Patent Abstract:
A system for simulating a surgical procedure, which includes a housing covering an anatomical model. The model is made up of simulated tissue supported on a base assembly that allows pivoting and rotation of the simulated tissue. The simulated tissue includes a portion that represents soft tissue, such as dermal tissue, muscle, connective tissue and the like, and a portion that represents hard tissue, such as osseous tissue. The housing includes apertures through which a surgical instrument may be inserted for simulating a procedure on the simulated tissue. Cannulas may be set within the apertures.

Full Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of, and claims priority to and the benefit of, co-pending U.S. patent application Ser. No. 13/927,756, filed Jun. 26, 2013, which claimed priority from U.S. patent application Ser. No. 12/711,885, filed Feb. 24, 2010, and which claimed priority from U.S. Provisional Application Ser. No. 61/153,096, filed Feb. 24, 2009, the full disclosures of which are hereby incorporated by reference herein for all purposes. 
    
    
     BACKGROUND 
     1. Field of Invention 
     The device and method described herein concerns the field of simulating medical procedures. More specifically, a device is described that provides a modular manner of simulating different surgical procedures. 
     2. Description of Related Art 
     Some newly developed medical procedures and/or devices are sufficiently innovative that their practice requires experienced medical practitioners to undergo specific training to become proficient with the new procedure. The training for the new medical procedures, such as surgery, may incorporate devices that model anatomy. Simulating a procedure on a model rather than a patient is significantly safer and less expensive. A drawback of currently known models is they often represent a unique or single portion of anatomy. Additionally, currently known models are typically inflexible and not adjustable for multiple orientations. 
     SUMMARY OF INVENTION 
     The device and method described herein includes a surgical simulation device. In an embodiment, a surgical simulation device includes simulated tissue, an aperture support offset a distance from the simulated tissue that comprises a curved dome that covers the simulated tissue, and an aperture formed through the aperture support and facing the simulated tissue so that when a surgical procedure is simulated on the simulated tissue, a surgical instrument is inserted through the aperture to simulate inserting the surgical instrument through an incision in tissue. 
     In an embodiment, disclosed is an anatomical model for use in simulating a surgical procedure that has a base having an upper surface, a curved dome having an inner surface facing the upper surface of the base and which defines a space, simulated tissue coupled to the base that is set a distance from the upper surface in the space and set back a distance from the dome, and an aperture strategically disposed in a sidewall of the dome, so that when a surgical procedure is simulated on the simulated tissue, a surgical instrument is inserted through the aperture to simulate inserting the surgical instrument through an incision 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       Some of the features and benefits of the present invention having been stated, others will become apparent as the description proceeds when taken in conjunction with the accompanying drawings, in which: 
         FIG. 1  is a side perspective view of training for a surgical procedure using a simulation device. 
         FIG. 2A  is a perspective view of a simulation assembly with simulated tissue and a substrate. 
         FIG. 2B  is a perspective view of an alternative embodiment of a simulation assembly with simulated tissue and a substrate. 
         FIG. 3  is a perspective view of a simulation device and simulation assembly in a housing. 
         FIG. 4  is a side perspective view of a simulation device and simulation assembly in a housing and cannulas protruding through the housing. 
         FIGS. 5A and 5B  are side perspective views of the device of  FIG. 4  having sutures in the simulated tissue and simulated substrate. 
         FIGS. 6A and 6B  are side perspective views of a simulation assembly in horizontal and vertical orientations in a housing with simulated tissue sutured to simulated substrate. 
         FIGS. 7A and 7B  are upper and lower side perspective views of a base. 
         FIG. 8  is a perspective view of an example substrate with a circumscribing ring. 
         FIG. 9  is a side perspective view of an example of a disc. 
         FIG. 10  is a perspective view of an embodiment of a yoke. 
     
    
    
     While the invention will be described in connection with the preferred embodiments, it will be understood that it is not intended to limit the invention to that embodiment. On the contrary, it is intended to cover all alternatives, modifications, and equivalents, as may be included within the spirit and scope of the invention as defined by the appended claims. 
