Patent Description:
The present disclosure relates generally to prosthetic implant introduction devices.

Current techniques for insertion of medical implants, such as breast implants, may create surgical wounds resulting in an extended, complex, and/or dynamic healing process, e.g., to allow a patient body to replace devitalized and missing cellular structures and/or tissue layers. For example, many current techniques require a relatively large incision at or near a surgical implantation site (e.g., a tissue pocket). The incision may need to be manipulated by retractors and/or tissue-spreaders to expand and hold it open, while an implant is physically manipulated into the implantation site. These techniques may result in heavy scarring, a high probability of damage to the implant, and/or a high probability of infection at the implantation site. Moreover, these techniques may require insertion of drainage tubes to evacuate serous fluids from surrounding tissue and prevent capillary damage; and/or may accelerate inflammatory responses that impact the healing process. In addition, it is recognized that the larger the incision, the greater potential incidence for keloid and hypertrophic scarring during and after healing. Certain patients are also more susceptible to, and are at higher risk of, keloid formation. <CIT> describes minimally invasive apparatuses for the implantation of medical devices and methods related thereto. <CIT> describes a closed loop fat transplantation system. <CIT> describes a silicon breast implant injector comprising a hollow tube and a plunger. <CIT> describes a propeller for an artificial breast bag implant device. <CIT> describes a silicone breast implant introducer comprising a hollow tube, a piston, a tube holder, attachment means and connecting means. <CIT> describes a prosthesis manipulation pouch as part of an apparatus for inserting prosthesis implants into a patient cavity.

No surgical methods form part of the invention. Aspects of the present disclosure are directed to an implant introducer, including: a handle including a conduit configured to receive a pressurized fluid; and a nozzle coupled to, and detachable from, the handle. The nozzle may have a proximal portion and a distal portion that includes a distal opening, the nozzle having a tapered profile such that a cross-sectional dimension of the proximal portion is larger than a cross-sectional dimension of the distal portion. The introducer may include a cavity distal to the handle, and may be configured to expel an implant housed within the cavity through the distal opening via fluid pressure through the conduit.

Optionally, the nozzle includes the cavity. Additionally or alternately, the proximal portion of the nozzle includes mating features complementary to mating features of a distal portion of the handle. Optionally, one of the handle or the nozzle includes protrusions, and the other of the handle of the nozzle includes channels configured to receive the protrusions; or, the handle and the nozzle include complementary threaded portions. Optionally, the introducer includes a middle portion between the handle and the nozzle, and the middle portion includes the cavity. Optionally, the distal opening of the nozzle has a cross-sectional dimension ranging from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>. Optionally, the handle includes an actuator configured to control a flow of pressurized fluid distally through the conduit to the cavity. Optionally, the actuator includes a valve configured to control a fluid pressure of about <NUM> kPa (about <NUM> psi) to about <NUM> kPa (about <NUM> psi) through the conduit. Optionally, the introducer includes a chamber disposed within the cavity, the chamber being in communication with the conduit and configured to expand upon a flow of fluid into the chamber.

Optionally, the handle includes a vent configured to selectively vent pressurized fluid from the chamber. Optionally, the introducer further comprises a cap covering the distal opening of the nozzle, the cap being removable from the distal opening and including an aperture in communication 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 asymmetrical shape. Optionally, the nozzle is configured to compress an elastic implant, such as a breast implant.

Aspects of the present disclosure are also directed to an implant introducer, comprising a handle including a conduit, and a nozzle coupled to, and detachable from, the handle via complementary mating features, the nozzle having a proximal portion and a distal portion that includes a distal opening, wherein the nozzle has a tapered profile such that a cross-sectional dimension of the proximal portion is larger than a cross-sectional dimension of the distal opening. The conduit may be in fluid communication with the nozzle, and the introducer includes a cavity distal to the handle, the introducer being configured to expel an implant housed within the cavity through the distal opening via fluid pressure through the conduit.

Optionally, the nozzle includes the cavity. Optionally, the introducer further includes a cap configured to form a fluid seal with the nozzle, the cap being removable from the nozzle, wherein the cap includes an opening to apply vacuum pressure to the nozzle. Optionally, the nozzle includes a plurality of flexible strips surrounding the distal opening. Optionally, the nozzle includes an extension adjacent to the distal opening. Optionally, the distal opening has an oval shape, a maximum diameter of the distal opening ranging from about <NUM> to about <NUM>.

Aspects of the present disclosure are directed to an implant introducer, including: a handle including an actuator; a nozzle coupled to, and detachable from, the handle, the nozzle having a proximal portion that includes a cavity and a distal portion that includes a distal opening in communication with the cavity, wherein a diameter of the cavity is greater than a diameter of the distal opening, and wherein the distal portion is more flexible than the proximal portion; and a conduit fluidly coupled to a chamber defined by a membrane, the chamber configured to expand at least partly in the cavity upon a flow of fluid into the chamber controlled by the actuator. Optionally, a breast implant is disposed in the cavity. Optionally, the breast implant includes a flexible shell and a visco-elastic filling gel.

Further aspects of the present disclosure are directed to a method for loading an implant into an introducer that includes a nozzle and a handle. The method may include inserting the implant into a cavity of the nozzle, the nozzle having a proximal portion that includes the cavity and a distal end portion that includes a distal opening, wherein the cavity has a diameter greater than a diameter of the distal opening, and attaching the proximal portion of the nozzle to the handle. The handle may include a conduit configured to receive pressurized fluid and supply the pressurized fluid to the nozzle. Optionally, inserting the implant into the cavity includes drawing 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 conduit.

Embodiments of the present disclosure may be implemented in connection with aspects illustrated in the attached drawings. These drawings show different aspects of the present disclosure and, where appropriate, reference numerals illustrating like structures, components, materials, and/or elements in different figures are labeled similarly. It is understood that various combinations of the structures, components, and/or elements, other than those specifically shown, are contemplated and are within the scope of the present disclosure. Further, even if it is not specifically mentioned, aspects described with reference to one embodiment may also be applicable to, and may be used with, other embodiments.

Moreover, the present disclosure is neither limited to any single aspect or embodiment, nor to any combinations and/or permutations of such aspects and/or embodiments. Each aspect of the present disclosure (e.g., device, method, etc.) and/or variations thereof, may be employed alone or in combination with one or more of the other aspects of the present disclosure and/or variations thereof. For the sake of brevity, certain permutations and combinations are not discussed and/or illustrated separately herein. Notably, an embodiment or implementation described herein as "exemplary" is not to be construed as preferred or advantageous, for example, over other embodiments or implementations. Rather, it is intended to reflect or indicate the embodiment(s) is/are "example" embodiment(s).

