Device for implantable medical device

Abstract

A medical introducer device (150) includes a shaft (152) extending between a proximal end and a distal end. The shaft includes an inner cavity therein. A handle (154) is coupled to the proximal end of the shaft and includes a mode selector (164). The mode selector (164) is adapted to switch between a first mode and a second mode of the introducer device. The introducer device also includes a compressed fluid source (162). In the first mode, the compressed fluid source is coupled to the shaft fluid, thereby applying negative pressure in at least a portion of the inner cavity. In the second mode, the compressed fluid source is coupled to the shaft fluid, thereby applying positive pressure in at least a portion of the inner cavity.

Description

[0001] This application is a divisional application of the application with application number 201780023175.6, application date 2017.4.14, and invention name “Device for Implantable Medical Device”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit under 35 U.S.C. § 119 of U.S. Provisional Patent Application No. 62 / 323,160, filed April 15, 2016, and U.S. Provisional Patent Application No. 62 / 393,970, filed September 13, 2016, which are both incorporated herein by reference in their entirety. Technical Field

[0004] Aspects of the present disclosure generally relate to medical devices and surgery. In particular, some aspects relate to minimally invasive devices and related methods for implanting medical devices. Background Art

[0005] Currently, breast implants are the largest implantable medical devices in the human body. Due to the size, mass, and surface area of these devices, implantation can require a relatively large incision for insertion and proper positioning. Current techniques often create large surgical wounds that mimic the complex and dynamic healing process, for example, to replace necrotic cellular structures and tissue layers. For example, many current techniques require large incisions manipulated by retractors and tissue expanders to stretch the incision site and maintain its open position for physical manipulation of the implant into the tissue pocket. These techniques can increase scar size, increase the likelihood of implant damage, and / or increase the potential for infection; may require the insertion of drains to drain serous fluid from surrounding tissue and damaged capillaries; and / or may accelerate inflammatory responses that can interfere with the healing process. Furthermore, keloid and hypertrophic scars represent an overgrowth of dense fibrous tissue that typically occurs after healing skin injuries. It should be recognized that the larger the incision, the greater the likelihood of keloid and hypertrophic scars. Certain patients are also more susceptible to and at higher risk of keloid formation.

[0006] The disclosed systems, devices, and methods may remedy or reduce some or all of the challenges described above, and / or may address some needs not met by the prior art. Summary of the Invention

[0007] Aspects of the present disclosure relate to, among other things, minimally invasive devices for implanting medical devices and related methods. Each of the aspects disclosed herein may include one or more of the features described in conjunction with other disclosed aspects.

[0008] In one aspect, a medical device may include a shaft extending between a proximal end and a distal end. The shaft may include an inner lumen. 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 switch between a first mode and a second mode of the medical device. The medical device may also include a source of compressed fluid. In the first mode, the source of compressed fluid may be fluidically coupled to the shaft, thereby applying a negative pressure to at least a portion of the inner lumen. In the second mode, the source of compressed fluid may be fluidically coupled to the shaft, thereby applying a positive pressure to at least a portion of the inner lumen.

[0009] Embodiments of the medical device may further include any one or more of the following features. A nozzle may be coupled to the distal end of the shaft. The nozzle may taper toward the distal opening. The distal opening of the nozzle may be oval-shaped. The nozzle may be removably coupled to the distal end of the shaft. The source of compressed gas may include a cartridge coupled to and detachable from the handle. The pump may be fluidically coupled to the source of compressed gas. The source of compressed gas may include a tubing assembly. The medical device may include a valve mechanism.

[0010] In another aspect, a medical device may include a shaft extending between a proximal end and a distal end. The shaft may include an inner lumen. A handle may be coupled to the shaft. The handle may include a mode selector and an actuator. The mode selector may be adapted to switch between a first mode and a second mode of the medical device. A valve mechanism may communicate with the mode selector and the actuator. A source of compressed fluid may be coupled to the shaft. In a first mode, the source of compressed fluid may apply a negative pressure, controlled by the actuator, to at least a portion of the inner lumen. In a second mode, the source of compressed fluid may apply a positive pressure, controlled by the actuator, to at least a portion of the inner lumen.

[0011] Embodiments of the medical device may also include any one or more of the following features. The compressed gas source may include a cartridge coupled to the handle and removable from the medical device via mating features. A pump may be fluidically coupled to the compressed gas source and housed within the handle. The compressed gas source may include a tubing assembly adapted to attach to a central gas supply. The nozzle may be removably attached to the distal end of the shaft. The nozzle may be tapered and include a distal opening.

[0012] In another aspect, the method may include selecting a first mode of the medical device via a mode selector coupled to a handle of the medical device. The medical device may further include a shaft comprising an inner cavity. The method may also include applying vacuum pressure to the inner cavity via an actuator coupled to the handle to pull the implant into the inner cavity. Furthermore, the method may include selecting a second mode of the medical device via the mode selector, thereby applying an exhaust pressure to the inner cavity via the actuator to expel the implant from the shaft.

[0013] Embodiments of the method may also include any one or more of the following features. The method may include coupling a nozzle to the distal end of the shaft after applying the vacuum pressure and before applying the exhaust pressure. The medical device may include or be coupled to a source of compressed gas for applying the vacuum pressure and the exhaust pressure. The implant may be a pectoral implant, and pulling the implant into the lumen may compress the pectoral implant. The method may include coupling the distal end of the shaft to a sterile package containing the implant before applying the vacuum pressure.

[0014] In another aspect, a medical device may include a shaft extending between a proximal end and a distal end. The shaft may include a lumen. A handle may be coupled to the proximal end of the shaft. A valve assembly may be positioned within the handle. A tubing assembly may have a first end coupled to the handle and a second end adapted to attach to a central gas supply.

[0015] Embodiments of the medical device may further include any one or more of the following features: The 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 oval.

[0016] The above summary and the following detailed description are exemplary and explanatory only and do not limit the claimed features. As used herein, the term "comprises / comprising" or other variations thereof are intended to cover non-exclusive inclusions, so that a process, method, article, or apparatus that includes a series of elements includes not only those elements but may also include other elements that are not explicitly listed or inherent to such processes, methods, articles, or apparatus. In addition, the term "exemplary" is used herein in the sense of "embodiment" rather than "ideal." As used herein, the terms "about," "substantially," and "approximately" indicate a range of values within + / - 5% of a specified value. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects and, together with the written description, serve to explain the principles of the disclosure.

[0018] Figure 1 showing multiple incision locations for implanting breast implants;

[0019] Figure 2 An exemplary introducer device according to aspects of the present disclosure is shown;

[0020] Figure 3 According to aspects of the present disclosure Figure 2 an exemplary chamber of an introducer device;

[0021] Figure 4A and 4B Showing other aspects of the present disclosure Figure 2Additional exemplary chambers of the introducer device;

[0022] Figure 5A and 5B According to aspects of the present disclosure Figure 2 Other exemplary chambers of the introducer device;

[0023] Figure 6 shows an exemplary chamber with a sheath according to aspects of the present disclosure;

[0024] Figure 7A and 7B Additional exemplary introducer devices according to aspects of the present disclosure are shown;

[0025] Figure 8A and 8B Depicts the formation of a subcutaneous tunnel during surgery;

[0026] Figure 9A and 9B A system for forming a tunnel and delivering an implant during surgery according to aspects of the present disclosure is shown;

[0027] Figures 10A-10C Another exemplary system for forming a tunnel and delivering an implant during surgery according to aspects of the present disclosure is shown;

[0028] Figure 11 and 12 illustrates an exemplary introducer device coupled to a source of compressed gas according to aspects of the present disclosure;

[0029] Figure 13 Another exemplary introducer device according to aspects of the present disclosure is shown;

[0030] Figure 14 and 15 illustrates fluid flow through an exemplary introducer device according to aspects of the present disclosure;

[0031] Figure 16A and 16B Another introducer device according to aspects of the present disclosure is shown;

[0032] Figure 17A and Figure 17B Yet another exemplary introducer device according to aspects of the present disclosure;

[0033] Figure 18 and 19 shows sterile packaging of an exemplary implant; and

[0034] Figure 20 Shown connected to Figure 18 and 19 An exemplary introducer device is provided in a sterile package. DETAILED DESCRIPTION

[0035] Embodiments of the present disclosure relate to systems, devices, and methods for treating an internal area of a patient's body. Such systems or devices may include an introducer device and an implant for introduction into the patient's body (e.g., into a pectoral pocket). Reference will now be made in detail to embodiments of the present disclosure, which are described above and illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts.

