second surgically invasive site ( the nasal region or ear to harvest cartilage). Invasive nasal surgery is difficult because the surgical site needs to be continuously used for breathing. Therefore, invasive surgical approaches are far from ideal. Non-surgical approaches when the nasal valve collapses involve strips or stent-like materials placed in or around the nose (e.g., "BreathRig ht", Breathe with EEZ, Nozovent). These temporary sub-optimal approaches have limited effectiveness and are of low cosmetic level.

[0153] This specification describes implants, assemblies, systems, and methods for improving and repairing the nasal valve. Such valve repair materials and methods can be used in minimally invasive procedures, for treating outpatient patients, and can recover quickly with minimal pain, especially when compared to conventional surgical interventions.

[0154] Another aspect of the invention provides a delivery system as shown in FIGS. 61A-61D, including a delivery assembly comprising a delivery instrument (FIG. 61A) and one or more nasal implants (FIGS. 6 1C-61D).

[0155] In some embodiments, the implant is, for example, an absorbable biocompatible material well-known in the art A homopolymer or copolymer (e.g., poly-L-lactic acid (PLLA), poly(D-lactic acid (PDLA), etc.) may be included. In a particular embodiment, the copolymer may include both PLLA (PLA ) and PDLA, for example, in a ratio of 70:30 PLLA / PDLA. The implant may have advantageous stress / strain mechanics ).

[0156] The implant can be sized by a physician. The implant may include a polymer configured to be absorbed more rapidly or more slowly when placed within nasal tissue . The implant can be configured to remain substantially intact for at least 3 months, at least 6 months, at least 9 months, or at least 12 months. The implant can be configured to be completely absorbed within substantially 18 months .

[0157] The implant can be selected to be tough but have advantageous stress / strain mechanics. The implant can have a strength similar to that of cartilage. The implant can be formable without breaking. The implant can have a curvature similar to that of cartilage. The implant can be configured to have a higher flexural rigidity than cartilage when placed within nasal tissue for longer than 6 months .

[0158] The implant can be of any size that provides a therapeutic or cosmetic benefit and / or promotes implant or bioabsorbability. The implant can be inserted with a needle, e.g., a pre-made needle (e.g., larger than 10 gauge, 10, 11, 12, 13, 14, 15, 16, 1 7, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 、31, or 32 gauge, or less than 32 gauge) and can be sized to fit The implant can be held on the needle by any means, such as being adhered (friction fit), tabs, fitting mechanisms , etc. The implant can have features (such as ridges, protrusions , etc.) and can contact the inner surface of the needle when placed in the delivery assembly .

[0159] The implant can provide a therapeutic or cosmetic benefit and / or can be of any shape that promotes implantation or biodegradation. The implant, when placed within the needle , allows for a maximum rod diameter and rib height with no excessive friction and can have one or more substantially flat sides and ribs. The rib structure can prevent movement of the implant . .

[0160] Another aspect of the present invention provides a plurality of interconnected implants, as shown, for example, in FIGS. 62A - 62D . FIGS. 62A - 62B show rod implants, FIG. 62C shows a detailed view of portion "A" shown in FIG. 62B. Two or more implants can be formed as a long structure. Two or more implants can be molded together, for example, by injection molding, onto a perforated sheet. The implants can be separated, for example, by a cutting instrument. Implants, such as those shown in FIGS. 62A - 62D, can have an anti - movement function. For example, an implant with an anti - movement function provides sharp longitudinal stability relative to a smooth implant . may have an increase (e.g., 5-fold). Implants with an anti-migration function may be easier to injection mold. Such implants may have predictable degradation. The implants may represent the mechanics of nasal cartilage. The implants may have a bending stiffness value stronger than cartilage for a certain period (e.g., 6 months) from implantation. The implants may be formable without breaking. The implants may have an average acute flexibility similar to that of reconstruction plate products. The implants may have a flat side to allow for a maximum rod diameter and rib height without excessive friction in the needle insertion passage. Another aspect of the present invention provides a delivery instrument assembly configured to deliver an implant into nasal tissue. The delivery instrument assembly may include a needle configured to receive the implant and a stylet configured to extrude the implant from the needle and insert it into nasal tissue during delivery of the implant (e.g., into a nasal tissue region). The delivery instrument assembly may include an implant positioning knob configured to move the implant to a desired (distal) intermediate preparation region. The distal intermediate preparation region may be at or near the tip of the needle. The delivery instrument assembly may include a trigger lock mechanism to prevent unwanted movement of the needle. The needle of the delivery instrument assembly can be configured to penetrate the nasal mucosa and place the implant at a desired location within the nasal tissue. The implant can be configured to be extruded from the needle simultaneously with the removal of the needle from the tissue. In some cases, simultaneous implant