Examples of the present disclosure relate to systems, devices, and methods for treating internal areas 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 a patient.

The terms and definitions provided herein control, if in conflict with terms and/or definitions of art. As used herein, the terms "comprises," "comprising," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term "exemplary" is used herein in the sense of "example," rather than "ideal. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of a stated value.

The terms "proximal" and "distal" are used herein to refer to the relative and directional positions of the components of an exemplary introducer device. "Proximal" or "proximally" refers to a position relatively closer to an operator of a device. In contrast, "distal" or "distally" refers to a position relatively farther away from the operator of a device, and or closer to an interior of a patient body.

Disclosed herein are instruments, devices (introducers, e.g., implantation or introducer devices), systems, and methods useful for the introduction of an implant, such as a prosthetic implant, into an implantation site. In some embodiments, devices, systems, and methods disclosed herein may provide for introduction of an implant into an implantation site in a minimally-invasive manner (e.g., in a manner intended to reduce the extent, size, and/or shape of incisions and/or tissue displacements at or near an implantation site). For example, the introducer devices described herein may be used to deliver implants via one or more minimally invasive procedures. In some cases, devices, systems, and methods disclosed herein may provide for introduction of an implant into an implantation site in a non-minimally-invasive procedure.

Implants according to the present disclosure may include, e.g., breast, gluteal, calf, and other medical implants, including aesthetic and/or reconstructive implants. Suitably, implants according to the present disclosure may be partly or entirely flexible (e.g., elastomeric, compressible, expandable, and/or resiliently deformable). In at least one example, an implant for use with the instruments, devices, systems, and methods disclosed herein may be a breast implant with elastic properties, e.g., super visco-elastic and/or highly elastic properties. According to some aspects of the present disclosure, the implant may comprise a fluid, such as a liquid or gel, including viscous gels. For example, the implant may comprise silicone filling gel, wherein the implant may be pre-filled with the silicone gel prior to, or after, implantation. The implant may comprise a shell (e.g., an outer casing) with biocompatible surfaces. For example, the implant may have a surface texture as disclosed in one or more of <CIT>, <CIT>, and/or <CIT>. In some aspects, the shell may have a combination of surface features or characteristics, such as, e.g., roughness, kurtosis (e.g., referring to the distribution of peak heights and valley depths of the surface), and/or skewness of the surface that provide for a surface texture with increased biocompatibility. The shell may have low-friction surface properties to facilitate smooth delivery and implantation of the implant within the body of the patient. While references to breast implants are used throughout the remainder of this disclosure, the disclosure is not so limited. Rather, the systems, devices, and methods disclosed herein may be used to deliver any suitable implants, e.g., aesthetic implants and/or implants used in reconstructive medical procedures. For example, the systems, device, and methods herein may be used to deliver one or more of breast, gluteal, calf, and/or other implants into the body of the patient.

Aspects of the introducer devices, systems, and methods of the present disclosure may be used in combination with the devices and methods disclosed in <CIT>.

The introducer devices described herein may be used to standardize and/or facilitate procedures for implantation of a breast implant or other implant device. In some examples, an introducer device may be configured for one-handed advancement of the implant into an implantation site. In some aspects, a combination of features of the implant and the introducer system may facilitate a minimally-invasive procedure, e.g., to improve patient well-being. For example, a breast implant characterized by elastic properties (such as, e.g., a combination of high shell elongation, high shell strength, and visco-elastic filling gel), optionally with surface texturing, may be implanted with an introducer device as described herein in a minimally-invasive insertion method to minimize scarring of the incision site, reduce the risk of damaging the implant during placement, and/or to accelerate and optimize healing of the surgical wound. Optionally, an introducer device as described herein may have surface friction properties to facilitate smooth delivery and implantation of the implant within the body of the patient. In some arrangements, the introducer devices described herein may adapt to a sterile packaging system to provide a "touchless" implantation procedure. That is, a physician, nurse, or other medical professional or user need not directly handle an implant when loading the implant into an introducer device or at other times during implantation. For example, the implant may be pre-packaged inside the nozzle in a sterile manner, such that the medical professional need not touch the implant during the procedure.

Reference will now be made to the figures of the present disclosure.

<FIG> illustrate an exemplary introducer <NUM>, which may be used for delivery of an implant into an implantation site. Introducer <NUM> may include a nozzle <NUM> and a handle <NUM>. Nozzle <NUM> may include a distal opening <NUM> and an engagement area <NUM> for engaging with a complementary engagement area <NUM> of handle <NUM>. Handle <NUM> may further include a fluid supply conduit or lumen <NUM>, a stopper <NUM>, an actuator <NUM>, and a fluid supply mouth <NUM>.

Introducer <NUM> may have any of a variety of suitable sizes, shapes, and characteristics suitable for holding and delivering an implant. Generally, introducer <NUM> may include, e.g., nozzle <NUM> and handle <NUM>, where each of nozzle <NUM> and handle <NUM> may have any one of various shapes and sizes. While <FIG> depict one variation of introducer <NUM> according to the present disclosure, <FIG> depicts an additional variation (introducer <NUM>'). Further, <FIG> and <FIG> depict additional variations of an introducer (introducers <NUM>, <NUM>) which may share any of the characteristics (e.g., nozzle characteristics, handle characteristics, reusability, identifying characteristics, interchangeability etc.) described herein with respect to introducer <NUM> and/or <NUM>'. Additionally, <FIG> depict exemplary nozzle sizes and shapes which may be applicable in combination with any of the introducers disclosed herein.

Introducer <NUM> and/or an implant for use with introducer <NUM> may include identifying characteristics, such as a unique device identifier (UDI) with information useful for identifying the introducer device or implant. For example, the UDI may include a micro-transponder for identification of introducer <NUM>, and/or in an implant for post-implantation implant recognition and traceability. In some aspects, introducer <NUM> and/or an implant for use with introducer <NUM> may include one or more sensors with the ability to measure temperature, change in electrical impedance, and/or pressure, e.g., to be used as a control signal to alert or diagnose shell rupture, infection of the patient's tissue, and/or signs of an inflammatory response of the patient's tissue by monitoring the surrounding tissue temperature. Such one or more sensors may be a part of or separate from a UDI. Such UDI and/or sensor(s) may be placed in any suitable position on or within introducer <NUM> or the implant, including, for example, an inner surface of introducer <NUM> proximate and/or in contact with the implant.