[0036] As used herein, the terms "proximal" and "distal" refer to the relative and directional positions of components of an exemplary introducer device. "Proximal," as used herein, refers to a position close to the exterior of a patient's body, or close to an operator and / or medical professional using the introducer device. Conversely, "distal" refers to a position away from an operator and / or medical professional using the introducer device, or close to the interior of a patient's body.

[0037] The introducer device described herein can be used to deliver any one or more implants via any one or more of a plurality of minimally invasive surgeries. In at least one embodiment, the implant can be a chest implant with elastic properties, for example, super viscoelastic and / or high elastic properties. According to some aspects of the present disclosure, the implant can include silicone-filled gel (for example, the chest implant can be pre-filled with silicone gel before implantation). The silicone-filled gel can have a permeability value within the range of 1.0-6.0. The permeability value is a factor that measures the firmness of a colloid (for example, silicone gel). The implant can include a shell (for example, an outer shell) with a biocompatible surface. In some aspects, the surface of the shell can have a combination of low roughness, high peaks (for example, referring to the distribution of peak height and valley depth on the surface) and skewness. Any structural features of the implant disclosed in U.S. Provisional Application No. 62 / 334,667, filed May 11, 2016, and U.S. Provisional Application No. 62 / 410,121, filed October 19, 2016, are incorporated herein by reference in their entirety. Thus, the housing may have frictional surface properties to facilitate smooth delivery and placement of the implant within the patient. Examples of suitable breast implants may include, but are not limited to, Motiva implants manufactured by Establishment Labs, e.g., Motiva Implant SilkSurface TM and VelvetSurface TM Although the remainder of this disclosure uses pectoral implants, the disclosure is not limited thereto. Rather, the systems, devices, and methods disclosed herein may be used to deliver any one or more pectoral, gluteal, calf, and / or other such implants to a patient.

[0038] Figure 1Multiple incision locations for implanting breast implants are shown. As shown, breast implants can be introduced into the patient's breast pocket (e.g., via a subpectoral or inframammary incision 2; a transaxillary or transaxillary incision 4; a transareola or transumbilical incision 6; or a transumbilical or transnaval incision 8). Figure 8A 130 in the breast pocket). As shown, various incision types may necessitate openings of varying sizes and / or dimensions. For example, the inframammary incision 2 is typically larger than the transumbilical incision 8. The choice of incision type (e.g., insertion site) and size may depend on a number of variables and patient / physician preferences, such as, for example, the size and / or shape of the implant, the patient's physical characteristics (e.g., the amount of fat tissue, the degree of skin elasticity), the patient's age, and / or the patient's lifestyle.

[0039] Various instruments, devices (eg, introducer devices), systems, and methods are disclosed herein to allow for minimally invasive implantation of elastic implants (eg, pectoral, gluteal, and / or calf implants). Figure 2 An exemplary introducer device 10 is shown for delivering an implant 12. The implant 12 may include a high strength shell 14 having viscoelastic and low friction surface properties as described above. The implant 12 is inserted in a compressed, extended configuration (e.g., Figure 2 、 3 and 5A) with a deployed or extended configuration (such as Figure 5B The implant 12 under the insertion configuration may be molded, bendable, compressible or otherwise removable between the insert device 10 and the shaft 16. The maximum diameter or the size of the implant 12 under the insertion configuration may be limited to the size of the inner cavity of the shaft 16 that can accommodate implant 12. For example, in some embodiments, the internal diameter of the shaft can be between approximately 1 to 3 inches or approximately 1.5 to 2.5 inches, for example, approximately 1, 1.5, 2, 2.5 or 3 inches. As shown in the figure, the insertion configuration is a thin or compressed configuration. The implant 12 under the insertion configuration can be positioned in the introducer device 10, and after being transported out and transported in the patient from introducer device 10, implant 12 can stretch, decompress or otherwise present deployment configuration.

[0040] like Figure 2 As shown, the introducer device 10 includes an inner cavity ( Figure 21. The shaft 16 is shaped like a tube, e.g., a tube having a plurality of holes ... In addition, for example, a 1-inch shaft can be used for a 200cc implant, or a shaft between about 2 to 3 inches can be used for a 500cc or larger implant. Any one or more portions of shaft 16, such as the inner surface of shaft 16, may include a lubricating (e.g., hydrophilic) coating to reduce the coefficient of friction between one or more portions (e.g., inner surface) of introducer device 10 and one or more portions (e.g., housing 14) of implant 12. For example, prior to implantation, implant 12 can be accommodated, received, or otherwise at least partially disposed within the lumen of shaft 16 of introducer device 10. The hydrophilic coating can reduce the coefficient of friction between the inner surface of housing 14 and shaft 16, thereby forming a smooth transition between insertion configuration and deployment configuration, for example, when implant 12 leaves from introducer device 10.

[0041] Optionally, the introducer device 10 may include a unique device identifier (UDI) with information for identifying the introducer device 10. For example, the UDI may include a microtransponder for device identification and tracking after implantation. In some aspects, the microtransponder includes one or more sensors capable of measuring temperature, electrical impedance changes, and / or pressure, for example, by monitoring the temperature of the surrounding tissue, and the measured values are used as control signals to alarm or diagnose signs of rupture of the shell 14, infection of the patient's tissue, and / or inflammatory response of the patient's tissue. Such UDI / sensors can be placed at any suitable location on or within the introducer device 10, including, for example, on the inner surface of the introducer device 10 near or in contact with the implant 12.

[0042] In some aspects, the implant 12 may be preloaded or inserted into the chamber (or introducer sheath) 18 to facilitate aseptic loading of the implant 12 onto the shaft 16 and / or manipulation (e.g., compression, elongation, etc.) of the implant 12 toward the inserted configuration. Figure 5A and 5BThe chamber 22 (described below) can protect the implant 12 during the implantation procedure. For example, the introducer device 10 can be provided for an implant cross-sectional diameter that is associated with a small incision ranging from about 1.0 cm to less than about 3.0 cm, or ranging from about 2.0 cm to 2.5 cm. In this way, the chamber 18 can compress the diameter of the implant 12 to be equal to or less than the incision size. The chamber 18 can have any suitable shape or arrangement to urge the implant 12 toward the insertion configuration and / or maintain the implant 12 in the insertion configuration while the implant 12 is within the introducer device 10. Figure 2 and 3 As shown, for example, chamber 18 is a foldable or rollable, highly flexible, thin polymeric sheath material that can be rolled or wrapped at least partially around implant 12, thereby compressing and / or stretching implant 12 to an insertion configuration. Once wrapped around implant 12, chamber 18 can have a U-shaped cross-section, such as Figure 3 Alternatively, once wrapped around the implant 12, the chamber 18 may have a C-shaped cross-section, as shown. Figure 4A As shown. Figure 3 and 4A The gap or space between the termination edge 18A and 18B of chamber 18 is shown separately, but the present disclosure is not limited to this. In some arrangements, edge 18A and 18B can be adjacent or overlap each other, so that chamber 18 encloses or surrounds the entire circumferential surface of the implant 12 under the insertion configuration. Optionally, chamber 18 can include hinge 20 between the various parts of chamber 18, for example, a general clamshell (for example, two-piece, half-and-half) arrangement is provided. Hinge 20 can be positioned along the inside or outside surface of chamber 18. In certain embodiments, hinge 20 has a living hinge (for example, a hinge formed by the thin size relative to the remainder of chamber 18, so that it is possible to bend along the thin part). In any way, hinge 20 is positioned so that hinge 20 is minimally exposed to implant 12 and / or surrounding patient tissue, thereby preventing the unintentional trauma, damage or wear of implant 12 and / or patient tissue.