[0161]

[0162]

[0163]

[0164] ​​​​​​​​​​​​​Extrusion from the needle and removal from the nasal tissue of the needle can result in unwanted movement of the implant or repositioning of the implant. It can result in repositioning of the implant.

[0165] In some embodiments, the delivery instrument can be configured to be held by hand as shown in FIGS. 63A - 6C (e.g., it can have an ergonomic design). The delivery device can be designed to penetrate the mucosa and place the implant in the desired position. The delivery device can be designed to penetrate the mucosa and place the implant in the desired position. The delivery device can be designed to penetrate the mucosa and place the implant in the desired position. It can be done.

[0166] In some embodiments, the delivery instrument can have a needle forward position (FIG. 64A) and a needle retracted position (FIG. 64B). The delivery instrument can have, for example, a body, a grip (e.g., a half - grip 5316), a trigger, a trigger lock 5314, a needle 5318, an implant positioning knob 5312, and an implant plunger 5320 or a stylet as shown in FIGS. 64A - 64B. The up - down trigger 5310 mechanism is configured to provide axial stability during needle placement, implant placement, and / or needle retraction. The implant positioning knob 5312 advances the implant to the distal intermediate preparation area at the tip of the needle. The needle (e.g., a 16 - gauge subcutaneous needle) can create a small entry site with minimal tissue cutting and pain. The implant plunger 5320 ejects the implant. The implant plunger can have a front - end "bone preparation" mechanism (drill bit). The trigger lock 5314 can provide safety during needle placement. The half - grip can hold a thin grip arm. The delivery instrument can have a body, a grip (e.g., a half - grip 5316), a trigger, a trigger lock 5314, a needle 5318, an implant positioning knob 5312, and an implant plunger 5320 or a stylet as shown in FIGS. 64A - 64B. The delivery instrument can have a body, a grip (e.g., a half - grip 5316), a trigger, a trigger lock 5314, a needle 5318, an implant positioning knob 5312, and an implant plunger 5320 or a stylet as shown in FIGS. 64A - 64B. 8, an implant positioning knob 5312, and an implant plunger 5320 or a stylet. The up - down trigger 5310 mechanism is configured to provide axial stability during needle placement, implant placement, and / or needle retraction. The implant positioning knob 5312 advances the implant to the distal intermediate preparation area at the tip of the needle. The up - down trigger 5310 mechanism is configured to provide axial stability during needle placement, implant placement, and / or needle retraction. The implant positioning knob 5312 advances the implant to the distal intermediate preparation area at the tip of the needle. The implant positioning knob 5312 advances the implant to the distal intermediate preparation area at the tip of the needle. The needle (e.g., a 16 - gauge subcutaneous needle) can create a small entry site with minimal tissue cutting and pain. The needle (e.g., a 16 - gauge subcutaneous needle) can create a small entry site with minimal tissue cutting and pain. The needle (e.g., a 16 - gauge subcutaneous needle) can create a small entry site with minimal tissue cutting and pain. The implant plunger 5320 ejects the implant. The implant plunger can have a front - end "bone preparation" mechanism (drill bit). The trigger lock 5314 can provide safety during needle placement. The half - grip can hold a thin grip arm. The half - grip can hold a thin grip arm.

