IMPLANT INSERTION DEVICE AND METHOD OF USE THEREOF

The present invention generally relates to an implant insertion device, and particularly, to a breast implant insertion device and method of using thereof. The present invention is related to surgical delivery of an implant. In particular, the invention describes a device for the delivery of a breast implant that avoids contact with the skin reducing potential sources of incidental infection.

FIELD OF THE INVENTION

The present invention generally relates to an implant insertion device, and particularly, to a breast implant insertion device and method of using thereof.

BACKGROUND OF THE INVENTION

Breast implants may be positioned within the chest, for example, in one of three positions: (1) implant over the pectoralis major muscle and under the breast tissue (subglandular); (2) implant partially under the muscle (partial submuscular or “dual plane”); and (3) implant completely under the muscle (submuscular). The subglandular placement puts the implant directly behind the breast tissue and mammary gland and in front of the pectoralis major muscle. This placement requires the least amount of dissection and yields the quickest recovery in comparative studies.

Partial submuscular placement involves placing the implant under the pectoralis major muscle. Because of the structure of this muscle, the implant is only partially covered. Completely submuscular placement puts the implant firmly behind the muscle. The implant is placed behind the pectoralis major muscle and behind all of the supporting fascia (connective tissue) and non-pectoral muscle groups.

Regardless of location of the implant, in the case of breast augmentation the surgery is carried out through an incision placed to minimize visibility of the resultant scar. The incision is made in, but is not limited to, one of three areas: (1) peri-areolar incision; (2) inframammary fold incision; and (3) transaxillary incision. The peri-areolar incision enables the surgeon to place the implant in the subglandular, partial submuscular or completely submuscular position, with the implant being inserted, or removed, through the incision. Like the peri-areolar incision, the inframammary fold incision provides for all three placement types and both insertion and removal of the implant through the incision. The incision is made in the crease under the breast, allowing for discreet scarring. Once the incision is made, the implant is inserted and worked vertically into place after creation of an appropriate sized pocket.

The transaxillary incision is made in the armpit. The incision is made in the fold of the armpit and a channel is dissected to gain access to the desired plane. The implant is inserted into the channel and worked into place. Like the peri-areolar and crease incisions, the armpit incision can be used for implant placement in all the previously described planes. Once the incision is created, the surgeon dissects a path through the tissue to the final destination of the implant. Once that path has been created, the tissue and/or muscle (depending on placement) is separated to create a pocket for the implant.

Since breast implants are usually placed into the body through incisions considerably smaller than the implant, it is a challenge to introduce them. With friction at the interface between the surface of the implants and the wound margins (body tissue), it is difficult to introduce the implants. Increased manipulation of both implants and patient tissue often results in trauma to both implants and patient tissue, thereby increasing the risk associated with the procedure both in terms of immediate consequences as well as delayed structural failure and the implications deriving therefrom.

Postoperative infection has also been a consequence of the need to manipulate the implant into place. If this occurs, the removal of the implant may be warranted and permanent disfigurement may result. In addition, bacterial seeding of the wound is postulated to lead to complications such as capsular contracture. The implant may, for example, become seeded with bacteria if it contacts the skin of the patient. Measures are taken in the operating room to avoid such risks. For example, antibiotic solution(s) may be used in the wound, the surgeon's gloves may be changed, and efforts may be made to reduce contact of the implant with the skin. However, such measures suffer from a variety of deficiencies and still provide opportunities for infection or bacterial seeding to occur.

Accordingly, it would be desirable to provide an implant insertion device capable of overcoming these and other complications alone or in combination.

Additional features and advantages of the invention will be set forth in the description that follows, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.

