1. Technical Field
The present disclosure relates to a radio frequency (RF) based surgical implant fixation apparatus and, more particularly, to a radio frequency-based surgical implant fixation apparatus including an approximator assembly having a plurality of electrically conductive delivery arms for positioning a surgical implant adjacent to tissue for subsequent fusion thereto. Fusion enhancements and non-RF methods of adhering the implant to tissue are also disclosed.
2. Description of the Related Art
Hernias are abnormal protrusions of an organ or other body structure through a defect or natural opening in a covering membrane, e.g., a wall of a cavity that normally contains the organ or other body structure. For example, inguinal hernias are, typically, caused by soft tissue from the intestines protruding through the inguinal wall. Ventral hernias, on the other hand, are caused by internal organs pushing through to a weak spot in the abdominal wall.
The use of prosthetic mesh has now become accepted practice in the treatment of patients with both inguinal and ventral hernias, as well as other types of hernias, e.g., hiatal, femoral, umbilical, diaphragmatic, etc. To endoscopically apply the mesh for hernia repair, a surgical region (i.e., adjacent the cavity wall) is, typically, insufflated. Subsequently, a surgeon selects points on the cavity wall where the surgeon believes a peripheral edge of the mesh, i.e., the expected corners of a mesh (assuming a rectangular mesh), will be affixed. In certain instances, prior to affixing the mesh, the mesh is, initially, held in position by pressing on the mesh from outside the body while observing the mesh through a laparoscope or, conversely, pressing upward against the mesh with the use of one or more suitable devices, e.g., an atraumatic grasper or the like. Thereafter, the surgical mesh is often affixed, i.e., sutured or tacked using a fastener, to the cavity wall by conventional suturing techniques. Unfortunately, this method has shortcomings. First, due to movement of the mesh, correctly conforming the mesh to tissue is difficult. Further, correction of mispositioned mesh is difficult and time consuming. There is a need for a device that both positions mesh and fastens mesh to tissue.
The present disclosure provides a radio frequency-based surgical implant fixation apparatus. The radio frequency-based surgical implant fixation apparatus includes a housing and a shaft that is operably coupled to housing. A longitudinal axis is defined through the shaft. The housing is adapted to connect to a source of electrosurgical energy. An approximator assembly has an elongated rod that is coaxially coupled to the shaft and is configured to reciprocate therethrough from an extended position to a retracted position. A plurality of delivery arms is operably coupled to a distal end of the elongated rod. The delivery arms are configured to releasably receive a portion of a surgical implant and selectively connect to the energy source to transmit electrosurgical energy to the surgical implant to fuse the surgical implant to tissue upon actuation thereof.
The present disclosure provides a radio frequency-based surgical implant fixation apparatus. The radio frequency-based surgical implant fixation apparatus includes a housing and a shaft that is operably coupled to housing. A longitudinal axis is defined through the shaft. The housing is adapted to connect to a source of electrosurgical energy. A handle assembly includes a movable handle that is movable through an approximation stroke. An approximator assembly has an elongated rod that is coaxially coupled to the shaft and configured to reciprocate therethrough from a retracted position to an extended position through approximation of the movable handle. The elongated rod includes a plurality of compressible and extensible delivery arms operably coupled to a distal end thereof. The plurality of delivery arms is configured to releasably receive a peripheral portion of a surgical implant and selectively connect to the energy source to transmit electrosurgical energy to the surgical implant to fuse the surgical implant to tissue upon actuation thereof. Additional embodiments augment or replace the RF fusion. Another embodiment incorporates a balloon or expansible device that deploys to further control the implant position and press the implant against the tissue.
The present disclosure also provides a method for attaching a surgical implant to tissue. The method includes deploying a surgical implant from a radio frequency-based surgical implant fixation apparatus for positioning the surgical implant adjacent tissue of interest. The surgical implant is, subsequently, expanded so that the surgical implant is substantially taut. The surgical implant is manipulated to force the surgical implant against tissue of interest. And, electrosurgical energy is provided to a portion of the surgical implant to fuse the surgical implant to tissue.
Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
Detailed embodiments of the present disclosure are disclosed herein; however, the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
Referring to
With continued reference to
Shaft 18 extends from the housing 11 and includes a generally elongated configuration. A longitudinal axis “A-A” is defined through the shaft 18. Shaft 18 is configured to house the elongated rod 16 for reciprocation therein from a retracted position (not shown) to an extended position (see
Handle assembly 20 is operably supported on the housing 11. Handle assembly 20 includes a movable handle 30 (see
Rotating assembly 28 (see
Elongated rod 16 is coaxially-coupled (see
Delivery arms 14 (four (4) delivery arms are shown in the representative drawings) are positioned and operably secured at the distal end 32 of an elongated rod 16 via one or more suitable securement methods, e.g., soldering, brazing, welding, press or friction fit, etc. In the illustrated embodiment, the delivery arms 14 are configured to releasably receive a peripheral portion of surgical implant 24 to position the surgical implant 24 adjacent tissue, e.g., a surgical opening or wound in an abdominal wall “AW”, and for pressing the surgical implant 24 thereagainst. To facilitate positioning the surgical implant 24 adjacent to tissue (e.g., abdominal wall “AW”, see
Each delivery arm of the delivery arms 14 is independently movable with respect to the other delivery arms to allow proper apposition of the surgical implant 24 against tissue. Secondary instruments, such as atraumatic graspers (and the like) may be utilized to effect movement of each delivery arm relative to the plurality of delivery arms 14. Alternatively, one or more steering mechanisms or control mechanisms may be in operable communication with the delivery arms 14 and/or the elongated rod 16 to effect independent movement or control of each delivery.
