Abstract:
A vertical organizational system for use in the operating room during surgery to hold surgical instrumentation is provided. The system includes a vertical support including a height and angle adjustable portion; vertical support assembly, a back panel, a pivoting spine assembly, a base interface member, casters, a base, an interactive user display, a tray shelf, a receptacle container, a primary working shelf, a formed base, a custom sterile drape, an identification system, a telescoping mayo stand, telescoping step stool, a light assembly, a sterile aerosol assembly, an instrument tray attachment device, telescoping cross rail extensions and a ceiling mounted boom assembly. The cantilever shelves are detachably attachable from the cross rails and helps maintain the sterile state of the instrumentation trays even if the rest of the rack is not maintained in a sterile state.

Description:
[0001]    This application is a non-provisional which claims the benefit of U.S. provisional patent application 62/121,710 filed Feb. 27, 2015, entitled CANTILEVER ORGANIZATIONAL RACK SYSTEM FOR SUPPORTING SURGICAL INSTRUMENTATION, which is incorporated herein by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       REFERENCE TO A “SEQUENCE LISTING” 
       [0003]    Not applicable. 
       BACKGROUND OF THE INVENTION 
       [0004]    1. Field of the Invention 
         [0005]    The present disclosure relates generally to surgical instrument organization and utilization throughout the life cycle of tools, instruments, and implant devices used in hospitals and surgery centers for a surgical procedure. In particular, the disclosure relates to an organizational system capable of providing a systematic protocol to ensure reliable inventory management for medical applications, more particularly to cabinets, racks, shelving, sterilization enhancement, software for operating rooms to be used during surgery. 
         [0006]    2. Description of Related Art 
         [0007]    Various cabinets, racks, tables and shelving have been used for assembling, storing, and transporting medical instruments, tools, and implant devices throughout hospitals and surgery centers for medical operations and procedures. Typically surgical instruments, tools and implant devices are washed, sterilized, wrapped, and stored until required instrumentation is set up in the operating room prior to surgery or a medical procedure. 
         [0008]    The numerous personnel including but not limited to patients, hospital administration, surgeons, nursing staff, scrub technicians, sterile processing employees, device manufacturers, manufacturers&#39; representatives along with the vast number of tools and instruments required for a specific surgery creates a need for precise coordination. 
       SUMMARY OF THE INVENTION 
       [0009]    The present disclosure is directed to various designs for an organizational system for use in the operating room during surgery to hold instruments. Preferred features for the design of the present disclosure include the following: 
         [0010]    1. multi-level rack design with adjustable angle shelves; 
         [0011]    2. modular rack units and options allow for customized room set-up based on surgeon, procedure, instrument requirements, and space limitations; 
         [0012]    3. mobility for easy movement of the racks around the hospital and operating room; 
         [0013]    4. removable sterilizable shelves that are easily set up, broken down, stored, wrapped and/or handled; 
         [0014]    5. rack includes a custom sterile drape; 
         [0015]    6. rack allows for co-branding opportunities, such as company and hospital brand, procedure techniques, logos, etc. 
         [0016]    7. adjustable rack height for technician or surgeon comfort and/or visual preferences; 
         [0017]    8. adjustable spine angle and orientation for technician or surgeon comfort and/or visual preferences; 
         [0018]    9. rack collapses into a down position for easy storage and stacking of multiple racks when not in use; 
         [0019]    10. rack may be designed to support at least 2 or more full instruments cases per shelf level; and 
         [0020]    11. rack ensures a consistent protocol for the use of surgical instruments; and 
         [0021]    Various embodiments of the present disclosure may exhibit one or more of the following objects, features and/or advantages: 
         [0022]    1. reduces or eliminates need for sterile cloth drapes to cover stainless steel tables; 
         [0023]    2. helps organize equipment trays with increased visibility and accessibility of instruments inside an operating room; 
         [0024]    3. reduces occurrence of situations where instruments are lost or misplaced due to a disorganized and inconsistent surgical room set-up and inventory management; 
         [0025]    4. allows accessible and organized surgery room storage of hundreds of instruments; 
         [0026]    5. prevents instrument trays from being “stacked” together during long surgical procedures and associated risk of bacteria growth; 
         [0027]    6. reduces or eliminates sterile field violations due to lack of floor space in sterile working area; 
         [0028]    7. helps reduce hospital infection rate; 
         [0029]    8. improved portability, instrument work space, efficiency, safety and/or standardization; 
         [0030]    9. helps to reduce the number of personnel in the operating room during surgery; 
         [0031]    10. reduces inefficiencies associated with instrumentation and implant use; 
         [0032]    11. creates opportunity for better space management of operating rooms; 
         [0033]    12. creates a standardized protocol for instrumentation use depending on surgery type, surgeon, device manufacturer; and 
         [0034]    13. allows a manufacturer&#39;s representative to be more effective and efficient. 
