Patent Description:
Breast implants are among the largest implantable medical devices in the human body today. Due to their volume, mass, and surface area, implantation of these devices can require larger incisions for insertion and proper positioning. Current techniques often create extensive surgical wounds that can stimulate a complex and dynamic healing process, e.g., to replace devitalized and missing cellular structures and tissue layers. For example, many current techniques require a large incision, manipulated by retractors and tissue-spreaders to expand and hold open the incision site for the physical manipulation of the implant into the tissue pocket. These techniques can increase the size of the scar, the probability of damage to the implant, and/or the possibility of infection; can require insertion of drainage tubes to evacuate serous fluids from surrounding tissue and capillary damage; and/or can accelerate inflammatory responses that impact the healing process. In addition, keloids and hypertrophic scars represent an overgrowth of dense fibrous tissue that usually develops after healing of a skin injury. It is recognized that the larger the incision, the greater potential incidence for keloid and hypertrophic scarring. Certain patients are also more susceptible to, and are at higher risk of, keloid formation. <CIT> describes an injector for a breast implant, the injector including a hollow tube and a plunger.

The systems and devices of the current disclosure may rectify or lessen some or all of the challenges described above, and/or may address other needs not met by prior technology.

The invention provides an introducer device as defined in claim <NUM>. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

In one aspect, the introducer device includes a shaft extending between a proximal end and a distal end. The shaft may include a lumen therein. A handle may be coupled to the proximal end of the shaft and may include a mode selector. The mode selector may be adapted to transition between a first mode and a second mode of the medical device. The medical device may further include a compressed fluid source. In the first mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a negative pressure in at least a portion of the lumen. In the second mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a positive pressure in the at least a portion of the lumen.

A nozzle is coupled to the distal end of the shaft. Examples of the medical device may further include any one or more of the following features. The nozzle may be tapered towards a distal opening. The distal opening of the nozzle may be ovular. The nozzle may be removably coupled to the distal end of the shaft. The compressed gas source may include a cartridge coupled to, and detachable from, the handle. A pump may be fluidly coupled to the compressed gas source. The compressed gas source may include a tubing assembly. The medical device may include a valve mechanism.

In another aspect, the introducer device includes a shaft extending between a proximal end and a distal end. The shaft may include a lumen therein. A handle may be coupled to the shaft. The handle may comprise a mode selector and an actuator. The mode selector may be adapted to transition between a first mode or a second mode of the medical device. A valve mechanism may be in communication with the mode selector and the actuator. A compressed fluid source may be coupled to the shaft. In the first mode, the compressed fluid source may impart a negative pressure controlled by the actuator in at least a portion of the lumen. In the second mode, the compressed fluid source may impart a positive pressure controlled by the actuator in the at least a portion of the lumen.

Examples of the medical device may further include any one or more of the following features. The compressed gas source may include a cartridge coupled to the handle and may be removable from the medical device via mating features. A pump may be fluidly coupled to the compressed gas source and housed within the handle. The compressed gas source may include a tubing assembly adapted for attachment to a centralized gas supply. A nozzle may be removably attached to the distal end of the shaft. The nozzle may be tapered and include a distal opening.

The following method is not claimed. In a further aspect, a method may include selecting a first mode of a medical device via a mode selector coupled to a handle of the medical device. The medical device may further include a shaft including a lumen. The method also may include applying vacuum pressure to the lumen via an actuator coupled to the handle to draw an implant into the lumen. Further, the method may include selecting a second mode of the medical device via the mode selector applying expulsion pressure to the lumen via the actuator to expel the implant from the shaft.

Examples of the method may further include any one or more of the following features. The method may include coupling a nozzle to a distal end of the shaft after applying the vacuum pressure and before applying the expulsion pressure. The medical device may include or may be coupled to a source of compressed gas for applying the vacuum pressure and the expulsion pressure. The implant may be a breast implant, and drawing the implant into the lumen may compress the breast implant. The method may include coupling a distal end of the shaft to a sterile package containing the implant before applying the vacuum pressure.

In a further aspect, a medical device may include a shaft extending between a proximal end and a distal end. The shaft may include a lumen therein. A handle may be coupled to the proximal end of the shaft. A valve assembly may be disposed within the handle. A tubing assembly may have a first end coupled to the handle and a second end adapted for attachment to a centralized gas supply.

Examples of the medical device may further include any one or more of the following features. A nozzle may be removably attached to the distal end of the shaft. The nozzle may be tapered and include a distal opening. The distal opening of the nozzle may be ovular.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, 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, 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 accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects that, together with the written description, serve to explain the principles of this disclosure.

Examples of the present disclosure relate to systems, devices, and methods for treating internal areas of a patient's body. Said methods are not claimed. Such systems or devices may include an introducer device and an implant for introduction into the body (e.g., into a breast pocket) of a patient. Reference will now be made in detail to examples of the present disclosure described above and illustrated in the accompanying drawings.

The terms "proximal" and "distal" are used herein to refer to the relative and directional positions of the components of an exemplary introducer device. When used herein, "proximal" refers to a position closer to the exterior of the body of the patient or closer to an operator and/or medical professional using introducer device. In contrast, "distal" refers to a position further away from the operator and/or medical professional using the introducer device, or closer to the interior of the body of the patient.

The introducer devices described herein may be used to deliver any one or more implants via any one or more of various minimally invasive procedures. In at least one example, the implant 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 silicone filling gel (e.g., the breast implant may be pre-filled with the silicone gel prior to implantation). The silicone filling gel may have a penetration value ranging from <NUM>-<NUM>. The penetration value is a factor that measures the firmness of a colloid, such as a silicone gel. The implant may comprise a shell (e.g., an outer casing) with biocompatible surfaces. In some aspects, the shell may have a combination of low roughness, high kurtosis (e.g., referring to the distribution of peak heights and valley depths of the surface), and skewness of the surface. Any of the features of implants disclosed in <CIT>, and/or <CIT>.

As such, the shell may have friction surface properties to facilitate smooth delivery and implantation of the implant within the body of the patient. Examples of suitable breast implants may include, but are not limited to, Motiva implants produced by Establishment Labs, such as, e.g., Motiva Implant Matrix® SilkSurface™ and VelvetSurface™. 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 one or more of breast, gluteal, calf, and/or other such implants into the body of the patient.

<FIG> illustrates a variety of incision locations for implantation of a breast implant. As shown, a breast implant may be introduced into a breast pocket (e.g., breast pocket <NUM>, <FIG>) of a patient through an under-the-breast or inframammary incision <NUM>; a transaxillar or through-the-armpit incision <NUM>; the periareolar or areolar incision <NUM>; or the transumbilical or through-the-belly-button incision <NUM>. As shown, the various incision types may necessitate an opening of varying size and/or dimension. For example, the size of an inframammary incision <NUM> is typically larger than a transumbilical incision <NUM>. The selection of an incision type (e.g., insertion site) and size may depend on a number of variables and patient/physician preferences such as, e.g., the size and/or shape of the implant, the physical characteristics of the patient (e.g., the amount of adipose tissue, degree of skin elasticity, and/or physical condition of the patient), the patient's age, and/or the patient's lifestyle.

