Introducer devices and methods of use thereof

Abstract

Aspects of the present disclosure relate to a medical implant introducer (100) and methods of using the same. The introducer (100) may include: a handle (120); a cavity for holding an implant, the cavity for holding the implant being disposed distally from the handle (120); a fluid supply conduit (122) fluidly coupled to an interior portion of the cavity of the retention implant; and a distal nozzle (110) having a proximal portion, a distal portion, an intermediate portion located between the proximal portion and the distal portion, the intermediate portion having a tapered profile such that the proximal portion is larger than the distal portion, and a distal opening (112) formed in the distal portion. Wherein the implant in the cavity of the retaining implant can be expelled from the introducer (100) through the distal opening (112).

Description

[0001] This application is a divisional application of invention patent 201980076212.9.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application No. 62 / 740,693, filed on October 3, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure generally relates to prosthetic implant introduction devices and methods of using the same. Background Art

[0005] Current techniques for inserting medical implants (such as breast implants) may cause surgical wounds, resulting in a prolonged, complex and / or dynamic healing process, for example, to allow the patient's body to replace inactivated and missing cell structures and / or tissue layers. For example, many current techniques require a relatively large incision at or near the surgical implant site (e.g., a tissue pocket). While physically manipulating the implant into the implant site, the incision may need to be manipulated by a retractor and / or a tissue expander to expand and remain open. These techniques can result in severe scarring, a high likelihood of damage to the implant, and / or a high likelihood of infection at the implant site. In addition, these techniques may require the insertion of a drainage tube to drain serous fluid from the surrounding tissue and prevent capillary damage; and / or may accelerate an inflammatory response that affects the healing process. In addition, it is recognized that the larger the incision, the higher the potential incidence of keloids and hypertrophic scars during and after healing. Some patients are also more susceptible to keloid formation and have a higher risk of forming keloids. Summary of the invention

[0006] Aspects of the present disclosure relate to an implant introducer comprising: a handle comprising a conduit configured to receive a pressurized fluid; and a nozzle coupled to the handle and removable from the handle. The nozzle may have a proximal portion and a distal portion comprising a distal opening, the nozzle having a tapered profile such that the cross-sectional dimensions of the proximal portion are greater than the cross-sectional dimensions of the distal portion. The introducer may include a cavity at the distal end of the handle, and may be configured to discharge an implant contained in the cavity through the distal opening via fluid pressure passing through the conduit.

[0007] Optionally, the nozzle includes the cavity. Additionally or alternatively, the proximal portion of the nozzle includes a mating feature complementary to the mating feature of the distal portion of the handle. Optionally, one of the handle or the nozzle includes a protrusion, and the other of the handle of the nozzle includes a channel configured to receive the protrusion; or, the handle and the nozzle include complementary threaded portions. Optionally, the introducer includes an intermediate portion located between the handle and the nozzle, and the intermediate portion includes the cavity. Optionally, the cross-sectional size of the distal opening of the nozzle ranges from about 20 mm to about 40 mm, such as about 25 mm to about 30 mm. Optionally, the handle includes an actuator configured to control the flow of pressurized fluid distally through the catheter to the cavity. Optionally, the actuator includes a valve configured to control the fluid pressure through the catheter to be about 20 psi to about 100 psi. Optionally, the introducer comprises a chamber disposed within the cavity, the chamber being in communication with the catheter and configured to expand when a fluid flows into the chamber.

[0008] Optionally, the handle includes a discharge port configured to selectively discharge pressurized fluid from the chamber. Optionally, the introducer further includes a cap covering the distal opening of the nozzle, the cap being removable from the distal opening and including a hole communicating with the distal opening. Optionally, the cap is configured to form a fluid-tight seal with the nozzle. Optionally, the distal portion of the nozzle is more flexible than the proximal portion of the nozzle, and optionally, the distal portion of the nozzle includes a plurality of flexible strips. Optionally, the nozzle includes an extension adjacent to the distal opening, the nozzle having an asymmetric shape. Optionally, the nozzle is configured to compress an elastic implant, such as a breast implant.

[0009] Aspects of the present disclosure also relate to an implant introducer, comprising: a handle, the handle comprising a catheter; and a nozzle, the nozzle being coupled to the handle via complementary mating features and removable from the handle, the nozzle having a proximal portion and a distal portion comprising a distal opening, wherein the nozzle has a tapered profile such that the cross-sectional dimension of the proximal portion is greater than the cross-sectional dimension of the distal opening. The catheter can be in fluid communication with the nozzle, and the introducer comprises a cavity at the distal end of the handle, the introducer being configured to discharge an implant contained in the cavity through the distal opening via fluid pressure passing through the catheter.

[0010] Optionally, the nozzle comprises the cavity. Optionally, the introducer further comprises a cap configured to form a fluid-tight seal with the nozzle, the cap being removable from the nozzle, wherein the cap comprises an opening for applying vacuum pressure to the nozzle. Optionally, the nozzle comprises a plurality of flexible strips surrounding the distal opening. Optionally, the nozzle comprises an extension adjacent to the distal opening. Optionally, the distal opening has an elliptical shape, and the maximum diameter of the distal opening ranges from about 25 mm to about 35 mm.

[0011] Aspects of the present disclosure relate to an implant introducer comprising: a handle comprising an actuator; a nozzle coupled to and detachable from the handle, the nozzle having a proximal portion comprising a cavity and a distal portion comprising a distal opening communicating with the cavity, wherein the diameter of the cavity is greater than the diameter of the distal opening, and wherein the distal portion is more flexible than the proximal portion; and a catheter fluidly coupled to a chamber defined by a membrane, the chamber being configured to expand at least partially within the cavity when fluid is controlled by the actuator to flow into the chamber. Optionally, a breast implant is disposed in the cavity. Optionally, the breast implant comprises a flexible shell and a viscoelastic filling gel.

[0012] Additional aspects of the present disclosure relate to a method for loading an implant into an introducer comprising a nozzle and a handle. The method may include: inserting the implant into a cavity of the nozzle, the nozzle having a proximal portion comprising the cavity and a distal portion comprising a distal opening, wherein the diameter of the cavity is greater than the diameter of the distal opening; and attaching the proximal portion of the nozzle to the handle. The handle may include a catheter configured to receive a pressurized fluid and supply the pressurized fluid to the nozzle. Optionally, inserting the implant into the cavity includes sucking the implant into the cavity by vacuum pressure. Optionally, the method may further include ejecting the implant from the introducer by pushing the implant through the distal opening of the nozzle via fluid pressure supplied through the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Embodiments of the present disclosure may be implemented in conjunction with the various aspects shown in the accompanying drawings. These drawings show different aspects of the present disclosure, and in appropriate cases, the reference numerals showing similar structural components, materials and / or elements in different figures are marked in a similar manner. It should be understood that various combinations of structures, assemblies and / or elements other than the specifically shown structures, assemblies and / or elements are considered, and the various combinations are within the scope of the present disclosure. Further, even if not specifically mentioned, the various aspects described with reference to one embodiment may also be applicable to other embodiments and may be used together with other embodiments.