         [0035]    According to one aspect of the present disclosure, an organization rack system includes a rack assembly and a detachably attachable shelf unit. The rack assembly includes a frame assembly, telescoping tube assembly and a spine assembly. The frame assembly includes a base, and at least one vertical support rail. The vertical support rail is mechanically connected to the base and extends upwardly from the base. The spine assembly is mechanically connected to the vertical support rail and is supported by the telescoping tube assembly. The telescoping tube assembly mechanical connects the vertical support rail to the spine assembly. The shelf unit is detachably attachable to the spine assembly and adapted so that when the tray unit is detachably attached to the spine assembly, the shelf unit will remain in a sterile condition even when the rack assembly is not maintained in a sterile condition. 
         [0036]    According to a further aspect of the present disclosure, an operating room rack system includes a frame assembly, a telescoping tube assembly, a spine assembly, and an identification assembly. The support frame is mechanically connected to the spine assembly and which pivots about the frame to increase or decrease the angle between the vertical support rail and the spine assembly by extending or collapsing the telescoping tube assembly that is mechanically connected to the frame and spine assembly. The identification assembly is detachably attachable to the spine assembly and adapted so that when the shelf unit is detachably attached to the spine assembly, the shelf unit will remain in a sterile condition even when the rack assembly is not maintained in a sterile condition. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0037]    The present disclosure will be more fully understood and appreciated by reading the detailed description in conjunction with the accompanying drawings and parts list, wherein like reference characters denote similar elements throughout several views: 
           [0038]      FIG. 1A  is a perspective view of a first embodiment of a rack according to the present system with the shelves removed with the rack in an operational position. 
           [0039]      FIG. 1B  is a perspective view of a first embodiment of a rack according to the present system with the shelves removed with the rack in a storage position. 
           [0040]      FIG. 2  is an exploded perspective view of a first embodiment of a frame assembly according to the present system. 
           [0041]      FIG. 3  is an exploded perspective view of a first embodiment of a spine assembly according to the present system. 
           [0042]      FIG. 4  is an exploded perspective view of a first embodiment of a telescoping tube assembly according to the present system. 
           [0043]      FIG. 5A  is a perspective view of a first embodiment of a rack according to the present system with the shelves removed and a user interface in an operational position. 
           [0044]      FIG. 5B  is a perspective view of a first embodiment of a rack according to the present system with the shelves removed and a user interface a storage position. 
           [0045]      FIG. 6  is a perspective view of a first embodiment of a rack according to the present system with the tray shelves in place and with the rack in an operational position. 
           [0046]      FIG. 7  is a perspective view of a first embodiment of a rack according to the present system with the tray shelves and receptacle shelves in place. 
           [0047]      FIG. 8A  is a perspective view of a first embodiment of a rack according to the present system with the primary working shelf in an operational position. 
           [0048]      FIG. 8B  is a perspective view of a first embodiment of a rack according to the present system with the tray shelves in an operational position and the primary working shelf in a storage position. 
           [0049]      FIG. 9  is a perspective view of a first embodiment of a rack according to the present system with the shelves removed and a formed base in place. 
           [0050]      FIG. 10  is a perspective view of a first embodiment of a rack according to the present system in an operational position with the user interface, instrument trays inside the tray shelves, and primary shelf working shelf in an operation position and the custom sterile drape in place. 
           [0051]      FIG. 11  is a perspective view of the embodiment of the rack of  FIG. 10  showing a telescoping tube assembly. 
           [0052]      FIG. 12A  is a perspective view of an embodiment of a rack according to the present system with an identification assembly attached to the rack. 
           [0053]      FIG. 12B . is a perspective view of an embodiment of an identification system according to the present disclosure. 
           [0054]      FIG. 13A  is perspective view of an embodiment of a mayo stand attachment device in an operation position. 
           [0055]      FIG. 13B  is perspective view of an embodiment of mayo stand attachment device in a storage position. 
           [0056]      FIG. 14A  is perspective view of an embodiment of a telescoping step stool attachment device in an operation position. 