[0167] The delivery instrument assembly can include a plurality of implants. The plurality of implants can be loaded at once. It can be worn. Alternatively, the implant can be worn, implanted, and another implant for delivery can be re-mounted on the delivery instrument assembly. Another implant for delivery can be re-mounted on the delivery instrument assembly.

[0168] The delivery instrument assembly can include a bone preparation mechanism (e.g., a drill bit).

[0169] Tactile clues can be used to place the implant within the nasal tissue. One such tactile clue can include palpating the nasal region (e.g., palpating the implant or needle from the outer surface of the nose). Another such tactile clue can include detecting resistance from the delivery instrument assembly placed within the nasal tissue, where this resistance indicates the delivery instrument assembly contacting bone.

[0170] One method of placing the implant in the nasal valve is to place the delivery instrument assembly in contact with the nasal tissue, the step where the delivery instrument assembly includes a needle that houses the implant, the step of advancing the needle and the implant into the nasal tissue until the needle contacts bone, the step of releasing the needle safety device of the delivery instrument assembly, and the step of pulling the needle proximally to extract the implant, thereby placing the implant adjacent to the bone. For example, the implant is maintained in the desired position when the needle is withdrawn from the implant.

[0171] In some embodiments, the implant is placed within the nasal tissue such that most or all of it is covered by the nasal tissue and / or the tissue overlying the maxilla. The nasal tissue can form a support, e.g., a tight support around the implant.

[0172] FIG. 65 shows, for example, an implant 533 disposed on the outer wall of the nasal valve to strengthen the nasal valve. One, two, or more implants can be placed. The implants may be parallel to each other or may be angled with respect to each other. The implants can be inserted into the nose through the mucosa and placed from the outside to the mucosa, from the inner cartilage to the outer cartilage, and / or from the surface to the maxilla.

[0173] FIGS. 66A - 66C show, for example, an implant 5340 disposed in an "expansion" region along the upper surface of the nose. Such an implant can be inserted into the nose through the mucosa, pushed between the outer cartilage and the septum, and / or widen the internal nasal angle. and / or widen the internal nasal angle. FIGS. 67A - 67C show one embodiment of a method for placing one or more implants within nasal tissue. Any number of implants can be placed in any orientation. The implants

[0174] can be placed substantially parallel to the bottom surface of the nose (as shown, for example, in FIG. 67C). The implants can be angled with respect to the plane of the nose. For example, the implants can form a line from the tip of the nose to the inner canthus. In some embodiments, the implant 5350 is sized to an appropriate length by the physician and can be inserted into the delivery device shown in FIG. 67A. As shown in FIG. 67B, the delivery device is inserted into the lower outer cartilage and advanced to the maxilla. The implant is pushed out of the delivery device and forms a support beam between the outer cartilage and the maxilla. Multiple implants 5352 can be placed. As shown in FIG. 67C, with the delivery device removed and forms a support beam between the outer cartilage and the maxilla. Multiple implants 5352 can be placed. As shown in FIG. 67C, with the delivery device removed and forms a support beam between the outer cartilage and the maxilla. Multiple implants 5352 can be placed. As shown in FIG. 67C, with the delivery device removed and forms a support beam between the outer cartilage and the maxilla. Multiple implants 5352 can be placed. As shown in FIG. 67C, with the delivery device removed and advanced to the maxilla. The implant is pushed out of the delivery device and forms a support beam between the outer cartilage and the maxilla. Multiple implants 5352 can be placed. As shown in FIG. 67C, with the delivery device removed and advanced to the maxilla. The implant is pushed out of the delivery device and forms a support beam between the outer cartilage and the maxilla. Multiple implants 5352 can be placed. As shown in FIG. 67C, with the delivery device removed and advanced to the maxilla. The implant is pushed out of the delivery device and forms a support beam between the outer cartilage and the maxilla. Multiple implants 5352 can be placed. As shown in FIG. 67C, with the delivery device removed is removed, leaving the implant as a support beam to prevent the nasal valve from collapsing.