Disclosed herein are a variety of instruments, devices (e.g., introducer devices), systems, and methods to allow for the introduction of an elastomeric implant (such as, e.g., breast, gluteal, and/or calf implants) in a minimally-invasive manner. <FIG> illustrates an exemplary introducer device <NUM> for delivery of an implant <NUM>. Implant <NUM> may comprise a high strength shell <NUM> with visco-elastic and low friction surface properties as discussed above. Implant <NUM> is moldable, pliant, compressible, or otherwise movable between a compressed, elongated, insertion configuration (as shown in e.g., <FIG>, and <FIG>) and a deployed or expanded configuration (as shown in, e.g., <FIG>). A maximum dimeter or dimension of implant <NUM> in the insertion configuration may be limited by a size of a lumen of a shaft <NUM> within which implant <NUM> may be received. For example, in some examples, the inner diameter of the shaft may range from about <NUM> - <NUM> (<NUM>-<NUM> inches) or from about <NUM> - <NUM> (<NUM>-<NUM> inches), e.g., about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> (<NUM>, <NUM>, <NUM>, <NUM>, or <NUM> inches). As shown, the insertion configuration is a low profile or compressed configuration. Implant <NUM> may be positioned within introducer device <NUM> in the insertion configuration and, following delivery out of introducer device <NUM> and into the body of the patient, implant <NUM> may expand, decompress, or otherwise assume the deployed configuration.

As shown in <FIG>, introducer device <NUM> includes a shaft <NUM> having a lumen (not shown in the orientation of <FIG>) therein. As mentioned above, the inner diameter of the shaft <NUM> may range from about <NUM> - <NUM> (<NUM>-<NUM> inches) or from about <NUM> - <NUM> (<NUM>-<NUM> inches), e.g., about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> (<NUM>, <NUM>, <NUM>, <NUM>, or <NUM> inches). Further, for example, the outer diameter of the shaft <NUM> may range from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches), e.g., about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> (<NUM>, <NUM>, <NUM>, <NUM>, or <NUM> inches). The length of the shaft <NUM> may range from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches), or froma bout <NUM> (<NUM> inches) to about <NUM> (<NUM> inches), e.g., a length of about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> inches). The dimensions of the shaft <NUM> may be selected or correspond to the volume of the implant <NUM>. In at least one example, an introducer device <NUM> having a shaft of <NUM> (<NUM> inches) may be used for a <NUM> cc implant. Further, for example, a shaft of <NUM> (<NUM> inch) may be used for a <NUM> cc implant, or a shaft between about <NUM> - <NUM> (<NUM>-<NUM> inches) may be used for an implant of <NUM> cc or more. Any one or more portions of shaft <NUM>, such as an inner surface of shaft <NUM> may include a lubricious (e.g., hydrophilic) coating to reduce the coefficient of friction between one or more portions (e.g., the inner surface) of introducer device <NUM> and one or more portions (e.g., shell <NUM>) of implant <NUM>. For example, prior to implantation, implant <NUM> may be housed, received, or otherwise at least partially disposed within the lumen of shaft <NUM> of introducer device <NUM>. The hydrophilic coating may reduce the coefficient of friction between shell <NUM> and the interior surface of shaft <NUM>, enabling a smooth transition between the insertion configuration and the deployed configuration, e.g., upon exit of implant <NUM> from introducer device <NUM>.

Optionally, introducer device <NUM> may include a unique device identifier (UDI) with information useful for identifying introducer device <NUM>. For example, the UDI may include a micro-transponder for post-implantation device recognition and traceability. In some aspects, the micro-transponder includes 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 <NUM> 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 a UDI/sensor may be placed in any suitable position on or within introducer device <NUM>, including, for example, the inner surface of the introducer device <NUM> proximate and/or in contact with implant <NUM>.

In some aspects, implant <NUM> may be pre-loaded or inserted into a chamber (or introducer sheath) <NUM> to facilitate the sterile loading of implant <NUM> into shaft <NUM> and/or manipulate (e.g., compress, elongate, etc.) implant <NUM> toward the insertion configuration. Additionally, chamber <NUM> (or chamber <NUM> of <FIG>, described below) may protect implant <NUM> during an implantation procedure. For example, introducer device <NUM> may provide for an implant profile diameter that correlates to a small incision in the range of about <NUM> to less than about <NUM>, or in the range of about <NUM> to <NUM>. As such, chamber <NUM> may compress the diameter of implant <NUM> equal to or smaller than the incision size. Chamber <NUM> may have any appropriate shape or arrangement to urge implant <NUM> toward and/or maintain implant <NUM> in the insertion configuration while inside introducer device <NUM>. As shown in <FIG>, for example, chamber <NUM> is a foldable or rollable, highly-flexible, thin polymeric sheathing material that may be rolled or wrapped at least partially around implant <NUM> to thereby compress and/or elongate implant <NUM> into the insertion configuration. Once wrapped around implant <NUM>, chamber <NUM> may have a U-shaped cross-section as shown in <FIG>. Alternatively, once wrapped around implant <NUM>, chamber <NUM> may have a C-shaped shaped cross-section, as shown in <FIG>. While each of <FIG> and <FIG> illustrate a gap or space between terminating edges 18A and 18B of chamber <NUM>, the disclosure is not so limited. In some arrangements, edges 18A and 18B may abut or overlap one another such that the chamber <NUM> envelopes or surrounds the entire circumferential surface of implant <NUM> in the insertion configuration. Optionally, chamber <NUM> may include a hinge <NUM> between portions of chamber <NUM>, e.g., providing a generally clam-shell (e.g., two-part, halved) arrangement. Hinge <NUM> may be located along an internal or external surface of chamber <NUM>. In some examples, hinge <NUM> may be a living hinge (e.g., a hinge formed of a thinned dimension relative to a remainder of chamber <NUM> so as to enable bending along the thinned portion). In any such manner, hinge <NUM> is positioned so as to minimize exposure of hinge <NUM> to implant <NUM> and/or surrounding patient tissue, thereby preventing inadvertent trauma, injury, or abrasion of implant <NUM> and/or patient tissue.

In some arrangements, the chamber may comprise a shape memory material. For example, chamber <NUM> may be replaced with chamber <NUM> illustrated in <FIG>. Chamber <NUM> includes one or more shape-memory materials. Exemplary shape-memory materials include, but are not limited to, shape memory polymers and metal alloys such as nickel-titanium (Nitinol, including nickel-titanium wire structures) that may have thermalrecovery properties. For example, chamber <NUM> includes a plurality of struts <NUM> monolithically formed or woven, braided, or otherwise joined together in an expandable structure. In such an arrangement, chamber <NUM> may be tubular and allow for the constriction and/or containment of implant <NUM> within the tubular structure of chamber <NUM> that incorporates the shape-memory material(s), at a low transition temperature (e.g., lower than ambient room temperature), thereby reducing the insertion diameter of implant <NUM> to less than or equal to the incision size, as shown in <FIG>. Upon warming (e.g., by exposure to body temperature or a warm saline flush), the shape-memory material may expand to a preset or predetermined shape and diameter, as shown in <FIG>. Expansion of chamber <NUM> according to this arrangement may allow for the expansion of implant <NUM> housed therein, and facilitate removal of the chamber <NUM>.

Returning to <FIG>, at least a portion (e.g., a proximal end) of chamber <NUM> (or chamber <NUM>) is received within the lumen of shaft <NUM> and secured thereto via a connector <NUM>. For example, connector <NUM> may include a compression ring that tightens circumferentially around chamber <NUM> (or chamber <NUM>) and around a distal end of shaft <NUM> to secure chamber <NUM> (or chamber <NUM>) to shaft <NUM>. In such a manner, connector <NUM> prevents movement of chamber <NUM> (or chamber <NUM>) relative to shaft <NUM>.