SUMMARY OF THE INVENTION

In an embodiment, an implant insertion device is provided comprising a body defining an interior cavity capable of receiving an implant therein, a neck having an end extending from the body and insertable in an incision of a patient, and an aperture on the neck and in communication with the cavity, where the aperture is positionable substantially coaxially with the incision and the implant is transferable from the cavity to exit out the aperture into the patient. The neck, body, and combination thereof may be foldable or stretchable. The end may be insertable through the incision without contacting the skin of the patient. The body may be flexible, substantially transparent, and combinations thereof. The body may further comprise a second aperture in communication with the cavity for insertion of the implant therein. The second aperture may be larger than the implant. The second aperture may be selectively closeable. The device may further comprise a port in the body that is extendable through at least a portion of the cavity and the first aperture. The port may be glove shaped. The device may further comprise a removable cover over the first aperture. The device may further comprise an implant positioned in the cavity. The implant may be a breast implant. The device may further comprise a compartment capable of being placed in fluid communication with the body. The compartment may contain a fluid including, but limited to a lubricant, disinfectant, sterilizer, antibiotic, antimicrobial, and combinations thereof. The compartment may be positioned in the cavity. The compartment may be selectively openable to release the fluid in the cavity.

In an embodiment, an implant insertion device comprises a body defining an interior cavity capable of receiving an implant therein, an aperture in communication with the cavity and positionable substantially coaxially with an incision in a patient, where the implant is transferable from the cavity to exit out the aperture into the patient, and a member extending from the body for selectively engaging the patient. The member may engage the patient to maintain alignment of the aperture with the incision, to prevent withdrawal of the device from the patient during insertion of the implant, to prevent over insertion of the device in the patient, and combinations thereof. The member may engage the external surface of the patient's skin. The member may engage a surface inside the patient. The member may be a flexible ring. The member may be a tab. The member may engage the internal surface opposite the external surface of the skin. The device may further comprise a second member extending from the body for engaging the external surface of the patient's skin. The second member may engage the external surface of the patient's skin to maintain alignment of the aperture with the incision, to prevent withdrawal of the device from the patient during insertion of the implant, to prevent over insertion of the device in the patient, and combinations thereof. The second member may be selectively positionable from a first non-engagement position to a second engagement position. The first member and the second member may compress or sandwich the skin therebetween when the second member is positioned in the second engagement position. The second member may be a flexible ring. The second member may have a diameter greater than the diameter of the first member, substantially equal to the diameter of the first member, or smaller than the diameter of the first member.

In an embodiment, an implant insertion device comprises a body defining an interior cavity capable of receiving an implant therein, an aperture in communication with the cavity and positionable substantially coaxially with an incision in a patient, where the implant is transferable from the cavity to exit out the aperture into the patient, and a neck extending from the body for selectively engaging the incision to maintain the incision in an open position. The aperture may be positioned on the neck. The neck may be moveable from a first non-engagement position to a second engagement position. The neck is insertable in said incision without substantially contacting the skin while in said first non-engagement position. The neck may comprise a first leg for engaging a first side of the incision, and a second leg for engaging a second side of the incision. The first leg and the second leg may be moveable from a first non-engagement position to a second engagement position. The device may further comprise a biasing member for selectively maintaining the first leg and the second leg in the second engagement position. The neck may maintain alignment of the aperture with the incision. The diameter of the neck in the first position is smaller than the diameter of the neck in the second position.

In one embodiment the invention relates to an implant insertion device comprising: a) a body defining an interior cavity capable of receiving an implant therein, b) an aperture in communication with the cavity, c) positionable substantially coaxially with an incision in a patient, where said implant is transferable from the cavity to exit out the aperture into the patient, and d) a member extending from the body for selectively engaging the patient. In one embodiment the invention relates to the method of using the device of described above to deliver an implant to a patient. In one embodiment the member may engage the patient to maintain alignment of the aperture with the incision, to prevent withdrawal of the device from the patient during insertion of the implant, to prevent over insertion of the device in the patient, and combinations thereof. In one embodiment the member may engage the external surface of the patient's skin. In one embodiment the member may engage a surface inside the patient. In one embodiment the member may be a flexible ring. In one embodiment the member may be a tab. In one embodiment member may engage the internal surface opposite the external surface of the skin. In one embodiment the device may further comprise a second member extending from the body for engaging the external surface of the patient's skin. In one embodiment the second member may engage the external surface of the patient's skin to maintain alignment of the aperture with the incision, to prevent withdrawal of the device from the patient during insertion of the implant, to prevent over insertion of the device in the patient, and combinations thereof. In one embodiment the invention relates to method of using the device described above to deliver an implant to a patient. In one embodiment the second member may be selectively positionable from a first non-engagement position to a second engagement position. In one embodiment the first member and the second member may compress or sandwich the skin therebetween when the second member is positioned in the second engagement position. In one embodiment the second member may be a flexible ring. In one embodiment the second member may have a diameter greater than the diameter of the first member, substantially equal to the diameter of the first member, or smaller than the diameter of the first member. In one embodiment the invention relates to method of using the device described above to deliver an implant to a patient.