     DETAILED DESCRIPTION OF INVENTION 
     The present invention will now be described more fully hereinafter with reference to the accompanying drawings in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the illustrated embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. 
     With reference now to  FIG. 1 , an example of a surgical simulation device  10  is shown in a perspective view. In this embodiment the surgical simulation device  10  includes a base  12  with a cylindrically shaped disc  13  mounted from below. The upper surface of the disc  13  registers with an aperture formed axially through the base  12 . The upper surface of the base  12  features a central circumferential taper toward the aperture. A lateral side is formed at the outer periphery of the base  12  where it projects substantially perpendicular to the axis of the base  12 . A bore  16  is shown extending laterally into the lateral side of the base  12 . The disc  13  is coaxially rotatable within the base  12  and provides a mounting surface for a yoke  14 . The yoke  14  shown is a “U” shaped member having a mid-portion mounted on the upper surface of the spindle  13 . The yoke  14  curves between the mid-portion and its opposing ends so that the opposing ends project away from the base  12 . An elastic member  18  is shown looping around both ends of the yoke  14  and suspended above and perpendicular to the base  12 . In other embodiments, the member  18  may be fully rigid or inelastic. The elastic member  18 , which in one example represents connective tissue, can be readily placed on or off the yoke  14  for simulating a surgical procedure. An example simulated surgical procedure is shown where a surgical instrument  15  is being manually manipulated to knot a demonstration cord  20  around the elastic member  18  for drawing together both sides of the elastic member  18 . The surgical instrument  15  and cord  20  are depicted for demonstration purposes, however actual surgical instruments and suture materials may also be included with the embodiment of  FIG. 1 . 
     An example of a simulation assembly  22  is shown in perspective view in  FIG. 2A  and having a shaped piece of simulated tissue  24  mounted on a substrate  26 . As shown, the simulated tissue  24  is generally planar and profiled at its corner portions so that it resembles a clover leaf. In this example the simulated tissue  24  can represent a rotator cuff. Example materials for the simulated tissue  24  include elastomers such as rubber and foam, as well as felt, cloth, combinations thereof and the like. The substrate  26  includes a hemispherical upper portion  27  shown set on a cylindrical lower portion  29 ; the simulated tissue  24  is mounted on the upper portion. A band of simulated tissue  28  circumscribes the outer periphery of the cylindrical lower portion  29 . The substrate  26  can be used for simulating bone. The substrate  26  material can be rigid but allow for suturing (example materials include foam, such as a polyurethane foam) but may be made of other materials as well such as a polystyrene or polystyrene like material. 
     An alternative example of a simulation assembly  22 A is illustrated in a side perspective view in  FIG. 2B . In this example the simulation assembly  22 A includes a substrate  26 A having a frusto-conical upper portion  27 A and a cylindrically shaped lower portion  29 A depending from the lower surface of the upper portion  27 A. The upper portion  27 A has a planar upper surface on which simulated tissue  24  is attached. The upper portion  27 A has lateral sides that taper radially outward from between the upper surface to the lower surface of the upper portion  27 A. 
       FIG. 3  provides in side perspective view an examples of the simulation assembly  22  mounted onto the yoke  14  of the simulation device  10 . A ring  31  is shown circumscribing the substrate  26 , bores (not shown) in the yoke  14  register with bores through the side wall of the ring  31 . Fasteners  30  are shown provided that extend through the registered bores in the yoke  14  and ring  31  and into the substrate  26 . The fasteners  30  can be threaded with matching threads in the bore in the ring  31 , or can be pin like members that pass through the bores in the ring  31 . Optionally, the fasteners  30 , when applied, can compress the ring  31  to bind the assembly  22  therein instead of piercing the substrate  26 . 