Once implant <NUM> is received within shaft <NUM>, e.g., via chamber <NUM> or chamber <NUM>, a medical professional may grasp a handle <NUM> of introducer device <NUM>. Handle <NUM> may be a squeeze-type or compression handle, e.g., operating in a manner similar to a caulking gun, in which a first arm <NUM> is rotatable about a pivot <NUM> and movable toward a second arm <NUM>. Pivot <NUM>, in turn, is coupled to a plunger rod <NUM> via any appropriate gear and/or linkage system (not shown) such that rotational movement of pivot <NUM> is transferred into linear movement of plunger rod <NUM>. Such a gearing and/or linkage system may include a ratchet <NUM> to enable controlled, gentle, and incremental advancement of implant <NUM> via a plunger head (not shown) coupled to a distal end of plunger rod <NUM>. The plunger head may have a dimension (e.g., diameter) corresponding or similar to a dimension (e.g., diameter) of implant <NUM> in the insertion configuration. As such, upon squeezing first arm <NUM> toward second arm <NUM>, plunger rod <NUM> is advanced toward chamber <NUM> (or chamber <NUM>) and the plunger head forces, pushes, advances, or otherwise moves implant <NUM> distally of chamber <NUM> (or chamber <NUM>) (as shown in <FIG>) and into the breast pocket of a patient (or other site of implantation suitable for the type of implant), while chamber <NUM> (or chamber <NUM>) remains securely connected to shaft <NUM> via connector <NUM>.

In another arrangement, however, plunger rod <NUM> is stationary so as to prevent implant <NUM> from "backing out" of chamber <NUM>, e.g., during an implantation procedure. For example, the plunger head of plunger rod <NUM> may be positioned at a proximal end of chamber <NUM> so as to limit proximal movement of implant <NUM> (e.g., the plunger head may abut, contact, or otherwise inhibit movement of implant <NUM> proximally). In such cases, introducer device <NUM> may include a mechanism for retracting chamber <NUM> in order to release implant <NUM> from chamber <NUM>. In at least one example, squeezing first arm <NUM> toward second arm <NUM> of handle <NUM> may pull chamber <NUM> proximally while plunger rod <NUM> remains stationary to prevent proximal movement of implant with chamber <NUM>.

<FIG> illustrates another example of retraction of chamber <NUM>, wherein a frangible sheath <NUM> is positioned about chamber <NUM>, e.g., proximate a distal end of chamber <NUM>. Sheath <NUM> may comprise a flexible polymeric material and include a perforate line <NUM> (e.g., a series of small holes or thinned portions extending through at least a portion of the thickness of sheath <NUM>) so as to facilitate tearing along perforate line <NUM>. A proximal end of sheath <NUM> includes one or more flanges, grips, or tabs <NUM> to allow for a secure grip on sheath <NUM> by the medical professional. Optionally, a distal end of sheath <NUM> includes one or more retractors <NUM>, described in further detail below. In such an arrangement, delivery of implant <NUM> is performed via proximal retraction of sheath <NUM> or chamber <NUM> (or chamber <NUM>) (e.g., in the direction of arrow P), e.g., relative to the plunger head of plunger rod <NUM> discussed above. To do so, a medical professional may pull on tabs <NUM> of sheath <NUM> which tears (e.g., peels away) sheath <NUM> along perforate line <NUM> thereby slowly exposing a distal portion of implant <NUM>, allowing the natural expansion of exposed implant <NUM> (e.g., the exposed gel-filled structure) to pull the remaining portion of implant <NUM> out of chamber <NUM> and into the breast pocket (or other site of implantation for the type of implant) of the patient.

As shown in <FIG>, retractor(s) <NUM> extend radially outward (e.g., relative to a longitudinal axis C of chamber <NUM>, <FIG>), and may have the shape of a flange or cone. In some examples, retractor(s) may have a shield-like configuration. In use, retractor(s) <NUM> may be placed within the incision during an implantation procedure and may help to minimize damage to the skin and/or other tissues of the patient, and/or may help to stabilize the introducer device <NUM> during the implantation procedure. As shown, retractor(s) <NUM> are integrated with sheath <NUM>. However, the disclosure is not so limited. In some arrangements, retractor(s) <NUM> may be separate components used independently of any other device, or, may be coupled to any one or more of chamber <NUM> (or chamber <NUM>) or shaft <NUM>. In any arrangement, however, retractor(s) <NUM> may help to minimize the risk of introducing bacteria (or other micro-organisms) into the incision site. Additionally or alternatively, the retractor(s) <NUM> may serve to minimize the exposure of implant <NUM> to other surgical instruments (e.g., scalpels, needles, forceps, etc.) to reduce the risk of damage to implant <NUM> during the implantation procedure. For example, retractor(s) <NUM> may minimize the risk of rupturing shell <NUM> of implant <NUM> during implantation.

Retractor(s) <NUM> may be flexible or semi-rigid (e.g., constructed of a material providing the appropriate flexibility, yet also providing stability upon insertion in the incision site) and may be adaptable for placement into incisions of various dimensions and locations (e.g., as illustrated in <FIG>). In some aspects, sheath <NUM> has a generally tubular shape, e.g., an extruded tubular structure. Additionally, sheath <NUM> and/or retractors <NUM> may comprise a polymer or copolymer that has sufficient rigidity to support implantation of implant <NUM> while employing a thin-wall construction that can be collapsed, folded, broken or peeled-away without displacing implant <NUM>. Exemplary materials suitable for such sheaths and retractors include, but are not limited to, nylon, polyethylene, polyurethanes, polyamides, fluoropolymers such as, e.g., polytetrafluoroethylene (PTFE), polyolefins, polyetheretherketones (PEEK), and flexible acrylics, and combinations thereof. The linear extrusion process of materials such as polytetrafluoroethylene may incorporate perforate line <NUM> (e.g., an intrinsic line of separation), e.g., due to the process or molecular orientation of the extruded material.

In some aspects of the present disclosure, retractor(s) <NUM> or sheath <NUM> may comprise a reinforced ring (not shown) that allows unrestricted movement of surgical tools used to create the tissue pocket (e.g., breast pocket) and to introduce implant <NUM>. The reinforced ring may be flexible or rigid, and may include a slick or lubricious surface to reduce friction, e.g., to facilitate the introduction of implant <NUM> with a lower risk of abrasion or friction against implant <NUM>. In combination with implants having biocompatible surface characteristics as discussed above (including, e.g., Motiva Implant Matrix® SilkSurface™ and VelvetSurface™ implants), retractor(s) <NUM> may allow implant <NUM> to be introduced into the tissue pocket while minimizing trauma to the surrounding tissue. Retractors <NUM> according to the present disclosure may be used for any location of the incision, such as incisions for inframammary, peri-areolar or trans-axillary implantation procedures (see, e.g., <FIG>).

<FIG> illustrate another exemplary introducer device <NUM> according to aspects of the present disclosure, in which chamber <NUM> (or chamber <NUM>) is not secured to introducer device <NUM>. In such a device, chamber <NUM> or <NUM> may be omitted completely, or alternatively, may be used to compress, elongate, or otherwise transition or maintain implant <NUM> in the insertion configuration (see, e.g., <FIG>). Once implant <NUM> has been positioned in the insertion (e.g., reduced profile) configuration, chamber <NUM> or chamber <NUM> may be used to insert implant <NUM> into a shaft <NUM> of introducer device <NUM> (e.g., prior to connection of nozzle <NUM> via ring <NUM>). Once received within shaft <NUM>, chamber <NUM> or <NUM> may be discarded or sterilized and reused. Shaft <NUM> may include any of the features or dimensions of shaft <NUM> above.