           [0057]      FIG. 14B  is perspective view of an embodiment of a telescoping step stool attachment device in a storage position. 
           [0058]      FIG. 15A  is perspective view of an embodiment of a light assembly attachment device in an operation position. 
           [0059]      FIG. 15B  is perspective view of an embodiment of a light assembly attachment device in a storage position. 
           [0060]      FIG. 16A  is perspective view of an embodiment of a sterile sprayer assembly attachment device in an operation position. 
           [0061]      FIG. 16B  is perspective view of an embodiment of a sterile sprayer assembly attachment device in a storage position. 
           [0062]      FIG. 17A  is a perspective view of an embodiment of a rack according to the present disclosure with the instrument tray attachment device mounted on an instrument tray and attached to the rack. 
           [0063]      FIG. 17B  is a perspective view of an embodiment of an instrument tray attachment device according to the present disclosure. 
           [0064]      FIG. 17C  is close up view of an embodiment of an instrument tray attachment device according to the present disclosure in an operational position attached to the rack. 
           [0065]      FIG. 17D  is an exploded assembly view of an embodiment of an instrument tray attachment device according to the present disclosure 
           [0066]      FIG. 18A  is a perspective view of an embodiment of a rack according to the present disclosure with the tray shelves removed and the telescoping cross rails in an operational position. 
           [0067]      FIG. 18B  is a perspective view of an embodiment of a rack according to the present disclosure with the tray shelves removed and the top and bottom telescoping cross rails in a storage position and the two middle telescoping cross rails in an operational position. 
           [0068]      FIG. 18C  is a perspective view of an embodiment of a rack according to the present disclosure with the telescoping cross rails, tray shelves, primary working table and interface assembly in an operational position. 
           [0069]      FIG. 19A  is a perspective view of an embodiment of a rack according to the present disclosure with the frame assembly mounted on a ceiling boom with the tray shelves removed and rack in an operation position. 
           [0070]      FIG. 19B  is a perspective front view of an embodiment of a rack according to the present disclosure with the frame assembly mounted on a ceiling boom with the tray shelves removed and the rack in a storage position. 
           [0071]      FIG. 19C  is a perspective view of an embodiment of a rack according to the present disclosure with a ceiling mounted boom frame, tray shelves, primary working table and interface assembly in an operational position. 
           [0072]      FIG. 20  is a perspective view of a first embodiment and a second embodiment of a rack according to the present disclosure in the storage position and nested together. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0073]    Organizational rack system as a cantilever rack  100  is an exemplary embodiment of the present disclosure designed for use in an operating room during surgery to hold surgical instruments. As shown in  FIGS. 1 to 16 , organizational rack system  100  can include: a frame assembly  102 ; a spine rail assembly  122 ; a telescoping tube assembly  134 ; an interface assembly  144 ; a tray shelf  150 ; a receptacle container  152 ; a primary working shelf  154 ; a formed base  156 ; a custom sterile drape  158 ; an identification assembly  200 ; a mayo stand attachment  230 ; a telescoping step stool attachment  240 ; a light assembly  250 ; a sterile spray assembly  260 ; an instrument tray attachment device  270 ; collapsible cross rail extensions  280 ; and a ceiling boom assembly  290 . 
         [0074]    As shown in  FIG. 1A , the organizational rack system  100 , includes the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly. A user can collapse the telescoping tube assembly  134  which decreases the angle between the frame assembly  102  and the spine rail assembly  122  to create a storage position as shown in  FIG. 2B . 
         [0075]      FIG. 2  shows an exploded assembly of the frame assembly  102 . A base  104  is mounted mechanically on two way locking casters  106  to create a platform for a vertical wall rail  110  mechanically connected with a tube nut plate insert  108  and is further supported by a radiating wall rail  112 . A backplane spacer  118  mechanically connects a backplane  116  to the vertical wall rail  110 . A pivotal or rotational connection, such as a knuckle  114  mechanically connects the spine rail assembly  122  (not pictured) to the vertical wall rail  110 , and a hinge  120  mechanically connects the telescoping tube assembly  134  (not pictured) to the vertical wall rail  110 . 
