Patent Document

FIELD OF THE INVENTION 
       [0001]    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 
       [0002]    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. 
         [0003]    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. 
         [0004]    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. 
         [0005]    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. 
         [0006]    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. 
         [0007]    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&#39;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. 
         [0008]    Accordingly, it would be desirable to provide an implant insertion device capable of overcoming these and other complications alone or in combination. 
         [0009]    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 
       [0010]    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. 
         [0011]    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&#39;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&#39;s skin. The second member may engage the external surface of the patient&#39;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. 
         [0012]    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. 
         [0013]    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&#39;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&#39;s skin. In one embodiment the second member may engage the external surface of the patient&#39;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. 
         [0014]    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. 
         [0015]    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. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0016]    Objects and advantages, together with the operation of the invention, may be better understood by reference to the following detailed description taken in connection with the following illustrations, wherein: 
           [0017]      FIG. 1  is a side view of an implant insertion device and a cross-sectional view of an incision in the tissue of a patient. 
           [0018]      FIG. 2A ,  FIG. 2B ,  FIG. 2C , and  FIG. 2D  are side views of the body of the implant insertion device. 
           [0019]      FIG. 3A  and  FIG. 3B  are side views of the implant insertion device with a removable cover. 
           [0020]      FIG. 4  is a side view of the implant insertion device with a fluid in the cavity. 
           [0021]      FIG. 5  is a side view of the implant insertion device provided with a compartment containing the fluid. 
           [0022]      FIG. 6  is a side view of the implant insertion device with a second aperture. 
           [0023]      FIG. 7A  is a side view of the implant insertion device with a selectively closeable second aperture in an open position. 
           [0024]      FIG. 7B  is a side view of the implant insertion device with a selectively closeable second aperture in a closed position. 
           [0025]      FIG. 8  is a side view of the implant insertion device with a neck. 
           [0026]      FIG. 8A  is a side view of the implant insertion device with a neck in a first non-engagement position. 
           [0027]      FIG. 8B  is a side view of the implant insertion device of  FIG. 8A  with the neck in a second engagement position to maintain the incision in an open position. 
           [0028]      FIG. 8C  is a side view of the implant insertion device of  FIG. 8A  with the neck in the engagement position to expand the incision. 
           [0029]      FIG. 9  is a side view of the implant insertion device with a neck comprising legs. 
           [0030]      FIG. 9A  is a side view of the implant insertion device provided with the neck in a first non-engagement position. 
           [0031]      FIG. 9B  is a side view of the implant insertion device of  FIG. 9A  with the neck in a second engagement position. 
           [0032]      FIG. 9C  is a side view of the implant insertion device of  FIG. 9A  with the neck in the engagement position. 
           [0033]      FIG. 10A  is a side view of the implant insertion device provided in  FIG. 9A  with a first member extending from the neck. 
           [0034]      FIG. 10B  is a side view of the implant insertion device provided in  FIG. 9B  with the first member extending from the neck. 
           [0035]      FIG. 10C  is a side view of the implant insertion device of  FIG. 9C  with the first member extending from the neck. 
           [0036]      FIG. 11A  is a side view of the implant insertion device provided with the first member in a non-engagement position. 
           [0037]      FIG. 11B  is a side view of the implant insertion device provided with the first member in an engagement position. 
           [0038]      FIG. 12  is a side view of the implant insertion device with the first member secured to the body. 
           [0039]      FIG. 13A  is a side view of the implant insertion device of  FIG. 12  with a leg extending from the first member. 
           [0040]      FIG. 13B  is a side view of the implant insertion device of  FIG. 12  with the first member in a non-engagement position. 
           [0041]      FIG. 13C  is a side view of the implant insertion device of  FIG. 12  with a portion of the body and the first member in a non-engagement position. 
           [0042]      FIG. 13D  is a side view of the implant insertion device with the neck and the first member in a non-engagement position. 
           [0043]      FIG. 14  is a side view of the implant insertion device provided with a biasing member. 
           [0044]      FIG. 15A  is a side view of the implant insertion device with the implant positioned partially therein. 
           [0045]      FIG. 15B  is a side view of the implant insertion device of  FIG. 15A  with the implant extruding outward from the cavity. 