[0014] In addition, the present disclosure is neither limited to any single aspect or embodiment, nor to any combination and / or arrangement of such aspects and / or embodiments. Each aspect (e.g., device, method, etc.) and / or its variations of the present disclosure may be adopted alone or in combination with one or more of the other aspects and / or its variations of the present disclosure. For the sake of brevity, certain arrangements and combinations are not discussed and / or described separately herein. It is noteworthy that the embodiments or implementations described herein as "exemplary" should not be interpreted as being preferred or advantageous over, for example, other embodiments or implementations. On the contrary, the embodiments or implementations are intended to reflect or indicate that one or more embodiments are one or more "example" embodiments.

[0015] Figure 1 and 2 A view of an introducer (implant introducing device) according to some aspects of the present disclosure is shown.

[0016] Figure 3 Views showing variations of introducers according to aspects of the present disclosure.

[0017] Figures 4A-4C Illustrative views of the distal tip of an introducer according to aspects of the present disclosure are shown.

[0018] Figure 5 , 6 7A and 7B show exemplary views of a nozzle of an introducer according to some aspects of the present disclosure.

[0019] Figure 8-10 Illustrative views of additional nozzles of introducers are shown in accordance with aspects of the present disclosure.

[0020] Fig.11A and 11B An exemplary two-part nozzle according to some aspects of the present disclosure is shown.

[0021] Figures 12A-12D Exemplary distal tip shapes of the nozzle of an introducer according to some aspects of the present disclosure are shown.

[0022] Fig.13 A perspective view of a handle of an introducer according to some aspects of the present disclosure is shown.

[0023] Figures 14A-14D Various views of a nozzle and cap assembly of an introducer according to aspects of the present disclosure are shown.

[0024] Fig.15 A side view of an assembled introducer is shown in accordance with some aspects of the present disclosure.

[0025] Fig.16 A cross-sectional side view of an assembled introducer is shown in accordance with some aspects of the present disclosure.

[0026] Fig.17 According to some aspects of the present disclosure Fig.15 and 16 A perspective view of the assembled introducer is shown in FIG.

[0027] Fig.18 A side view of another introducer according to aspects of the present disclosure is shown.

[0028] Fig.19A and 19B A side cross-sectional view of components of another introducer according to aspects of the present disclosure is shown.

[0029] Fig. 20 A flowchart illustrating steps in an exemplary method according to some aspects of the present disclosure. DETAILED DESCRIPTION

[0030] Examples of the present disclosure relate to systems, devices and methods for treating an internal area of ​​a patient's body. Such systems, devices and methods may include an introducer (also referred to herein as an introducer device) and an implant (e.g., a prosthesis for introduction into the body) of the patient.

[0031] If there is a conflict with the terms and / or definitions of the art or the terms and / or definitions incorporated by reference, the terms and definitions provided herein shall prevail. The term "comprises / comprising" or other variations of the term used herein are intended to cover non-exclusive inclusions, so that the process, method, article or equipment including a series of elements not only includes those elements, but also may include other elements not clearly listed or other elements inherent to such processes, methods, articles or equipment. In addition, the term "exemplary" is used herein in the sense of "example" rather than "exemplary". The terms "about", "substantially" and "approximately" used herein indicate a range of values ​​within + / - 5% of a specified value.

[0032] The terms "proximal" and "distal" are used herein to refer to the relative position and directional position of the components of an exemplary introducer device."proximal" or "proximally" refers to a position relatively closer to the device operator.By contrast, "distal" or "distally" refers to a position relatively further away from the device operator and or closer to the position inside the patient's body.

[0033] Disclosed herein are instruments, devices (introducers, e.g., implant devices or introducer devices), systems and methods that can be used to introduce implants such as prosthetic implants into implantation sites. In certain embodiments, devices, systems and methods disclosed herein can provide for introducing implants into implantation sites in a minimally invasive manner (e.g., in a manner intended to reduce the degree, size and / or shape of incisions and / or tissue displacements at or near the implantation site). For example, introducer devices as described herein can be used to deliver implants by one or more minimally invasive procedures. In some cases, devices, systems and methods disclosed herein can provide for introducing implants into implantation sites in non-minimally invasive procedures.

[0034] Implants according to the present disclosure may include, for example, breasts, gluteal muscles, calves and other medical implants, including aesthetic implants and / or reconstruction implants. Suitably, implants according to the present disclosure may be partially or completely flexible (e.g., elastic, compressible, expandable and / or elastically deformable). In at least one example, implants for use with instruments, devices, systems and methods disclosed herein may be breast implants with elastic properties (e.g., super viscoelastic and / or high elastic properties). According to some aspects of the present disclosure, implants may include fluids such as liquids or gels (including viscous gels). For example, implants may include silicone-filled gels, wherein the implants may be pre-filled with silicone gels before or after implantation. Implants may include a shell (e.g., an outer shell) having a biocompatible surface. For example, implants may have surface textures disclosed in one or more of WO 2015 / 121686, WO 2017 / 093528 and / or WO 2017 / 196973. In some aspects, the shell can have a combination of surface features or properties (e.g., roughness, kurtosis (e.g., the distribution of peak heights and valley depths of a reference surface)) and / or surface skewness that provide a surface texture with increased biocompatibility. The shell can have low friction surface properties that facilitate smooth delivery and implantation of the implant within the patient's body. Although references to breast implants are used throughout the remainder of this disclosure, the disclosure is not limited thereto. Rather, the systems, devices, and methods disclosed herein can be used to deliver any suitable implant, such as aesthetic implants and / or implants used in reconstructive medical procedures. For example, the systems, devices, and methods herein can be used to deliver one or more of breast, gluteal, calf, and / or other implants into a patient's body.

[0035] Aspects of the introducer devices, systems, and methods of the present disclosure may be used in conjunction with the devices and methods disclosed in WO 2017 / 181144, which is incorporated herein by reference.

[0036] Introducer devices described herein can be used for standardization and / or promotion of procedures for implanting breast implants or other implant devices. In some instances, the introducer device can be configured to advance the implant to the implantation site with one hand. In some respects, the combination of the features of the implant and the introducer system can promote minimally invasive processes, for example, to improve patient health. For example, characterized by elastic properties (for example, a combination of high shell elongation, high shell strength and viscoelastic filling gel), a breast implant optionally with surface texture can be implanted using an introducer device as described herein in a minimally invasive insertion method, to minimize the scar at the incision site, reduce the risk of damaging the implant during placement and / or accelerate and optimize the healing of surgical wounds. Optionally, the introducer device as described herein can have the surface friction properties that promote the smooth delivery and implantation of the implant in the patient's body. In some arrangements, the introducer device described herein can be applicable to a sterile packaging system to provide a "non-contact" implantation procedure. That is, a physician, a nurse or other medical professional or a user does not need to directly handle the implant when the implant is loaded into the introducer device or at other times during implantation. For example, the implant may be pre-packaged within the nozzle in a sterile manner such that the medical professional need not touch the implant during the procedure.

[0037] Reference will now be made to the drawings that accompany the present disclosure.