In some embodiments, introducer <NUM> may be a single-use (e.g., disposable) device. In further embodiments, some or all of introducer <NUM> (e.g., handle <NUM> and/or nozzle <NUM>) may be reusable, such as after sterilization.

Referring now to further characteristics of introducer <NUM>, nozzle <NUM> may define a cavity for housing an implant pre-implantation. In some embodiments, a cavity defined by nozzle <NUM> may be configured to house an implant in a compressed, rolled, or otherwise reduced-size configuration. In such embodiments, a diameter or cross-sectional dimension of nozzle <NUM> may define the cross-sectional size of the implant in the compressed/rolled etc. configuration. The dimensions of nozzle <NUM> may be selected based on the dimensions (e.g., size and shape) of the implant to be delivered using introducer <NUM>, and/or vice-versa (e.g., characteristics of the implant may be selected based on the dimensions of nozzle <NUM>).

Nozzle <NUM> may have any configuration suitable for inserting an implant through an incision, e.g., as described herein and/or in <CIT>. Nozzle <NUM> may have a portion having tapered profile, such that it has a larger diameter or cross-sectional dimension at its proximal end portion than the diameter or cross-sectional dimension at its distal end portion. Additionally, nozzle <NUM> may have a proximal end portion for coupling with, e.g., handle <NUM>, and a distal opening <NUM>. In some embodiments, a portion of nozzle <NUM> having a tapered profile may include the majority of nozzle <NUM>. In other embodiments, a relatively smaller percentage of nozzle <NUM> may include a tapered profile (e.g., less than about <NUM>%, less than about <NUM>%, less than about <NUM>%, or less than about <NUM>% of nozzle <NUM> may have a tapered profile).

Nozzle <NUM> may be a single piece, or may comprise multiple pieces that are fitted, slotted, assembled, clipped, welded, or otherwise joined together at one or more joining points. Nozzle <NUM> also may have additional profiles and features (e.g., with respect to a cavity for housing an implant and/or with respect to distal opening <NUM>), as described further herein. Nozzle <NUM> may be formed from or may otherwise comprise one or more biocompatible polymer or copolymer material(s) (e.g., polyurethane, polyethylene, silicone, polycarbonate, a combination thereof, etc.). Nozzle <NUM> may be rigid, semi-rigid, flexible or a combination thereof. For example, distal opening <NUM> of nozzle <NUM> may be rigid enough to dilate an incision site on a patient and direct an implant to the incision site, but soft enough to avoid tearing or damaging the site and/or to avoid deformation of the implant. Moreover, distal opening <NUM> may be more flexible than, e.g., a proximal end portion of nozzle <NUM>, which may be more rigid to facilitate engagement with handle <NUM>. In some embodiments, nozzle <NUM> may be disposable.

As described elsewhere herein, implants suitable for use with, e.g., introducer <NUM> may be moldable, pliant, compressible, and/or otherwise movable between a compressed, insertion configuration and a deployed, expanded configuration. For example, an implant for use with introducer <NUM> may comprise a high-strength flexible shell with visco-elastic and low friction surface properties. As mentioned, nozzle <NUM> may define a chamber to receive an implant in an insertion configuration (e.g., a fully or partially compressed, folded, rolled, or any other low-profile configuration). Following delivery out of distal opening <NUM> and into the body of a patient, the implant may expand, decompress, or otherwise assume a deployed configuration.

Any one or more portions of nozzle <NUM>, such as an inner surface of nozzle <NUM>, may include a lubricious coating to reduce the coefficient of friction between one or more portions (e.g., the inner surface) of introducer <NUM> and one or more portions of an implant housed within. For example, a lubricious coating may be a water-activated coating fixed on one or more surfaces of nozzle <NUM>, such as an interior surface. Additionally or alternately, a lubricious coating may include a biocompatible lubricant and/or any other biocompatible coating. The coating may reduce a coefficient of friction between the implant shell and the interior surface of nozzle <NUM>, promoting a smooth transition between the insertion configuration and the deployed configuration of the implant, e.g., upon exit of the implant from introducer <NUM>.

Some aspects of nozzle <NUM> may be designed to reduce the risk of tearing or other damage to an implant or patient tissue. In some aspects, characteristics of nozzle <NUM> may be designed to aid in achieving a desired expulsion pressure against an implant when introducer <NUM> is actuated to deposit the implant, and/or may aid in achieving a desired ejection speed of an implant through the distal end of nozzle <NUM>. In some embodiments, characteristics of, e.g., distal opening <NUM> may be designed or selected to achieve a desired implant ejection speed or implant ejection pressure, or may be designed or selected to improve placement precision of introducer <NUM>, biocompatibility of introducer <NUM> with patient tissue, compatibility with a particular incision size, and/or other goals.

Distal opening <NUM> may be an aperture at or near a distal portion of nozzle <NUM> through which an implant housed in a cavity of introducer <NUM> (e.g., inside nozzle <NUM>) may exit introducer <NUM> during an implantation procedure. In some embodiments, distal opening <NUM> may be at a distal-most end of nozzle <NUM>. Distal opening <NUM> may be a distally-facing opening, and/or may be angled with respect to a proximal-distal axis of nozzle <NUM>. A cross-sectional size of distal opening <NUM> (e.g., a diameter of distal opening <NUM>) may have any suitable size, e.g., to achieve one or more of the objectives above. In some embodiments, a cross-sectional size of distal opening <NUM> may range from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM>.

In some examples, at least a portion of nozzle <NUM>, such as a perimeter of distal opening <NUM>, may be configured to flex, e.g., as the implant passes through the distal opening of the nozzle, such that the cross-sectional size of distal opening <NUM> may increase as an implant passes therethrough (e.g., increasing from about <NUM> to about <NUM>, to about <NUM>, to about <NUM>, or to about <NUM>).