In one embodiment the invention relates to an implant insertion device comprising: a) a body defining an interior cavity capable of receiving an implant therein, b) a neck having an end extending from the body and insertable in an incision of a patient, c) an aperture on the neck and in communication with the cavity, where said aperture is positionable substantially coaxially with the incision, and d) said implant is transferable from the cavity to exit out the aperture into the patient. In one embodiment the invention relates to method of using the device described above to deliver an implant to a patient. In one embodiment the neck, body, and combination thereof may be foldable or stretchable. In one embodiment the end may be insertable through the incision without contacting the skin of the patient. In one embodiment the body may be flexible, substantially transparent, and combinations thereof. In one embodiment the body may further comprise a second aperture in communication with the cavity for insertion of the implant therein. In one embodiment the second aperture may be larger than the implant. In one embodiment the second aperture may be selectively closeable. In one embodiment the device may further comprise a port in the body that is extendable through at least a portion of the cavity and the first aperture. In one embodiment the port may be glove shaped. In one embodiment the device may further comprise a removable cover over the first aperture. In one embodiment the device may further comprise an implant positioned in the cavity. In one embodiment the implant may be a breast implant. In one embodiment the device may further comprise a compartment capable of being placed in fluid communication with the body. In one embodiment the compartment may contain a fluid including, but limited to a lubricant, disinfectant, sterilizer, antibiotic, antimicrobial, and combinations thereof. In one embodiment the compartment may be positioned in the cavity. In one embodiment the compartment may be selectively openable to release the fluid in the cavity. In one embodiment the invention relates to method of using the device described above to deliver an implant to a patient.

In one embodiment the invention relates to an implant insertion device comprising: a) a body defining an interior cavity capable of receiving an implant therein, b) an aperture in communication with the cavity and positionable substantially coaxially with an incision in a patient, where the implant is transferable from the cavity to exit out the aperture into the patient, and c) a neck extending from the body for selectively engaging the incision to maintain the incision in an open position. In one embodiment the invention relates to method of using the device described above to deliver an implant to a patient. In one embodiment said aperture may be positioned on the neck. In one embodiment said neck may be moveable from a first non-engagement position to a second engagement position. In one embodiment said neck is insertable in said incision without substantially contacting the skin while in said first non-engagement position. In one embodiment said neck may comprise a first leg for engaging a first side of the incision, and a second leg for engaging a second side of the incision. In one embodiment said first leg and said second leg may be moveable from a first non-engagement position to a second engagement position. In one embodiment said device further comprises a biasing member for selectively maintaining the first leg and the second leg in the second engagement position. In one embodiment said neck may maintain alignment of the aperture with the incision. In one embodiment the diameter of the neck in the first position is smaller than the diameter of the neck in the second position. In one embodiment the invention relates to method of using the device described above to deliver an implant to a patient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the present invention is described with reference to embodiments described herein, it should be clear that the present invention is not limited to such embodiments. Therefore, the description of the embodiments herein is merely illustrative of the present invention and will not limit the scope of the invention as claimed.

As shown inFIG. 1, an implant insertion device10(hereinafter referred to as the “device10”) is provided comprising a body15defining a cavity20therein that is accessible via an aperture25. An implant30is positionable in the cavity20and the aperture25is substantially coaxially alignable with an incision35in the tissue37of a human or animal (hereinafter referred to as the “patient”) for insertion of the implant30therein.