[0038] Figure 1 and 2 An exemplary introducer 100 is shown that can be used to deliver an implant into an implantation site. The introducer 100 can include a nozzle 110 and a handle 120. The nozzle 110 can include a distal opening 112 and an engagement area 116 for engaging with a complementary engagement area 124 of the handle 120. The handle 120 can further include a fluid supply conduit or lumen 122, a stopper 126, an actuator 128, and a fluid supply port 130.

[0039] The introducer 100 can have any of a variety of suitable sizes, shapes, and characteristics suitable for holding and delivering an implant. Generally, the introducer 100 can include, for example, a nozzle 110 and a handle 120, wherein each of the nozzle 110 and the handle 120 can have any of a variety of shapes and sizes. Although Figure 1 and 2 One variation of an introducer 100 according to the present disclosure is depicted, Figure 3Another variation (introducer 100') is depicted. Further, Figure 13-17 and Fig.18 Additional variations of introducers (introducers 600, 700) are depicted that may share any of the characteristics described herein with respect to introducers 100 and / or 100' (e.g., nozzle characteristics, handle characteristics, reusability, identification characteristics, interchangeability, etc.). Additionally, Figures 4A-12D Depicted are exemplary nozzle sizes and shapes that may be suitable for combination with any of the introducers disclosed herein.

[0040] Introducer 100 and / or the implant used together with introducer 100 can include identification characteristics, such as the unique device identifier (UDI) with the information that can be used to identify introducer device or implant.For example, UDI can include the microtransponder for identifying introducer 100, and / or in the implant for implanting the microtransponder of implant identification and traceability after implantation.In some aspects, introducer 100 and / or the implant used together with introducer 100 can include one or more sensors that can measure temperature, electrical impedance and / or pressure variation, for example, to be used as the control signal of the sign of the infection of shell rupture, patient tissue and / or the inflammatory reaction of patient tissue by monitoring surrounding tissue temperature.Such one or more sensors can be the part of UDI or be separated from UDI.Such UDI and / or one or more sensors can be placed on or in any suitable position of introducer 100 or implant, including the inner surface of the introducer 100 that for example is adjacent to implant and / or contacts with implant.

[0041] In some embodiments, introducer 100 can be a single-use (eg, disposable) device. In other embodiments, some or all of introducer 100 (eg, handle 120 and / or nozzle 110) can be reusable, such as after sterilization.

[0042] Now with reference to the other characteristics of the introducer 100, the nozzle 110 can define a cavity for accommodating the pre-implantation of an implant. In some embodiments, the cavity defined by the nozzle 110 can be configured to accommodate an implant in a configuration of a size that is compressed, rolled up, or otherwise reduced. In such embodiments, the diameter or cross-sectional size of the nozzle 110 can define the cross-sectional size of the implant in a configuration such as a compressed / rolled up configuration. The size of the nozzle 110 can be selected based on the size (e.g., size and shape) of the implant to be delivered using the introducer 100 and / or vice versa (e.g., the characteristics of the implant can be selected based on the size of the nozzle 110).

[0043] The nozzle 110 can have any configuration suitable for inserting an implant through an incision, for example, as described herein and / or described in WO 2017 / 181144, which is incorporated herein by reference. The nozzle 110 can have a portion with a tapered profile, so that the diameter or cross-sectional size of the nozzle at its proximal portion is greater than the diameter or cross-sectional size at its distal portion. In addition, the nozzle 110 can have a proximal portion and a distal opening 112 for coupling with, for example, a handle 120. In some embodiments, the portion of the nozzle 110 with a tapered profile can include most of the nozzle 110. In other embodiments, a relatively small percentage of the nozzle 110 can include a tapered profile (e.g., less than about 50%, less than about 40%, less than about 30%, or less than about 25% of the nozzle 110 can have a tapered profile).

[0044] The nozzle 110 may be a single piece or may include a plurality of pieces that are matched, slotted, assembled, clamped, welded or otherwise combined at one or more joints. As further described herein, the nozzle 110 may also have additional profiles and features (e.g., relative to the distal opening 112 for accommodating an implant and / or relative to the distal opening 112). The nozzle 110 may be formed by or may otherwise include the following: one or more biocompatible polymers or one or more copolymer materials (e.g., polyurethane, polyethylene, silicone, polycarbonate, combinations thereof, etc.). The nozzle 110 may be rigid, semi-rigid, flexible or a combination thereof. For example, the distal opening 112 of the nozzle 110 may be rigid enough to expand the incision site on the patient and guide the implant to the incision site, but soft enough to avoid tearing or damaging the site and / or avoiding deformation of the implant. In addition, the distal opening 112 may be more flexible than, for example, the proximal portion of the nozzle 110, which may be more rigid to facilitate engagement with the handle 120. In some embodiments, the nozzle 110 may be disposable.

[0045] As described elsewhere herein, the implant that is suitable for use with for example introducer 100 can be moldable, flexible, compressible and / or otherwise removable between the insertion configuration of compression and the expanded configuration of deployment.For example, the implant that is used for use with introducer 100 can comprise the high-strength flexible shell with viscoelasticity and low-friction surface property.As mentioned, nozzle 110 can be limited to the chamber for receiving implant with insertion configuration (for example, fully or partially compressed, folded, rolled up or any other low profile configuration).After delivering from distal opening 112 and entering in the patient's body, implant can expand, release compression or otherwise present the configuration of deployment.

[0046] Any one or more parts of nozzle 110 (such as the inner surface of nozzle 110) can include a lubricious coating for reducing the friction coefficient between one or more parts of introducer 100 (such as, inner surface) and one or more parts of the implant contained therein. For example, the lubricious coating can be a water-activated coating fixed on one or more surfaces (such as the inner surface) of nozzle 110. In addition or alternatively, the lubricious coating can include a biocompatible lubricant and / or any other biocompatible coating. Coating can reduce the friction coefficient between the inner surface of implant shell and nozzle 110, thereby promoting the smooth transition between the insertion configuration of the implant and the deployment configuration, for example, when the implant leaves from introducer 100.

[0047] Some aspects of the nozzle 110 can be designed to reduce the risk of tearing or other damage to the implant or patient tissue. In some aspects, the characteristics of the nozzle 110 can be designed to assist in achieving a desired discharge pressure for the implant when the introducer 100 is actuated to deposit the implant, and / or can assist in achieving a desired implant jetting speed through the distal end of the nozzle 110. In some embodiments, for example, the characteristics of the distal opening 112 can be designed or selected to achieve a desired implant jetting speed or implant jetting pressure, or can be designed or selected to improve the placement accuracy of the introducer 100, the biocompatibility of the introducer 100 with the patient's tissue, the compatibility with a specific incision size, and / or other goals.

[0048] The distal opening 112 can be a hole at or near the distal portion of the nozzle 110, through which an implant contained in the cavity of the introducer 100 (e.g., within the nozzle 110) can leave the introducer 100 during the implantation procedure. In some embodiments, the distal opening 112 can be located at the distal end of the nozzle 110. The distal opening 112 can be an opening facing the distal side, and / or can be angled relative to the proximal-distal axis of the nozzle 110. The cross-sectional size of the distal opening 112 (e.g., the diameter of the distal opening 112) can have any suitable size, for example, to achieve one or more of the above-mentioned goals. In some embodiments, the cross-sectional size of the distal opening 112 can range from about 0.5 cm to about 5 cm, such as about 0.5 cm to about 3.5 cm, about 1 cm to about 3 cm, about 1 cm to about 2 cm, or about 1.5 cm to about 2.5 cm.