         [0076]      FIG. 3  shows an exploded assembly of the spine rail assembly  122 . A shaft  126  mechanically connects the knuckle  114  (not pictured) to the spine  124  and is secured with a coller  128 . A bottom cross rail  132  and shelf cross rail  130  are mechanically connected to the spine  124 . The spine  124  can be separately adjusted to be orientated at different angles relative to the floor by employing mechanical components able to transfer rotational motion to linear motion such as, but not limited to a system of angled worms and worm gears or a similar system of rack and pinion angle adjustments. (not pictured) 
         [0077]    The spine rail assembly  122  includes at least one, and in certain configurations a plurality of shelf cross rails. Each shelf cross rail is configured to operably engage and retain at least one tray shelf  150 . While the spines  124  are shown having a plurality of shelf cross rails  130  at a common mounting angle to the spine, with the bottom cross rail at a different mounting angle, it is understood, each on different sub combinations, of the shelf cross rails can be a different angles. Typically, the angle of the cross shelf rail  130  the spines  124  is fixed. However, it is understood such angle can be varied or adjustable. 
         [0078]    The extending arm assembly can have any of a variety of configurations that provide for the selective elongation (extension) or contraction of the length of the extending arm assembly. Thus, extendable pistons, servers, linear actuators, worm gears or threading can be used to implement the extendable arm assembly. Further, it is contemplative that motors or the servers can be operably connected to the controller, such that the controller can impart movement of the extending arm assembly. For purposes of description, the extending arm assembly is set forth as a telescoping tube assembly. However, it is understood the present system is not limited to a telescoping tube configuration. 
         [0079]      FIG. 4  shows an exploded assembly of the telescoping tube assembly  134 , which mechanically connects the spine rail assembly  122  to the frame assembly  102  and provides the adjustment to allow for a storage position of the rack  100  as shown in  FIG. 1  B. A lower slide tube  136  is supported by a lower slide tube cross member  138  so that an upper slide tube  140  which is supported by an upper slide tube cross member  142  can provide the telescoping function. 
         [0080]    As shown in  FIG. 5A , the organizational rack system  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102 . The interface assembly  144  is mechanically connected to the frame assembly  102 . A user can collapse the telescoping tube assembly  134  and interface assembly  144  to create a storage position as shown in  FIG. 5B . 
         [0081]    As shown in  FIG. 6 , the organizational rack system  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102 . The tray shelf  150  is detachable attached by employing specific integrated geometry such as, but not limited to the square j hook attachment on the back edge of tray shelf  150  which is supported by the spine rail assembly  122  and allows for the visible storage of a surgical instrument tray  160  (not pictured) during a procedure. 
         [0082]    As shown in  FIG. 7 , the organizational rack system  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102 . The tray shelf  150  and a receptacle container  152  are detachable attached to the spine rail assembly  122  by employing specific integrated geometry such as, but not limited to the square J hook attachment on the back edge of tray shelf  150  and receptacle container  150 . The containment receptacle  152  allows for the storage of used surgical instruments with liquid during a procedure so as not to infringe on protocol while maintaining instrument correlation with its specified location. The tray shelf  150  and receptacle container  152  can be integral or separate compartments. 
         [0083]    As shown in  FIG. 8A , the organizational rack system  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102 . A primary working shelf  154  is mechanically connected to the spine rail assembly  122  so that it provides an enlarged work space to be used as needed. A user can collapse the primary working shelf  154  by employing a collapsible linkage support such as, but not limited to a drop leaf mechanism with or without hydraulic qualities (not pictured). The tray shelf  150  may be attached to spine rail assembly  122  without having to remove the primary working shelf  154  by employing specific integrated geometry such as, but not limited to the square J hook attachment on the back edge of tray shelf  150 , seen in  FIG. 8B . 
         [0084]      FIG. 9  shows the organizational rack system  100  and the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  and a formed base cowling  156  to add a stylized piece that can be customized for the system  100 . 
         [0085]    One embodiment of the cantilever organizational rack system  100  is shown in  FIG. 10  with the caster  106  protruding from the stylized base cowling  156 , the frame assembly  102  supporting the interface assembly  144  and a custom drape  158  that maintains the sterility of the rack  100  and the primary working shelf  154 . That is, the drape  158  forms a barrier between the tray shelves  150  (with the accompanying instrument trays  160 ) and the remainder of the organizational rack system  100 . 
         [0086]      FIG. 12A  shows a organizational rack system  100  and the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102  and an identification assembly  200 . 
         [0087]    As shown in  FIG. 12B , the identification assembly  200  is comprised not inclusively nor limited to a camera, a scanner  202 , an identification interface  204 , a scale  206 , a label printer  208  and attachment latch  270  which provides the support necessary to mount the identification assembly  200  onto spine rail assembly  122  (not pictured). 