           [0046]      FIG. 16A  is a side view of the implant insertion device with the implant positioned in the cavity. 
           [0047]      FIG. 16B  is a side view of the implant insertion device of  FIG. 16A  with the implant exiting therefrom. 
           [0048]      FIG. 17A  and  FIG. 17B  are side views of the implant insertion device provided with a second member. 
           [0049]      FIG. 18A  and  FIG. 18B  are side views of the implant insertion devices of  FIGS. 17A and 17B  with the second member engaging the external surface of the patient&#39;s skin. 
           [0050]      FIG. 19A  and  FIG. 19B  are side views of the implant insertion device provided with the first member and the second member. 
           [0051]      FIG. 20A  and  FIG. 20B  are side views of the implant insertion devices of  FIG. 19A  and  FIG. 19B  with the first and second members engaging the tissue of the patient. 
           [0052]      FIG. 21A ,  FIG. 21B , and  FIG. 21C  are side views of the neck of the implant insertion device with selectively positionable first and second members. 
           [0053]      FIG. 22A  is a side view of the implant insertion device with the second member positioned in a non-engagement position. 
           [0054]      FIG. 22B  is a side view of the implant insertion device of  FIG. 22A  with the second member positioned in an engagement position. 
           [0055]      FIG. 23A  is a side view of the implant insertion device with the first and second members positioned in an extended position. 
           [0056]      FIG. 23B  is a side view of the implant insertion device of  FIG. 23A  with the first and second members positioned in a retracted position. 
           [0057]      FIG. 24A  is a side view of the implant insertion device with the first and second members positioned in an extended (non-engagement) position. 
           [0058]      FIG. 24B  is a side view of the implant insertion device of  FIG. 24A  with the first and second members positioned in a retracted (engagement) position. 
           [0059]      FIG. 25  is a side view of the implant insertion device with an invertible body. 
           [0060]      FIG. 26  is a side view of the implant insertion device with an access port. 
           [0061]      FIG. 27  is a side view of the implant insertion device with a glove shaped access port. 
           [0062]      FIG. 28  is a side view of the implant insertion device comprising an access port insertable through the incision. 
           [0063]      FIG. 29A  is a side view of the implant insertion device with an implant positioned therein. 
           [0064]      FIG. 29B  is a side view of the implant insertion device of  FIG. 29A  with the implant being inserted in the incision. 
           [0065]      FIG. 29C  is a side view of the device of  FIG. 29A  with the implant partially inserted through the incision. 
           [0066]      FIG. 29D  is a side view of the device of  FIG. 29A  with the implant partially inserted through the incision. 
           [0067]      FIG. 29E  is a side view of the device of  FIG. 29A  with the implant inserted through the incision. 
           [0068]      FIG. 30  shows a smaller sized embodiment of the current invention both in open and closed positions. 
           [0069]      FIG. 31  shows a medium sized embodiment of the current invention both in open and closed positions. 
           [0070]      FIG. 32  shows a large sized embodiment of the current invention both in open and closed positions. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0071]    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. 
         [0072]    As shown in  FIG. 1 , an implant insertion device  10  (hereinafter referred to as the “device  10 ”) is provided comprising a body  15  defining a cavity  20  therein that is accessible via an aperture  25 . An implant  30  is positionable in the cavity  20  and the aperture  25  is substantially coaxially alignable with an incision  35  in the tissue  37  of a human or animal (hereinafter referred to as the “patient”) for insertion of the implant  30  therein. 
         [0073]    The device  10  may 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 incision  35  ranging from about two centimeters to about three centimeters. For silicone breast implants, the incision  35  ranges from about five centimeters and above. It is to be understood, however, that the device  10  may be used with incisions  35  having larger and smaller sizes. In addition, although the implant  30  is described herein as a breast implant, it is to be understood that the device  10  is not limited to breast implants, and may be used to insert any type of implant  30  in the patient. 
         [0074]    The body  15  may be provided in a variety of shapes and materials. In the non-limiting examples as shown in  FIG. 2A-D , the body  15  may be substantially cylindrical, spherical, funnel shaped, or bag-like. The body  15  may 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 implant  30  and the tissue  37 . The body  15  may be coated with a lubricant including, but not limited to, silicone. In a non-limiting example, the body  15  may be of metal, plastic, polymer, fabrics, composites, and combinations thereof. In a non-limiting example, the body  15  may 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 body  15  may be impregnated with an antimicrobial. 