[0043] In some arrangements, the chamber may include a shape memory material. For example, the chamber 18 may be Figure 5A and 5B, instead of the chamber 22 shown in . The chamber 22 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 structures), which may have thermal recovery properties. For example, the chamber 22 includes a plurality of struts 24 that are integrally formed or woven, braided or otherwise bonded together to form a stretchable structure. In this arrangement, the chamber 22 can be tubular and allow the implant 12 to shrink and / or close within the tubular structure having the chamber 22 with the shape memory material at a low transition temperature (e.g., below ambient room temperature), thereby reducing the insertion diameter of the implant 12 to less than or equal to the incision size, such as Figure 5A Once warmed (e.g., by exposure to body temperature or warm saline flushing), the shape memory material may stretch to a preset or predetermined shape and diameter, such as Figure 5B The expansion of the chamber 22 according to this arrangement can allow for expansion of the implant 12 housed therein and facilitate removal of the chamber 22.

[0044] See Figure 2 At least a portion (e.g., a proximal end) of chamber 18 (or chamber 22) is received within the lumen of shaft 16 and secured thereto via connector 26. For example, connector 26 may include a compression ring that tightens circumferentially around chamber 18 (or chamber 22) and around the distal end of shaft 16 to secure chamber 18 (or chamber 22) to shaft 16. In this manner, connector 26 prevents chamber 18 (or chamber 22) from moving relative to shaft 16.

[0045] Once the implant 12 is received in the shaft 16, for example, via the chamber 18 or the chamber 22, the medical professional can grasp the handle 30 of the introducer device 10. The handle 30 can be a squeeze type or compression handle, for example, operating in a manner similar to a caulking gun, wherein the first arm 32 can rotate around a pivot 34 and can move toward the second arm 36. The pivot 34 is then coupled to a plunger rod 38 via any appropriate transmission and / or linkage system (not shown), such that the rotational movement of the pivot 34 is transmitted to the linear movement of the plunger rod 38. Such transmission and / or linkage system can include a ratchet 40 to achieve controlled, gentle, and incremental advancement of the implant 12 via a plunger head (not shown) coupled to the distal end of the plunger rod 38. The size (e.g., diameter) of the plunger head can correspond to or be similar to the size (e.g., diameter) of the implant 12 in the insertion configuration. Thus, upon squeezing the first arm 32 toward the second arm 36, the plunger rod 38 is advanced toward the chamber 18 (or chamber 22), and the plunger head pushes, pushes, advances, or otherwise moves the implant 12 (e.g., toward the distal end of the chamber 18 (or chamber 22). Figure 2) and into the patient's chest pocket (or other implantation site suitable for the type of implant), while chamber 18 (or chamber 22) remains securely connected to shaft 16 via connector 26.

[0046] However, in another arrangement, the plunger rod 38 is stationary, thereby preventing the implant 12 from "backing out" of the chamber 18, for example, during an implantation procedure. For example, the plunger head of the plunger rod 38 can be positioned at the proximal end of the chamber 18, thereby limiting the proximal movement of the implant 12 (e.g., the plunger head can abut, contact, or otherwise inhibit the proximal movement of the implant 12). In such cases, the introducer device 10 can include a mechanism for retracting the chamber 18 to release the implant 12 from the chamber 18. In at least one embodiment, squeezing the first arm 32 toward the second arm 36 by the handle 30 can push the chamber 18 proximally while the plunger rod 38 remains stationary to prevent the implant from moving proximally through the chamber 18.

[0047] Figure 6 Another embodiment of the retraction of the chamber 18 is shown, wherein a frangible sheath 42 is positioned around the chamber 18, for example, near the distal end of the chamber 18. The sheath 42 may comprise a flexible polymer material and include a perforation line 44 (e.g., a series of small holes or thin sections extending through at least a portion of the thickness of the sheath 42), thereby promoting tearing along the perforation line 44. The proximal end of the sheath 42 includes one or more flanges, grips, or tongues 46, thereby enabling a secure grip of the sheath 42 by a medical professional. Optionally, the distal end of the sheath 42 includes one or more retractors 48, as described in further detail below. In this arrangement, delivery of the implant 12 is performed (e.g., in the direction of arrow P) via the proximal retraction of the sheath 42 or chamber 18 (or chamber 22), for example, relative to the plunger head of the plunger rod 38. In this way, the medical professional can pull the tongue 46 of the sheath 42, which tears (e.g., peels) the sheath 42 along the perforation line 44, thereby slowly exposing the distal portion of the implant 12, thereby allowing the natural expansion of the exposed implant 12 (e.g., the exposed adhesive-filled structure) to pull the remaining portion of the implant 12 out of the cavity 18 and into the patient's chest pocket (or other implantation site for the implant type).

[0048] like Figure 6 As shown, the retractor 48 is radially outward (e.g., relative to Figure 3The retractor 48 extends along the longitudinal axis C of the middle chamber 18 and may have a flange or cone shape. In some embodiments, the retractor may have a shield-like configuration. When in use, the retractor 48 can be positioned within the incision during the implantation procedure and can help minimize damage to the skin and / or patient tissue, and / or can help stabilize the introducer device 10 during the implantation procedure. As shown, the retractor 48 is integrated with the sheath 42. However, the present disclosure is not limited to this. In some arrangements, the retractor 48 can be a separate component used independently of any other device, or can be coupled to any one or more of the chamber 18 (or chamber 22) or the shaft 16. However, in any arrangement, the retractor 48 can help minimize the risk of bacteria (or other microorganisms) being introduced into the incision site. In addition or alternatively, the retractor 48 can be used to minimize the exposure of the implant 12 to other surgical instruments (e.g., a surgical scalpel, needle, clamps, etc.) to reduce the risk of damage to the implant 12 during the implantation procedure. For example, the retractor 48 can minimize the risk of rupturing the shell 14 of the implant 12 during implantation.

[0049] The retractor 48 can be flexible or semi-rigid (e.g., constructed of a material that provides suitable flexibility and stability after insertion into the incision site) and can be adapted for placement into incisions of various sizes and locations (e.g., Figure 1 ). In some aspects, the sheath 42 has a generally tubular shape, for example, an extruded tubular structure. Additionally, the sheath 42 and / or the retractor 48 can comprise a polymer or copolymer having sufficient rigidity to support implantation of the implant 12 while employing a thin-walled structure that can collapse, fold, break, or peel without requiring the implant 12 to shift. Exemplary materials suitable for such sheaths and retractors include, but are not limited to, nylon, polyethylene, polyurethane, polyamide, fluoropolymers such as, for example, polytetrafluoroethylene (PTFE), polyolefins, polyetheretherketone (PEEK), and flexible acrylic resins, and combinations thereof. The linear extrusion process of a material such as polytetrafluoroethylene can be combined with a perforation line 44 (e.g., an inherent separation line), for example, due to the process or molecular orientation of the extruded material.

[0050] In some aspects of the present disclosure, the retractor 48 or sheath 42 may include a stiffening ring (not shown) that allows for unrestricted movement of surgical tools used to create a tissue pocket (e.g., a chest pocket) and introduce the implant 12. The stiffening ring may be flexible or rigid and may include a smooth or lubricated surface to reduce friction, for example, to facilitate introduction of the implant 12 with a low risk of wear or friction on the implant 12. SilkSurface TMand VelvetSurface TM The retractor 48 can be used with any incision, including those for transumbilical, transareolar, or transaxillary implantation procedures (see, e.g., Figure 1 ).