Introducer device <NUM> may have a similar construction and manner of use as introducer device <NUM>. As such, introducer device <NUM> includes a shaft <NUM> extending from a handle <NUM> (e.g., a squeeze-type or compression handle) including a first arm <NUM> rotatable about a pivot <NUM> (e.g., a dowel rod) (see <FIG>) and movable toward a second arm <NUM>. First arm <NUM> is biased away from second arm <NUM> via a bracket <NUM> and torsion spring <NUM> supported by a dowel rod <NUM>, as shown in <FIG>. To compress handle <NUM>, a medical professional may first overcome the force imparted by spring <NUM>. Handle <NUM> includes first (e.g., left) half portion 54A and second (e.g., right) half portion 54B positioned on opposite sides of a plane extending along longitudinal axis L. Housed within first half portion 54A and second half portion 54B are a pair of lock plates <NUM> on opposite sides of a plunger rod <NUM>. Each lock plate <NUM> secures a shaft base <NUM> to a respective one of first half portion 54A and second half portion 54B via a plurality of fasteners (e.g., screws <NUM>). First half portion 54A and second half portion 54B are each coupled to a respective cover <NUM> and <NUM>, as shown in <FIG>.

Plunger rod <NUM> includes a proximal end coupled to (e.g., threadably, adhesively, etc.) a T-handle <NUM> which may be sized to enable grasping by a medical professional as needed and/or desired. A distal end of plunger rod <NUM> is coupled to a plunger head <NUM>. Plunger head <NUM> includes a pair of circumferentially extending channels or grooves <NUM> and <NUM>, within each of which a respective one of a pair of o-rings <NUM> and <NUM> is received. O-rings <NUM> and <NUM> prevent fluid (e.g., lubrication, aspiration, and/or irrigation fluid from passing proximally of plunger head <NUM>. Additionally, proximal end of shaft <NUM> includes a portion <NUM> releasably coupleable to a proximal lock or ring <NUM>, e.g., via threads or other complementary mating features of an internal surface of ring <NUM>. For example, portion <NUM> may include threads and the internal surface of ring <NUM> may be correspondingly threaded. That is, each of threaded portion <NUM> and ring <NUM> may include a thread profile having a matching pitch and/or orientation. Upon connection of portion <NUM> and ring <NUM>, a gasket <NUM> is compressed between and/or about a periphery of shaft base <NUM> so as to secure shaft base <NUM>, and thereby handle <NUM>, to shaft <NUM>. A distal end of shaft <NUM> includes a portion <NUM> releasably coupleable to a distal lock or ring <NUM>, e.g., via complementary mating features. For example, portion <NUM> may include threads and the internal surface of ring <NUM> may be correspondingly threaded. That is, each of portion <NUM> and ring <NUM> may include a thread profile having a matching pitch and/or orientation. Upon connection of portion <NUM> and ring <NUM>, a gasket <NUM> is compressed between and/or about a periphery of a proximal end of a nozzle <NUM> so as to secure nozzle <NUM> to shaft <NUM>.

Nozzle <NUM> may be formed from or otherwise include a pliable polymer (e.g., polyurethane, polyethylene, silicone, etc.), which may be rigid enough to dilate an incision site, but soft enough to avoid tearing or damaging the site. An opening <NUM> at the distal end of nozzle <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), or angular in shape. The shape of nozzle <NUM> may be selected to accommodate the shape of implant <NUM> to be introduced into a patient (e.g., a half-oval or angular shape to accommodate a non-round implant). Nozzle <NUM>, as shown in <FIG>, is tapered such that a distal end diameter is smaller than a proximal end diameter of nozzle <NUM>. Additionally, the length of nozzle <NUM> may be varied, as needed or desired. For example, the degree or angle of taper, diameter of the distal opening, and length of nozzle <NUM> may be selected so as to correlate to, and to accommodate, differently sized implants. In use, a medical professionally may deliver implant <NUM> (not shown in <FIG>) loaded within shaft <NUM> via actuation of handle <NUM> to advance plunger head <NUM> towards nozzle <NUM>. As plunger head <NUM> is advanced distally, implant <NUM> is pushed through opening <NUM> and delivered into the breast pocket of a patient.

As noted above, implant <NUM> may be inserted through an umbilicus incision <NUM> to minimize visible scarring. In such a procedure, incision <NUM> is typically made in the umbilicus to introduce a blunt dissecting instrument to form a tunnel <NUM> (see <FIG>), over which a larger cannula or tube is inserted and advanced to a tissue pocket <NUM> where implant <NUM> is to be positioned. Forming tunnel <NUM> separates subcutaneous tissue <NUM> (e.g., fat located under the skin <NUM>) from the rectus sheath <NUM> positioned anterior of the rectus abdominis muscle <NUM>.

A challenge associated with this approach is compressing implant <NUM> sufficiently to be "pushed" through tunnel <NUM>. Typically, the cannula used to form tunnel <NUM> is too small in diameter to deliver current implant <NUM> designs, such that the cannula only serves to establish a subcutaneous tunnel. After formation of tunnel <NUM>, implant <NUM> is advanced through tunnel <NUM>, which imparts many additional forces and stresses on implant <NUM>, thus increasing the probability of damage to implant <NUM>, such as rupture of shell <NUM>.

To improve patient safety and reduce the trauma to implant <NUM> and subcutaneous tissues <NUM> of the patient associated with such procedures, an introducer system employing one or more of the features of the examples above may be used. For example, introducer device <NUM> or introducer device <NUM> may be used in conjunction with a tunneling sheath <NUM> (see <FIG> and <FIG>). Alternatively, any introducer device herein described may be used instead of introducer device <NUM>. Introducer device <NUM> (or any other described introducer device) as well as tunneling sheath <NUM> includes a length sufficient to reach the intended area (e.g., breast pocket <NUM>) for implantation from umbilicus incision <NUM> (see, e.g., <FIG>).

For example, as shown in <FIG>, tunneling sheath <NUM>, having a dimension or length sufficient to extend from incision <NUM> to breast pocket <NUM>, and having an internal diameter sufficient to receive therein shaft <NUM> of insertion device <NUM> and/or implant <NUM> in the insertion configuration (e.g., reduced profile configuration) is advanced through incision <NUM> to breast pocket <NUM>. The diameter of tunneling sheath <NUM> may correlate to the size of an incision, and as such, may be between about <NUM> and about <NUM>, e.g., between about <NUM> and about <NUM>, e.g., about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. To enhance the stability and pushability of tunneling sheath <NUM>, an inner trocar <NUM> or cannula (having a smaller diameter) may be used (<FIG>). That is, inner trocar <NUM> may be inserted through a lumen of tunneling sheath <NUM> and both may be simultaneously advanced through tunnel <NUM>. A blunt distal end <NUM> of inner trocar <NUM> may separate tissues to form tunnel <NUM>. Inner trocar <NUM> and tunneling sheath <NUM> form a coaxial system to facilitate insertion and advancement of implant <NUM>. Once the tunneling sheath <NUM> is properly positioned, inner trocar <NUM> may be removed to allow for access to a lumen extending through tunneling sheath <NUM>. Next, shaft <NUM> of insertion device <NUM> may be inserted into the channel of tunneling sheath <NUM> (<FIG>) so as to advance implant <NUM> through tunneling sheath <NUM>, and may be actuated as discussed above, to advance implant <NUM> into breast pocket <NUM>. Such an insertion approach may minimize the entry wound/incision and length of travel from the entry incision to breast pocket <NUM>. Smaller incisions and tunnel <NUM> lengths may reduce trauma and result in faster healing rates and fewer complications.