         [0075]    The cavity  20  may extend a portion of or the entire length of the body  15 . In an embodiment, at least a portion of the body  15  is flexible and capable of allowing a user  200 , such as a physician, to manipulate or otherwise apply pressure to the implant  30  via the body  15  when positioned in the cavity  20  by hand or with an instrument to transfer the implant  30  from the cavity  20  and into the patient via the incision  35 . Accordingly, the implant  30  may be inserted in the patient without exposing the implant  30  or the patient and the surgical pocket to contamination from a variety of sources, including but not limited to, the physician&#39;s gloves, hands, retractors, and the patient&#39;s skin, thereby reducing the chance of infection and bacterial seeding of the implant  30 . 
         [0076]    It is to be understood that the implant  30  is insertable in the cavity  20  via the aperture  25 . The aperture  25  may be smaller (or have a smaller diameter) than the implant  30 , substantially same as the implant  30 , or larger than the implant  30 . In a non-limiting example as best shown in  FIG. 15A  and  FIG. 15B , the aperture  25  may be smaller than the implant  30  and the body  15  may be resistant to stretching, thereby causing the implant  30  to extrude through the aperture  25 . In a non-limiting example as best shown in  FIG. 16A  and  FIG. 16B , a portion of the body  15  adjacent to or surrounding the aperture  25  may be stretchable or expandable to increase the size or diameter of the aperture  25  for insertion or removal of the implant  30  therethrough without substantially compressing or extruding the implant  30 , thereby reducing trauma to the implant  30 . 
         [0077]    As best shown in  FIG. 3A , the device  10  may be provided with an implant  30  positioned in the cavity  20 . A cover  45  may be provided for the aperture  25 , for example, to maintain the sterility of at least a portion of the body  15 , the cavity  20 , the implant  30 , and combinations thereof. As shown in  FIG. 3B , the cover  45  may be removed before inserting the implant  30  through the incision  35 . 
         [0078]    As shown in  FIG. 4 , a fluid  47  may be provided in the cavity  20 , for example, to sterilize the implant  30 . The fluid  47  may include, but is not limited to, lubricant, disinfectant, sterilizer, antibiotic, antimicrobial, and combinations thereof. The disinfectant  47  may be provided in contact with the implant  30  as shown in  FIG. 4 , or in a compartment  50  capable of being opened to place the compartment  50  in fluid communication with the cavity  20  as shown in  FIG. 5 . The compartment  50  may be opened prior to insertion of the implant  30  through the incision  35  to release the fluid  47  into the cavity  20 . In a non-limiting example, the compartment  50  may be opened by applying pressure to the body  15 , for example, by pinching between the user&#39;s  200  fingers. 
         [0079]    A switch  55  may be provided outside of the cavity  20  as shown in  FIG. 5  that may be activated to open the compartment  50 . In a non-limiting example, the switch  55  may be a string that can be pulled to open the compartment  50 . It is to be understood, however, that a variety of configurations may be used to open the compartment  50 . 
         [0080]    As shown in  FIG. 6 , the body  15  may be provided with a second aperture  60  capable of receiving the implant  30  for placement in the cavity  20 . In a non-limiting example as best shown in  FIG. 7A  and  FIG. 7B , the second aperture  60  may be provided with a closure  65  that may be selectively opened ( FIG. 7A ) and closed ( FIG. 7B ) for access to the cavity  20 . The closure  65  may include, but is not limited to, a Zip-loc closure, a suture, zipper, button, adhesive, strings for tying for tying the second aperture  60  closed, and combinations thereof. The second aperture  60  may have a diameter less than, substantially equal to, or greater than the diameter of the implant  30 . 
