Patent Publication Number: US-2023149724-A1

Title: Systems and Methods Configured to Insert an Implant in an Abdominal Wall Cavity

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. Pat. Application No. 16/955,362 filed Jun. 18, 2020, which is a U.S. National Stage application under 35 U.S.C. § 371 of International Application PCT/GB2018/053767 (published as WO 2019/122934 A1) filed Dec. 21, 2018, which claims the benefit of priority to U.S. Provisional Application No. 62/609,230 filed Dec. 21, 2017. Each of these prior applications are hereby incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure is related to embodiments of a system including an implant, one or more instruments configured to insert the implant, and a method of inserting the implant into a cavity in a body cavity. More specifically, the present disclosure is directed to embodiments of an implant, one or more instruments configured to insert the implant, and a method of inserting the implant into a pocket in an abdominal wall. 
     BACKGROUND 
     Medical devices exist that deliver stimulation to therapeutic targets within a body of a patient. For example, implants, such as pacemakers, deliver stimulation to one or more regions of a heart. Often these medical devices draw power from a power supply to function. Some known implants are implanted subcutaneously within the body of the patient. 
     U.S. Pat. No. 7,559,900 is directed to a medical device that includes a housing. The housing is subcutaneously implanted outside a patient’s ribcage. 
     U.S. Pat. No. 8,838,234 discloses a method for implanting a subcutaneous defibrillator. The method includes the steps of making an incision in the thorax, through a patient’s skin, creating a subcutaneous pathway, and moving a device through the incision into the subcutaneous pathway. 
     The above examples illustrate existing implants and methods of implantation that include accessing the internal tissues of a body of a patient by piercing the skin. Such approaches can lead to an increased potential for infection. A system configured to be implanted in an intra-abdominal pocket, and a method of implanting the system in an intra-abdominal pocket may result in a decreased potential for infection resulting from the implantation of the system. 
     SUMMARY 
     According to an aspect of the disclosure, a method of inserting an implant includes the step of making an incision in an abdominal wall with an instrument positioned within an abdominal cavity. The method further includes the steps of forming a pocket between a first surface of the abdominal wall and a second surface of the abdominal wall, such that the incision defines an opening into the pocket, inserting an implant through the opening and into the pocket, and closing the opening such that the implant is captured within the pocket. 
     According to an aspect of the disclosure, an implantation system configured to be inserted into a pocket defined by an abdominal wall includes an implant and an attachment mechanism. The attachment mechanism defines an interior space configured to receive the implant, and the attachment mechanism further defines an opening configured to provide passage into the interior space. The opening is further configured to be closed such that when the implant is positioned within the interior space, the implant is prevented from exiting the interior space through the opening and/or intra-abdominal contents are prevented from coming into contact with the implant. The attachment mechanism is configured to be secured to a surface of the abdominal wall defining the pocket. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description of illustrative embodiments of the application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the present disclosure, there is shown in the drawings illustrative embodiments. It should be understood, however, that the application is not limited to the specific embodiments and methods disclosed, and reference is made to the claims for that purpose. In the drawings: 
         FIG.  1    is a cross-sectional view of an abdominal wall; 
         FIG.  2    is a cross-sectional view of layers of the abdominal wall; 
         FIG.  3    is a view of an area where the falciform ligament attaches to the anterior abdominal wall; 
         FIG.  4    is a view of a pocket being formed in the area illustrated in  FIG.  2   ; 
         FIG.  5    is a view of the pocket illustrated in  FIG.  3   , being increased in size; 
         FIG.  6    is another view of the pocket illustrated in  FIG.  3   , being increased in size; 
         FIG.  7    is a view of an implant being inserted into the pocket illustrated in  FIG.  5   ; 
         FIG.  8    is a view of the implant and the pocket illustrated in  FIG.  6   , the implant being attached to the pocket; and 
         FIG.  9    is a view of the pocket illustrated in  FIG.  7   , after the implant is attached to the pocket and the pocket is closed. 
     
    
    
     DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS 
     Aspects of the disclosure will now be described in detail with reference to the drawings, wherein like reference numbers refer to like elements throughout, unless specified otherwise. Certain terminology is used in the following description for convenience only and is not limiting. The term “plurality,” as used herein, means more than one. The terms “a portion” and “at least a portion” of a structure include the entirety of the structure. Certain features of the disclosure, which are described herein in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure that are described in the context of a single embodiment may also be provided separately or in any subcombination. 