Distal opening <NUM> may have any suitable shape, such as, e.g., round, oval, half-oval (e.g., having one side that is flat and another side that is rounded or oval), otherwise curved, or angular in shape. The size and shape of distal opening <NUM> may be selected to accommodate the size and shape of the implant to be introduced into a patient, to guide the implant through an incision into an implantation site, and/or to facilitate introduction of a distal portion of nozzle <NUM> through an incision. For example, distal opening <NUM> may have a half-oval or angular shape to accommodate a non-round implant. An angling of distal opening <NUM>, and/or diameter of distal opening <NUM>, may also be customized. Moreover, distal opening <NUM> may be bordered, flanked, and/or defined by one or more slits, flaps, petals or extensions disposed about a perimeter of distal opening <NUM>. Such features may be disposed in a circumferential arrangement about distal opening <NUM>, or may be disposed symmetrically or asymmetrically about distal opening <NUM>. In some embodiments, such features may assist in positioning distal opening <NUM> through an incision and/or guiding placement of an implant through distal opening <NUM> into an implantation site. In some embodiments, such features may be flexible (e.g., flexible enough to bend upon pressure being exerted on them by the passage of an implant, or, in some embodiments, more flexible than a proximal region of nozzle <NUM>). The present disclosure includes multiple exemplary variations of distal openings on nozzles, any of which may be used in combination with nozzle <NUM> of introducer <NUM>, or with any other introducer described or encompassed by this disclosure. It will be apparent to those of skill in the art that variations upon each of these exemplary nozzles are contemplated as well.

Other characteristics of nozzle <NUM> may be selected so as to accommodate differently sized and shaped implants, and/or to provide a desired flexibility, expulsion pressure, and/ or other characteristic to introducer <NUM>. For example, a degree or angle of taper, a taper shape, and/or a length of nozzle <NUM> may be selected so as to accommodate differently sized and shaped implants and/or to facilitate guidance of a portion of nozzle <NUM> through an incision and/or placement of an implant in an implantation site. In some embodiments, nozzle <NUM> may include a flared shape (e.g., at a distal portion of nozzle <NUM>), which may aid in insertion of nozzle <NUM> into an incision and/or safe and effective deployment of an implant.

Handle <NUM> may be coupleable, either reversibly or permanently, to nozzle <NUM>. Handle <NUM> may include a body that houses fluid supply lumen <NUM>. A shape and size of handle <NUM> may be configured for ease of use by an individual. In some embodiments, handle <NUM> may be grippable by one hand, to allow for a user to manipulate introducer <NUM> one-handed.

Handle <NUM> may be configured to be attached, detached and/or reattached to nozzle <NUM> via a suitable mechanism, which may include engagement surface <NUM> of handle <NUM> and/or engagement surface <NUM> of nozzle <NUM>. Exemplary attachment mechanisms include, but are not limited to, threads, clamps, screws, and tabs, which may be disposed at, on, and/or around contacting portions of handle <NUM> and/or nozzle <NUM>. In some embodiments, as shown in <FIG>, engagement surface <NUM> may include a plurality of threads complementary to a plurality of threads of engagement surface <NUM>. In further embodiments, engagement surfaces <NUM>, <NUM> may include other mating features (e.g., clips, clamps, adhesive, etc.) to facilitate attachment of handle <NUM> to nozzle <NUM> either permanently or reversibly.

Handle <NUM> may define or encompass fluid supply lumen <NUM>, which may be configured for the passage of a fluid, e.g., from a source of fluid (not shown) to which it is connected, through handle <NUM> and fluid supply mouth <NUM> to an interior portion of nozzle <NUM>. Fluid supply lumen <NUM> may be coupled or coupleable to a fluid supply via any suitable connection, such as, but not limited to, a Luer connection, threaded connection, clip connection, lock connection, etc. The fluid supply may include a pressurized fluid source, such as a pressurized gas or liquid. In some embodiments, the pressurized fluid source may include, e.g., a portable compressed fluid canister, a pressurized fluid line (e.g., a gas line or water line), or the like. In some embodiments, for example, the fluid source may be a disposable or refillable canister of compressed gas. An implant loaded into introducer <NUM> may be installed such that fluid supply lumen <NUM> and fluid supply mouth <NUM> may be positioned to deliver pressurized fluid to a region located proximally from the implant. Such pressurized fluid, when delivered, may impart pressure on the implant to drive the implant distally towards and through distal opening <NUM> of nozzle <NUM>. In some embodiments, as discussed elsewhere herein, fluid supply lumen <NUM> and fluid supply mouth <NUM> may be configured to conduct pressurized fluid from a fluid supply into an expandable cavity, such as a balloon, expandable chamber, or cavity defined by a membrane, disposed at least partially within a proximal region of nozzle <NUM>. Pressure from pressurized fluid into such an expandable cavity may expand the cavity and/or move a membrane, balloon wall, or cavity wall to impart pressure on an implant and drive it distally, through distal opening <NUM>. As described elsewhere herein (e.g., with respect to introducers <NUM>, <NUM>), handle <NUM> may further include an openable vent between the expandable cavity and an exterior of the introducer, to allow for venting of pressurized fluid from the expandable cavity.

Handle <NUM> may include a stopper <NUM>, e.g., defined by a distal end or distal-facing wall of handle <NUM>. Stopper <NUM> may be sized and configured to cover and/or close a proximal end of nozzle <NUM>. In some embodiments, when handle <NUM> is coupled to nozzle <NUM>, stopper <NUM> may define a proximal-most wall of a cavity that may house an implant in introducer <NUM>. In at least one example, stopper <NUM> is configured to seal the proximal end of nozzle <NUM> after an implant has been positioned in the cavity. Stopper <NUM> may be held in place against nozzle <NUM> by connection or mating features that may attach handle <NUM> to nozzle <NUM>, such as, e.g., engagement surfaces <NUM>, <NUM>, which may include threads, a Luertype connection, an adhesive, a vacuum- or suction-type closure, clips, clamps, etc. In some embodiments, stopper <NUM> may include an elastomeric surface, e.g., to better form a seal against nozzle <NUM>. Fluid supply mouth <NUM> may pass through stopper <NUM> (as shown in <FIG>), to allow for delivery of pressurized fluid to a cavity distal to stopper <NUM>.

Handle <NUM> may include actuator <NUM> for selectively supplying and terminating the flow of compressed gas or other pressurized fluid from the fluid supply through fluid supply mouth <NUM>. Actuator <NUM> may include, e.g., a button, knob, valve, switch, clip, or combinations thereof, which may open/create and/or close a connection between a more proximal portion of fluid supply lumen <NUM> and fluid supply mouth <NUM>. In some embodiments, actuator <NUM> may be spring-loaded or otherwise may employ consistent pressure to maintain an open flow of pressurized fluid towards an implant housed in a cavity of nozzle <NUM>.