[0175] Figures 68A-68D illustrate the steps of preparing the implant and implanting the implant into the nose. Figure 68A illustrates the step of forming the implant. Figure 68B illustrates the preparation for delivery of the implant. Figures 68C-68D respectively illustrate an internal view and an external view of the implant delivery. Figure 69A shows the subjective interpretation of nasal obstruction symptoms 6 months and 12 months after implant placement in a preliminary trial compared to the pre-implantation symptoms using a valid NOSE (Nasal Obstruction Symptom Evaluation) scale. The nasal obstruction was reduced.

[0176]

[0177] [[Appendix 1]] A nasal implant delivery system comprising: A delivery device comprising a graspable housing having an implant delivery conduit with a piercing end configured to pierce nasal tissue, the conduit comprising an internal alignment portion having a cross-sectional shape configured to align the implant with respect to the conduit; and A longitudinal implant comprising an elastically deformable portion configured to have a contracted first shape and an expanded second shape, the first shape including a non-circular cross-section configured to align the implant with respect to the conduit by the conduit alignment portion when the implant is disposed within the conduit, and the second shape including an expanded shape configured to fix the implant to the nasal tissue when the implant is disposed within the nasal tissue. [[Appendix 2]] The system according to Appendix 1, wherein the delivery device is configured to hold the implant near the distal end of the conduit when the implant is within the conduit.​​​​ [Supplementary Note 3] The system according to Supplementary Note 1, wherein the catheter is configured to hold the implant near the distal end of the catheter when the implant is within the catheter. [Supplementary Note 4] The system according to Supplementary Note 1, wherein the catheter includes a 14-gauge, 16-gauge, or 18-gauge needle and the implant is configured to be received within the needle. [Supplementary Note 5] The system according to Supplementary Note 1, wherein the delivery device comprises a window along the length of the delivery device configured to receive the implant within the catheter. [Supplementary Note 6] The system according to Supplementary Note 1, wherein the delivery device is configured to hold the implant proximal to the bevel of the distal end of the catheter when the implant is within the catheter. [Supplementary Note 7] The system according to Supplementary Note 1, wherein the cross-sectional shape of the catheter includes an ellipse. [Supplementary Note 8] The system according to Supplementary Note 1, wherein the catheter and the implant are configured to form a friction fit between the catheter and the implant when the implant is within the catheter. [Supplementary Note 9] The system according to Supplementary Note 1, wherein the elastically deformable portion comprises teeth configured to have the contracted first shape and the expanded second shape. [Supplementary Note 10] The system according to Supplementary Note 1, wherein the elastically deformable portion comprises teeth at an end of the implant. [Supplementary Note 11] The system according to Supplementary Note 1, wherein the length of the implant comprises a plurality of repeating features. [Supplementary Note 12] The system according to Supplementary Note 1, wherein the implant comprises a plurality of ribs having alternating raised regions and recessed regions. [Supplementary Note 13] The system according to appended claim 1, wherein the implant comprises a feature of a first end and a feature of a second end different from the feature of the first end. [Appended claim 14] The system according to appended claim 13, wherein the feature of the first end and the conduit are configured to form a friction fit when the implant is within the conduit, thereby holding the implant within the conduit. [Appended claim 15] The system according to appended claim 13, wherein the feature of the first end includes a rounded end. [Appended claim 16] The system according to appended claim 1, wherein the implant comprises a biodegradable material. [Appended claim 17] The system according to appended claim 1, wherein the implant comprises a biocompatible biodegradable poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA). [Appended claim 18] The system according to appended claim 1, wherein the implant is configured to have an implant bending stiffness of 2.5e-6 to 1.5e-5. [Appended claim 19] The system according to appended claim 1, further comprising a stylet having a proximal gripping portion and a distal pushing portion, wherein the implant and the distal pushing portion are disposed within the conduit, and when the pushing portion moves within the conduit, the pushing portion is configured to conform to the conduit and move the implant through the conduit into tissue. [Appended claim 20] A nasal implant comprising: A biodegradable longitudinal implant having a first end with an elastically deformable portion configured to have a contracted first shape and an expanded second shape, wherein the first shape includes a non-circular cross-section configured to orient the implant with respect to a delivery conduit of a nasal implant delivery device, and the second shape includes an expanded shape configured to fix the implant to nasal tissue when the implant is disposed within the nasal tissue. A second feature different from the first feature, and a second end portion including a length between the first feature and the second feature; An implant having an outer diameter of less than 1.5 mm when the implant is in the contracted first shape. [Appendix 21] The implant according to Appendix 20, configured to have an implant bending stiffness of 2.5e-6 to 1.5e-5. [Appendix 22] The implant according to Appendix 20, wherein the length of the implant is less than 30 mm. [Appendix 23] The implant according to Appendix 20, wherein the length of the implant is less than 25 mm. [Appendix 24] The implant according to Appendix 20, wherein the outer diameter is less than 1.2 mm when in