     Referring to  FIGS.  1  and  2   , a method of inserting an implant can include the step of making an incision  2  in a biological structure  4 . According to one aspect of the disclosure, the biological structure  4  is an abdominal cavity  5 , which can include an abdominal wall  6 . The abdominal cavity  5  can include a falciform ligament  8 , and a liver. The falciform ligament  8  holds the liver in place within the abdominal cavity  5 . 
     The incision  2  can be made at a location  10  on the abdominal wall  6 , for example the location  10  can include where the falciform ligament  8  attaches to the abdominal wall  6 . The abdominal wall  6  can include a plurality of layers of soft tissue. As shown, the abdominal wall  6  can include, a peritoneal surface  12  and skin  14 , the skin  14  spaced from the peritoneal surface  12  in an anterior direction AD. The abdominal wall  6  can further include, in order in the anterior direction AD from the peritoneal surface  12  to the skin  14 , extra peritoneal fat  16 , endoabdominal fascia  18 , transverse abdominus  20 , internal oblique  22 , external oblique  24 , Scarpa’s fascia  26 , Camper’s fascia  28 , or any combination thereof, 
     According to one aspect of the disclosure, the step of making the incision  2  includes the step of making the incision  2  in the peritoneal surface  12 . The step of making the incision  2  in the peritoneal surface  12  includes the step of terminating the incision  2 , with respect to the anterior direction AD, prior to reaching the skin  14 . According to one embodiment, the step of making the incision  2  in the peritoneal surface  12  includes the step of terminating the incision  2  with respect to the anterior direction AD, prior to reaching the endoabdominal fascia  18 . 
     Referring to  FIGS.  3  and  4   , an implantation system  100  can include instrumentation  102  configured to form a pocket  30  in the biological structure  4 . The instrumentation  102  can include forceps  104 , for example endoscopic forceps configured to manipulate the biological structure  4 , before, during, and after the incision  2  has been made. The step of making the incision  2  results in an opening  32  being formed. As shown in the illustrated embodiment, the opening  32  can provide passage through the peritoneal surface  12  in the anterior direction AD. The method can include the step of enlarging the opening  32 . According to one aspect of the disclosure, the step of enlarging the opening  32  includes the step of manipulating a portion  34  of the peritoneal surface  12  adjacent to the opening  32  and applying a force to the portion  34 . As shown, the portion  34  can be adjacent, for example inferior, to the opening  32 . The force can be applied via the forceps  104 , and can be applied in an inferior direction ID, which is perpendicular to the anterior direction AD, in the posterior direction PD, or both in the inferior direction ID and the posterior direction PD. 
     Referring to  FIGS.  5  and  6   , the method can include the step of forming the pocket  30 . The step of forming the pocket  30  can include the step of moving a first surface  38  of the abdominal wall  6  relative to a second surface  40  of the abdominal wall  6  in a posterior direction PD, which is opposite the anterior direction AD. Alternatively, the step of forming the pocket  30  can include the step of moving the second surface  40  of the abdominal wall  6  relative to the first surface  38  in an anterior direction AD, which is opposite the posterior direction OD. As shown, the step of forming the pocket  30  can include the step of moving the peritoneal surface  12  relative to the skin  14  in the posterior direction PD. The step of forming the pocket  30  can further include the step of moving tissue that is between the peritoneal surface  12  and the skin  14 , the step of removing tissue from between the peritoneal surface  12  and the skin  14 , or both. 
     Referring to  FIGS.  7  and  8   , the implantation system  100  can include an implant  120 . The implant  120  can include a housing  122  that encloses additional components of the implant  120 . The implant  120  can include a power source, an antenna, or both positioned within the housing  122 . The power source can include a rechargeable battery configured to receive power from a source remote from the implant  120 . For example, the power source can be configured such that when the implant  120  is positioned within the pocket  30 , the power source can receive power from a source located outside of the patient’s body. According to one aspect of the disclosure, the remote source is not in direct physical contact with the implant  120 . 
     The antenna can be configured to transmit data, receive data, or both. According to one aspect of the disclosure, the antenna can be configured to transmit data about the implant  120 , for example an amount of power remaining in the power supply, to a data receiver that is remote from the implant  120 . For example, the antenna can be configured such that when the implant  120  is positioned within the pocket  30 , the antenna can transmit or receive data from a data receiver or data source located outside of the patient’s body. In some embodiments, a plurality of antennae may be provided. In such cases, a first antenna may be provided for communication between the implantation system  100  and the data receiver that is remote from the implant  120 ; and a second antenna may be provided for wireless charging of the implantation system. Communication between the implantation system  100  and the data receiver may be performed via Bluetooth, for example, or any other suitable communications protocol. 