In some aspects, blunt distal end <NUM> of trocar <NUM> may include features for attachment of a suture or thread. For example, distal end <NUM> may include an eyelet <NUM>, as shown in <FIG>. A line <NUM> such as a monofilament thread having a small diameter is secured to eyelet <NUM> and pulled through tunneling sheath <NUM> with trocar <NUM> (<FIG>). A small incision or opening through or proximate to breast pocket <NUM> enables a medical professional to grasp and thread line <NUM> from the breast pocket <NUM>, through the opening, and exterior of the patient's body for handling, e.g., pulling, by the medical professional. Exemplary materials for line <NUM> include, but are not limited to, polymers, fibers (e.g., similar to suture material or a fishing line), and metals or metal alloys, such as metallic wire. Following formation of tunnel <NUM> and threading at least a portion of line <NUM> through the opening in the breast pocket <NUM>, trocar <NUM> may be withdrawn through the lumen of tunneling sheath <NUM>, thereby pulling a portion of line <NUM> therewith. As such, at least a portion of line <NUM> is left in tunnel <NUM> (<FIG>) established by the trocar <NUM> once trocar <NUM> is removed. Line <NUM> then may detached, e.g., untied, from eyelet <NUM> and later secured to a separate bag, sack, or chamber <NUM> (or optionally chamber <NUM>) in which implant <NUM> is housed in the insertion configuration. Once coupled, the medical professional may gently pull implant <NUM> (within the separate bag, sack, or chamber, e.g., chamber <NUM> or <NUM>) through tunnel <NUM> from the opposing end (<FIG>). Additionally or alternatively, upon removal of trocar <NUM>, an elongated plunger (not shown) may be used to advance (e.g., push) implant <NUM> through the lumen of tunneling sheath <NUM> until implant <NUM> exits the distal end of tunneling sheath <NUM> and expands towards the deployed configuration within the breast pocket <NUM>.

As mentioned above, introducer devices described herein (e.g., introducer devices <NUM>, <NUM>) may be used for implantation of implant <NUM> with visco-elastic and/or highly elastic properties, e.g., comprising an elastic shell and visco-elastic silicone gel. Such elastic properties of implant <NUM> enable implant <NUM> to be stretched or elongated for loading into a chamber (e.g., chamber <NUM>, chamber <NUM>, etc.) in a reduced profile for implantation in a minimally-invasive manner with less trauma to the patient. For example, various properties of implant <NUM> may allow for uniform radial compression of implant <NUM>, which may provide an ability to safely compress implant <NUM> for advancement into a smaller incision (e.g., an incision of less than about <NUM>) than is conventionally used in the implantation procedure.

As noted above, a plunger (e.g., plunger rod <NUM> or <NUM> having a plunger head <NUM>, etc.) may be used for pushing or urging the compressed implant <NUM> from the introducer device through a tapered funnel or nozzle (e.g., nozzle <NUM>, <FIG>) and into the incision site. In some examples, and depending on the type and features of the implant, for example, this pushing mechanism may impose a significant load on a proximal portion of implant <NUM>, e.g., creating excessive pressure between implant <NUM> and the introducer device (e.g., an inner wall of shaft <NUM> or shaft <NUM>). In some cases, the pressure may lead to a rupture of shell <NUM> of implant <NUM>, and/or may cut, sever, or otherwise deform implant <NUM> upon expulsion from the introducer device (e.g., introducer device <NUM>, introducer device <NUM>, etc.).

In some arrangements, a fluid barrier between the plunger head (e.g., plunger head of plunger rod <NUM>, plunger head <NUM> of plunger rod <NUM>, etc.) and implant <NUM> may be used to at least partially alleviate pressure between implant <NUM> and the introducer device. Depending on the type of implant and/or introducer device, however, mechanical pressure may cause water or other fluid (e.g., saline solution) to flow around circumferential edges and/or creases or fold of implant <NUM> and/or leak out of a distal portion of the selected introducer device. Such leaking water or fluid, however, may impart additional pressure to implant <NUM>, such that implant <NUM> may be further compressed thus further elongating implant <NUM> and/or reducing a diameter of implant <NUM>.

In some aspects of the present disclosure, an introducer device may use compressed gas (e.g., CO<NUM>, air, or other suitable inert gas) to advance implant <NUM> from inside a shaft and/or a chamber, and through a tapered nozzle located at a distal end of the introducer device. For example, the gas may provide a buffer between implant <NUM> and the walls of the introducer device shaft similar to water. In a manner similar to the leaking water flow example discussed above, compressed gas may leak around the circumference of implant <NUM> as it is urged out of the distal end of the device. However, the pressure from the compressed gas may help further radially-compress the implant as the continuous air pressure pushes implant <NUM> from the proximal end of the introducer device toward the nozzle at the distal end of the device chamber.

In some aspects of the present disclosure, a compressed gas source <NUM> may be used to pull an implant into a shaft (similar to shaft <NUM>, shaft <NUM>, etc.) of the introducer device. The implant may be lubricated, e.g., comprising a lubricant on the surface of the implant. For example, as shown in <FIG>, ring <NUM> of introducer device <NUM> may be unscrewed or otherwise uncoupled from handle <NUM> and fluidly coupled to compressed gas source <NUM> (e.g., a negative pressure source referred to as a venturi vacuum) via any appropriate conduit <NUM>. Additionally, nozzle <NUM> may be uncoupled from shaft <NUM> by unscrewing or otherwise uncoupling ring <NUM> from shaft <NUM>. Shaft <NUM> may include any of the features or dimensions of shaft <NUM> and/or <NUM> above. Once so arranged, a distal end of shaft <NUM> (e.g., an end closer to ring <NUM>) may be positioned near, adjacent to, or in contact with implant <NUM> (e.g., having a lubricated shell <NUM> as discussed above). Next, compressed gas source <NUM> may be activated in any appropriate manner so as to pull, suck, or otherwise draw implant <NUM> into shaft <NUM> through the distal end of shaft <NUM>. Once received within shaft <NUM>, ring <NUM> may be unscrewed or otherwise uncoupled from conduit <NUM> and compressed gas source <NUM>, and then may be coupled to handle <NUM>, as discussed above. Additionally, nozzle <NUM> may be coupled to the distal end of shaft <NUM> via ring <NUM>. While <FIG> refer to components of introducer device <NUM>, the disclosure is not so limited. Rather, a proximal end of the shaft <NUM> of introducer device <NUM> may likewise be coupled to compressed gas source <NUM> to draw implant <NUM> through a distal end of shaft <NUM> (e.g., following removal of compression ring <NUM> and chamber <NUM> or chamber <NUM>).

Alternatively, following drawing implant <NUM> into shaft <NUM>, compressed gas source <NUM> may remain coupled to shaft <NUM> and switched or toggled in a reverse direction so as to produce a positive pressure source to force or push implant <NUM> so as to expel implant <NUM> from shaft <NUM> and into an appropriate implantation location (e.g., breast pocket <NUM>) of a patient. In order to facilitate switching between negative and positive pressure types (e.g., a direction of flow of compressed gas), compressed gas source <NUM> and/or introducer device <NUM> may utilize a valve mechanism (not shown) that allows the user to switch between these two functions. In other words, compressed gas source <NUM> may be used to both load and expel implant <NUM> from introducer device <NUM>. Thus, the device may provide a self-contained system equipped to provide a vacuum or expulsion pressure, as opposed to connecting different wall attachments for vacuum or compressed air/gas. In at least one example in which compressed gas source <NUM> is used to expel implant <NUM>, handle <NUM> need not be reattached to shaft <NUM> via ring <NUM>.

<FIG> illustrates various features of exemplary introducer device <NUM> according to aspects of the present disclosure. Introducer device <NUM> may be a self-contained introducer device including a shaft <NUM> having a handle <NUM> coupled to a first (e.g., proximal end) of shaft via a ring <NUM> and a tapered nozzle <NUM> coupled to a distal end of shaft <NUM> via a ring <NUM>. As shown in <FIG>, a disposable compressed gas cartridge <NUM> (e.g., a compressed CO<NUM> or air cartridge) is coupled to handle <NUM> via any suitable connector or adaptor, and may be replaced as needed to replenish the source of compressed gas. Handle <NUM> includes a toggle or switch <NUM> actuatable to alternate between vacuum and expulsion pressure generated with the compressed gas cartridge <NUM>. The mechanism may include a toggle switch for changing between a vacuum mode and a pressure mode. Additionally, handle <NUM> includes a trigger <NUM> or other suitable actuator for generating the vacuum or pressure.