         [0081]    In an embodiment as shown in  FIG. 8 , the device  10  may be provided with a neck  70  extending from the body  15  and capable of engaging the incision  35  to facilitate insertion of the implant  30  through the incision  35 . As shown in  FIG. 9A ,  FIG. 9B , and  FIG. 9C  the neck  70  may comprise two or more legs  75  that are positionable in a first non-engagement position for insertion in the incision  35  and a second engagement position to maintain the incision  35  in an open position (having a size or diameter d 1 ). As shown in  FIG. 9B  and  FIG. 9C , the neck  70  may stretch or expand the size or diameter d 1  of the incision  35  while in the engagement position to a larger diameter d 2 . As shown in  FIG. 9A , the legs  75  (or neck  70 ) may be inserted in or through the incision  35  without contacting an external surface  90  of the skin (or substantially) any portion of the incision  35  walls), thereby minimizing the introduction of bacteria or other foreign matter to the implant  30  or in the patient&#39;s body (including the surgical pocket). 
         [0082]    Although shown as being substantially rod shaped, it is to be understood that the legs  75  (or the neck  70 ) may be any shape capable of insertion in or through the incision  35 . Although shown as extending substantially perpendicularly outward from the body  15 , the legs  75  (or neck  70 ) may extend outward from the body  15  at any angle. Although shown as extending outward from the body  15  substantially parallel to each other, the legs  75  may extend outward from the body  15  at any angle with respect to each other. 
         [0083]    The legs  75  (or neck  70 ) may be biased such that the legs  75  may be compressed to the first non-engagement position for insertion in the incision  35 . When released, the legs  75  extend outward from each other to engage the tissue  37  surrounding the incision  35  to maintain the incision  35  in an open position or increase the size of the incision  35 . In a non-limiting example, the legs  75  may comprise a shape memory material to provide the biasing force to the legs  75 . In a non-limiting example as shown in  FIG. 14 , a biasing member  105  may be provided to provide the biasing force to the legs  75 . In a non-limiting example, the biasing member  105  may be a spring. Although the biasing member  105  is shown as being positioned between the legs  75 , it is to be understood that the biasing member  105  may be positioned anywhere on the device  10  to 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 legs  75 . 
         [0084]    A locking mechanism (not shown) may be provided to lock the legs  75  in 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 legs  75  from being compressed inwardly from the second engagement position to prevent accidental withdrawal from the incision  35 . 
         [0085]    As shown in  FIG. 10A ,  FIG. 10B , and  FIG. 10C , the neck  70  may be provided with one or more engagement members  80  (hereinafter referred to as “the first member  80 ”). The first member  80  is capable of engaging the patient to prevent removal of the device  10  from the patient during insertion of the implant  30 , to maintain alignment of the aperture  25  with the incision  35 , to prevent over insertion of the device  10  in the patient, and combinations thereof. The first member  80  may extend outward from the body  15  or the neck  70  to engage an internal part of the patient&#39;s body. In a non-limiting example, the first member  80  may engage an internal surface  85  opposite the external surface  90  or a portion of a surgical pocket (not shown) in the patient formed for the placement of the implant  30  therein. 
         [0086]    As shown in  FIG. 10A ,  FIG. 10B  and  FIG. 10C , the first member  80  may extend substantially perpendicularly outward from the legs  75  (or neck  70 ). It is to be understood, however, that the first member  80  may extend at any angle outward from the legs  75  (or neck  70 ) and may be curved or otherwise shaped to conform to the shape of the tissue to which it will engage. 
         [0087]    As shown in  FIG. 11A  and  FIG. 11B , the first member  80  may be selectively moveable between a non-engagement position ( FIG. 11A ) and an engagement position ( FIG. 11B ). The first member  80  may be moved by using one or more actuators  95 , such as a button, tab, or the like. The first member  80  may be positioned in the non-engagement position ( FIG. 11A ) for insertion through the incision  35  and extended to the engagement position ( FIG. 11B ) to engage the internal surface  85  for insertion of the implant  30  through the incision  35 . 
         [0088]    In a non-limiting example, the first member  80  may be secured to the body  15 . The first member  80  may be comprised of metal, polymer, plastic, fabrics, composites, and combinations thereof. It is to be understood that the first member  80  may be rigid, compressible, foldable, expandable, or stretchable. As shown in  FIG. 12 , the first member  80  may be substantially ring shaped and may extend outward from a flexible, bag-like body  15 . In a non-limiting example, the first member  80  may be comprised of a flexible material, including but not limited to a polymer, capable of being compressed or folded for insertion through the incision  35 . 