[0049] In some instances, at least a portion of the nozzle 110 (e.g., the periphery of the distal opening 112) can be configured to flex, for example, as an implant passes through the distal opening of the nozzle, such that the cross-sectional size of the distal opening 112 can increase as the implant passes therethrough (e.g., from about 0.5 cm to about 2 cm, about 2.5 cm, about 3 cm, or about 3.5 cm).

[0050] The distal opening 112 can have any suitable shape, such as circular, elliptical, semi-elliptical (e.g., one side is flat and the other side is circular or elliptical), otherwise curved or angled shapes. The size and shape of the distal opening 112 can be selected to adapt to the size and shape of the implant to be introduced into the patient, guide the implant to enter the implantation site through the incision and / or promote the distal portion of the nozzle 110 to be introduced through the incision. For example, the distal opening 112 can have a semi-elliptical or angled shape to adapt to non-circular implants. The angle of the distal opening 112 and / or the diameter of the distal opening 112 can also be customized. In addition, the distal opening 112 can be defined, flanked and / or limited by one or more slits, fins, petals or extensions arranged around the periphery of the distal opening 112. Such features can be arranged in a circumferential arrangement around the distal opening 112, or can be arranged symmetrically or asymmetrically around the distal opening 112. In certain embodiments, such features can help locate distal opening 112 and / or guide implants to be placed in implantation sites by distal opening 112 through incision. In certain embodiments, such features can be flexible (e.g., sufficiently flexible to bend when applying pressure thereon through the passage of implant, or in certain embodiments, more flexible than the proximal area of ​​nozzle 110). The present disclosure includes a plurality of exemplary variations of the distal opening on the nozzle, and any variation in the plurality of exemplary variations can be used in combination with the nozzle 110 of introducer 100 or with any other introducer described or covered by the present disclosure. It will be apparent to those skilled in the art that variations to each nozzle in these exemplary nozzles are also contemplated.

[0051] Other characteristics of nozzle 110 can be selected to adapt to implants of different sizes and shapes, and / or to provide desired flexibility, discharge pressure and / or other characteristics for introducer 100. For example, the taper degree or angle, the taper shape and / or the length of nozzle 110 can be selected to adapt to implants of different sizes and shapes and / or to facilitate guiding the portion of nozzle 110 through an incision and / or placing the implant in the implantation site. In some embodiments, nozzle 110 can include a trumpet shape (e.g., at the distal portion of nozzle 110), which can assist in inserting nozzle 110 into an incision and / or in safely and effectively deploying the implant.

[0052] The handle 120 can be reversibly or permanently coupled to the nozzle 110. The handle 120 can include a body that houses a fluid supply lumen 122. The shape and size of the handle 120 can be configured for ease of use by an individual. In some embodiments, the handle 120 can be graspable by one hand to allow a user to manipulate the introducer 100 with one hand.

[0053] The handle 120 can be configured to be attached, detached, and / or reattached to the nozzle 110 via a suitable mechanism, which can include an engagement surface 124 of the handle 120 and / or an engagement surface 116 of the nozzle 110. Exemplary attachment mechanisms include, but are not limited to, threads, clamps, screws, and tabs, which can be disposed at, on, and / or around contact portions of the handle 120 and / or the nozzle 110. In some embodiments, as Figure 1 and 2 As shown, the engagement surface 124 may include a plurality of threads that are complementary to the plurality of threads of the engagement surface 116. In further embodiments, the engagement surfaces 124, 116 may include other mating features (e.g., clips, clamps, adhesives, etc.) to facilitate permanent or reversible attachment of the handle 120 to the nozzle 110.

[0054] Handle 120 can limit or surround fluid supply lumen 122, and described fluid supply lumen can be configured for fluid, for example, from the fluid source (not shown) connected to, through handle 120 and fluid supply port 130 to reach the inner part of nozzle 110.Fluid supply lumen 122 can be connected to or can be connected to fluid supply via any suitable connection such as but not limited to Luer (Luer) connection, threaded connection, clip connection, lock connection, etc.Fluid supply can include pressurized fluid sources such as pressurized gas or fluid.In certain embodiments, pressurized fluid source can include, for example, portable compressed fluid tank, pressurized fluid pipeline (for example, gas pipeline or water pipeline) etc.For example, in certain embodiments, fluid source can be disposable or refillable compressed gas tank.Can be installed to be loaded into the implant in introducer 100, so that fluid supply lumen 122 and fluid supply port 130 can be positioned to deliver pressurized fluid to the region positioned proximally from implant. Such pressurized fluid can exert pressure on the implant when delivered to drive the implant distally toward the distal opening 112 of the nozzle 110 and through it. In some embodiments, as discussed elsewhere herein, the fluid supply lumen 122 and the fluid supply port 130 can be configured to conduct the pressurized fluid from the fluid supply to an expandable cavity at least partially disposed in the proximal region of the nozzle 110, such as a balloon, an expandable chamber, or a cavity defined by a membrane. The pressure entering such an expandable cavity from the pressurized fluid can expand the cavity and / or move the membrane, the balloon wall, or the cavity wall, thereby exerting pressure on the implant and driving the implant distally through the distal opening 112. As described elsewhere herein (e.g., with respect to introducer 600, 700), the handle 120 can further include an openable discharge port between the expandable cavity and the outside of the introducer to allow the pressurized fluid to be discharged from the expandable cavity.

[0055] The handle 120 may include a stopper 126, for example, defined by a distal end or distally facing wall of the handle 120. The stopper 126 may be sized and configured to cover and / or close the proximal end of the nozzle 110. In some embodiments, when the handle 120 is coupled to the nozzle 110, the stopper 126 may define the most proximal sidewall of the cavity in which the implant may be accommodated in the introducer 100. In at least one example, the stopper 126 is configured to seal the proximal end of the nozzle 110 after the implant has been positioned in the cavity. The stopper 126 may be held in place against the nozzle 110 by a connection or mating feature that may attach the handle 120 to the nozzle 110 (e.g., engagement surfaces 124, 116), which may include threads, Luer-type connections, adhesives, vacuum or evacuation seals, clips, clamps, etc. In some embodiments, the stopper 126 may include an elastomeric surface, for example, to better form a seal against the nozzle 110. The fluid supply port 130 may pass through the barrier 126 (eg, Figure 1 ) to allow pressurized fluid to be delivered to the cavity distal to the barrier 126.

[0056] The handle 120 may include an actuator 128 for selectively supplying and terminating the flow of compressed gas or other pressurized fluid from the fluid supply through the fluid supply port 130. The actuator 128 may include, for example, a button, a knob, a valve, a switch, a clamp, or a combination thereof, which may open / establish and / or close the connection between the more proximal portion of the fluid supply lumen 122 and the fluid supply port 130. In some embodiments, the actuator 128 may be spring-loaded or otherwise may employ a constant pressure to maintain an open flow of pressurized fluid toward an implant contained in the cavity of the nozzle 110.