Nozzle <NUM> may be disposable and may comprise a biocompatible material, such as a pliable polymer (e.g., a polyurethane, polyethylene, silicone, etc.) that is rigid enough to dilate an incision site, but soft enough to avoid tearing or damaging the incision site. Similar to nozzle <NUM>, a distal opening <NUM> of nozzle <NUM> may have any suitable shape, such as, e.g., round, oval, slitted-duckbill, half-oval (e.g., having one side that is flat and another side that is rounded or oval), or angular in shape to accommodate implant <NUM> to be implanted. The dimensions of nozzle <NUM> (e.g., length and distal diameter) may be selected in accordance with the dimensions and/or requirements of implant <NUM>.

Switch <NUM> may include a mechanism by which the medical professional may select a negative pressure (e.g., the venturi vacuum) to pull implant <NUM> into shaft <NUM> of introducer device <NUM> (e.g., prior to attachment of nozzle <NUM>), and then actuate switch <NUM> to reverse the valve mechanism to provide compressed gas for expelling implant <NUM>. Other such vacuum effects can be generated by known displacement or rotary vacuum mechanisms. It is also contemplated that trigger <NUM> and/or switch <NUM> may be electrical or digital, and operate by sending signals to one another and/or to the valve mechanism to move between the negative (e.g., vacuum) and positive pressure configurations, and to actuate the dispensing of compressed gas from cartridge <NUM>.

<FIG> are a schematic views of a proximal portion of an introducer device during the vacuum configuration or mode that may be used to load an implant into the delivery chamber of the introducer device. As shown, when switch <NUM> (<FIG>) is set to the vacuum configuration, a user may pull trigger <NUM> (<FIG>) to cause compressed gas to move from cartridge <NUM>, through an opening <NUM> in a circumferential side surface of the device. Optionally, opening <NUM> may include an inlet conduit as shown in <FIG>. Once the gas moves through opening <NUM>, the valve mechanism urges gas proximally through and out of the device via an exhaust port <NUM> positioned at the proximal end of the device. Operating the device in this manner may have the effect of a vacuum on portions of the introducer device <NUM> that are distal to opening <NUM> (e.g., shaft <NUM> within which implant <NUM> may be loaded). By toggling switch <NUM> to the pressure/dispensing configuration or mode, the valve mechanism may be altered such that once the compressed gas moves from cartridge <NUM> and through opening <NUM>, the gas may be directed distally through shaft <NUM> to urge implant <NUM> distally out of introducer device <NUM>. In some aspects, introducer device <NUM> may further include a pressure relief valve to relieve excess pressure within shaft <NUM>.

<FIG> illustrate a further exemplary introducer device <NUM> according to aspects of the present disclosure. Introducer device <NUM> may have a similar construction and manner of use as introducer device <NUM> (e.g., <FIG>). For example, similar to introducer device <NUM>, introducer device <NUM> includes a compressed gas cartridge <NUM>. Handle <NUM> includes first (e.g., left) half portion 184A and second (e.g., right) half portion 184B positioned on opposite sides of a plane extending along longitudinal axis L and coupled together via a plurality of connectors (e.g., screws <NUM>). In addition to compressed gas cartridge <NUM>, housed within first half portion 184A and second half portion 184B is a pump <NUM>. Pump <NUM> may include any appropriate pumping mechanism such a reciprocal or rotary pump. As shown in <FIG>, each of compressed gas cartridge <NUM> and pump <NUM> is fluidly coupled to a valve mechanism <NUM> via one or more conduits <NUM> (e.g., conduits 196A-196D).

For example, conduits 196A and <NUM> D may control pressure, and conduits 196B and 196C may control suction, e.g., through a venture vacuum. Additionally, each end of each conduit 196A-196D may include a fitting <NUM> to fluidly couple and secure a respective one end of each conduit 196A-196D to one or more of compressed gas cartridge <NUM>, pump <NUM>, valve mechanism <NUM>, and shaft <NUM>, as shown in <FIG>. Shaft <NUM> may include any of the features or dimensions of shaft <NUM>, <NUM>, and/or <NUM> above.

Handle <NUM> includes a toggle or switch <NUM> (also referred to herein as a mode selector) actuatable to alternate between vacuum and expulsion pressure (e.g., a vacuum mode and pressure mode) generated with the compressed gas cartridge <NUM>. The switch <NUM> may include a toggle switch for adjusting valve mechanism <NUM> between a vacuum mode and a pressure mode. A lower surface of switch <NUM> may define a cam surface that contacts valve <NUM> to switch between a suction mode and a pressure mode, e.g., via conduits 196B and 196C, and conduits 196A and 196D. As such, in a first orientation of switch <NUM> relative to handle <NUM>, valve mechanism <NUM> is arranged to generate vacuum pressure in shaft <NUM>. In a second orientation of switch <NUM> relative to handle <NUM>, valve mechanism <NUM> is arranged to positive expulsion pressure in shaft <NUM>.

Additionally, handle <NUM> includes a trigger <NUM> for generating vacuum or positive pressure in shaft <NUM>. As shown, for example, trigger <NUM> may include an L-shaped bracket or arm having one end <NUM> pivotably coupled to handle <NUM> via shaft or dowel rod/pin <NUM>. Additionally, trigger <NUM> is coupled to valve mechanism <NUM>. Further, as shown in <FIG>, handle <NUM> includes locking levers <NUM> that secure the proximal end of shaft <NUM> to handle <NUM>. Each locking lever <NUM> pivots about a pin <NUM> extending through an aperture of locking lever <NUM> and is coupled to a spring <NUM>. By pivoting locking levers <NUM> radially outward about pins <NUM>, the ends of locking levers <NUM> may release from a circumferential groove at the proximal end of shaft <NUM> to release shaft from handle <NUM>. Thus, handle <NUM> may be detached from shaft <NUM> following a procedure and be reused, following sterilization of handle <NUM>, e.g., via autoclave.

Further, handle <NUM> includes a core seal <NUM> retained between first half portion 184A and second half portion 184B. Core seal <NUM> may comprise any appropriate material such as, for example, a polymer, rubber, or the like. As shown in <FIG>, one or more of fittings <NUM> may be coupled to a lumen <NUM> extending through core seal <NUM> so as to deliver negative and/or positive pressure to shaft <NUM>. A distal portion of core seal <NUM> is at least partially received within a lumen of shaft <NUM> while a remainder of core seal <NUM> is received within handle <NUM>. An o-ring <NUM> is positioned about a circumference of core seal <NUM>, such that, upon coupling of core seal <NUM> and handle <NUM>, o-ring <NUM> is received within an internal channel of handle <NUM> and prevents fluid (e.g., gas) from leaking proximally of o-ring <NUM>. A second o-ring <NUM> is positioned about a circumference of core seal <NUM> and distally of o-ring <NUM>. Upon coupling of core seal <NUM> and shaft <NUM>, o-ring <NUM> is received within the lumen of shaft <NUM> and prevents fluid (e.g., gas) from leaking proximally of o-ring <NUM>. Beyond prevention of proximal egress of gas or fluid, o-rings <NUM> and <NUM> may facilitate securing shaft <NUM> to handle <NUM>. Additionally, a distal end of shaft <NUM> is releasably coupleable (e.g., via an interference fit, threaded coupling, etc.) to a proximal a proximal end of a nozzle <NUM> so as to secure nozzle <NUM> to shaft <NUM>.