Delivery arms 14 are fabricated from a resilient material that allow each delivery arm 14 to transition from a compressed state when the elongated rod 16 is in the retracted position (not explicitly shown), to an expanded state when the elongated rod 16 is in the extended position (see
With reference to
Continuing with reference to
Return electrode 38 includes a generally flat circumferential base 39 operable to releasably support the surgical implant 24 thereon (see
In certain instances, it may prove advantageous to provide an exterior surface of the active electrode 36 and/or return electrode 38 with one or more lubricious materials thereon, e.g., a coating of polytetrafluoroethylene (PTFE), to decrease charring and/or sticking of the surgical implant 24 to the active and/or return electrodes 36 and 38, respectively. A layer of insulative material 44 is operably disposed between the active and return electrodes 36 and 38, see
With reference again to
Surgical implant 24 is configured such that electrosurgical energy transmitted to the electrodes 36, 38 fuses the surgical implant 24 (or a portion thereof) to tissue positioned thereagainst. The surgical implant 24 may be configured such that the entirety of the surgical implant 24 fuses to tissue during the transmission of electrosurgical energy to the electrodes 36, 38, or only a portion of the surgical implant 24 fuses to tissue.
In certain embodiments, a peripheral portion 25 of the surgical implant 24 adjacent the electrodes may be made from or coated with metal, e.g., silver, nickel, titanium, gold, etc., that is configured to augment tissue fusion. In particular, the metal around the peripheral portion 25 is configured to provide an even distribution of electrosurgical energy to the surgical implant 24 to help fuse the surgical implant 24 to tissue and provide a more uniform and consistent fusion or union therebetween. Metal around the peripheral portion 25 can also assist by creating and distributing heat to the mesh and tissue. When creating heat in a metalized mesh, the energy applied by the electrode may need to be at a higher frequency, for example 13.56 MHZ.
Operation of the fixation device 10 is described in terms of a method for attaching a surgical implant 24 to tissue to repair a ventral hernia.
In use, shaft 18 is inserted through an access port previously affixed to an opening in tissue, i.e., though a muscle layer “ML” (see
Elongated rod 16 is, initially, in a retracted position with the delivery arms 14 in a compressed state. Proximal movement of the movable handle 30 moves the rod 16 from the retracted position to the extended position (see
Thereafter, electrosurgical energy is transmitted from electrosurgical energy source “ES” to the active electrodes 36 and return electrodes 38 of the delivery arms 14 and, thus, to a peripheral edge of the surgical implant 24 to fuse the surgical implant 24 to tissue (see
As can be appreciated, the above-mentioned shortcomings typically associated with conventional hernia repair methods are reduced and/or eliminated. That is, the surgical implant 24 is maintained in a substantially fixed orientation while the surgical implant 24 is being fused to the abdominal wall “AW” and, thus, the likelihood of the surgical implant 24 moving during attachment is reduced, if not eliminated.
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example, to facilitate positioning the surgical implant 24 adjacent tissue, one or more apertures 46 (shown in phantom in
To facilitate pulling tissue and surgical implant 24 toward one another or maintaining the surgical implant 24 against tissue, the return electrode 38 may include a generally “cup-like” configuration, i.e., the return electrode 38 may function as a suction cup. In this instance, a peripheral edge of the return electrode 38 may be curved or otherwise configured to provide suction around a perimeter of the return electrode 38.
As can be appreciated, plumes of smoke may develop when the surgical implant 24 is being fused to tissue. Accordingly, and in certain embodiments, the aperture 46 may be operable to evacuate plumes of smoke from the surgical site to provide better visualization of the surgical site to the surgeon.
A supplemental device may be utilized to facilitate pressing the surgical implant 24 against tissue prior to or during the application of electrosurgical energy. In particular, in some embodiments, the approximator assembly 12 may include or be in operative communication with an expandable member, such as, for example, a balloon 50 (see
In certain embodiments, one or more sensors 52 (see
Balloon 50 may be thermally or electrically conductive or non-conductive to achieve a desired surgical effect. For example, an exterior surface (or portion thereof) of the balloon 50 may include one or more conductive materials disposed thereon or may be made of a conductive material. The conductive exterior surface of the balloon 50 may be configured to facilitate or direct current flow from the active electrode 36 to the return electrode 38 when the surgical implant 24 is being fused to tissue.
Additional methods of attaching the mesh to tissue can also be to replace or augment using fusion at the end of arms 14. Mechanical methods include the use of known tacks and fasteners for hernia fixation. For instance, electrode 36 may be replaced with detachable barbed fasteners. Biological glues or bioadhesives that can also provide adhesion between a living biological tissue and a synthetic or biological material (e.g., hernia patch/mesh); thus, providing an attachment between tissue and the patch/mesh. The glues can be either multi component (e.g., fibrin glue or fibrin sealant), single component (e.g., cyanoacrylate) that are chemically or thermally initiated, UV initiated by light guides in arms 14 or any other glue suitable for clinical use. The glue may be dispensed automatically at the ends of the arms 14 or preapplied to the mesh.
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/469,898, filed on Mar. 31, 2011, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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61469898 | Mar 2011 | US |