<FIG> depicts an introducer <NUM>', similar to introducer <NUM>. Introducer <NUM>' includes a nozzle <NUM>' having a distal opening <NUM>', and a handle <NUM>' having fluid supply lumen <NUM>', stopper <NUM>', and engagement area <NUM>'. Aspects of introducer <NUM>' may share any characteristics with like aspects of introducer <NUM>. As shown, nozzle <NUM>' includes a conical tapered portion and a distal tip (including distal opening <NUM>') forming an angle with the conical tapered portion. Introducer <NUM>' further includes a holding attachment <NUM>' attached to a proximal portion of nozzle <NUM>'. Holding attachment <NUM>' may aid in, e.g., manipulation of introducer <NUM>'. This may reduce or remove the need to touch nozzle <NUM>', which may aid in, e.g., maintaining cleanliness and/or sterility of nozzle <NUM>' and/or of a user's hand prior to or during a surgical procedure. In some embodiments, holding attachment <NUM>' may aid in loading an implant into nozzle <NUM>'. Holding attachment <NUM>' may be attachable to, e.g., nozzle <NUM>' or handle <NUM>' by any suitable means, such as complementary threads, a clip, a snap-on connection, adhesive, etc..

As mentioned above, introducers described herein (e.g., introducer <NUM> described above, and/or introducers <NUM>, <NUM>, or variations thereof) may be used for implantation of an implant with visco-elastic and/or other elastic properties, e.g., the implant comprising an elastic shell and visco-elastic filling gel. Such elastic properties of the implant facilitate manipulation of the implant, e.g., allowing the implant to be compressed, stretched, and/or elongated for loading into a nozzle (e.g., nozzle <NUM>) of an introducer (e.g., introducer <NUM>) in a reduced profile, for implantation in a manner which may reduce trauma to a patient. In some embodiments, such implantation may be part of a minimally-invasive procedure. Various properties of introducer <NUM> and/or the implant may allow for radial compression of the implant, which may provide an ability to safely compress the implant for advancement into a smaller incision. For example, various properties of introducer <NUM> may be sized and configured to assist in compressing the implant for advancement into an incision of about <NUM> or less, e.g., about <NUM> or less, about <NUM> or less, about <NUM> or less, about <NUM> or less, or about <NUM> or less, such as about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. For example, introducer <NUM> may be suitable for implantation of an implant into an incision having a length of between about <NUM> and about <NUM>, between about <NUM> and about <NUM>, or between about <NUM> and <NUM>.

In some embodiments, as described above, introducers disclosed herein (e.g., introducers <NUM>, <NUM>', <NUM>, <NUM>, or variations thereof) may be configured for use with different types of nozzles interchangeably. For example, handles (e.g., handle <NUM>) may have attachment features complementary to different sizes, shapes, and/or types of nozzles. In such embodiments, nozzle shape, size, and/or type may therefore be selected for a given implant, procedure, and/or patient. Various characteristics of the nozzles disclosed herein (e.g., rigidity/flexibility of the materials defining the distal opening of the nozzle, the shape of the distal opening, the cross-sectional size of the distal opening, etc.) may allow the medical professional to better control the trajectory and/or speed at which the implant is delivered and/or allow for a more precise placement of the implant into the desired implantation site.

<FIG> depict a conically-tapered nozzle <NUM>, similar to nozzles <NUM>, <NUM>', having an asymmetrical tip. For example, nozzle includes an extension <NUM> adjacent to the distal opening of the nozzle. <FIG> depicts a perspective view of extension <NUM>, and <FIG> depicts a side cross-sectional view of nozzle <NUM>. Extension <NUM> may allow for more precise placement of the distal end of nozzle <NUM> into or at an incision site, and may guide expulsion of an implant through nozzle <NUM> into a desired position. <FIG> depicts how extension <NUM> may be cut from a solid cylindrical portion at an end of the nozzle, by, e.g., removal of section <NUM>. Extension <NUM> need not be a separate component and may instead be an integral part of nozzle <NUM>. In some embodiments, nozzle <NUM> and/or extension <NUM> may be made from or comprise a relatively rigid material (e.g., a relatively rigid polymer such as polypropylene, polycarbonate, polyurethane, polyetheretherketone (PEEK), or other rigid or semi-rigid plastic or polymer, or a biocompatible metal), so as to be able to precisely deliver an implant to a desired site. Moreover, extension <NUM>, once inserted through an incision, may aid in keeping a relatively small incision open so that an implant may pass through the incision and into the desired site.

In some examples, the distal end of nozzles according to the present disclosure may be defined by or comprise two or more strips extending generally parallel to the longitudinal axis of the nozzle. Such strips may allow for the distal opening to widen as the strips flex radially outwards in response to a compressed implant passing through the distal opening. Such a configuration may help to avoid deformation of the implant during the implantation procedure. In some examples, one or more of the strips may extend farther than one or more of the other strips, e.g., to assist in guiding the implant into an incision site. Each strip may have the same or different amount of rigidity or flexibility than the other strips. For example, <FIG> depict two tapering bulb-shaped nozzles <NUM>, <NUM>, having differing distal ends. Nozzle <NUM> includes strips <NUM> at the distal tip, extending in the distal direction. Strips <NUM> may facilitate placement of an implant into a relatively small incision, wherein strips <NUM> may separate (flex away from each other) as an implant passes through the distal end of nozzle <NUM>. Thus, for example, strips <NUM> may flex radially outward such that the implant does not become over-compressed as it is expelled into a surgical site. Nozzle <NUM> includes one strip <NUM> longer than the rest of the strips <NUM>, similar to extension <NUM> of nozzle <NUM>. Extended strip <NUM> similarly may allow for more precise placement of the distal end of nozzle <NUM> into or at an incision site, and help to guide expulsion of the implant through nozzle <NUM> into the desired site. Nozzles <NUM>, <NUM> may comprise any material suitable for other nozzles disclosed herein (e.g., nozzle <NUM>). In some embodiments, nozzles <NUM>, <NUM> may comprise a semi-rigid material (e.g., a semi-rigid plastic, silicone, or other polymer) that may allow for the strips to flex in response to pressure.

<FIG> depict a conically-tapered nozzle <NUM> with a narrow opening at the distal end. The narrow opening is defined by strips <NUM>, which may separate and flex radially outward as an implant passes through the opening. The narrowness of the opening may facilitate introduction of nozzle <NUM>'s distal end into a small incision (e.g., an incision less than <NUM>, e.g., <NUM> to <NUM>, or <NUM> or less). Nozzle <NUM> may comprise any material suitable for other nozzles disclosed herein (e.g., nozzle <NUM>).