         [0089]    As best shown in  FIG. 13A , one or more arms  100  may be provided extending from the first member  80 . As best shown in  FIG. 13B , the arms  100  may be manipulated, for example by squeezing together, to compress or fold the first member  80 , the neck  70 , the portion of the body  15  surrounding the aperture  25 , or any combination thereof, to the non-engagement position for insertion through the incision  35 . As shown in  FIG. 13C  and  FIG. 13D , the first member  80 , the neck  70 , the portion the body  15  surrounding the aperture  25 , or any combination thereof, may be folded to the non-engagement position for insertion through the incision  35 . Although not shown in  FIG. 13C  and  FIG. 13D , it is to be understood that one or more arms  100  may be provided. 
         [0090]    Accordingly, the first member  80 , the neck  70 , the portion the body  15  surrounding the aperture  25 , or any combination thereof may be inserted in or through the incision  35  to reduce exposure of the patient and the implant  30  to contamination from the physician&#39;s gloves, hands, retractors and the like, thereby reducing the risk of infection or bacteria seeding. The arms  100  (if provided), the neck  70 , the first member  80 , the body  15 , or any combination thereof, may be released to allow the first member  80 , the neck  70 , the portion of the body  15  surrounding the aperture  25 , or any combination thereof, to return to the engagement position as shown in  FIG. 13A . 
         [0091]    In an embodiment, an engagement member  120  (hereinafter referred to as “the second member  120 ”) may be provided for engaging the external surface  90  of the patient&#39;s skin. As shown in  FIG. 17A  and  FIG. 17B , the first member  120  may be secured to the body  15  or the neck  70 . As shown in  FIG. 18A  and  FIG. 18B , the second member  120  may engage the external surface  90  to secure the device  10  to the patient, to maintain alignment of the aperture  25  with the incision  35 , to prevent over insertion of the any portion of the device  10  in the incision  35  (for example, during insertion of the implant  30 ), and combinations thereof. Over insertion of the device  10  in the patient may introduce bacteria or foreign matter in the patient, or cause trauma to the patient. 
         [0092]    In a non-limiting example, the second member  120  may be capable of providing a vacuum when engaged with the external surface  90  to secure the device  10  thereto. It is to be understood, however, that other configurations of the second member  120  may be used to secure the device  10  to the external surface  90 , including, but not limited to clamps, ribbons, and the like. Although shown as substantially ring shaped, the second member  120  may be any shape capable of engaging the external surface  90 . The second member  120  may be comprised of metal, polymer, plastic, fabrics, composites, and combinations thereof. It is to be understood that the second member  120  may be rigid, compressible, expandable or stretchable. 
         [0093]    It is to be understood that the second member  120  may be integral with the body  15  or the neck  70  and may be removeably secured to the body  15  or the neck  70 . As best shown in  FIG. 19A  and  FIG. 19B , the second member  120  may be provided in combination with the first member  80 . As shown in  FIG. 20A  and  FIG. 20B , the second member  120  may engage the external surface  90  and the first member  80  may engage the internal surface  85 . In a non-limiting example, the second member  120  and the first member  80  may be selectively positionable or biased toward each other to sandwich or compress the tissue  37  therebetween. 
         [0094]    The second member  120 , the first member  80 , or both the second member  120  and the first member  80  may be selectively positionable along the neck  70  or body  15 . In a non-limiting example as shown in  FIG. 21A ,  FIG. 21B , and  FIG. 21C , the neck  70  may be provided with a series of apertures  130 . The second member  120 , the first member  80 , or both the second member  120  and the first member  80  may be provided with an actuator  140 , such as a pin, to selectively engage the apertures  130  to lock the second member  120  or the first member  80  at a desired position on the neck  70 . 
         [0095]    In another illustrative example, as shown in  FIG. 23A  and  FIG. 23B , either or both of the members  120  and  80  may be rotated to wrap the body  15  (and/or neck  70 ) thereabout to decrease the distance d m1  and d m2  therebetween (where d m1 &gt;d m2 ). As shown in FIGS.  FIG. 24A  and  FIG. 24B , the second member  120  may be rotated after insertion of the first member  80  through the incision  35  to selectively engage the tissue  37  therebetween. 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 members  120  and  80  along the body  15  or neck  70 . 