[0051] Figure 7A and 7B Another exemplary introducer device 50 according to aspects of the present disclosure is shown in which chamber 18 (chamber 22) is not secured to the introducer device 50. In such devices, chamber 18 or 22 may be omitted entirely, or may be used to compress, elongate, or otherwise transform or maintain the implant 12 in the insertion configuration (see, e.g., Figure 2 ). Once the implant 12 has been positioned in the insertion (e.g., shortened profile) configuration, chamber 18 or chamber 22 can be used to insert the implant 12 into the shaft 52 of the introducer device 50 (e.g., before connecting the nozzle 110 via the ring 106). Once received in the shaft 52, chamber 18 or 22 can be discarded or sterilized and reused. The shaft 52 can include any of the features or dimensions described above for the shaft 16.

[0052] The introducer device 50 can have a similar construction and use as the introducer device 10. Thus, the introducer device 50 includes a shaft 52 extending from a handle 54 (e.g., a squeeze or compression handle) and includes a shaft 52 that can be pivoted about a pivot 58 (e.g., a dowel rod) (see Figure 7B ) is a first arm 56 that is rotatable and movable toward a second arm 60. The first arm 56 is biased away from the second arm 60 via a torsion spring 64 supported by a bracket 62 and a dowel rod 65, as shown in FIG. Figure 7B As shown. To compress the handle 50, the medical professional can first overcome the force applied by the spring 64. The handle 54 includes a first (e.g., left) half 54A and a second (e.g., right) half 54B, which are positioned on opposite sides of a plane extending along the longitudinal axis L. A pair of locking plates 66 on opposite sides of the plunger rod 68 are housed in the first half 54A and the second half 54B. Each locking plate 66 secures the shaft base 70 to a corresponding one of the first half 54A and the second half 54B via a plurality of fasteners (e.g., screws 72). The first half 54A and the second half 54B are each coupled to respective covers 82 and 84, as shown Figure 7A and Figure 7B shown.

[0053] The plunger rod 68 includes a proximal end coupled (e.g., by screwing, bonding, etc.) to a T-shaped handle 86, the size of which can be set to allow a medical professional to grip as needed and / or in a desired manner. The distal end of the plunger rod 68 is coupled to a plunger head 88. The plunger head 88 includes a pair of circumferentially extending grooves or grooves 90 and 92, each of which receives a corresponding one of a pair of o-rings 94 and 96. The o-rings 94 and 96 prevent fluid (e.g., lubrication, suction, and / or irrigation fluid) from flowing proximally through the plunger head 88. In addition, the proximal end of the shaft 52 includes a portion 98 that is releasably coupled to a proximal lock or ring 100, for example, via threads or other complementary mating features on the inner surface of the ring 100. For example, the portion 98 may include threads, and the inner surface of the ring 100 may be correspondingly threaded. That is, each of the threaded portion 98 and the ring 100 may include thread profiles with matching pitches and / or orientations. Once the portion 98 and the ring 100 are connected, the washer 102 may be compressed between and / or around the periphery of the shaft base 70, thereby securing the shaft base 70 to the shaft 52, thereby securing the handle 54 to the shaft 52. In addition, the distal end of the shaft 52 includes a portion 104 that is releasably coupled to a distal lock or ring 106, for example, via complementary mating features. For example, the portion 104 may include threads, and the inner surface of the ring 106 may be correspondingly threaded. That is, each of the portion 104 and the ring 106 may include thread profiles with matching pitches and / or orientations. Once the portion 104 and the ring 106 are connected, the washer 108 may be compressed between and / or around the periphery of the proximal end of the nozzle 110, thereby securing the nozzle 110 to the shaft 52.

[0054] The nozzle 110 can be formed from or otherwise include a flexible polymer (e.g., polyurethane, polyethylene, silicone, etc.) that is rigid enough to expand the incision, yet soft enough to avoid tearing or damaging the site. The opening 112 at the distal end of the nozzle 110 can have any suitable shape, such as, for example, circular, oval, semi-oval (e.g., one side is flat and the other side is circular or oval), or an angular shape. The shape of the nozzle 110 can be selected to accommodate the shape of the implant 12 to be introduced into the patient (e.g., a semi-oval or angular shape to accommodate a non-circular implant). Figure 7A and 7B As shown, the nozzle 110 is tapered, thereby making the distal diameter smaller than the proximal diameter of the nozzle 110. In addition, the length of the nozzle 110 can be varied as needed or desired. For example, the degree or angle of taper, the diameter of the distal opening, and the length of the nozzle 110 can be selected to be associated with or accommodate implants of different sizes. In use, a medical professional can deliver the implant 12 ( Figure 7A and 7B), the actuation advances the plunger head 88 toward the nozzle 110. As the plunger head 88 advances distally, the implant 12 is pushed through the opening 112 and delivered to the patient's pectoral pocket.

[0055] As described above, the implant 12 can be inserted through the umbilical incision 8 to minimize visible scarring. In this type of surgery, an incision 8 is typically made in the umbilicus to introduce a blunt dissection instrument, thereby forming a tunnel 120 (see Figure 8A and 8B ), a larger cannula or tube is inserted through the tunnel 120 and advanced to the tissue pocket 130 where the implant 12 will be positioned. The tunnel 120 is formed to separate the subcutaneous tissue 122 (e.g., fat beneath the skin 124) from the rectus sheath 126 located in front of the rectus abdominis muscle 128.

[0056] The challenge with this approach is to adequately "push" the implant 12 through the tunnel 120. Typically, the cannula used to form the tunnel 120 is too small in diameter for delivery of current implant 12 designs, leaving the cannula to serve only to establish the subcutaneous tunnel. After the tunnel 120 is formed, the implant 12 is pushed through the tunnel 120, which applies significant additional forces and stresses to the implant 12, thereby increasing the probability of damage to the implant 12 (e.g., rupture of the shell 14).

[0057] To improve patient safety and reduce the trauma to the implant 12 and the patient's subcutaneous tissue 122 caused by such a procedure, an introducer system that utilizes one or more features of the described embodiments may be used. For example, the introducer device 10 or the introducer device 50 may be used with a tunnel sheath 132 (see Figures 9A-9B and 10A-10C). Alternatively, any introducer device described herein may be used in place of introducer device 10. Introducer device 10 (or any other such introducer device) and tunnel sheath 132 include sufficient access to the desired area (e.g., chest pocket 130) for implantation through umbilical incision 8 (see, e.g., Figure 1 ) length.

[0058] For example, if Figure 9A and 9BAs shown, the tunnel sheath 132 is of sufficient size or length to extend from the incision 8 to the chest pocket 130 and has an inner diameter sufficient to receive the shaft 16 of the insertion device 10 and / or the implant 12 in the insertion configuration (e.g., shortened profile configuration) as it is advanced through the incision 8 to the chest pocket 130. The diameter of the tunnel sheath 132 can be related to the incision size and, therefore, can be between about 1.0 cm and about 3.0 cm, for example, between about 1.5 cm and about 2.5 cm, for example, about 1, 1.5, 2, 2.5, or 3 cm. To enhance the stability and pushability of the tunnel sheath 132, an inner trocar 134 or cannula (smaller diameter) ( Figure 9A ). That is, the inner trocar 134 can be inserted through the lumen of the tunnel sheath 132, and the two can be simultaneously advanced through the tunnel 120. The blunt distal end 136 of the inner trocar 134 can separate the tissue to form the tunnel 120. The inner trocar 134 and the tunnel sheath 132 form a coaxial system to facilitate the insertion and advancement of the implant 12. Once the tunnel sheath 132 is properly positioned, the inner trocar 134 can be removed, thereby allowing access to the lumen extending through the tunnel sheath 132. Subsequently, the shaft 16 of the insertion device 10 can be inserted into the slot ( Figure 9B ) to advance the implant 12 through the tunnel sheath 132 and can be actuated as described above to advance the implant 12 to the chest pocket 130. This method of insertion can minimize the wound opening / incision and the length of travel from the incision opening to the chest pocket 130. A smaller incision and tunnel 120 length can reduce trauma, resulting in faster healing and fewer complications.