<FIG>, similar to <FIG>, depict tapered nozzles <NUM>, <NUM> with distally-extending strips <NUM> that define the distal opening. As compared to nozzles <NUM>, <NUM>, nozzles <NUM>, <NUM> have larger openings, which may allow for larger implants, or implants with less compressibility, to pass through. Nozzle <NUM>, similar to nozzle <NUM>, includes one strip <NUM> extending distally beyond the other strips <NUM>. Strip <NUM> may facilitate placement of the distal end of nozzle <NUM> into or at an incision site, and may help to guide and/or control expulsion of an implant through nozzle <NUM> into a desired position. Nozzles <NUM>, <NUM> may comprise any material suitable for other nozzles disclosed herein (e.g., nozzle <NUM>).

<FIG> depicts a conically-tapered nozzle <NUM> with distally-ending strips <NUM> defining the distal opening. The strips <NUM> may be covered or joined together by a flexible film <NUM> (e.g., an elastic silicone film) which may allow the strips <NUM> to separate or flex away from each other, while simultaneously preventing the strips <NUM> from splitting apart and piercing, scratching, and/or nicking patient tissue and/or an implant. The material of the film <NUM> may be the same or different than the material of the remainder of the nozzle <NUM>. For example, the film <NUM> and the remainder of the nozzle may comprise the same type of polymer, wherein the film <NUM> has a thinner wall thickness that allows the film <NUM> to stretch.

<FIG> depict a two-part nozzle according to some aspects of the present disclosure. <FIG> depicts a first component <NUM> having a long extension <NUM> extending in the distal direction, adjacent to the distal opening. Component <NUM> may be relatively rigid and may comprise, e.g., a rigid or semi-rigid plastic or other polymer, or a biocompatible metal. <FIG> depicts a second component <NUM> having an inwardly-tapered shape, which arrives at a narrowest point proximate a middle portion of the second component <NUM> and then flares outward in the distal direction. A distal opening in the second component <NUM> may be angled, so as to form an angled opening. Component <NUM> may be more flexible than component <NUM>, e.g., comprising a semi-rigid or flexible polymer, or any material suitable for other nozzles disclosed herein (e.g., nozzle <NUM>). Components <NUM> and <NUM> may be configured to fit together for use. For example, component <NUM> may nest within component <NUM>, wherein distal extension <NUM> of component <NUM> is received within a sleeve <NUM> of component <NUM>. The first and second components <NUM>, <NUM> may be affixed or otherwise coupled together to form the nozzle.

<FIG> depict further exemplary nozzles <NUM>, <NUM>, <NUM>, <NUM> having different exemplary shapes of distal openings <NUM>, <NUM>, <NUM>, <NUM>, respectively. Thus, for example, the perimeter of the distal opening may be generally oval, oblong, trapezoidal, or may be asymmetrical in shape. These nozzles may comprise, e.g., any material suitable for other nozzles disclosed herein (e.g., nozzle <NUM>). Each nozzle may be constructed or provided with a variety of distal opening sizes. For example, distal openings <NUM>, <NUM>, <NUM>, <NUM> may each have a cross-sectional diameter ranging from about <NUM> to about <NUM>, such as about <NUM>, about <NUM>, or about <NUM>. For example, the maximum cross-sectional diameter may range from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM>.

<FIG> depict views of an introducer <NUM> according to aspects of the present disclosure. Introducer <NUM> includes handle <NUM> and nozzle <NUM>. Handle <NUM> (shown in <FIG>, <FIG>, <FIG>, and <FIG>) includes fluid supply conduit <NUM>, actuator <NUM>, vent switch <NUM>, and retention apertures <NUM>. Nozzle <NUM> (shown in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>) includes a distal portion <NUM> having a distal opening <NUM>, a middle portion <NUM>, and a proximal end portion with mating elements, e.g., protrusions <NUM>, complementary to the handle <NUM> as discussed below. Introducer <NUM> further includes a distal cap <NUM> having a distal cap nozzle <NUM>.

Introducer <NUM>, handle <NUM>, and nozzle <NUM>, and their parts (e.g., actuator <NUM>, fluid supply conduit <NUM>, distal opening <NUM>, etc.) may share any characteristics, materials, functionality, etc. with, e.g., introducer <NUM>, handle <NUM>, and nozzle <NUM> and their parts, and as such, will not be described in repetitive detail. For example, distal opening <NUM> may have any size, shape, extensions, tabs, etc., described with respect to any other nozzle disclosed herein. Fluid supply conduit <NUM> may be coupled to any suitable source of fluid, as has been described previously with respect to fluid supply lumen <NUM>. In some embodiments, distal portion <NUM> of nozzle <NUM> is elongated (e.g., as compared to nozzle <NUM>), which may assist in guiding expulsion of an implant into a desired implantation site.

Middle portion <NUM> of nozzle <NUM> may define a cavity, and may be configured to be loaded with, and house, an implant in a radially compressed and/or elongated configuration for introduction into an implantation site. In some embodiments, as shown, the distal portion <NUM> of nozzle <NUM> may be more tapered (have a smaller cross-sectional dimension) than middle portion <NUM>, such that an implant loaded into middle portion <NUM> is not as compressed as it would be in distal portion <NUM>. In some embodiments, middle portion <NUM> may have an approximately equal diameter along its length. In some embodiments, for example, middle portion <NUM> may be generally cylindrical in shape. A proximal end portion of nozzle <NUM> may be open to allow for loading of an implant into the cavity defined by middle portion <NUM>.

As shown in <FIG>, <FIG>, <FIG>, and <FIG>, distal cap <NUM> may be coupleable to nozzle <NUM>, over distal opening <NUM>, e.g., via friction fit or other complementary mating features. Distal cap <NUM> may be configured to form a seal around distal opening <NUM> to channel fluid through the distal cap nozzle <NUM> and prevent fluids from leaking or otherwise escaping other than through distal cap nozzle <NUM>. Distal cap nozzle <NUM> may include a distal opening to which a vacuum may be applied. Application of a vacuum to distal opening <NUM> of the nozzle <NUM>, via distal cap nozzle <NUM>, may facilitate loading of an implant through the proximal end portion of nozzle <NUM> via suction. Once an implant is loaded into nozzle <NUM>, or once an implantation site is ready to receive an implant, distal cap <NUM> may be removed from nozzle <NUM> such that distal opening <NUM> is exposed.