[0057] Figure 3Describe introducer 100 's similar to introducer 100.Introducer 100 ' comprises nozzle 110 ' with distal opening 112 ' and handle 120 ' with fluid supply lumen 122 ', stopper 126 ' and engagement area 124 '.Aspects of introducer 100 ' can share any characteristics with similar aspects of introducer 100.As shown, nozzle 110 ' comprises conical portion and distal tip (comprising distal opening 112 ') that forms a row angle with described conical portion.Introducer 100 ' further comprises holding attachment 144 ' attached to the proximal part of nozzle 110 '.Holding attachment 144 ' can for example assist in manipulating introducer 100 '.This can reduce or eliminate the need of touching nozzle 110 ', which can for example assist in for example maintaining the cleanliness and / or sterility of nozzle 110 ' and / or the user's hand before or during surgical procedure. In some embodiments, the retaining attachment 144' can assist in loading the implant into the nozzle 110'. The retaining attachment 144' can be attached to, for example, the nozzle 110' or the handle 120' by any suitable means such as complementary threads, clips, snap connections, adhesives, and the like.

[0058] As mentioned above, introducer as herein described (for example, above-mentioned introducer 100 and / or introducer 600,700 or its modification) can be used for implanting the implant with viscoelasticity and / or other elastic properties, for example, comprises the implant of elastic shell and viscoelastic filling gel.This elastic property of implant promotes the manipulation of implant, for example, thereby allows implant to be compressed, stretched and / or elongated so that with the profile that reduces, is loaded into the nozzle (for example, nozzle 110) of introducer (for example, introducer 100) for implanting in the mode that can alleviate the trauma to patient.In certain embodiments, such implantation can be the part of minimally invasive procedure.The various properties of introducer 100 and / or implant can allow the radial compression of implant, and this can provide the ability that safely compresses implant to advance to smaller incision. For example, the various properties of introducer 100 can be sized and configured to help compress implant to advance in following incision: about 5cm or less, for example, about 4cm or less, about 3cm or less, about 2cm or less, about 1.5cm or less, about 1cm or less, as about 0.5cm, about 1cm, about 1.5cm, about 2cm, about 2.5cm, about 3cm, about 3.5cm, about 4cm, about 4.5cm or about 5cm. For example, introducer 100 can be suitable for implanting an incision having a length between about 0.5cm and about 5cm, between about 1cm and about 3cm or between about 1.5cm and 3.5cm.

[0059] In certain embodiments, as described above, introducer disclosed herein (e.g., introducer 100, 100', 600, 700 or its variation) can be configured to be used interchangeably with different types of nozzles. For example, a handle (e.g., handle 120) can have an attachment feature complementary to the nozzle of different sizes, shapes and / or types. Therefore, in such embodiments, nozzle shape, size and / or type can be selected for a given implant, program and / or patient. The various characteristics of nozzle disclosed herein (e.g., rigidity / flexibility of the material of the distal opening of the nozzle, the shape of the distal opening, the cross-sectional size of the distal opening, etc.) can allow medical professionals to better control the trajectory and / or speed of implant delivery and / or allow implants to be more accurately placed in the desired implantation site.

[0060] Figure 4A and 4C A conical nozzle 200 having an asymmetric tip similar to nozzles 110, 110' is depicted. For example, the nozzle includes an extension 212 adjacent a distal opening of the nozzle. Figure 4A depicts a perspective view of the extension 212, and Figure 4C Depicted is a side cross-sectional view of nozzle 200. Extension 212 may allow for more precise placement of the distal end of nozzle 200 in or at the incision site and may direct the discharge of an implant through nozzle 200 into a desired location. Figure 4B Depicted is how the extension 212 can be cut away from the solid cylindrical portion at the end of the nozzle, for example by removing the section 202. The extension 212 need not be a separate component, and may instead be an integral part of the nozzle 200. In some embodiments, the nozzle 200 and / or the extension 212 can be made of or include a relatively rigid material (e.g., a relatively rigid polymer such as polypropylene, polycarbonate, polyurethane, polyetheretherketone (PEEK) or other rigid or semi-rigid plastics or polymers, or a biocompatible metal) to enable the implant to be accurately delivered to the desired site. In addition, once the extension 212 is inserted through the incision, it can assist in keeping the relatively small incision open so that the implant can pass through the incision and into the desired site.

[0061] In some instances, the distal end of a nozzle according to the present disclosure may be defined by or include two or more strips extending generally parallel to the longitudinal axis of the nozzle. When such strips flex radially outward in response to compression of the implant through the distal opening, the strips may allow the distal opening to widen. Such a configuration may help avoid deformation of the implant during the implantation procedure. In some instances, one or more of the strips may extend further than one or more of the other strips, for example, to help guide the implant into the incision site. Each strip may have the same or a different amount of rigidity or flexibility as the other strips. For example, Figure 5 and 6 Depicted are two tapered spherical nozzles 300, 304 with different distal ends. Nozzle 300 includes a strip 302 extending in the distal direction at the distal tip. Strip 302 can facilitate placement of an implant in a relatively small incision, wherein when the implant passes through the distal end of nozzle 300, strip 302 can separate (flex away from each other). Thus, for example, strip 302 can be radially deflected outward so that the implant does not become overly compressed when discharged into the surgical site. Nozzle 304 includes a strip 306 that is longer than the remainder of strip 302, similar to extension 212 of nozzle 200. Extension strip 306 can similarly allow the distal end of nozzle 304 to be more accurately placed in or at the incision site, and help guide the implant to be discharged into the desired site through nozzle 304. Nozzles 300, 304 can include any material suitable for other nozzles (e.g., nozzle 110) disclosed herein. In some embodiments, the nozzles 300, 304 may include a semi-rigid material (eg, semi-rigid plastic, silicone, or other polymer) that may allow the strip to flex in response to pressure.

[0062] Fig. 7A and 7B A conical nozzle 310 having a narrow opening at the distal end is depicted. The narrow opening is defined by a strip 312 that can separate and flex radially outward when the implant passes through the opening. The narrowness of the opening can facilitate the introduction of the distal end of the nozzle 310 into a small incision (e.g., less than 3 cm, e.g., 0.5 cm to 2.5 cm or 2 cm or less). The nozzle 310 can include any material suitable for other nozzles disclosed herein (e.g., nozzle 110).

[0063] Similar to Figure 5 and 6 , Figure 8 and 9Depict tapered nozzles 400, 410 with a strip 402 extending distally defining a distal opening. Compared to nozzles 300, 304, nozzles 400, 410 have larger openings that can allow larger implants or implants with less compressibility to pass through. Similar to nozzle 304, nozzle 410 includes a strip 404 extending distally beyond other strips 402. Strip 404 can facilitate placement of the distal end of nozzle 410 in or at the incision site, and can help guide and / or control the discharge of implants into a desired location through nozzle 410. Nozzles 400, 410 can include any material suitable for other nozzles disclosed herein (e.g., nozzle 110).