[0059] In some aspects, the blunt distal end 136 of the trocar 134 can include features for attaching sutures or threads. For example, the distal end 136 can include an eyelet 138, such as Figure 10A A wire 140, such as a smaller diameter monofilament thread, is secured to the eyelet 138 and pulled through the tunnel sheath 132 ( Figure 10A ). A small incision or opening through or near the chest pocket 130 enables a medical professional to grasp the threaded wire 140 from the chest pocket 130, through the opening, and outside the patient's body for processing, e.g., for the medical professional to pull. Exemplary materials for the wire 140 include, but are not limited to, polymers, fibers (e.g., similar to suture material or fishing line), and metals or metal alloys, such as metal wire. After the tunnel 120 is formed through the opening of the chest pocket 130 and threading is performed on at least a portion of the wire 140, the trocar 134 can be withdrawn through the lumen of the tunnel sheath 132, thereby pulling the portion of the wire 140 therein. In this way, at least a portion of the wire 140 remains in the tunnel 120 ( Figure 10B), which tunnel is established by the trocar 134 after the trocar 134 is removed. Subsequently, the wire 140 can be separated from the eyelet 138, e.g., untied, and then secured to a separate bag, pouch, or chamber 22 (or optionally, chamber 18) containing the implant 12 in the insertion configuration. Once coupled, the medical professional can slowly pull the implant 12 (within the separate bag, pouch, or chamber (e.g., chamber 22 or 18)) from the opposite end ( Figure 10C ) through tunnel 120. Additionally or alternatively, once trocar 134 is removed, an elongated plunger (not shown) may be used to advance (e.g., push) implant 12 through the lumen of tunnel sheath 132 until implant 12 exits the distal end of tunnel sheath 132 and extends within pectoral pocket 130 toward a deployed configuration.

[0060] As mentioned above, introducer device as herein described (for example, introducer device 10,50) can be used for implanting the implant 12 with viscoelasticity and / or high elasticity characteristic, for example, comprises elastic shell and viscoelastic silica gel.This elasticity characteristic of implant 12 enables implant 12 to be stretched or elongated, for being loaded into the chamber (for example, chamber 18, chamber 22 etc.) under the cross section of shortening, thus implanting in a minimally invasive manner causing less trauma to the patient.For example, the various characteristics of implant 12 can realize the consistent radial compression of implant 12, which can provide the ability of safely compressing implant 12 to advance to the smaller incision (for example, less than about 3.0cm incision) than the incision conventionally used in implantation surgery.

[0061] As described above, a plunger (e.g., plunger rod 38 or 68 having plunger head 88, etc.) can be used to push or force the pressurized implant 12 from the introducer device through the tapered funnel or nozzle (e.g., nozzle 110, Figures 7A-7B ) to the incision site. In some embodiments and depending on the type and characteristic structure of the implant, for example, this pushing mechanism can apply a significant load to the proximal portion of the implant 12, for example, forming an overpressure between the implant 12 and the introducer device (e.g., the inner wall of the shaft 16 or shaft 52). In some cases, the pressure can cause the housing 14 of the implant 12 to rupture, and / or can be cut, cut off, or otherwise deformed after being discharged from the introducer device (e.g., introducer device 10, introducer device 50, etc.).

[0062] In some arrangements, a fluid barrier between the plunger head (e.g., the plunger head of plunger rod 38, the plunger head 88 of plunger rod 68, etc.) and the implant 12 can be used to at least partially relieve pressure between the implant 12 and the introducer device. However, depending on the type of implant and / or introducer device, mechanical pressure can cause water or other fluids (e.g., saline solution) to flow around the peripheral edge and / or crease or fold of the implant 12 and / or to leak from the distal portion of the selected introducer device. However, such water or fluid leakage can apply additional pressure to the implant 12, thereby causing the implant 12 to be further compressed, thereby further extending the implant 12 and / or reducing the diameter of the implant 12.

[0063] In some aspects of the present disclosure, the introducer device can use compressed gas (e.g., CO2, air or other suitable inert gas) to advance the implant 12 from inside the shaft and / or chamber and through a tapered nozzle positioned at the distal end of the introducer device. For example, the gas can provide a buffer similar to water between the implant 12 and the wall of the introducer device shaft. In a manner similar to the water seepage flow embodiment described above, the compressed gas can leak around the circumference of the implant 12 when it is pushed away from the device distal end. However, the pressure from the compressed gas can further contribute to radial compression of the implant when continuous air pressure pushes the implant 12 from the proximal end of the introducer device toward the nozzle at the distal end of the device chamber.

[0064] In some aspects of the present disclosure, a compressed gas source 142 can be used to pull the implant onto a shaft of the introducer device (similar to shaft 16, shaft 52, etc.). The implant can be lubricated, for example, by including a lubricant on the implant surface. For example, Figure 11 As shown, the ring 100 of the introducer device 150 can be threaded or otherwise disconnected from the handle 154 and fluidly connected to the compressed gas source 142 (e.g., a negative pressure source called a venturi tube) via any suitable conduit 144. In addition, the nozzle 158 can be disconnected from the shaft 152 by threading or otherwise disconnecting the ring 160 from the shaft 152. The shaft 152 may include any of the features or dimensions of the shafts 16 and / or 52 described above. Once so arranged, the distal end of the shaft 152 (e.g., the end near the ring 160) can be positioned close to, adjacent to, or in contact with the implant 12 (e.g., having a lubricated housing 14 as described above). The compressed gas source 142 can then be actuated in any suitable manner, thereby pulling, aspirating, or otherwise drawing the implant 12 through the distal end of the shaft 152 to the shaft 152. Once received within the shaft 152, the ring 100 can be threaded or otherwise disconnected from the conduit 144 and the compressed gas source 142 and then can be coupled to the handle 154 as described above. Additionally, the nozzle 158 can be coupled to the distal end of the shaft 152 via the ring 160. Although Figure 11 and12 150. The present disclosure is not limited in this regard. Rather, the proximal end of the shaft 16 of the introducer device 10 can also be coupled to the compressed gas source 142 to pull the implant 12 through the distal end of the shaft 16 (e.g., after removing the compression ring 26 and either the chamber 18 or the chamber 22).

[0065] Alternatively, after pulling the implant 12 to the shaft 152, the compressed gas source 142 can remain connected to the shaft 152 and be switched or toggled in the reverse direction, thereby generating a positive pressure source to push or propel the implant 12, thereby causing the implant 12 to be discharged from the shaft 152 to the patient's appropriate implantation location (e.g., chest bag 130). To facilitate switching between negative and positive pressure types (e.g., the flow direction of the compressed gas), the compressed gas source 142 and / or the introducer device 150 can utilize a valve mechanism (not shown) to allow the user to switch between the two functions. In other words, the compressed gas source 142 can be used to load and discharge the implant 12 from the introducer device 150. Thus, the device can provide a self-contained system equipped to provide vacuum or discharge pressure, as opposed to different wall attachments for connecting vacuum or compressed air / gas. In at least one embodiment in which the compressed gas source 142 is used to discharge the implant 12, the handle 154 does not need to be reattached to the shaft 152 via the ring 100.

[0066] Figure 13 1 shows various features of an exemplary introducer device 150 according to aspects of the present disclosure. The introducer device 150 can be a self-contained introducer device comprising a shaft 152 having a handle 154 coupled to a first end (e.g., proximal end) of the shaft via a ring 156 and a converging nozzle 158 coupled to a distal end of the shaft 152 via a ring 160. Figure 13 As shown, a disposable compressed gas cartridge 162 (e.g., a pressurized CO2 or air cartridge) is coupled to the handle 154 via any suitable connector or adapter and can be replaced as needed to supplement the compressed gas source. The handle 154 includes a toggle or switch 164 that can be actuated to alternate between a vacuum and the exhaust pressure generated by the compressed gas cartridge 162. The mechanism can include a toggle switch for changing between a vacuum mode and a pressure mode. In addition, the handle 154 includes a trigger 166 or other suitable actuator for generating a vacuum or pressure.