     In the configuration of  FIG. 3 , the assembly  22  may pivot about an axis A X  aligned with the fasteners  31 ; the assembly  22  may also rotate about an axis A Y  of the base  12  and the disc  13 . In an example, the disc  13  is coaxial with the axis A Y  and thus rotates within the base  12  about the axis A Y . Provided with this embodiment is a housing  32  shown secured to the base  12  and enclosing the simulation assembly  22 . In the example illustrated, the housing  32  lower end is open and encircles the outer periphery of the base  12 , the housing  32  extends upward from the base  12  substantially parallel with the axis A Y  and curves inward to form a dome like upper portion over the simulated tissue  24 . Alternatively, the housing  32  can have an upper end with other shapes, such as conical, cylindrical or asymmetric and can have an outer surface that is uneven or includes undulations. In yet another alternative, the housing  32  can be clear, translucent, or opaque and/or may include strips that have at least a portion supported in a space around the simulation assembly  22 . 
     Referring now to  FIG. 4 , the housing  32  is equipped with apertures  36  and cannulas  34  are shown inserted through the apertures  36 . Thus in  FIG. 4 , the housing  32  serves as a support for the aperture  36 . Alternatively, an aperture support can be any member for supporting an aperture  36  in space and offset from the simulation assembly  22 . Examples include a planar web element having an end supported on a surface proximate the simulation assembly  22  that extends to a location offset from the simulation assembly  22 . Grommets  38  as shown may optionally be set within the apertures  36 . The cannulas  34 , which are obtainable from most medical supply sources, provide conduits for insertion of surgical instruments (not shown) through the housing  32  and into the simulation assembly  22 . Thus a surgical procedure can be simulated by directing cannulas  34  at the simulation assembly  22  and inserting surgical instruments through the cannulas  34  to simulate a procedure on the simulation assembly  22 . In an example, the housing  32  represents patient or subject tissue through which surgical instruments are inserted and the apertures  36  can each represent an incision. 
       FIGS. 5A and 5B , which are similar to the illustration in  FIG. 4 , further include sutures  40  shown formed through the simulated tissue  24  and the substrate  26 . The sutures  40  were formed with a surgical device inserted through a cannula  34  mounted in the housing  32 . Referring now to  FIG. 5B , the simulation assembly  22  is shown pivoted about the axis A X  and oriented transverse from its orientation of  FIG. 5B . Accordingly, the pivoting ability of the simulation assembly  22  on the yoke  14  provides flexibility for different simulation orientations.  FIGS. 5A and 5B  depict simulated examples of a completed arthroscopic rotator cuff repair. In an example, the simulated tissue  24 ,  28  represents mammal soft tissue, such as epidermis, connective tissue, muscle, tendons, ligaments, combinations thereof, and the like. Optionally, the substrate  26  represents hard tissue, such as an osseous or osseous like material. 
     Further orientation flexibility is demonstrated in  FIGS. 6A and 6B  where the simulation assembly  22  is shown with its lower side disposed in a plane substantially parallel with axis A Y  ( FIG. 6A ) and its lower side facing the housing ( FIG. 6B ). In both views sutures  40  are provided through the simulated tissue  28  and the substrate  26  lower surface.  FIGS. 6A and 6B  portray examples of a completed glenoid labrum repair. Thus the simulation assembly  22  can be fully rotated about both A X  and A Y  axes to position the assembly  22  into arty desired orientation thereby providing for a simulated surgical procedure from multiple directions. 
       FIG. 7A  illustrates a perspective and view of an example of the base  12 . The base  12  as shown is a disc-like member with its radius greater than its length or thickness and includes an annulus  126  aligned with its axis. Side bores  122 ,  124  are shown laterally extending through the base  12 ; side bore  124  extends from the base  12  outer periphery to the annulus  126 . Vertical bores  128  are shown formed upward into the base  12  from its bottom surface. A lip  129  can optionally be included on the base  12  periphery at its lower end. The annulus  126  is shown circumscribed by a recess  122  at its lower entrance. The side bore  124  may be fitted with a resilient member  125 , such as a spring, and a detent element  123 , wherein the member  125  urges the detent element  123  from the side bore  124  into the annulus  126 .  FIG. 7B  illustrates a side sectional view of the disc  12 . Here the lip  129  is shown extending radially outward past the enter radius of the annulus  126 . 