[0064] Fig.10 A conical nozzle 412 is depicted with a distal strip 402 defining a distal opening. The strips 402 may be covered or connected together by a flexible membrane 414 (e.g., an elastic silicone membrane) that may allow the strips 402 to separate or flex away from each other while preventing the strips 402 from splitting apart and piercing, scraping, and / or scratching patient tissue and / or implants. The material of the membrane 414 may be the same or different from the material of the remainder of the nozzle 412. For example, the membrane 414 and the remainder of the nozzle may include the same type of polymer, wherein the membrane 414 has a thinner wall thickness that allows the membrane 414 to stretch.

[0065] Fig.11A and 11B A two-part nozzle according to some aspects of the present disclosure is depicted. Fig.11A A first component 420 is depicted having an elongated extension 422 extending in a distal direction adjacent a distal opening. Component 420 may be relatively rigid, and may include, for example, a rigid or semi-rigid plastic or other polymer or a biocompatible metal. Fig. 11B A second component 424 is depicted having a shape that tapers inwardly, reaching a narrowest point closest to the middle portion of the second component 424 and then flaring outwardly in a distal direction. The distal opening in the second component 424 may be angled so as to form an angled opening. Component 424 may be more flexible than component 420, for example, including a semi-rigid or flexible polymer or any material suitable for other nozzles disclosed herein (e.g., nozzle 110). Components 420 and 424 may be configured to fit together for use. For example, component 424 may be nested within component 420, with the distal extension 422 of component 420 being received within a sleeve 426 of component 424. The first component 420 and the second component 424 may be attached or otherwise coupled together to form a nozzle.

[0066] Figures 12A-12DDescribes other exemplary nozzles 500, 510, 520, 530 with different exemplary shapes of distal openings 502, 512, 522, 532, respectively. Therefore, for example, the periphery of the distal opening can be generally elliptical, rectangular, trapezoidal or can be an asymmetric shape. These nozzles can include, for example, any material suitable for other nozzles (e.g., nozzle 110) disclosed herein. Each nozzle can be constructed or provided with various distal opening sizes. For example, the distal openings 502, 512, 522, 532 can each have a cross-sectional diameter ranging from about 20mm to about 40mm, such as about 24mm, about 28mm or about 30mm. For example, the range of the maximum cross-sectional diameter can be about 20mm to about 40mm, about 30mm to about 40mm, about 25mm to about 35mm or about 25mm to about 30mm.

[0067] Figure 13-17 Depicted is a view of an introducer 600 according to aspects of the present disclosure. The introducer 600 includes a handle 610 and a nozzle 650. The handle 610 ( Fig.13 , 15 , 16 and 17) includes a fluid supply conduit 612, an actuator 614, a discharge port switch 616 and a retaining hole 618. The nozzle 650 (shown in Fig.14A , 14C , 14D, 15, 16 and 17) comprises a distal portion 660 having a distal opening 654, an intermediate portion 656 and a proximal portion having a mating element (e.g., a protrusion 652) complementary to the handle 610 as discussed below. The introducer 600 further comprises a distal cap 680 having a distal cap nozzle 682.

[0068] The introducer 600, handle 610 and nozzle 650 and its components (e.g., actuator 614, fluid supply conduit 612, distal opening 654, etc.) can share any characteristics, materials, functions, etc. with, for example, introducer 100, handle 120 and nozzle 110 and its components, and as such, will not be described in repetitive detail. For example, the distal opening 654 can have any size, shape, extension, tab, etc. described with respect to any other nozzle disclosed herein. The fluid supply conduit 612 can be coupled to any suitable fluid source as previously described with respect to the fluid supply lumen 122. In some embodiments, the distal portion 660 of the nozzle 650 is elongated (e.g., compared to the nozzle 110), which can help guide the implant to be discharged into the desired implantation site.

[0069] The middle part 656 of nozzle 650 can define a cavity, and can be configured to load and hold implants for introduction into the implantation site with radial compression and / or elongated configuration. In certain embodiments, as shown, the distal portion 660 of nozzle 650 can be more tapered (with smaller cross-sectional dimensions) than the middle part 656, so that the implant loaded into the middle part 656 is not compressed as in the distal part 660. In certain embodiments, the middle part 656 can have approximately equal diameters along its length. In certain embodiments, for example, the middle part 656 can be generally cylindrical in shape. The proximal portion of nozzle 650 can be open to allow implants to be loaded into the cavity defined by the middle part 656.

[0070] like Fig.14A , 14B , 14D and 16, the distal cap 680 can be coupled to the nozzle 650 over the distal opening 654, for example, by a friction fit or other complementary mating features. The distal cap 680 can be configured to form a seal around the distal opening 654 to guide the fluid through the distal cap nozzle 682 and prevent the fluid from leaking or escaping in other ways except through the distal cap nozzle 682. The distal cap nozzle 682 can include a distal opening to which a vacuum can be applied. Applying a vacuum to the distal opening 654 of the nozzle 650 via the distal cap nozzle 682 can facilitate loading the implant via suction through the proximal portion of the nozzle 650. Once the implant is loaded into the nozzle 650, or once the implantation site is ready to receive the implant, the distal cap 680 can be removed from the nozzle 682 to expose the distal opening 654.

[0071] The proximal portion of the nozzle 650 can be coupled to the distal end of the handle 610 (eg, Fig.16 ). For example, the proximal portion of the nozzle 650 can be tightly fitted within the distal end of the handle by sliding the protrusion 652 proximally into the channel defined by the retaining hole 618 of the handle 610. Each protrusion 652 can slide into a circumferential portion of the channel defined by the retaining hole 618 to secure the nozzle 650 to the handle 610. As shown, the channel can optionally have an L shape so that rotating the nozzle 650 relative to the handle 610 can lock the protrusion 652 within the channel. After the nozzle 650 has been loaded with an implant, the nozzle 650 can be coupled to the handle 610 in this manner to enclose the implant within the introducer 600. Although Fig.13 , 14A , 14C, 14D and 15 depict a nozzle 650 having a protrusion 652 and a handle 610 having a channel for receiving the protrusion 652, but in other examples, the nozzle 650 may include a channel for receiving the protrusion of the handle (see, e.g. Figures 12A-12D). Further, other complementary mating elements may be used to removably secure the nozzle 650 to the handle 610.

[0072] like Fig.16 As shown, the flexible membrane 620 can be coupled to the handle 610, such as the distal portion of the handle 610. In some embodiments, the membrane 620 can be at least partially disposed in the cavity of the middle portion 656, and the membrane 620 defines a chamber 622 into which the fluid can be received from the fluid supply conduit 612. During the operation of the introducer 600, the actuator 614 can be engaged to allow the fluid to travel to the chamber 622 defined by the membrane 620 via the fluid supply conduit 612. The actuator 614 can be a switch, button, lever or connector that connects the fluid supply conduit 612 to the cavity 622 when engaged. When the fluid is received in the chamber 622, the membrane 620 can expand into the cavity of the middle portion 656. The pressure from the fluid can push the implant disposed in the cavity defined by the middle portion 656 to the distal side through the distal portion 660 and the distal opening 654 of the nozzle 650, and into the desired implantation site. In some embodiments, the chamber 622 and / or the membrane 620 can be expandable enough to fill a majority of the interior of the nozzle 650, such that distal expansion of the chamber 622 and distal movement of the membrane 620 displaces the implant within the nozzle 650 until it is expelled from the introducer 600. In some embodiments, as opposed to being surrounded by the membrane 620, the chamber 622 can be defined in part by the membrane 620 and in part by, for example, the distal end of the handle 610. The membrane 620 can be securely attached to the handle 610 to allow fluid to enter the chamber 622 without removing the membrane 620 from the handle 610.