The device10may be used for the insertion of a breast implant into a surgical pocket formed in the patient. The breast implant may be any type, including, but not limited to, saline and silicone breast implants. In a non-limiting example, saline breast implants are generally inserted through the incision35ranging from about two centimeters to about three centimeters. For silicone breast implants, the incision35ranges from about five centimeters and above. It is to be understood, however, that the device10may be used with incisions35having larger and smaller sizes. In addition, although the implant30is described herein as a breast implant, it is to be understood that the device10is not limited to breast implants, and may be used to insert any type of implant30in the patient.

The body15may be provided in a variety of shapes and materials. In the non-limiting examples as shown inFIG. 2A-D, the body15may be substantially cylindrical, spherical, funnel shaped, or bag-like. The body15may be comprised of metal, polymers or plastics, composites, and combinations thereof, and may be covered with a friction reducing coating to minimize trauma to the implant30and the tissue37. The body15may be coated with a lubricant including, but not limited to, silicone. In a non-limiting example, the body15may be of metal, plastic, polymer, fabrics, composites, and combinations thereof. In a non-limiting example, the body15may include, but is not limited to, Mylar®, plastics made from Tygon® brands of plastics, vinyls, polyvinyl chloride, ethylene and alpha-olefin copolymers, silicone, and the like. It is to be understood that the body15may be impregnated with an antimicrobial.

The cavity20may extend a portion of or the entire length of the body15. In an embodiment, at least a portion of the body15is flexible and capable of allowing a user200, such as a physician, to manipulate or otherwise apply pressure to the implant30via the body15when positioned in the cavity20by hand or with an instrument to transfer the implant30from the cavity20and into the patient via the incision35. Accordingly, the implant30may be inserted in the patient without exposing the implant30or the patient and the surgical pocket to contamination from a variety of sources, including but not limited to, the physician's gloves, hands, retractors, and the patient's skin, thereby reducing the chance of infection and bacterial seeding of the implant30.

It is to be understood that the implant30is insertable in the cavity20via the aperture25. The aperture25may be smaller (or have a smaller diameter) than the implant30, substantially same as the implant30, or larger than the implant30. In a non-limiting example as best shown inFIG. 15AandFIG. 15B, the aperture25may be smaller than the implant30and the body15may be resistant to stretching, thereby causing the implant30to extrude through the aperture25. In a non-limiting example as best shown inFIG. 16AandFIG. 16B, a portion of the body15adjacent to or surrounding the aperture25may be stretchable or expandable to increase the size or diameter of the aperture25for insertion or removal of the implant30therethrough without substantially compressing or extruding the implant30, thereby reducing trauma to the implant30.

As best shown inFIG. 3A, the device10may be provided with an implant30positioned in the cavity20. A cover45may be provided for the aperture25, for example, to maintain the sterility of at least a portion of the body15, the cavity20, the implant30, and combinations thereof. As shown inFIG. 3B, the cover45may be removed before inserting the implant30through the incision35.

As shown inFIG. 4, a fluid47may be provided in the cavity20, for example, to sterilize the implant30. The fluid47may include, but is not limited to, lubricant, disinfectant, sterilizer, antibiotic, antimicrobial, and combinations thereof. The disinfectant47may be provided in contact with the implant30as shown inFIG. 4, or in a compartment50capable of being opened to place the compartment50in fluid communication with the cavity20as shown inFIG. 5. The compartment50may be opened prior to insertion of the implant30through the incision35to release the fluid47into the cavity20. In a non-limiting example, the compartment50may be opened by applying pressure to the body15, for example, by pinching between the user's200fingers.

A switch55may be provided outside of the cavity20as shown inFIG. 5that may be activated to open the compartment50. In a non-limiting example, the switch55may be a string that can be pulled to open the compartment50. It is to be understood, however, that a variety of configurations may be used to open the compartment50.