The proximal end portion of nozzle <NUM> may be coupled to a distal end of handle <NUM> (as shown in, e.g., <FIG>). For example, the proximal end portion of the nozzle <NUM> may fit snugly within the distal end of the handle by sliding protrusions <NUM> proximally into channels defined by retention apertures <NUM> of the handle <NUM>. Each protrusion <NUM> may slide into a circumferential portion of the channels defined by retention apertures <NUM> to secure nozzle <NUM> to handle <NUM>. The channels optionally may have an L-shape, as shown, such that rotating the nozzle <NUM> relative to the handle <NUM> may lock the protrusions <NUM> within the channels. After nozzle <NUM> has been loaded with an implant, the nozzle <NUM> may be coupled to handle <NUM> in this manner to enclose the implant within the introducer <NUM>. While <FIG>, <FIG>, <FIG> depict the nozzle <NUM> with protrusions <NUM> and the handle <NUM> with channels that receive protrusions <NUM>, in other examples, the nozzle <NUM> may include channels (see, e.g., <FIG>) that receive protrusions of the handle. Further, other complementary mating elements may be used to detachably secure the nozzle <NUM> to the handle <NUM>.

As shown in <FIG>, a flexible membrane <NUM> may be coupled to the handle <NUM>, e.g., a distal portion of handle <NUM>. In some embodiments, membrane <NUM> may be at least partially disposed within the cavity of middle portion <NUM>, the membrane <NUM> defining a chamber <NUM> into which fluid may be received from fluid supply conduit <NUM>. During operation of introducer <NUM>, actuator <NUM> may be engaged to allow fluid to travel via fluid supply conduit <NUM> into chamber <NUM> defined by membrane <NUM>. Actuator <NUM> may be a switch, button, lever, or connector that, when engaged, connects fluid supply conduit <NUM> to cavity <NUM>. As fluid is received into chamber <NUM>, membrane <NUM> may expand into the cavity of middle portion <NUM>. Pressure from the fluid may push an implant disposed in cavity defined by middle portion <NUM> distally, through distal portion <NUM> of nozzle <NUM> and distal opening <NUM>, and into a desired implantation site. In some embodiments, chamber <NUM> and/or membrane <NUM> may be expandable enough to fill a majority of an interior of nozzle <NUM>, such that distal expansion of chamber <NUM> and distal movement of membrane <NUM> displaces an implant within nozzle <NUM> until it is expelled from introducer <NUM>. In some embodiments, chamber <NUM> may be partly defined by membrane <NUM> and partly defined by, e.g., a distal end of handle <NUM>, as opposed to being surrounded by membrane <NUM>. Membrane <NUM> may be affixed securely to handle <NUM> to allow passage of fluid into chamber <NUM> without detachment of membrane <NUM> from handle <NUM>.

Vent switch <NUM> may control a vent fluidly coupling an interior of chamber <NUM> with an exterior of introducer <NUM>. According to some aspects, when vent switch <NUM> is closed, vent switch <NUM> prevents fluid from chamber <NUM> escaping. Further, for example, when actuated or opened, vent switch <NUM> may allow for fluid within chamber <NUM> to vent outside of introducer <NUM>, thereby deflating or reducing fluid pressure within chamber <NUM> to an extent that chamber <NUM> is pressurized relative to an exterior of introducer <NUM>. Vent switch <NUM> may operate mechanically or electronically. In some embodiments, for example, vent switch <NUM> may include a powered switch that may, e.g., activate suction, a fan, or a blower to actively remove fluid from within chamber <NUM>. Vent switch <NUM> may thereby be used to stop or reduce expulsion pressure within nozzle <NUM>, e.g., to stop or slow expulsion of an implant from nozzle <NUM>, and/or to reset introducer <NUM> after an implant has been expelled from nozzle <NUM>.

As has been described with respect to introducer <NUM>, one or more parts of introducer <NUM> may be reusable (e.g., handle <NUM>, distal cap <NUM>, nozzle <NUM>). For example, the material(s) that form various parts of introducer <NUM> may be capable of sterilization. One or more parts of introducer <NUM> may also or alternately be disposable, e.g., wherein the one or more parts of introducer <NUM> may be replaced with new, unused parts.

<FIG> depicts an introducer <NUM> loaded with an implant <NUM>, the introducer <NUM> sharing some characteristics of introducer <NUM> and including different characteristics than introducer <NUM>. For example, introducer <NUM> includes handle <NUM>, actuator <NUM>, fluid supply conduit <NUM>, electrical supply conduit <NUM>, a middle portion <NUM> defining a cavity in which implant <NUM> is disposed, a nozzle <NUM> affixed to middle portion <NUM> by extensions <NUM> on middle portion <NUM> slid into channels defined by retention apertures <NUM> of nozzle <NUM>. Nozzle <NUM> includes distal opening <NUM> and distal extension <NUM>.

Parts of introducer <NUM>, such as, handle <NUM>, actuator <NUM>, fluid supply conduit <NUM>, electrical supply conduit <NUM>, middle portion <NUM> and nozzle <NUM> may share any characteristics, materials, functionality, etc. with, e.g., introducers <NUM>, <NUM>', <NUM>, handles <NUM>, <NUM>, actuators <NUM>, <NUM>, fluid supply lumen <NUM>, fluid supply conduit <NUM>, and\or distal openings <NUM>, <NUM>, etc. As such, they will not be described in repetitive detail.

Middle portion <NUM> may be separate from, or separable (detachable) from, nozzle <NUM>, in some embodiments. As shown with respect to introducer <NUM>, middle portion <NUM> may be coupled separately to handle <NUM> and/or nozzle <NUM>. Additionally or alternately, middle portion <NUM> may be a piece of (e.g., integrated with) handle <NUM>. In such cases, implant <NUM> may be loaded through a distal opening of middle portion <NUM> before nozzle <NUM> is coupled to middle portion <NUM>. Handle <NUM> may be equipped with a user-friendly grip. In some embodiments, actuator <NUM> is a rotatable trigger. Electrical supply conduit <NUM> may supply electrical power to one or more aspects of introducer <NUM>. For example, in some embodiments, electrical supply conduit <NUM> may supply electrical power to a vacuum source disposed in handle <NUM> and/or middle portion <NUM>, which may be used to create suction in, and load implant <NUM> into, middle portion <NUM>.

<FIG> depict, in schematic form, a nozzle <NUM> holding and depositing an implant <NUM> through an incision in tissue <NUM>. Nozzle <NUM> includes two flexible or semi-flexible strips <NUM>, disposed on (or forming) at least two sides of a tapering portion <NUM>. Strips <NUM> may be relatively more flexible than tapering portion <NUM>, which may comprise a rigid or semi-rigid material. In some embodiments, tapering portion <NUM> may be relatively rigid at a proximal end, and semi-rigid (more flexible) at a distal end portion. Thus, for example, materials of different flexibility or the same material with different configurations that allow for variable flexibility, may be used in the tapering portion <NUM>. Strips <NUM> may assist in positioning the nozzle <NUM> at or through the incision site. During expulsion or deployment of implant <NUM>, strips <NUM> may flex or bend outward to widen distal opening <NUM>, as shown in <FIG>. This flexibility may assist in guiding implant <NUM> through the incision and into an implantation site as the implant <NUM> expands free of the confines of tapering portion <NUM>.