[0067] The nozzle 158 can be a disposable nozzle and can include a biocompatible material, for example, a flexible polymer (e.g., polyurethane, polyethylene, silicone, etc.) that is rigid enough to expand the incision site but soft enough to avoid tearing or damaging the incision site. Similar to the nozzle 110, the distal opening 168 of the nozzle 158 can have any suitable shape, such as, for example, round, oval, slotted duckbill, semi-oval (e.g., one side is flat and the other side is round or oval), or an angular shape to accommodate the implant 12 to be implanted. The size of the nozzle 158 (e.g., length and distal diameter) can be selected according to the size and / or requirements of the implant 12.

[0068] The switch 164 may comprise a mechanism by which a medical professional can select negative pressure (e.g., a venturi tube) to draw the implant 12 to the shaft 152 of the introducer device 150 (e.g., before attaching the nozzle 158), and then actuate the switch 164 to reverse the valve mechanism to provide compressed gas to expel the implant 12. Other such vacuum effects may be produced by known displacement or rotation vacuum mechanisms. It is also contemplated that the trigger 166 and / or the switch 164 may be electrical or digital and operated by sending signals to each other and / or to the valve mechanism to move between negative pressure (e.g., vacuum) and positive pressure configurations and actuate the dispensing of compressed gas from the cartridge 162.

[0069] Figure 14 and 15 is a schematic diagram of the proximal portion of the introducer device during a vacuum configuration or mode that can be used to load an implant into the delivery chamber of the introducer device. As shown, when switch 164 ( Figure 13 ) is set to vacuum configuration, the user can pull the trigger 166 ( Figure 13 ) to move the compressed gas from the cartridge 162 through an opening 170 on the circumferential side surface of the device. Optionally, the opening 170 may include an inlet conduit, such as Figure 15 As shown. Once the gas moves through the opening 170, the valve mechanism pushes the gas through the proximal side and exits the device via an exhaust port 172 positioned at the proximal end of the device. The effect of operating the device in this way is to form a vacuum at the portion of the introducer device 150 away from the opening 170 (e.g., the shaft 152 in which the implant 12 can be loaded). By toggling the switch 164 to a pressure / dispensing configuration or mode, the valve mechanism can be changed so that once the compressed gas moves from the barrel 162 through the opening 170, the gas can be directed distally through the shaft 152 to push the implant 12 distally out of the introducer device 150. In some aspects, the introducer device 150 may further include a pressure relief valve to release excess pressure within the shaft 152.

[0070] Figure 16A and16B Another exemplary introducer device 180 according to aspects of the present disclosure is shown. The introducer device 180 can have a similar construction and usage as the introducer device 150 (e.g., Figure 13 ). For example, similar to the introducer device 150, the introducer device 180 includes a compressed gas cylinder 186. The handle 184 includes a first (e.g., left) half 184A and a second (e.g., right) half 184B, which are positioned on opposite sides of a plane extending along the longitudinal axis L and are coupled together via a plurality of connectors (e.g., screws 190). In addition to the compressed gas cylinder 186, a pump 192 is also housed in the first half 184A and the second half 184B. The pump 192 may include any suitable pumping mechanism, such as a reciprocating or rotary pump. Figure 16B As shown, each of the compressed gas cylinder 186 and the pump 192 are fluidly coupled to a valve mechanism 194 via one or more conduits 196 (eg, conduits 196A- 196D).

[0071] For example, conduits 196A and 196D can control pressure, while conduits 196B and 196C can control suction, for example, via a venturi. Additionally, each end of each conduit 196A-196D can include a fitting 198 to fluidly couple and secure one end of each conduit 196A-196D to one or more of the compressed gas cylinder 186, the pump 192, the valve mechanism 194, and the shaft 182, as shown. Figure 16B The shaft 182 may include any of the features or dimensions of the shafts 16 , 52 , and / or 152 described above.

[0072] The handle 184 includes a toggle or switch 200 (also referred to herein as a mode selector) that can be actuated to alternate between vacuum and discharge pressure generated by the compressed gas cylinder 186 (e.g., vacuum mode and pressure mode). The switch 200 can include a toggle switch for adjusting the valve mechanism 194 between the vacuum mode and the pressure mode. The lower surface of the switch 200 can define a raised surface that contacts the valve 194 to switch between the suction mode and the pressure mode, for example, via conduits 196B and 196C and conduits 196A and 196D. Thus, in a first orientation of the switch 200 relative to the handle 184, the valve mechanism 194 is arranged to generate vacuum pressure in the shaft 182. In a second orientation of the switch 200 relative to the handle 184, the valve mechanism 194 is arranged to generate positive discharge pressure in the shaft 182.

[0073] In addition, the handle 184 includes a trigger 210 for generating a vacuum or positive pressure in the shaft 182. As shown, for example, the trigger 210 may include an L-shaped bracket or arm having one end 212 pivotally coupled to the handle 184 via an axis or dowel rod / pin 214. In addition, the trigger 210 is coupled to the valve mechanism 194. In addition, as shown Figure 16B As shown, handle 184 includes rockers 197 that secure the proximal end of shaft 182 to handle 184. Each rocker 197 pivots about a pin 199 that extends through an aperture of rocker 197 and is coupled to spring 195. By pivoting rockers 197 radially outward about pins 199, the distal ends of rockers 197 can be released from circumferential grooves at the proximal end of shaft 182 to release the shaft from handle 184. Thus, handle 184 can be separated from shaft 182 after surgery and can be reused after handle 184 is sterilized (e.g., via autoclave).

[0074] In addition, the handle 184 includes a core seal 240 held between the first half 184A and the second half 184B. The core seal 240 may include any suitable material, such as, for example, a polymer, rubber, etc. Figure 16B As shown, one or more of the fittings 198 can be coupled to a lumen 242 extending through the core seal 240, thereby delivering negative and / or positive pressure to the shaft 182. A distal portion of the core seal 240 is at least partially received within the lumen of the shaft 182, while the remaining portion of the core seal 240 is received within the handle 184. An o-ring 244 is positioned around the circumference of the core seal 240 such that, upon coupling the core seal 240 to the handle 184, the o-ring 244 is received within an internal groove of the handle 184 and prevents fluid (e.g., gas) from leaking proximally of the o-ring 244. A second o-ring 246 is positioned around the circumference of the core seal 240 and distally of the o-ring 244. Upon coupling the core seal 240 to the shaft 182, the o-ring 246 is received within the lumen of the shaft 182 and prevents fluid (e.g., gas) from leaking proximally of the o-ring 246. In addition to preventing proximal escape of gas or fluid, o-rings 244 and 246 may also help secure shaft 182 to handle 184. Additionally, the distal end of shaft 182 may be releasably coupled (e.g., via an interference fit, a threaded coupling, etc.) to the proximal end of nozzle 248 to secure nozzle 248 to shaft 282.

[0075] Similar to the nozzle 110 described above, the nozzle 248 can be formed from or otherwise include a flexible polymer (e.g., polyurethane, polyethylene, silicone, etc.) that is rigid enough to expand the incision site, yet soft enough to avoid tearing or damaging the site. The opening 250 at the distal end of the nozzle 248 can have any suitable shape, such as, for example, circular, oval, semi-oval (e.g., one side is flat and the other side is circular or oval), or an angular shape. The shape of the nozzle 248 can be selected to accommodate the shape of the implant 12 to be introduced into the patient (e.g., semi-oval or angular shape to accommodate non-circular implants). Figure 16A and 16B As shown, the nozzle 248 is tapered so that the distal diameter is smaller than the proximal diameter of the nozzle 248. In addition, the length of the nozzle 248 can be varied as needed or in a desired manner. For example, the degree or angle of the taper of the nozzle 248, the diameter of the distal opening 250, and the length can be selected so as to be relevant to or adapt to implants 12 of different sizes. For example, a tapered nozzle (e.g., nozzles 110, 158, 248, or 298 (described below)) can help to implant the implant 12 in a desired orientation or "face up" manner. The diameter of such nozzles can be varied to accommodate implants of varying sizes and is relevant to the size and position of the incision through which the implant is delivered. In at least one embodiment, the nozzle can have an angular aperture, for example, providing a larger opening for the implant to leave.