     The method can include the step of charging the power supply of the implant  120  from a power source located outside the abdominal cavity of the patient, for example outside the patient’s body, while the implant  120  is located in the pocket  30 . The method can include the step of sending data to the antenna of the implant  120  from a data source located outside the abdominal cavity of the patient, for example outside the patient’s body, while the implant  120  is located in the pocket  30 . The method can include the step of receiving data from the antenna of the implant  120  while the implant  120  is located in the pocket  30 . 
     The implantation system  100  can include an attachment mechanism  130  configured to secure the implant  120  within the pocket  30 . According to one aspect of the disclosure, the attachment mechanism  130  includes a mesh envelope  132 . The attachment mechanism  130  can include an interior space  134  configured to receive the implant  120 . The attachment mechanism  130  can further include an opening  136  that defines a pathway into the interior space  134 . The attachment mechanism  130  can be configured such that the opening  136  is able to be closed once the implant  120  is positioned within the interior space  134  to prevent removal of the implant  120  from the interior space  134 . The attachment mechanism  130  may include at least one suture. Accordingly, the implant  120  (or a part thereof - for example, the mesh envelope  132 ) may be provided with at least one suture hole, each configured to receive a suture. The implant  120  (or a part thereof - for example, the mesh envelope  132 ) may be provided with at least one suture tab which extends beyond the main portion of the implant  120  or mesh envelope  132 , and/or is positioned at the extremities of the implant  120  or mesh envelope  132 . The at least one suture tab may be evenly spaced about the implant  120  or mesh envelope  132 . Optionally, each suture tab may have a rectangular opening, which may or may not be the same as the suture hole. Each suture hole may be positioned on a different suture tab. In one example, the attachment mechanism  130  comprises four sutures, and the implant  120  or mesh envelope  132  is provided with four evenly-spaced suture tabs, each having a suture hole which is configured to receive one of the four sutures. 
     The attachment mechanism  130  can be configured such that when the opening  136  is closed, a pathway is defined to allow a portion of the implant  120  to exit the interior space  134  without allowing the housing  122  to exit the interior space  134 . According to one aspect of the disclosure, the implantation system  100 , for example the implant  120 , can include an electrical cable  140 . The implantation system  100  can include an electrode and the electrical cable  140  can be configured to deliver power from the power supply to the electrode. 
     According to one aspect of the disclosure, the electrical cable extends from the housing  122 , and the attachment mechanism  130  is configured to define a pathway for the electrical cable  140  to exit the interior space  134  when the opening  136  is closed. The attachment mechanism  130  can be configured to be secured to a surface of the abdominal wall  6  to secure the implant  120  relative to the abdominal wall  6 . As shown in the illustrated embodiment, the attachment mechanism  130  can include a mesh body  138  that is configured to be sutured to a surface of the abdominal wall  6  within the pocket  30 . The mesh body  138  can include a plurality of holes configured to allow passage of one or more sutures or other fixation means, such as staples, clips or tacks to secure the attachment mechanism  130  to the abdominal wall  6 . 
     The method can include the step of inserting the implant  120  through the opening  136  of the attachment mechanism  130  and into the interior space  134  of the attachment mechanism  130 . The method can include the step of inserting the implant  120 , the attachment mechanism  130 , or both into the pocket  30 . The method can include the step of attaching the implantation system  100  to the abdominal wall  6  when the implantation system  100  is in the pocket  30 . According to one aspect of the disclosure, the step of attaching the implantation system  100  to the abdominal wall  6  can include the step of attaching the attachment mechanism  130 , with the implant  120  positioned in the interior space  134 , to the abdominal wall  6 , for example by suturing, tacking (with absorbable tacks, permanent tacks, or both), gluing, or any combination thereof the attachment mechanism  130  to the abdominal wall  6 . According to another aspect of the disclosure, the step of attaching the implantation system  100  to the abdominal wall  6  can include the step of attaching the implant  120  directly to the abdominal wall  6 , for example by suturing the implant  120  directly to the abdominal wall  6 . 
     The method can include the step of attaching the attachment mechanism  130  to the abdominal wall  6  when the attachment mechanism  130  is in the pocket  30 . According to one embodiment, the step of attaching the attachment mechanism  130  to the abdominal wall  6  can include the steps of fixing the implant  120  to the attachment mechanism  130 , and fixing the attachment mechanism  130  to the abdominal wall  6 . For example, when the attachment mechanism  130  comprises at least one suture and the implant  120  (or a part thereof - for example, the mesh envelope  132 ) has corresponding suture tabs and suture holes, each suture may be placed through a corresponding suture hole. The suture may then be tied, at its midpoint, to the suture tab. This reduces the risk of the suture being dislodged during subsequent manipulations. 