the contracted first shape. [Appendix 25] The implant according to Appendix 20, wherein the elastically deformable portion has teeth at an end of the implant. [Appendix 26] The implant according to Appendix 20, wherein the length includes a plurality of repeating features. [Appendix 27] The implant according to Appendix 20, wherein the length includes a plurality of ribs having alternating raised regions and recessed regions. [Appendix 28] The implant according to Appendix 20, wherein the feature of the first end portion includes a rounded end. [Appendix 29] The implant according to Appendix 20, comprising biocompatible biodegradable poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA). [Appendix 30] A system for placing an implant into a patient's nasal tissue, comprising: An assembly comprising a grippable housing and a delivery tube control mechanism; A hollow implant delivery conduit having a piercing end configured to pierce body tissue, configured to hold an implant and dispose the implant within the body tissue, and the movement of the delivery conduit being controllable by the delivery conduit control mechanism; A system, wherein the delivery conduit control mechanism is configured to move the delivery conduit away from the implant and towards the housing without moving the implant. [Appendix 31] The system according to Appendix 30, further comprising an implant pushing member, the pushing member being connected to an end of the implant within the delivery conduit when the implant is disposed within the conduit and configured to control the position of the implant, and the delivery conduit control mechanism being further configured to move the conduit away from the implant pushing member. [Appendix 32] The housing further comprises a first trigger member on its exterior, the first trigger member being configured to be actuated by a user's finger, and such actuation moves the delivery conduit from a first position to a second position. The system according to Appendix 30. [Appendix 33] The system according to Appendix 32, wherein the first trigger member is configured to move the delivery conduit into the housing when actuated. [Appendix 34] The system according to Appendix 31, wherein the trigger member is configured to be actuated by a user's finger pulling on the trigger member. [Appendix 35] The system according to Appendix 31, further comprising a handgrip proximal to the first trigger member, the handgrip being configured to be partially covered by the user's hand when the user's finger is placed on the first trigger member. [Appendix 36] The system according to appended note 32, wherein the trigger configuration and the handgrip are further configured to be usable by either a left-handed or right-handed person. [Appended note 37] The system according to appended note 32, further comprising a second trigger member generally opposite the first trigger member, wherein the first trigger member and the second trigger member are configured to be simultaneously pulled by a finger of the user's hand. [Appended note 38] The system according to appended note 31, wherein the implant pushing member is configured to hold the implant in place when the delivery conduit moves away from the implant. [Appended note 39] The system according to appended note 30, wherein a user-controllable safety element is configured to hold the delivery conduit in a position advanced relative to the housing. [Appended note 40] The system according to appended note 30, further comprising an implant. [Appended note 41] The system according to appended note 40, wherein the implant comprises a biodegradable material. [Appended note 42] The system according to appended note 40, further comprising an implant pushing member, wherein the implant pushing member and the implant comprise mating end portions. [Appended note 43] The system according to appended note 30, further comprising a support member connected to the grippable housing, wherein the support member is configured to contact the patient's face when the delivery conduit is retracted from the implant during use of the assembly. [Appended note 44] A method of implanting an implant into a patient's nasal tissue comprising: mounting the implant within a grippable housing, the housing comprising a delivery conduit control mechanism for controlling movement of the delivery conduit; attaching an implant delivery conduit to the housing; Advancing the implant through the conduit until the implant is proximal to the distal end of the conduit; Inserting into nasal tissue at the piercing end of the implant delivery conduit by moving the implant delivery conduit through the nasal tissue, the movement of the conduit being controllable by the delivery conduit control mechanism; Using the delivery conduit control mechanism to retract the delivery conduit into the grippable housing from the implant, thereby leaving the implant in place in the nasal tissue; and Removing the implant delivery conduit from the patient. A method comprising: [Appendix 45] Releasing a safety mechanism controlled by a user, thereby enabling movement of the delivery conduit; and further advancing the implant to the tip of the end of the conduit. The method according to Appendix 44, further comprising: [Appendix 46] Placing the proximal end of the implant juxtaposed to the implant pushing member, thereby preventing movement of the implant relative to the delivery conduit during the step of retracting the delivery conduit. The method according to Appendix 44, further comprising: [Appendix 47] The housing is connected to a support member, and the method further comprises contacting the support member with the patient's face during the step of retracting the delivery conduit, thereby holding the housing in place on the patient's face. The method according to Appendix 44, further comprising: [Appendix 48] A method of delivering a nasal implant, comprising: Placing a hollow delivery conduit holding an elastically deformable implant having a first shape into nasal tissue; and Removing the hollow delivery conduit away from the implant, thereby deforming the implant into a second shape. A method comprising:

Claims

1. A nasal implant for supporting a nasal valve, comprising: a first end portion having a plurality of teeth that are elastically deformable between a contracted shape and an expanded shape; a second end portion having a second end shape different from the contracted shape and the expanded shape of the plurality of teeth; an elongated body portion extending between the first end portion and the second end portion; and when the plurality of teeth are in the contracted shape, the plurality of teeth define a non-circular cross-sectional shape; when the plurality of teeth are in the expanded shape, respective ends of the plurality of teeth protrude outwardly at the first end portion, and when the nasal implant is within nasal tissue, the plurality of teeth are configured to fix the nasal implant to the nasal tissue; the elongated body portion includes a plurality of repeating features along the longitudinal direction of the nasal implant between the first end portion and the second end portion, and the plurality of repeating features include a plurality of ribs defined by a plurality of alternating raised regions and recessed regions, the nasal implant.

2. The nasal implant according to claim 1, wherein the second end portion has a rounded end shape.

3. The nasal implant according to claim 1, wherein the plurality of teeth face away from the second end portion of the nasal implant.

4. The plurality of teeth consist of two teeth, when the plurality of teeth are in the contracted shape, respective ends of the two teeth are spaced apart by a first distance, when the plurality of teeth are in the expanded shape, respective ends of the two teeth are spaced apart by a second distance, and the second distance is greater than the first distance, the nasal implant according to claim 1.

5. The nasal implant according to claim 1, wherein the first end portion, the second end portion, and the elongated body portion comprise a material having biodegradability and biocompatibility.

6. The nasal implant according to claim 5, comprising poly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA).

7. The nasal implant according to claim 1, wherein when the plurality of teeth are in the contracted shape, a maximum transverse dimension of the nasal implant is less than 1.5 mm.

8. The nasal implant according to claim 1, having a length of less than 30 mm.

9. The length between the first end portion and the second end portion is such that the nasal implant is configured to be adjacent to a first region that is substantially the maxilla and a second region that is substantially cartilage, and to support the cartilage from being crushed. The nasal implant according to claim 1.

10. The nasal implant according to claim 9, wherein the first region is in close contact with soft tissue above the maxilla, whereby the implant is retained.

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