       FIG. 8  illustrates in a perspective side view an example of a substrate  26  with an accompanying ring  31 . The substrate  26  is shown having an upper bore  262  shown formed into the upper portion  27  of the substrate  26  and substantially aligned with the axis A Y . The upper bore  262  can be threaded to couple with an attachment for the simulated tissue  24  (see  FIG. 3 ). Side bores  310  are shown formed through the side wall of the ring  31  for coupling the ring  31  to the lower portion  29  of the substrate  26 . The bores  310  can be smooth or threaded and dimensioned to receive fasteners  30  therein. 
     A side perspective view of an example of the disc  13  is provided in  FIG. 9 . As shown, the disc  13  includes a cylindrically shaped spindle  132  set substantially coaxial with an axis A D  of the disc  13 . A disc like flange  130  projects radially outward from the lower end of the spindle  132 . A slot  134  is provided on the upper surface of the spindle  132  and transverse to the axis A D  of the disc  13 . The slot  134 , as shown, is formed to receive the mid-portion of the yoke  14 . A bore  138  shown formed coaxial with the axis A D  extends through the spindle  132  from the bottom of the slot  134 . A threaded fastener, not shown, can be inserted into the bore  138  to secure the yoke  14  within the slot  134 . Bores  136  are illustrated formed in the outer periphery of the spindle  132  and oriented generally towards the axis A D . The spindle  132  is insertable into the annulus  126  of the base  12  and can axially rotate therein. Rotating the disc  13  with respect to the base  12  selectively registers the bores  136  with the side bore  124 ; the pushing force supplied by the resilient member  125  urges the detent element  123  (see  FIG. 7A ) to enter an aligned bore  136  when registered with the side bore  124 . Applying a rotational torque onto the base  12  can disengage the detent element  123  from the registered bare  136  enabling the disc  13  to rotate within the base  12  and into a different angular orientation. The disengaging force required to disengage from locking detent element  123  can prevent the base  12  from freely rotating about its axis A X . The amount of force necessary to compress the resilient member  125  will dictate the disengaging rotational force. 
       FIG. 10  illustrates an example of the yoke  14  in a side perspective view. As shown, the yoke  14  is a generally curved member having a bore  140  formed through at roughly its midsection  148 . The bore  140  is shown as threaded to receive a fastener (not shown), which may be threaded, for attachment to the disc  13 . The line yoke  14  curves with distance from its midsection  148  with its ends  142  a distance apart and away fern the midsection  148 . The yoke  14  as shown is an elongated member having a generally rectangular cross section. Curved recesses  146 , that may receive the elastic member  18 , are shown provided on the lateral sides of each of the ends  142 . Also shown formed on the ends are bores  144  oriented towards one another and normal to the bore  140 . The bores  144  may be registered with bores  310  so fasteners  30  can be inserted through the registered bores  144 ,  310 . 
     In an embodiment, a simulation assembly  22  combined with a simulation device  10  can be used as a trainer for shoulder arthroscopy. The use of arthroscope and/or surgical cannulas is optional. The embodiments of the simulation device  10 , and all portions thereof described herein can be used to perform surgical procedures such as knot tying, suturing techniques, suture anchor insertion, suture management, rotator cuff repair, anterior glenoid labrum (Bankart) repair, posterior glenoid labrum repair, SLAP repair, and combinations thereof. The simulated tissue may be flexible and include in its composition single as well as dual density EPF foam and other bone simulation materials. Red sponge rubber, neoprene, and Veltex® can be used as simulation tissue. Colors of the simulation tissue, or other components of the simulation device  10 , can be changed to match particular or desired color schemes. The surgical simulations can be semi-anatomic or schematic, can simulate left or tight body anatomy, can be oriented to represent “beach chair” or lateral decubitus position without repositioning the base. 
     It is to be understood that the invention is not limited to the exact details of construction, operation, exact materials, or embodiments shown and described, as modifications and equivalents will be apparent to one skilled in the art. It is not necessary that the supports have an annular opening, optionally the supports may comprise a shoulder or be semi-circular. In the drawings and specification, there have been disclosed illustrative embodiments of the invention and, although specific terms are employed, they are used in a generic and descriptive sense only and not for the purpose of limitation. Accordingly, the invention is therefore to be limited only by the scope of the appended claims.

Technology Classification (CPC): 6