     After placement of the sutures, the implant  120  may be held using a laparoscopic tenaculum which is configured to grip the rectangular opening in each of the suture tabs. This is used to guide the implant  120  through the trocar into the abdominal cavity. Then, within the pocket  30 , the orientation and position of the implant  120  is determined. This may require placing the implant  120  in the pocket initially. The cranial most extent of the implant  120  is then determined, and incisions, each having a length of 2-3 mm, are made in the skin approximately 2 cm apart. These incisions form at least one opening which correspond to the desired location of the extremities of the implant  120 . 
     A transfascial suture passer, for example a Carter-Thomason suture passer or an EndoClose suture passer, is introduced through each of the openings and advanced through the fascia. For an implant  120  having four suture holes, using two sutures, one end of each suture is placed through a corresponding suture hole on the two cranial most suture tabs. The end of each suture is then grasped and used to draw the implant  120  into the pocket  30 . The end of each suture is then clamped above the skin. Next, the suture passer is introduced through the same opening and is passed through the fascia approximately  5  to 10 mm more lateral than the previously placed suture. The second end of each of the sutures is then brought out to this laterally spaced hole. This process may then be repeated on the caudal two most sutures. Similar methods may also be used with different numbers of sutures. 
     Subsequently, the sutures are tied to secure the implant  120  in place in the pocket  30 . The security the implant  120  is confirmed by passing a probe between the fascia and the implant  120 . If stability of the implant  120  is deemed satisfactory the sutures are then cut. 
     In another example, the step of attaching the attachment mechanism  130  to the abdominal wall  6  can include the steps of suturing the implant  120  to the attachment mechanism  130 , for example a small section of mesh, and suturing, tacking (with absorbable tacks, permanent tacks, or both), gluing, or any combination thereof the attachment mechanism  130  to the abdominal wall  6 . According to one aspect of the disclosure, the attachment mechanism  130  is configured to self-affix or self-retain to the abdominal wall  6  without the use of an additional fixation element. 
     The method can include the step of closing the opening  136  of the attachment mechanism  130  such that the housing  122  of the implant  120  is prevented from exiting the interior space  134  through the opening  136 . 
     The method can include the step of attaching an electrode to a biological structure, for example a splenic nerve. The method can further include the step of connecting the electrode to power supply of the implant  120 , for example by coupling the electrical cable to at least one of the power supply and the electrode. 
     Referring to  FIG.  9   , the method can include the step of closing the pocket  30  when the implant  120  is inside the pocket  30 , such that the implant  120  is prevented from exiting the pocket  30  through the opening  32 . The step of closing the pocket  30  may further include the step of isolating the implant  120 , the attachment mechanism  130 , or both and any intra-abdominal contents. According to one aspect of the disclosure, the closing step can include tacking the first surface  38  to the second surface  40 . The closing step can include the step of providing a pathway for a portion of the implantation system  100  to exit the pocket  30 . 
     As shown in the illustrated embodiment, the closing step includes the step of providing a pathway through which a portion of the implantation system  100 , for example the electrical cable, can exit. According to one aspect of the disclosure, the portion of the implantation system  100  that exits the pocket  30  can be positioned at a location used for other intra-abdominal procedures. For example, the portion of the implantation system  100  can be positioned at a location commonly used for setting laparoscopic bands, for example an upper, or superior, portion of a stomach. Positioning the portion of the implantation system  100  in a location used in other procedures can result in an improved long-term safety profile for the implantation of the implantation system  100 . 
     Referring to  FIGS.  1  to  9   , according to one aspect of the disclosure, the method can be performed in its entirety without making an incision in the skin  14 . According to another embodiment, the instrumentation  102  can include a trocarThe instrumentation  102  can further include a camera, for example a 5 mm camera, configured to be inserted through the trocar. The method can include the step of discharging a patient from a facility where the implantation was performed within twenty-four hours of completion of the implantation. 
     The following is a non-exhaustive list of embodiments of the invention, which may or may not be claimed.