[0076] During use, the medical professional can remove (if not already done) the nozzle 248 from the distal end of the shaft 182 and flip the switch 200 to the vacuum mode. Subsequently, the distal end of the shaft 182 can be positioned close to, adjacent to, or in contact with the implant 12 (e.g., with a lubricated housing 14 as described above). Next, the compressed gas source 186 can be actuated via the trigger 210, thereby pulling, sucking, or otherwise pulling the implant 12 through the distal end of the shaft 182 to the shaft 182. Once the implant 12 is housed within the shaft 182, the switch 200 can be flipped to the pressure mode (e.g., discharge mode), and the nozzle 248 can be coupled to the distal end of the shaft 182, as described above. Next, the nozzle 248 can be positioned within, through, or near the incision site, and the compressed gas source 186 can be actuated via the trigger 210 to push, press, or otherwise discharge the implant 12 from the shaft 182, through the nozzle 248 to the patient (e.g., to the chest bag 130).

[0077] Compressed gas sources 162, 186 can have any suitable volume and size, thereby containing compressed gas and connecting it to the corresponding introducer device (e.g., introducer device 150, introducer device 180). For example, one or both of sources 162 and 186 can include a total length of approximately 88.4 mm (approximately 3.5 inches) and a total width (e.g., diameter) of approximately 22 mm (approximately 0.875 inches). The neck or connection between the remainder of sources 162, 186 and introducer devices 150, 180 can have a length of approximately 9 mm (approximately 0.375 inches) and a width (e.g., diameter) of approximately 9 mm (approximately 0.375 inches), respectively. These dimensions are merely exemplary and can vary depending on the other dimensions of the introducer device and / or the volume of compressed gas desired or required. Additionally, in some aspects, introducer device 180 can also include a pressure relief valve to release excess pressure in shaft 182.

[0078] Figure 17A and 17B Another exemplary introducer device 270 according to aspects of the present disclosure is shown. Introducer device 270 can have a similar construction and usage as introducer device 180 (e.g., Figures 16 and 16B), except that compressed gas source 186 and pump 192 have been replaced by a tubing assembly 280 that can be coupled to a compressed gas source, such as a facility gas supply (e.g., a gas source supplied via a utility connection line to a hospital or medical center building). In some embodiments, introducer device 270 can be single-use or disposable.

[0079] For example, tubing assembly 280 includes a suction line 282 and a positive pressure line 284. Each of suction line 282 and pressure line 284 includes a fitting 286 at its proximal end for connecting to a facility gas supply (not shown) and includes a fitting 288 (e.g., a Luer adapter) for connecting to a corresponding connection line of introducer device 270. For example, fitting 288 of suction line 282 is coupled to a first end of suction connection 290, while fitting 288 of pressure line 284 is coupled to a first end of pressure connection 292. Additionally, a second end of suction connection 290 is coupled to fitting 294 of core seal 298, while a second end of pressure connection 292 is coupled to fitting 296 of core seal 298. As shown, core seal 298 is in turn received within handle 274, e.g., between shaft 272 and handle 274. Shaft 274 may include any of the features or dimensions of shafts 16, 52, 152, and / or 182 described above. As shown, handle 274 includes a first (e.g., left) half 274A and a second (e.g., right) half 274B that are coupled together via any suitable means, such as, for example, via screw 276. Additionally, the distal end of shaft 272 is releasably coupleable (e.g., via an interference fit, a threaded coupling, a pin 300, etc.) to the proximal end of nozzle 298 to secure nozzle 298 to shaft 272. The shape and configuration of nozzle 298 can be similar to nozzle 248 described above.

[0080] In addition, the handle 274 includes two actuators to control suction and vacuum. For example, the handle 274 may include a first actuator, a trigger 304 for generating one of vacuum or positive pressure in the shaft 272 (e.g., controlled by the user's index finger) and a second actuator for generating the other of vacuum or positive pressure, e.g., actuator 307 (e.g., controlled by the user's thumb). The actuator 307 may extend through the handle and define a portion of the valve. As shown, the trigger 304 is rotatably coupled to the handle 274 via a bearing 306, which controls a valve 305, e.g., a trumpet-type valve 305. In at least one embodiment, in some aspects, the introducer device 270 may further include a pressure relief valve to release excess pressure within the shaft 272.

[0081] In at least one embodiment, trigger 304 controls pressure, while second actuator 307 controls suction. In some embodiments, both actuators can be pressed simultaneously to apply pressure and suction. For example, actuator 307 can fluidly couple suction line 282 to shaft 272, and trigger 304 can fluidly couple pressure line 284 to shaft 272. In such an arrangement, if desired, suction and pressure can each be applied to shaft 272 simultaneously. For example, to reduce the degree of suction applied via actuation of actuator 307, a medical professional can press trigger 304, thereby fluidly coupling pressure line 284 to shaft 272.

[0082] During use, medical professional can remove (if not yet completed) nozzle 298 from the far-end of shaft 272, and couple suction line 282 with shaft 272 in a fluidic manner. Subsequently, the far-end of shaft 272 can be positioned near, adjacent to or contact implant 12 (for example, with lubricated housing 14 as described above). Then, trigger 210 can be actuated to pull, absorb or otherwise pull implant 12 through the far-end to shaft 272. Once implant 12 is contained in shaft 272, pressure line 284 can be coupled to shaft 272 in a fluidic manner. Then, nozzle 298 can be coupled to shaft 272 far-end, as described above, and nozzle 298 can be positioned in, through or near the incision site. Subsequently, trigger 210 can be actuated to push, press or otherwise discharge implant 12 from shaft 272, through nozzle 298 to patient (for example, to chest bag 130).

[0083] In some arrangements, the introducer devices described herein (e.g., introducer devices 150, 180, 270, etc.) can be adapted to a sterile packaging system to provide a "touch-free" implantation procedure. That is, a physician, nurse, or other medical professional or user does not need to directly handle the implant 12 when loading the implant 12 into the introducer device (e.g., introducer device 150, 180, 270, etc.) or at other times during implantation.

[0084] For example, if Figure 18 and 19 As shown, a separate sterile package 320 can be sized and / or shaped to contain an implant 12. As shown, the package 320 can have a hemispherical shape with a diameter suitable for enclosing an implant 12 of a specified size and volume (e.g., a breast implant). In some embodiments, a pull tab opening 322 can be integrated into either side of the sterile package 320. The opposite side can be covered with a Tyvek material for packaging sterile medical devices or other suitable material for sterile packaging. The Tyvek cover or other portion of the package can also include a separate injection port (not shown) that can further accommodate the injection of sterile saline and / or lubricant.

[0085] like Figure 20 As shown in Figure 320, for example, packaging 320 can be used together with introducer device 150. Or, packaging 320 can be used together with any introducer device described herein. In certain embodiments, packaging 320 may include structural features complementary to the distal end of a nozzle (e.g., nozzle 110, nozzle 158, nozzle 248, nozzle 298, etc.) or a shaft (e.g., shaft 16, shaft 52, shaft 152, shaft 182, shaft 272, etc.) to allow the introducer device to be connected to packaging 320. For example, the distal end of the shaft 152 of the introducer device may be threaded (or have other matching structural features) to allow the distal end of the shaft 152 to be connected to packaging 320 via the complementary threads (or other matching structural features) of packaging 320. In certain embodiments, the introducer device may include a reverse thread or a connection tab positioned in the shaft 152. For example, the thread may be heat-formed to the outer surface of packaging 320 containing implant 12.

[0086] In other embodiments, the package may include an opening of reduced diameter to receive the shaft 152. Optionally, the package 320 may include an o-ring (e.g., Figure 20 as shown) to provide a better seal between the shaft 152 and the package 320.