As shown inFIG. 6, the body15may be provided with a second aperture60capable of receiving the implant30for placement in the cavity20. In a non-limiting example as best shown inFIG. 7AandFIG. 7B, the second aperture60may be provided with a closure65that may be selectively opened (FIG. 7A) and closed (FIG. 7B) for access to the cavity20. The closure65may include, but is not limited to, a Zip-loc closure, a suture, zipper, button, adhesive, strings for tying for tying the second aperture60closed, and combinations thereof. The second aperture60may have a diameter less than, substantially equal to, or greater than the diameter of the implant30.

In an embodiment as shown inFIG. 8, the device10may be provided with a neck70extending from the body15and capable of engaging the incision35to facilitate insertion of the implant30through the incision35. As shown inFIG. 9A,FIG. 9B, andFIG. 9Cthe neck70may comprise two or more legs75that are positionable in a first non-engagement position for insertion in the incision35and a second engagement position to maintain the incision35in an open position (having a size or diameter d1). As shown inFIG. 9BandFIG. 9C, the neck70may stretch or expand the size or diameter d1of the incision35while in the engagement position to a larger diameter d2. As shown inFIG. 9A, the legs75(or neck70) may be inserted in or through the incision35without contacting an external surface90of the skin (or substantially) any portion of the incision35walls), thereby minimizing the introduction of bacteria or other foreign matter to the implant30or in the patient's body (including the surgical pocket).

Although shown as being substantially rod shaped, it is to be understood that the legs75(or the neck70) may be any shape capable of insertion in or through the incision35. Although shown as extending substantially perpendicularly outward from the body15, the legs75(or neck70) may extend outward from the body15at any angle. Although shown as extending outward from the body15substantially parallel to each other, the legs75may extend outward from the body15at any angle with respect to each other.

The legs75(or neck70) may be biased such that the legs75may be compressed to the first non-engagement position for insertion in the incision35. When released, the legs75extend outward from each other to engage the tissue37surrounding the incision35to maintain the incision35in an open position or increase the size of the incision35. In a non-limiting example, the legs75may comprise a shape memory material to provide the biasing force to the legs75. In a non-limiting example as shown inFIG. 14, a biasing member105may be provided to provide the biasing force to the legs75. In a non-limiting example, the biasing member105may be a spring. Although the biasing member105is shown as being positioned between the legs75, it is to be understood that the biasing member105may be positioned anywhere on the device10to provide the biasing force. In addition, it is to be understood that a variety of materials and configurations may be used to provide the biasing force to the legs75.

A locking mechanism (not shown) may be provided to lock the legs75in the first non-engagement position, the second engagement position, or any position therebetween. In a non-limiting example, the locking mechanism may be used to prevent the legs75from being compressed inwardly from the second engagement position to prevent accidental withdrawal from the incision35.

As shown inFIG. 10A,FIG. 10B, andFIG. 10C, the neck70may be provided with one or more engagement members80(hereinafter referred to as “the first member80”). The first member80is capable of engaging the patient to prevent removal of the device10from the patient during insertion of the implant30, to maintain alignment of the aperture25with the incision35, to prevent over insertion of the device10in the patient, and combinations thereof. The first member80may extend outward from the body15or the neck70to engage an internal part of the patient's body. In a non-limiting example, the first member80may engage an internal surface85opposite the external surface90or a portion of a surgical pocket (not shown) in the patient formed for the placement of the implant30therein.

As shown inFIG. 10A,FIG. 10BandFIG. 10C, the first member80may extend substantially perpendicularly outward from the legs75(or neck70). It is to be understood, however, that the first member80may extend at any angle outward from the legs75(or neck70) and may be curved or otherwise shaped to conform to the shape of the tissue to which it will engage.

As shown inFIG. 11AandFIG. 11B, the first member80may be selectively moveable between a non-engagement position (FIG. 11A) and an engagement position (FIG. 11B). The first member80may be moved by using one or more actuators95, such as a button, tab, or the like. The first member80may be positioned in the non-engagement position (FIG. 11A) for insertion through the incision35and extended to the engagement position (FIG. 11B) to engage the internal surface85for insertion of the implant30through the incision35.