     1. A method of inserting an implant comprises the steps of: making an incision in an abdominal wall with an instrument positioned within an abdominal cavity; forming a pocket between a first surface of the abdominal wall and a second surface of the abdominal wall, such that the incision defines an opening into the pocket; inserting an implant through the opening and into the pocket; and closing the opening such that the implant is captured within the pocket.   2. The method of embodiment 1, wherein the abdominal cavity includes a falciform ligament, and the step of making the incision includes the step of making the incision in an area where the falciform ligament attaches to the abdominal wall.   3. The method of embodiment 1 or 2, wherein the abdominal wall includes an anterior portion, and the area includes where the falciform ligament attaches to the anterior portion of the abdominal wall.   4. The method of any previous embodiment, wherein the step of forming the pocket includes the step of moving the second surface of the abdominal wall relative to the first surface of the abdominal wall.   5. The method of any previous embodiment, wherein the step of forming the pocket includes the step of moving tissue positioned between the first surface and the second surface within the pocket.   6. The method of any previous embodiment, wherein the step of forming the pocket includes the step of removing tissue positioned between the first surface and the second surface from the pocket.   7. The method of any previous embodiment, further comprising the step of securing the implant to at least one of the first surface and the second surface.   8. The method of any previous embodiment, wherein the step of securing the implant to at least one of the first surface and the second surface includes the step of suturing, tacking, gluing, or any combination thereof, the implant to at least one of the first surface and the second surface.   9. The method of any previous embodiment, further comprising the step of securing the implant to an attachment mechanism.   10. The method of any previous embodiment, wherein the attachment mechanism defines an interior space and an opening configured to provide passage into the interior space.   11. The method of any previous embodiment, further comprising the steps of: moving the implant through the opening and into the interior space; and reducing a size of the opening such that the implant is prevented from exiting the interior space through the opening.   12 The method of any previous embodiment, further comprising the step of securing the attachment mechanism to at least one of the first surface and the second surface.   13. The method of any previous embodiment, wherein the step of securing the attachment mechanism to at least one of the first surface and the second surface includes the step of suturing, tacking, gluing, or any combination thereof, the attachment mechanism to at least one of the first surface and the second surface.   14. The method of any previous embodiment, further comprising the steps of: attaching an electrode to a biological structure; and connecting a power supply of the implant to the electrode.   15. The method of any previous embodiment, wherein the connecting step includes the step of electrically coupling an electrical cable to both the power supply and the electrode.   16. The method of any previous embodiment, wherein the closing step includes the step of defining a pathway for the electrical cable to exit the pocket.   17. The method of any previous embodiment, further comprising the step of transferring power to the power supply from a power source, which is remote from the power supply.   18. The method of any previous embodiment, wherein the transferring step includes transferring power from the power source, which is located such that skin of the abdominal wall, and optionally also one, some or all of subcutaneous tissues, the anterior rectus sheath, the rectus abdominus muscle, the posterior rectus sheath, and tissues located between the peritoneal surface of the falciform ligament and the posterior rectus sheath, is between the power source and the power supply, to the power supply.   19. An implantation system configured to be inserted into a pocket defined by an abdominal wall comprises: an implant; and an attachment mechanism defining an interior space configured to receive the implant, the attachment mechanism further defining an opening configured to provide passage into the interior space, the opening further configured to be closed such that when the implant is positioned within the interior space, the implant is prevented from exiting the interior space through the opening, wherein the attachment mechanism is configured to be secured to a surface of the abdominal wall defining the pocket.   20. The implantation system of embodiment 19, wherein the implant includes a power supply.   21. The implantation system of embodiment 19 or 20, further comprising an electrode and an electrical cable, the electrical cable configured to deliver power from the power supply to the electrode.   22. The implantation system of any one of embodiments 19 to 21, wherein the attachment mechanism is further configured to provide a pathway for the electrical cable to exit the interior space while preventing the implant from exiting the interior space through the opening.   23. The implantation system of any one of embodiments 19 to 22, wherein the attachment mechanism includes a mesh body.   24. The implantation system of any one of embodiments 19 to 23, wherein the implant includes an antenna for transmitting and/or receiving data, and the antenna is configured to transmit data to a receiver, which is remote from the implant.   25. The implantation system of any one of embodiments 19 to 24, wherein the antenna is configured to receive data from a receiver, which is remote from the implant.   26. The implantation system of any one of embodiments 19 to 25, wherein the implant includes an antenna, and the antenna is configured to receive data from a receiver, which is remote from the implant.   27. The implantation system of any one of embodiments 19 to 26, wherein the implant includes an antenna for receiving power, and the antenna is configured to receive power from a power source, which is remote from the implant, for recharging the implant.   28. The implantation system of any one of embodiments 19 to 27, wherein the implant is configured to be inserted laparoscopically, robotically or via open surgery.   

     It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present disclosure as defined by the claims.