[0073] The vent switch 616 can control the vent that couples the interior of the chamber 622 with the external fluid of the introducer 600. According to some aspects, when the vent switch 616 is closed, the vent switch 616 prevents fluid from escaping from the chamber 622. Further, for example, when actuated or opened, the vent switch 616 can allow the fluid in the chamber 622 to be discharged to the outside of the introducer 600, thereby reducing or reducing the fluid pressure in the chamber 622 to the extent that the chamber 622 is pressurized relative to the outside of the introducer 600. The vent switch 616 can be operated mechanically or electronically. In some embodiments, for example, the vent switch 616 can include an electric switch that can, for example, activate suction, a fan or a blower to actively remove fluid from the chamber 622. The vent switch 616 can thus be used to stop or reduce the discharge pressure in the nozzle 650, for example, to stop or slow down the discharge of the implant from the nozzle 650, and / or reset the introducer 600 after the implant is discharged from the nozzle 650.

[0074] As already described with respect to introducer 100, one or more components of introducer 600 (e.g., handle 610, distal cap 680, nozzle 650) can be reusable. For example, one or more materials forming the various components of introducer 600 can be sterilized. One or more components of introducer 600 can also or alternatively be disposable, for example, wherein one or more parts of introducer 600 can be replaced by new, unused components.

[0075] Fig.18 An introducer 700 loaded with an implant 720 is depicted, which introducer 700 shares some features of introducer 600 and includes features that differ from introducer 600. For example, introducer 700 includes a handle 710, an actuator 714, a fluid supply conduit 716, an electrical supply conduit 718, a middle portion 756 defining a cavity in which the implant 720 is disposed, a nozzle 760 attached to the middle portion 756 by an extension 762 on the middle portion 756 that slides into a channel defined by a retaining hole 768 of the nozzle 760. The nozzle 760 includes a distal opening 764 and a distal extension 766.

[0076] Components of introducer 700 (e.g., handle 710, actuator 714, fluid supply conduit 716, electrical supply conduit 718, intermediate portion 756, and nozzle 760) may share any characteristics, materials, functions, etc. with, for example, introducers 100, 100', 600, handles 120, 610, actuators 128, 614, fluid supply lumen 122, fluid supply conduit 612, and / or distal openings 112, 654, etc. As such, they will not be described in repetitive detail.

[0077] In some embodiments, the middle portion 756 can be separated from the nozzle 760 or can be separated (detachable) from the nozzle. As shown in relation to the introducer 700, the middle portion 756 can be separately connected to the handle 710 and / or the nozzle 760. In addition or alternatively, the middle portion 756 can be a piece of the handle 710 (e.g., integrated with the handle). In such cases, before the nozzle 760 is connected to the middle portion 756, the implant 720 can be loaded through the distal opening of the middle portion 756. The handle 710 can be equipped with a user-friendly handle. In some embodiments, the actuator 714 is a rotatable trigger. The electrical supply conduit 718 can supply power to one or more aspects of the introducer 700. For example, in some embodiments, the electrical supply conduit 718 can supply power to a vacuum source placed in the handle 710 and / or the middle portion 756, which can be used to generate suction in the middle portion 756 and load the implant 720 into the middle portion.

[0078] Fig.19A and 19BA nozzle 800 is depicted in schematic form for holding and storing an implant 810 through an incision in tissue 820. The nozzle 800 includes two flexible or semi-flexible strips 804 disposed on (or forming) at least two sides of a tapered portion 802. The strips 804 can be relatively more flexible than the tapered portion 802, which can include a rigid or semi-rigid material. In some embodiments, the tapered portion 802 can be relatively rigid at the proximal end and semi-rigid (more flexible) at the distal portion. Thus, for example, materials with different flexibility or the same material with different configurations that allow for variable flexibility can be used in the tapered portion 802. The strips 804 can help position the nozzle 800 at or through the incision site. As shown in FIG. Fig.19B As shown, during expulsion or deployment of the implant 810, the strip 804 can flex or bend outward to widen the distal opening 820. This flexibility can help guide the implant 810 through the incision and into the implantation site when the implant 810 is expanded without being constrained by the tapered portion 802.

[0079] As about Figure 1-19B As mentioned and described, the present disclosure contemplates methods of loading an implant into an introducer and delivering the implant to an implantation site, such as within tissue of a patient. Fig. 20 An exemplary method 1000 for loading an implant and delivering the implant to an implantation site is depicted in the form of a flow chart. The method 1000 and its variations can be applied to any introducer described or covered by the present disclosure, as well as other introducers. One of ordinary skill in the art will appreciate that Fig. 20 Only exemplary methods are depicted, many variations are possible. In some embodiments, the Fig. 20 The steps of method 1000 and variations of the steps may be performed by one or more users (eg, medical professionals, technicians, assistants, etc.).

[0080] According to step 1002 of method 1000, an implant can be loaded into a cavity of an implant introducer (e.g., a cavity defined by a nozzle such as nozzle 110, 110', 650, 760, etc.). For example, a user with an assembled introducer (e.g., introducer 100, 100', 600, 700, etc.) can first remove a nozzle (e.g., nozzle 110, 110', 650, 760) from a handle or other component of the introducer. Then, the implant can be loaded into, for example, a proximal opening of a nozzle (e.g., a proximal opening of nozzle 110, 110', 650) or a distal opening of a cavity (e.g., a cavity defined by the middle portion 756 of introducer 700).

[0081] In some respects, implant can be inserted into the nozzle or the cavity of introducer with the help of the sheath or other device suitable for compressing implant.For example, implant can be preloaded or inserted in the introducer sheath, to promote the implant aseptic loading into the nozzle, and / or to manipulate (for example, compression, elongation, etc.) implant towards the insertion configuration. In other respects, vacuum or suction can be used to load implant into the cavity.For example, about introducer 600 and its modification, distal cap 680 can be attached to the distal opening 654 of nozzle 650, for example, to form a fluid-tight seal.When implant is placed at the open proximal end of nozzle 650, vacuum can be applied by the opening of distal cap nozzle 682. The pressure reduction caused by the applied vacuum can suck implant into the proximal opening of nozzle 650, sucking in the cavity defined by the middle part 656 of nozzle 650.

[0082] The cavity can be coupled to a handle of the introducer according to step 1004. For example, the nozzle can be coupled to (e.g., attached to, reattached to, clipped on, screwed on, etc.) a handle body.