[0087] The package 320 can be designed so that the user can use the pull tab 322 to open the sterile package (similar to opening a sealed can) to access the enclosed implant 12. The pull tab can be located on a curved portion of the package 320, such as Figure 18-20 320, or can be positioned on an opposing portion of the generally planar surface of the package 320. For example, in some embodiments, the pull tab can be removed from the planar surface of the package 320 and the implant can be pulled to the shaft 152.

[0088] When packaging 320 is opened, and before packaging 320 is connected to shaft 152, the user can inject sterile saline and / or lubricant into packaging 320 to help implant 12 move to shaft 152. Once the connection between packaging 320 and shaft 152 is tightened, the vacuum mode of the system can be used to subsequently pull the lubricated sterile implant 12 into shaft 152 to prepare the implant 12 to be injected into the incision site. A mating feature structure or mechanism other than the thread can be used to connect shaft 152 to sterile packaging 320. This loading system can help avoid or minimize implant 12 from contacting any entity with the user and / or the surrounding environment, thereby reducing or eliminating the risk of puncturing or introducing particulate debris into the surface of implant 12.

[0089] From experimentation, it has been determined that the appropriate expulsion pressure for expelling the implant 12 from the introducer device can be related to: i) the volume / size of the implant 12, ii) the location and size of the incision, and iii) the diameter of the nozzle of the introducer device inserted into the incision. A table defining these correlations for optimal device placement can be provided to the end user. For example, the table can be developed from clinical and preclinical evaluations.

[0090] By way of example only, assuming that the implant 12 forms a perfect seal against the inner surface of the shaft (e.g., shaft 16, 52, 152, 182, 272, etc.), the volume of gas / fluid sufficient to expel the implant 12 may be equal to the implant volume (up to 925 cc (cubic centimeters)). Another method of calculating the air pressure required to expel the implant 12 is to determine the pressure required to expel the entire volume of the shaft (e.g., shaft 16, 52, 152, 182, 272, etc.), or approximately 625 cc (in one embodiment, the shaft measures approximately 2 inches (diameter) by 12 inches (length)). The same pressure can be used to vacuum load the implant into the chamber of the introducer device.

[0091] For some exemplary implant surgeries, 1000cc or approximately 60ci (cubic inches) is sufficient to propel an implant of up to approximately 925cc in volume. Thus, if the vacuum pump has 100% efficiency, 60ci of CO2 (or other suitable gas) can be used to load the implant into the shaft of the introducer device and then propel the implant from the shaft. By using Boyle's Law (P1V1=P2V2) and the following assumptions, the following table provides possible volume ranges for various compressed gas sources (e.g., source 162, source 186) that supply sufficient gas pressure to load and discharge silicone implants within a volume range requiring 30psi:

[0092] Constant temperature of 70°F

[0093] 800 psi minimum gas supply fill pressure

[0094] Implant 12 is charged and discharged at 25 psi

[0095] 12g (3 inches) gas supply 18cc (1ci)

[0096] Table 1

[0097] size Volume at STP (14.7 psi) Volume at 30 psi* 12 g 6L 3L (183ci) 16g 8L 4L (244ci) 20g 10L 5L (305ci) 33g 17L 8L (494ci) 45g 23L 11L (671ci)

[0098] Additionally, it is known that at STP (standard temperature and pressure, 0°C (273.15°K) and 1 atmosphere (14.7 psi)), 1 mole of an ideal gas occupies a volume of 22.4 liters. Using the following parameters, a 16 g gas supply can provide sufficient volume and pressure for an average-sized breast implant.

[0099] The ideal gas law PV = nRT can be used to calculate the volume of a gas at atmospheric pressure for a given amount of gas, where:

[0100] P is the pressure of the gas (atm)

[0101] V is the volume of the gas (L)

[0102] T is the absolute temperature of the gas, 273.15°K

[0103] The value of R is: 0.08206 L·atm / (mol·K).

[0104] n is the number of moles of gas (mass / molecular weight)

[0105] Thus, by way of example only, for a gas supply containing 16 g of CO2:

[0106] 1 mole of CO2 is 44g (i.e., molecular weight = 44g / mol)

[0107] n = (16 g) / (44 g / mol) = 0.36 moles of CO2

[0108] P = 1 atm

[0109] PV = nRT

[0110] V = about 8 liters (0.28 cubic feet) of CO2 at 1 atm

[0111] To calculate the volume of a gas at a constant temperature and other pressures: P1V1 = P2V2.

[0112] Thus, this system can provide for the use of a disposable gas (e.g., CO2, air, or air / CO2 mixture) source (e.g., 162, 186) ranging from 12-33g and 180ci to 500ci, thereby providing an average pressure of 30psi for both vacuum and exhaust processes during implantation surgery.

[0113] The introducer devices described herein can be used to standardize and / or facilitate the implantation of breast implants or other such implant devices. In some embodiments, the introducer device can be configured to facilitate one-handed advancement of the implant. Additionally, any one or more of the shaft (e.g., 16, 52, 152, 182, 272), chamber (e.g., 18, 22), tunnel sheath 132, or other such devices can be constructed of a low friction material, such as polytetrafluoroethylene (PTFE). And / or coated with a high lubricity (e.g., hydrophilic) material to reduce the coefficient of friction between the introducer device and the implant 12. In some aspects, the combination of the features of the implant and the introducer system can help optimize minimally invasive surgery, for example, to improve patient health. For example, a breast implant characterized by surface texture, high elongation, high shell strength, and super viscoelastic and consistent silicone filler can be implanted with an introducer device as described above in a minimally invasive insertion method to minimize scarring at the incision site, reduce the risk of damage to the implant during placement, and / or accelerate and optimize the healing of surgical wounds.

[0114] Although the principles of the present disclosure are described herein with reference to the illustrative aspects for specific applications, it should be understood that the present disclosure is not limited thereto. For example, as described above, any device in the disclosed introducer device (e.g., introducer device 150, 180 or 270) described above may include a pressure relief valve to release excess pressure in the shaft (e.g., shaft 152, 182 or 272). Personnel with ordinary skill in the art and understanding the teachings provided herein will recognize that other modifications, applications, embodiments and equivalent substitutions within the scope of aspects described herein. Therefore, the present disclosure is not considered to be limited to the foregoing description.

Claims

1. A medical device comprising: a shaft extending between a proximal end and a distal end, the shaft including a single lumen therein, the distal end including a tapered nozzle, the lumen being adapted to receive the implant; a handle detachably coupled to the proximal end of the shaft and comprising a valve mechanism and an actuator; a core seal received within the handle; and a pressure line and a suction line extending from a distal end of the handle, a source of compressed fluid and a pump coupled to the valve mechanism via the pressure line and the suction line, respectively, the pressure line and the suction line coupled to the core seal via fittings securing the pressure line and the suction line to the handle, one or more of the fittings being coupleable to an internal lumen extending through the core seal; Wherein, the actuator is configured to engage the valve mechanism to switch the lumen of the shaft between a vacuum mode for drawing an implant into the lumen of the shaft and a pressure mode for expelling the implant from the lumen of the shaft.

2. The medical device of claim 1, wherein the inner diameter of the shaft is in the range of 1.5-2.5 inches.

3. The medical device of claim 1, wherein the nozzle comprises a flexible polymer and tapers toward a distal aperture.

4. The medical device of claim 3, wherein the distal aperture of the nozzle is oval and angular.

5. The medical device of claim 1, wherein the nozzle is removably coupled to the distal end of the shaft.

6. The medical device of claim 1, wherein the handle comprises a first half and a second half positioned on opposite sides of a plane extending along a longitudinal axis of the handle, the first half and the second half coupled together via a plurality of connectors.

7. The medical device according to claim 1, wherein There are o-rings positioned around the circumference of the core seal on the proximal and distal sides of the core seal, respectively.

8. The medical device of claim 1, further comprising a pressure relief valve to relieve excess pressure from the shaft.

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