In a non-limiting example, the first member80may be secured to the body15. The first member80may be comprised of metal, polymer, plastic, fabrics, composites, and combinations thereof. It is to be understood that the first member80may be rigid, compressible, foldable, expandable, or stretchable. As shown inFIG. 12, the first member80may be substantially ring shaped and may extend outward from a flexible, bag-like body15. In a non-limiting example, the first member80may be comprised of a flexible material, including but not limited to a polymer, capable of being compressed or folded for insertion through the incision35.

As best shown inFIG. 13A, one or more arms100may be provided extending from the first member80. As best shown inFIG. 13B, the arms100may be manipulated, for example by squeezing together, to compress or fold the first member80, the neck70, the portion of the body15surrounding the aperture25, or any combination thereof, to the non-engagement position for insertion through the incision35. As shown inFIG. 13CandFIG. 13D, the first member80, the neck70, the portion the body15surrounding the aperture25, or any combination thereof, may be folded to the non-engagement position for insertion through the incision35. Although not shown inFIG. 13CandFIG. 13D, it is to be understood that one or more arms100may be provided.

Accordingly, the first member80, the neck70, the portion the body15surrounding the aperture25, or any combination thereof may be inserted in or through the incision35to reduce exposure of the patient and the implant30to contamination from the physician's gloves, hands, retractors and the like, thereby reducing the risk of infection or bacteria seeding. The arms100(if provided), the neck70, the first member80, the body15, or any combination thereof, may be released to allow the first member80, the neck70, the portion of the body15surrounding the aperture25, or any combination thereof, to return to the engagement position as shown inFIG. 13A.

In an embodiment, an engagement member120(hereinafter referred to as “the second member120”) may be provided for engaging the external surface90of the patient's skin. As shown inFIG. 17AandFIG. 17B, the first member120may be secured to the body15or the neck70. As shown inFIG. 18AandFIG. 18B, the second member120may engage the external surface90to secure the device10to the patient, to maintain alignment of the aperture25with the incision35, to prevent over insertion of the any portion of the device10in the incision35(for example, during insertion of the implant30), and combinations thereof. Over insertion of the device10in the patient may introduce bacteria or foreign matter in the patient, or cause trauma to the patient.

In a non-limiting example, the second member120may be capable of providing a vacuum when engaged with the external surface90to secure the device10thereto. It is to be understood, however, that other configurations of the second member120may be used to secure the device10to the external surface90, including, but not limited to clamps, ribbons, and the like. Although shown as substantially ring shaped, the second member120may be any shape capable of engaging the external surface90. The second member120may be comprised of metal, polymer, plastic, fabrics, composites, and combinations thereof. It is to be understood that the second member120may be rigid, compressible, expandable or stretchable.

It is to be understood that the second member120may be integral with the body15or the neck70and may be removeably secured to the body15or the neck70. As best shown inFIG. 19AandFIG. 19B, the second member120may be provided in combination with the first member80. As shown inFIG. 20AandFIG. 20B, the second member120may engage the external surface90and the first member80may engage the internal surface85. In a non-limiting example, the second member120and the first member80may be selectively positionable or biased toward each other to sandwich or compress the tissue37therebetween.

The second member120, the first member80, or both the second member120and the first member80may be selectively positionable along the neck70or body15. In a non-limiting example as shown inFIG. 21A,FIG. 21B, andFIG. 21C, the neck70may be provided with a series of apertures130. The second member120, the first member80, or both the second member120and the first member80may be provided with an actuator140, such as a pin, to selectively engage the apertures130to lock the second member120or the first member80at a desired position on the neck70.

In another illustrative example, as shown inFIG. 23AandFIG. 23B, either or both of the members120and80may be rotated to wrap the body15(and/or neck70) thereabout to decrease the distance dm1and dm2therebetween (where dm1>dm2). As shown in FIGS.FIG. 24AandFIG. 24B, the second member120may be rotated after insertion of the first member80through the incision35to selectively engage the tissue37therebetween. It is to be understood, however, that the foregoing illustrative examples are not limiting and that a variety of configurations may be provided for selectively positioning the members120and80along the body15or neck70.