As has been alluded to and described with respect to <FIG>, methods of loading an implant into an introducer and delivering the implant to an implantation site, e.g., within patient tissue, are contemplated by the present disclosure. <FIG> depicts, in flow chart form, an exemplary method <NUM> for loading an implant and delivering the implant to an implantation site. Method <NUM>, and variations thereof, may be applicable to any introducer described or encompassed by this disclosure, as well as other introducers. It will be contemplated by those of ordinary skill in the art that <FIG> depicts merely an exemplary method, of which many variations are possible. In some embodiments, one or more steps of <FIG> may be added, removed, duplicated, or performed out of order. The steps of method <NUM>, and variations thereon, may be performed by one or more users, such as medical professionals, technicians, assistants, etc..

According to step <NUM> of method <NUM>, an implant may be loaded into a cavity of an implant introducer (e.g., a cavity defined by a nozzle, such as nozzles <NUM>, <NUM>', <NUM>, <NUM>. For example, a user having an assembled introducer (e.g., introducers <NUM>, <NUM>', <NUM>, <NUM>, etc.) may first remove a nozzle (e.g., nozzle <NUM>, <NUM>', <NUM>, <NUM>) from a handle or other components of the introducer. Then, the implant may be loaded into, e.g., a proximal opening of the nozzle (e.g., a proximal opening of nozzle <NUM>, <NUM>', <NUM>), or a distal opening of a cavity (e.g., the cavity defined by middle portion <NUM> of introducer <NUM>).

In some aspects, the implant may be inserted into the nozzle or into a cavity of the introducer with the assistance of a sheath or other device suitable for compressing the implant. For example, the implant may be pre-loaded or inserted into an introducer sheath to facilitate the sterile loading of the implant into the nozzle, and/or to manipulate (e.g., compress, elongate, etc.) the implant toward the insertion configuration. In further aspects, a vacuum or suction may be used to load an implant into a cavity. For example, with respect to introducer <NUM> and variations thereof, distal cap <NUM> may be affixed over distal opening <NUM> of nozzle <NUM>, e.g., to form a fluid-tight seal. A vacuum may be applied through the opening of distal cap nozzle <NUM> while an implant is placed at an open proximal end of nozzle <NUM>. The reduction in pressure caused by the applied vacuum may draw the implant into the proximal opening of nozzle <NUM>, into the cavity defined by middle portion <NUM> of nozzle <NUM>.

According to step <NUM>, the cavity may be coupled to a handle of the introducer. For example, the nozzle may be coupled (e.g., affixed, reaffixed, clipped, screwed, etc.) to the handle body.

According to step <NUM>, a distal end opening of the introducer (e.g., distal opening <NUM>, <NUM>', <NUM>, or <NUM>) may be at least partially inserted into an incision of an implantation site. Depending on a location of the implantation site, the size of incision, the size (shape and volume) of the implant to be inserted, the length of the nozzle, etc., a larger or smaller fraction of the introducer may be inserted into the incision. In some embodiments, a distal tip of a nozzle may be inserted through an incision and at least partially into an implantation site.

According to step <NUM>, the introducer may be actuated to eject the implant from the cavity, through the distal end opening, and into the implantation site. An actuator (e.g., trigger, button, or other mechanism), such as actuator <NUM>, <NUM>, <NUM> may be engaged so as to allow a source of fluid (e.g., compressed air, liquid, etc.) to exert force on the implant, either directly or indirectly (e.g., through a membrane or balloon, such as membrane <NUM>) in order to push, force, or otherwise expel the implant through the distal opening of the nozzle (e.g., distal opening <NUM>, <NUM>', <NUM>, or <NUM>), and into the implantation site via the incision (e.g., into a breast tissue pocket, gluteal tissue pocket, or other implantation site). In some aspects, retractors, such as those described in <CIT>, may be used to ease expulsion of an implant and/or suitable placement of an implant into a surgical site, such as a desired portion of a patient's body (e.g., a breast pocket or other implantation site).

In embodiments where an actuator (e.g., trigger, button, or other mechanism) may be engaged so as to communicate with a source of fluid (e.g., compressed air or liquid) in order to inflate or expand an internal cavity, balloon, or diaphragm (e.g., cavity <NUM> depicted in <FIG>) to push, force, or otherwise expel the implant through the distal opening of the nozzle, once the implant has been expelled, a release mechanism (e.g., vent switch <NUM>, depicted in <FIG>) may be employed to release fluid and deflate or contract the internal cavity, balloon, or diaphragm.

Appropriate expulsion pressures to expel an implant an introducer device according to the present disclosure may correlate to factors such as, e.g., (i) the volume/size/shape of the implant, (ii) the incision location and size, and/or (iii) the nozzle diameter. A chart may be provided to a medical professional or other user that defines these parameters for appropriate placement of the introducer device and the implant. The chart may be developed by bench and pre-clinical assessments, for example. In some embodiments, for example, a pressure of about <NUM> kPa (about <NUM> psi) to about <NUM> kPa (about <NUM> psi) may be suitable for expelling an implant, such as from about <NUM> kPa (about <NUM> psi) to about <NUM> kPa (about <NUM> psi), from about <NUM> kPa (about <NUM> psi) to about <NUM> kPa (about <NUM> psi), or from about <NUM> kPa (about <NUM> psi) to about <NUM> kPa (about <NUM> psi), such as about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), about <NUM> kPa (about <NUM> psi), or about <NUM> kPa (about <NUM> psi).

Additional aspects of preparing, loading, actuating, and using introducer devices, as well as aspects of calculating appropriate pressures and fluid volumes for loading and expelling implants from the introducer devices, are described in <CIT>.

Claim 1:
An implant introducer (<NUM>, <NUM>', <NUM>, <NUM>), comprising:
a handle (<NUM>, <NUM>', <NUM>, <NUM>);
a nozzle (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) coupled to the handle, the nozzle having:
a cavity (<NUM>) configured to receive an implant (<NUM>, <NUM>); and
a distal opening (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>); and
a flexible membrane (<NUM>) defining a chamber (<NUM>), wherein when the chamber receives a fluid, the flexible membrane expands into the cavity of the nozzle and pushes the implant through the distal opening of the nozzle.