Similar to nozzle <NUM>, described above, nozzle <NUM> may be formed from or otherwise include a pliable polymer (e.g., polyurethane, polyethylene, silicone, etc.), which may be rigid enough to dilate an incision site, but soft enough to avoid tearing or damaging the site. An opening <NUM> at the distal end of nozzle <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), or angular in shape. The shape of nozzle <NUM> may be selected to accommodate the shape of implant <NUM> to be introduced into a patient (e.g., a half-oval or angular shape to accommodate a non-round implant). Nozzle <NUM>, as shown in <FIG>, is tapered such that a distal end diameter is smaller than a proximal end diameter of nozzle <NUM>. Additionally, the length of nozzle <NUM> may be varied, as needed or desired. For example, the degree or angle of taper, diameter of the distal opening <NUM>, and length of nozzle <NUM> may be selected so as to correlate to, and to accommodate, differently sized implants <NUM>. For example, a tapered nozzle (e.g., nozzle <NUM>, <NUM>, <NUM>, or <NUM> (described below)) may facilitate implantation of implant <NUM> in a desired orientation or "right side up" manner. The diameter of such a nozzle may vary to accommodate varying sized implants and correlate with a size or location of an incision through which the implant is to be delivered. In at least one example, the nozzle may have an angled aperture, e.g., providing a larger opening for implant to exit.

In use, a medical professional may remove (if not already done) nozzle <NUM> from the distal end of shaft <NUM> and toggle switch <NUM> to the vacuum mode. Then, the distal end of shaft <NUM> may be positioned near, adjacent to, or in contact with implant <NUM> (e.g., having a lubricated shell <NUM> as discussed above). Next, compressed gas source <NUM> may be activated via trigger <NUM> as to pull, suck, or otherwise draw implant <NUM> into shaft <NUM> through the distal end of shaft <NUM>. Once implant <NUM> is housed within shaft <NUM>, switch <NUM> may be toggled to the pressure mode (e.g., expulsion mode) and nozzle <NUM> may be coupled to the distal end of shaft <NUM>, as noted above. Next, nozzle <NUM> may be positioned within, through, or near the incision site and compressed gas source <NUM> may be activated via trigger <NUM> as to push, force, or otherwise expel implant <NUM> from shaft <NUM>, through nozzle <NUM>, and into the patient (e.g., into breast pocket <NUM>).

Compressed gas sources <NUM>, <NUM> may have any appropriate volume and dimensions so as to contain and connect compressed gas to a respective introducer device (e.g., introducer device <NUM>, introducer device <NUM>). For example, either or both of sources <NUM> and <NUM> may include a total length of about <NUM> (approximately <NUM> inches), and a total width (e.g., diameter) of about <NUM> (approximately <NUM> inches). A neck or connection between source <NUM>, <NUM> and a remainder of introducer device <NUM>, <NUM>, respectively may have a length of about <NUM> (approximately <NUM> inches) and a width (e.g., diameter) of approximately <NUM> (approximately <NUM> inches). These dimensions are exemplary only and may vary depending on other dimensions of the introducer device and/or volume of compressed gas desired or required. Additionally, in some aspects, introducer device <NUM> may further include a pressure relief valve to relief excess pressure within shaft <NUM>.

<FIG> illustrate a further exemplary introducer device <NUM> according to aspects of the present disclosure. Introducer device <NUM> may have a similar construction and manner of use as introducer device <NUM> (e.g., <FIG>), except compressed gas source <NUM> and pump <NUM> have been replaced with tubing assembly <NUM>, coupleable to a source of compressed gas, such as facility gas supplies (e.g., hospital or medical center building-supplied gas sources via utility hookups). In some examples, introducer device <NUM> may be single-use or disposable.

For example, tubing assembly <NUM> includes a suction line <NUM> and a positive pressure line <NUM>. Each of suction line <NUM> and pressure line <NUM> includes a fitting <NUM> on a proximal end thereof for connection to the facility gas supplies (not shown) and a fitting <NUM> (e.g., luer adapter) for connection to a corresponding connection line of the introducer device <NUM>. For example, fitting <NUM> of suction line <NUM> is coupled to a first end of suction connection <NUM> while fitting <NUM> of pressure line <NUM> is coupled to a first end of pressure connection <NUM>. Additionally, a second end of suction connection <NUM> is coupled to a fitting <NUM> of a core seal <NUM> while a second end of pressure connection <NUM> is coupled to a fitting <NUM> of core seal <NUM>. As shown, core seal <NUM>, in turn, is received within handle <NUM>, e.g., between shaft <NUM> and handle <NUM>. Shaft <NUM> may include any of the features or dimensions of shaft <NUM>, <NUM>, <NUM>, and/or <NUM> above. As shown, handle <NUM> includes first (e.g., left) half portion 274A and second (e.g., right) half portion 274B coupled together via any appropriate manner such as, e.g., via screws <NUM>. Additionally, a distal end of shaft <NUM> is releasably coupleable (e.g., via an interference fit, threaded coupling, pins <NUM>, etc.) to a proximal end of a nozzle <NUM> so as to secure nozzle <NUM> to shaft <NUM>. Nozzle <NUM> may be similar in shape and construction as nozzle <NUM>, described above.

Further, handle <NUM> includes two actuators to control suction and vacuum. For example, handle <NUM> may include a first actuator, trigger <NUM> (e.g., controlled by an index finger of the user) for generating one of vacuum or positive pressure in shaft <NUM>, and a second actuator, e.g., actuator <NUM> (e.g., controlled by a thumb of the user) for generating the other of vacuum or positive pressure. Actuator <NUM> may extend through the handle and define a portion of a valve. As shown, trigger <NUM> is rotatably coupled to handle <NUM> via bearing <NUM>, which controls valve <NUM>, e.g., trumpet valve <NUM>. In at least one example, In some aspects, introducer device <NUM> may further include a pressure relief valve to relief excess pressure within shaft <NUM>.

In at least one example, the trigger <NUM> controls pressure and the second actuator <NUM> controls suction. In some examples, both actuators may be pressed simultaneously to apply both pressure and suction. For example, actuator <NUM> may fluidly couple suction line <NUM> with shaft <NUM>, and trigger <NUM> may fluidly coupled pressure line <NUM> with shaft <NUM>. In such an arrangement, each of the suction and pressure may be applied to shaft <NUM> simultaneously, if so desired. For example, to reduce the degree of suction applied via actuation of actuator <NUM>, a medical professional may press trigger <NUM> to fluidly couple pressure line <NUM> with shaft <NUM>.

In use, a medical professional may remove (if not already done) nozzle <NUM> from the distal end of shaft <NUM> and fluidly couple suction line <NUM> with shaft <NUM>. Then, the distal end of shaft <NUM> may be positioned near, adjacent to, or in contact with implant <NUM> (e.g., having a lubricated shell <NUM> as discussed above). Next, trigger <NUM> may be actuated so as to pull, suck, or otherwise draw implant <NUM> into shaft <NUM> through the distal end of shaft <NUM>. Once implant <NUM> is housed within shaft <NUM>, pressure line <NUM> may be fluidly coupled with shaft <NUM>. Next, nozzle <NUM> may be coupled to the distal end of shaft <NUM>, as noted above, and nozzle <NUM> may be positioned within, through, or near the incision site. Trigger <NUM> then may be actuated so as to push, force, or otherwise expel implant <NUM> from shaft <NUM>, through nozzle <NUM>, and into the patient (e.g., into breast pocket <NUM>).

In some arrangements, the introducer devices described herein (e.g., introducer devices <NUM>, <NUM>, <NUM>, etc.) may adapt to a sterile packaging system to provide a "touchless" implantation procedure. That is, the physician, nurse, or other medical professional or user need not directly handle implant <NUM> when loading the implant <NUM> into the introducer device (e.g., introducer devices <NUM>, <NUM>, <NUM>, etc.) or at other times during implantation.