         [0096]    As shown in  FIG. 22A  and  FIG. 22B , the first member  80  may be inserted through the incision  35  to engage the internal surface  85 . As shown in  FIG. 22B , the second member  120  may be selectively positioned to engage the external surface  90  to sandwich or compress the tissue  37  therebetween to, for example, secure the device  10  to the tissue  37 , to maintain alignment of the aperture  25  with the incision  35 , prevent over insertion of the device  10  through the incision  35 , and combinations thereof. 
         [0097]    As shown in  FIG. 25 , the body  15  may be capable of being inverted to allow the user  200  to insert their hand  205  (or a portion thereof) through the incision  35  to manipulate or otherwise position the implant  30  in the surgical pocket without directly contacting the skin, the implant  30 , or the surgical pocket. Accordingly, the user  200  may 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 implant  30  and in the patient and the surgical pocket. 
         [0098]    In an embodiment as shown in  FIG. 26 , a port  150  is provided for insertion of a hand or tool in the cavity  20 . As best shown in  FIG. 27 , the port  150  may be shaped like a glove to facilitate insertion of the user&#39;s hand  205  therein. The port  150  provides access to the cavity  20  to allow the user  200  to manipulate the implant  30  therein, and allows the user  200  to transfer the implant  30  through the aperture  25  and the incision  35 . As best shown in  FIG. 28 , the port  150  may allow the user  200  to insert at least a portion of their hand  205  through the incision  35 , for example, to manipulate the implant  30  in the surgical pocket to facilitate proper positioning. It is to be understood that the port  150  may be comprised of the same material as the body  15 . In a non-limiting example, the body  15 , the neck  70 , and combinations thereof may be comprised of a rigid material and the port  150  may be comprised of a flexible material. 
         [0099]    Turning to the device  10 , an illustrative example of how to use the device  10  as illustrated in  FIG. 1 - FIG. 29D  is set forth below. As best shown in  FIG. 8A ,  FIG. 9A ,  FIG. 10A ,  FIG. 13B ,  FIG. 13C , and  FIG. 13D  the neck  70  (or a portion of the body  15 ) may be provided in a non-engagement position for insertion in the incision  35  without contacting (or substantially contacting) the external surface  90  to, for example, minimize the introduction of foreign material in the patient and the surgical pocket. As best shown in  FIG. 8B ,  FIG. 8C ,  FIG. 9B ,  FIG. 9C ,  FIG. 10B , and  FIG. 10C , the neck  70  (or a portion of the body  15 ) may be moveable from the non-engagement position to the engagement position to selectively engage the incision  35  walls to maintain the incision  35  in an open position with the aperture  25  substantially coaxially aligned with the incision  35 . 
         [0100]    As shown in  FIG. 22A , the first member  80  may be provided to engage the internal surface  85  to, for example, prevent withdrawal of the device  10  from the incision  35  during insertion of the implant. The second member  120  may be provided to engage the external surface  90  to, for example, secure the device  10  to the external surface  90  to maintain alignment of the aperture  25  with the incision  35 , to prevent over insertion of the device  10  in the patient, and combinations thereof. As shown in  FIG. 22A  and  FIG. 22B , the second member  120  may be selectively positionable from a first non-engagement position ( FIG. 22A ) to a second engagement position ( FIG. 22B ). 
         [0101]    As best shown in  FIG. 29A  and  FIG. 29B , the implant  30  may be aligned with the incision  35  for insertion therethrough. It is to be understood that the body  15  (or a portion thereof) may be flexible and allow the user  200  to manipulate or transfer the implant  30  through the incision  35 , as shown in  FIG. 29C ,  FIG. 29D , and  FIG. 29E , without directly contacting the implant  30 , to minimize the introduction of foreign matter and bacteria to the implant  30  and in the patient and the surgical pocket. As best shown in  FIG. 29B ,  FIG. 29C ,  FIG. 29D , and  FIG. 29E , the aperture  25  may be larger than the implant  30  and the body  15  may be flexible and shaped so as not to constrict or otherwise compress the implant  30  during insertion through the incision  35 . Accordingly, the device  10  may limit compression or trauma exerted on the implant  30  to that imposed thereon by the tissue  37  surrounding the incision  35 , the fingers, or tools of the user  200  used to transfer the implant  30  therethrough. 
         [0102]    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.

Technology Category: 1