As shown inFIG. 22AandFIG. 22B, the first member80may be inserted through the incision35to engage the internal surface85. As shown inFIG. 22B, the second member120may be selectively positioned to engage the external surface90to sandwich or compress the tissue37therebetween to, for example, secure the device10to the tissue37, to maintain alignment of the aperture25with the incision35, prevent over insertion of the device10through the incision35, and combinations thereof.

As shown inFIG. 25, the body15may be capable of being inverted to allow the user200to insert their hand205(or a portion thereof) through the incision35to manipulate or otherwise position the implant30in the surgical pocket without directly contacting the skin, the implant30, or the surgical pocket. Accordingly, the user200may minimize the risk of introducing foreign matter (including but not exclusive to lint from surgical towels or powder from surgical gloves) or bacteria on the implant30and in the patient and the surgical pocket.

In an embodiment as shown inFIG. 26, a port150is provided for insertion of a hand or tool in the cavity20. As best shown inFIG. 27, the port150may be shaped like a glove to facilitate insertion of the user's hand205therein. The port150provides access to the cavity20to allow the user200to manipulate the implant30therein, and allows the user200to transfer the implant30through the aperture25and the incision35. As best shown inFIG. 28, the port150may allow the user200to insert at least a portion of their hand205through the incision35, for example, to manipulate the implant30in the surgical pocket to facilitate proper positioning. It is to be understood that the port150may be comprised of the same material as the body15. In a non-limiting example, the body15, the neck70, and combinations thereof may be comprised of a rigid material and the port150may be comprised of a flexible material.

Turning to the device10, an illustrative example of how to use the device10as illustrated inFIG. 1-FIG. 29Dis set forth below. As best shown inFIG. 8A,FIG. 9A,FIG. 10A,FIG. 13B,FIG. 13C, andFIG. 13Dthe neck70(or a portion of the body15) may be provided in a non-engagement position for insertion in the incision35without contacting (or substantially contacting) the external surface90to, for example, minimize the introduction of foreign material in the patient and the surgical pocket. As best shown inFIG. 8B,FIG. 8C,FIG. 9B,FIG. 9C,FIG. 10B, andFIG. 10C, the neck70(or a portion of the body15) may be moveable from the non-engagement position to the engagement position to selectively engage the incision35walls to maintain the incision35in an open position with the aperture25substantially coaxially aligned with the incision35.

As shown inFIG. 22A, the first member80may be provided to engage the internal surface85to, for example, prevent withdrawal of the device10from the incision35during insertion of the implant. The second member120may be provided to engage the external surface90to, for example, secure the device10to the external surface90to maintain alignment of the aperture25with the incision35, to prevent over insertion of the device10in the patient, and combinations thereof. As shown inFIG. 22AandFIG. 22B, the second member120may be selectively positionable from a first non-engagement position (FIG. 22A) to a second engagement position (FIG. 22B).

As best shown inFIG. 29AandFIG. 29B, the implant30may be aligned with the incision35for insertion therethrough. It is to be understood that the body15(or a portion thereof) may be flexible and allow the user200to manipulate or transfer the implant30through the incision35, as shown inFIG. 29C,FIG. 29D, andFIG. 29E, without directly contacting the implant30, to minimize the introduction of foreign matter and bacteria to the implant30and in the patient and the surgical pocket. As best shown inFIG. 29B,FIG. 29C,FIG. 29D, andFIG. 29E, the aperture25may be larger than the implant30and the body15may be flexible and shaped so as not to constrict or otherwise compress the implant30during insertion through the incision35. Accordingly, the device10may limit compression or trauma exerted on the implant30to that imposed thereon by the tissue37surrounding the incision35, the fingers, or tools of the user200used to transfer the implant30therethrough.

The invention has been described above and, obviously, modifications and alternations will occur to others upon a reading and understanding of this specification. It is to be understood that all features in the various embodiments can be combined with other embodiments. The claims as follows are intended to include all modifications and alterations insofar as they come within the scope of the claims or the equivalent thereof.