For example, as shown in <FIG>, a separate sterile package <NUM> may be sized and/or shaped so as to contain implant <NUM> therein. As illustrated, package <NUM> may have the shape of a hemisphere with a diameter suitable for enclosing a specified sized and volume of implant <NUM> (e.g., a breast implant). In some examples, a pull-tab opening <NUM> may be integrated into either side of the sterile package <NUM>. The opposing side may be covered by a Tyvek material used in packaging sterile medical devices or other suitable material for sterile packaging. The Tyvek lid or other portion of the package may also include a separate injection port (not shown) that may further accommodate injection of sterile saline and/or lubricant.

As shown in <FIG>, for example, package <NUM> may be used in conjunction with introducer device <NUM>. Alternatively, package <NUM> may be used in conjunction with any introducer device described herein. In some examples, package <NUM> may include features complementary to features of a nozzle (e.g., nozzle <NUM>, nozzle <NUM>, nozzle <NUM>, nozzle <NUM>, etc.) or a distal end of a shaft (e.g., shaft <NUM>, shaft <NUM>, shaft <NUM>, shaft <NUM>, shaft <NUM>, etc.) to allow the introducer device to connect to package <NUM>. For example, the distal end of the shaft <NUM> of introducer device may be threaded (or have other mating features) to allow the connection of the distal end of shaft <NUM> to package <NUM> via complementary threads (or other complementary mating features) of package <NUM>. In some examples, the introducer device may include counter-threads or connection tabs located within the shaft <NUM>. For example, threads may be thermoformed into the outer surface of package <NUM> that contains implant <NUM>.

In other examples, package may include a reduced diameter opening to receive shaft <NUM>. Optionally, package <NUM> may include an o-ring (as illustrated in <FIG>) to provide for a better seal between shaft <NUM> and package <NUM>.

Package <NUM> may be designed in such a way that the user can use a pull-tab <NUM> to open the sterile package (similar to opening a sealed can), providing access to the enclosed implant <NUM>. Pull-tab may be located on the curved portion of package <NUM>, as shown in <FIG>, or may be located on the opposite, substantially planar, portion of package <NUM>. For example, in some examples, pull tab may be removed from the planar portion of package <NUM> and the implant drawn into shaft <NUM>.

While package <NUM> is opened, and prior to the connection of package <NUM> to the shaft <NUM>, the user can inject sterile saline and/or lubricant into package <NUM> to aid in the movement of implant <NUM> into shaft <NUM>. Once the connection between package <NUM> and shaft <NUM> is secured, the vacuum mode of the system may be used to then pull the lubricated, sterile implant <NUM> into shaft <NUM>, to prepare implant <NUM> for injection into the incision site. Mating features or mechanisms other than threads may be used to connect the shaft <NUM> to sterile package <NUM>. This loading system may help avoid any physical contact or minimize physical contact of implant <NUM> with the user and/or the surrounding environment, thereby reducing or eliminating the risks of puncture or introduction of particulate debris to the surface of implant <NUM>.

Following experimentation, appropriate expulsion pressures to expel implant <NUM> from an introducer device may correlate to i) the volume/size of implant <NUM>, ii) the incision location and size, and iii) the nozzle diameter of the introducer device that is inserted within the incision. A chart may be provided to the end-user that defines these correlations for optimal device placement. The chart may be developed by bench and pre-clinical assessments, for example.

By way of example only, assuming implant <NUM> makes a perfect seal against an inner surface of the shaft (e.g., shaft <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, etc.), the volume of gas/fluid sufficient to expel implant <NUM> may be equal to the implant volume (up to <NUM> cc (cubic centimeters)). An alternative way to calculate required air pressure to expel implant <NUM> is to determine the pressure needed to expel the entire volume of the shaft (e.g., shaft <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, etc.) (in one example, the dimensions of the shaft are approximately <NUM> (<NUM> inches) (diameter) by <NUM> (<NUM> inches) (length)), or about <NUM> cc. The same pressure may be used to vacuum load the implant into the chamber of the introducer device.

For some exemplary implantation procedures, <NUM> cc or about <NUM> ci (cubic inches) is sufficient to propel an implant having a volume of up to about <NUM> cc. Thus, if the vacuum pump is <NUM>% efficient, <NUM> ci of CO<NUM> (or other suitable gas) may be used to load implant into the shaft of the introducer device, and to subsequently propel implant from the shaft. Using Boyle's Law (P<NUM>V<NUM>=P<NUM>V<NUM>), along with the following assumptions, the chart below provides for the range of potential volumes of various compressed gas sources (e.g., source <NUM>, source <NUM>) that would supply sufficient gas pressure for loading and expulsion of a silicone gel implant with a range of volumes that require <NUM> psi:.

• A constant temperature at <NUM>°K (<NUM> °F)
• Gas supply minimum fill pressure of <NUM> psi
• <NUM> psi for both loading and expulsion of implant <NUM>
• <NUM> (<NUM> inch) gas supply <NUM> cc (<NUM> ci).

In addition, it is known that one mole of an ideal gas occupies a volume of <NUM> liters at STP (Standard Temperature and Pressure, <NUM> (<NUM>°K) and one atmosphere pressure (<NUM> psi)). Using the following parameters, a <NUM> gas supply may provide sufficient volumes and pressures for an average size breast implant procedure.

The ideal gas law PV=nRT may be used to calculate the volume of gas at atmospheric pressure for a given amount of gas, wherein:.

Accordingly, and by way of example only, for a gas supply containing <NUM> of CO<NUM>:.

Therefore, this system may provide for the use of disposable gas (e.g., CO<NUM>, air, or air/CO2 mixtures) sources (e.g., <NUM>, <NUM>) in the range of <NUM>-<NUM> and volumes from <NUM> ci to <NUM> ci, providing an average pressure of <NUM> psi for both the vacuum and expulsion processes during an implantation procedure.

The introducer devices described herein may be used to standardize and/or facilitate procedures for implantation of a breast implant or other such implant device. In some examples, the introducer device may be configured for one-handed advancement of the implant. Additionally, any one or more of the shafts (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), chambers (e.g., <NUM>, <NUM>), tunneling sheath <NUM> or other such device may be constructed of a low-friction material, such as polytetrafluoroethylene (Teflon®), and/or coated with a highly lubricious (e.g., hydrophilic) material to reduce the coefficient of friction between the introducer device and implant <NUM>. In some aspects, a combination of features of the implant and the introducer system may help to optimize a minimally-invasive procedure, e.g., to improve patient wellbeing. For example, a breast implant characterized by surface texturing, high elongation, high shell strength, and super visco-elastic and consistent silicone filling gel may be implanted with an introducer device as described above 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.

Claim 1:
An introducer device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) configured to deliver a pre-filled breast implant (<NUM>) to a subject, the introducer device comprising:
a shaft (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) configured to receive the pre-filled breast implant; and
a nozzle (<NUM>, <NUM>, <NUM>, or <NUM>) coupled to the shaft,
wherein
the subject has an incision (<NUM>, <NUM>, <NUM>, <NUM>) in the range of about <NUM> to less than about <NUM> and a breast pocket (<NUM>),
the shaft is configured such that, when a negative pressure source in communication with the shaft is operated, the pre-filled breast implant is drawn into the shaft,
with the nozzle positioned through the incision, a positive pressure source is operable to expel the pre-filled breast implant from the shaft, through the nozzle, and into the breast pocket of the subject, and
the introducer device comprises a toggle switch (<NUM>, <NUM>) configured to alternate between the negative pressure source and the positive pressure source.