[0083] According to step 1006, the distal opening of the introducer (e.g., distal opening 112, 112', 654 or 764) can be at least partially inserted into the incision of the implantation site. Depending on the location of the implantation site, the size of the incision, the size (shape and volume) of the implant to be inserted, the length of the nozzle, etc., a larger or smaller portion of the introducer can be inserted into the incision. In some embodiments, the distal tip of the nozzle can be inserted through the incision and at least partially inserted into the implantation site.

[0084] According to step 1008, the introducer can be actuated to eject the implant from the cavity through the distal opening and into the implantation site. An actuator such as actuator 128, 614, 714 (e.g., a trigger, button or other mechanism) can be engaged to allow a fluid source (e.g., compressed gas, liquid, etc.) to apply force to the implant directly or indirectly (e.g., through a membrane or balloon, such as membrane 620) to push, forcefully move or otherwise cause the implant to be discharged through the distal opening of the nozzle (e.g., distal opening 112, 112', 654 or 764) and enter the implantation site (e.g., into a breast tissue pocket, a gluteal muscle tissue pocket or other implantation site) via an incision. In some aspects, a retractor such as a retractor described in WO 2017 / 181144, incorporated herein by reference, can be used to easily discharge the implant and / or appropriately place the implant into a surgical site such as a desired portion of the patient's body (e.g., a chest pocket or other implantation site).

[0085] An actuator (e.g., a trigger, button, or other mechanism) may be engaged to communicate with a fluid source (e.g., compressed gas or liquid) to open the interior cavity, balloon, or diaphragm (e.g., Fig.16 In embodiments where the implant is expanded or extended to push, force, or otherwise expel the implant through the distal opening of the nozzle, a release mechanism (e.g., Fig.13 A vent switch 616 (depicted in FIG. 6 ) is provided to release fluid and deflate or collapse the internal cavity, balloon, or diaphragm.

[0086] Can be relevant with the factors such as volume / size / shape, (ii) incision position and size and / or (iii) nozzle diameter of (i) implant according to the suitable discharge pressure that is used for implant introducer device discharge of the present disclosure.Can provide the chart that defines these parameters that are used to place introducer device and implant appropriately to medical professional or other user.Described chart can be developed for example by benchmark assessment and preclinical assessment.In certain embodiments, for example, the pressure of about 20psi to about 100psi may be suitable for discharging implant, described pressure such as about 20psi to about 80psi, about 20psi to about 60psi or about 30psi to about 50psi, such as about 25psi, about 30psi, about 35psi, about 40psi, about 45psi, about 50psi, about 55psi, about 60psi, about 65psi, about 70psi, about 75psi, about 80psi, about 85psi, about 90psi, about 95psi or about 100psi.

[0087] Further aspects of preparing, loading, actuating, and using an introducer device, as well as aspects of calculating appropriate pressures and fluid volumes for loading and expelling an implant from an introducer device, are described in WO 2017 / 181144, which is incorporated herein by reference.

[0088] Although the principles of the present disclosure are described herein with reference to the illustrative aspects of specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and those who obtain the teachings provided herein will recognize that other modifications, applications, aspects, and replacements of equivalents all fall within the scope of the various aspects described herein. Therefore, the present disclosure is not to be considered as being limited by the foregoing description.

Claims

1. An implant introducer, comprising: handle; A nozzle is coupled to the handle, the nozzle having: a cavity configured to receive an implant; and distal opening; as well as A flexible membrane defines a chamber, wherein when the chamber receives a fluid, the flexible membrane expands into the cavity of the nozzle and pushes an implant through a distal opening of the nozzle.

2. The introducer of claim 1 further comprising a vent switch, the vent being configured to selectively discharge pressurized fluid from the chamber wherein the nozzle contains the cavity.

3. The introducer of claim 1, wherein the flexible membrane is coupled to a distal portion of the handle.

4. The introducer of claim 1, wherein the handle further comprises: fluid Supply catheter; and An actuator is configured to direct fluid via the fluid supply conduit into a chamber defined by the flexible membrane.

5. The introducer according to claim 4, wherein: The fluid supply conduit is coupled to a fluid supply including a portable compressed fluid tank, a pressurized gas line, or a pressurized water line.

6. The introducer of claim 4, wherein the actuator is located on an upper surface of the handle.

7. The introducer of claim 1, wherein the fluid is at a pressure of about 20 psi to about 60 psi.

8. The introducer of claim 7, wherein the pressure of the fluid is about 50 psi, about 55 psi, or about 60 psi.

9. An implant introducer, comprising: a handle having a fluid supply conduit; as well as A nozzle coupled to the handle, the nozzle having: a cavity configured to receive an implant; as well as A distal portion includes a distal opening and an asymmetric tip formed by an extension adjacent to the distal opening.

10. The introducer according to claim 9, wherein: The cavity of the nozzle is generally cylindrical in shape.

11. The introducer according to claim 9, wherein: The distal portion of the nozzle has a smaller cross-sectional dimension than the cavity of the nozzle.

12. The introducer of claim 11, wherein the distal portion of the nozzle has a cross-sectional dimension of about 20 mm to about 40 mm.

13. The introducer of claim 12, wherein the distal portion of the nozzle has a cross-sectional dimension of about 25 mm to about 30 mm.

14. The introducer of claim 9, wherein the distal portion of the nozzle is elongated to help guide the implant to a desired implantation site.

15. The introducer of claim 9, wherein the nozzle further comprises a proximal portion having mating features complementary to the handle.

16. The introducer according to claim 15, wherein: A proximal portion of the nozzle is open and configured to receive the implant during loading.

17. The introducer of claim 9, wherein a distal portion of the nozzle is more flexible than a proximal portion of the nozzle.

18. The introducer of claim 9, wherein an inner surface of the nozzle comprises a water activated lubricating coating.

19. The introducer of claim 11, wherein the cross-sectional dimension of the distal portion of the nozzle is about 5 mm to about 50 mm.

20. The introducer of claim 9, wherein the implant is elastic and the nozzle is configured to compress the elastic implant.

21. The introducer of claim 9, wherein the extension is an integral part of the nozzle.

22. The introducer of claim 22, wherein the nozzle is constructed of a relatively rigid material.

23. The introducer of claim 22, wherein the relatively rigid material comprises polypropylene, polycarbonate, polyurethane, polyetheretherketone (PEEK), or a biocompatible metal.

24. An implant introducer, comprising: handle; A nozzle coupled to the handle, the nozzle having: proximal part; Cavity; and distal opening; as well as a distal cap removably coupled to the distal opening of the nozzle, wherein the distal cap has: a first configuration wherein the distal cap is coupled to a distal opening of the nozzle, the distal cap having an opening to apply a vacuum to the distal opening of the nozzle and to draw suction through the proximal portion of the nozzle to load an implant into a cavity of the nozzle; as well as A second configuration wherein the distal cap is removed to expose the distal opening of the nozzle.

25. The introducer of claim 24, further comprising a flexible membrane defining a chamber, wherein in the second configuration, when the chamber receives a fluid, the flexible membrane expands into the chamber of the nozzle and pushes the implant through the exposed distal opening of the nozzle.

26. The method of claim 24, wherein the nozzle further comprises an extension adjacent the distal opening to form an asymmetric tip.

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