         [0088]    As shown in  FIG. 13A , a cantilever rack  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102  and a mayo stand attachment  230  which can be detachable attached to the frame assembly  102  by employing mechanical features such as, but not limited to a tear drop interface between frame assembly  102  and mayo stand attachment  230 . A user can collapse the mayo stand attachment  230  by depressing the spring loaded pin  232  and subsequently maneuvering with linear and rotating movements relative to the frame assembly  102  in order to accommodate a storage position as shown in  FIG. 13B . 
         [0089]    As shown in  FIG. 14A , the organizational rack system  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102  and the telescoping step stool attachment  240  which can be detachable attached to the frame assembly  102  by employing mechanical features such as, but not limited to a tear drop interface between frame assembly  102  and step stool attachment  240 . The step stool attachment can accommodate a user of five feet or less by providing a vertical boost in order to gain access to the upper most tray shelf  150  with reduced physical strain. The telescoping step stool  240  can also collapse to allow for a storage position as shown in  FIG. 14B . While set forth as a telescoping step stool  240 , it is understood any extending linkage construction can be employed, such as, but not limited to a series of sequentially smaller structural members so that each member moves freely inside the sequentially larger member and outside the sequentially smaller member in series. Each structural member is held in the desired position of use or storage by employing the spring loaded pin  242 . 
         [0090]    As shown in  FIG. 15A , a cantilever rack  100  has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102  and light assembly  250  which can be detachable attached to the frame assembly  102  and can provide extra light when necessary. The light assembly  250  gets the necessary power transmittance from sufficient gaged electrical wire running interiorly to the frame assembly  102  with the male plug (not pictured) located in a reasonably accessible location as to not interfere with caster  106 . A user can collapse the light assembly  250  by adjusting the gooseneck or similar flexible mounting arm of the light assembly  250  in order to accommodate a storage position as shown in  FIG. 15B . 
         [0091]    As shown in  FIG. 16A , the organizational rack system  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102  and the sterile spray assembly  260  which can be detachable attached to the frame assembly  102  and provide an aerosol that increases sterility of surgical instruments. The sterilant is stored in a pressurized container (not pictured) housed inside the frame assembly  102  and upon a manual activation such as, but not limited to a valve or push button (not pictured) the pressurized sterilant is forced to the atomizer  262  creating a blanket of sterile aerosol that falls on to the instrument tray  160  (not pictured). The sterile spray assembly  260  can be collapsed by adjusting the gooseneck or similar flexible mounting arm of the sterile spray assembly  260  in order to accommodate to accommodate a storage position as shown in  FIG. 16B . 
         [0092]    As shown in  FIG. 17A , the organizational rack system  100 , has spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102  and the instrument tray attachment assembly  270  which can be detachable attached to the instrument tray  160  so that it can be detachably attached to a spine rail assembly  122  without needing the tray shelf  150  (not pictured). 
         [0093]      FIG. 17B  shows the tray attachment assembly  270  removed from instrument tray  160  (not pictured).  17 C shows an exploded view of tray attachment assembly  270 .  FIG. 17D  shows a closed up view of the instrument tray attachment assembly  270  attached to instrument tray  160  so that the spine rail assembly  122  can maintain support of the instrument tray  160  without the need for the tray shelf  150  (not pictured). 
         [0094]    As shown in  FIG. 18A , the organizational rack system  100 , has the spine rail assembly  122  that rotates about the frame assembly  102  and is supported by the telescoping tube assembly  134  which is also mechanically connected to the frame assembly  102  and the telescoping cross rail  280 . 
         [0095]      FIG. 18B  shows different variations of the telescoping cross rail  280  two are collapsed and two are fully extended. The telescoping cross rail  280  can be adjusted from the collapsed position into the fully extended orientation by depressing the spring loaded pin  282  (not pictured). 
         [0096]    As shown in  FIG. 18C  the telescoping cross rail  280  supports the tray shelf  150  along with the primary working shelf  154  while the frame assembly  102  supports the user interface assembly  144  in order to provide a visible and specific location the instrument tray  160  (not pictured). 
         [0097]    As shown in  FIG. 19A  the ceiling boom frame assembly  290  is mechanically connected the vertical wall rail  110  which is mechanically connected to the telescoping tube assembly  134  which supports the spine rail assembly  122 . The fully extended orientation of the telescoping tube assembly  134  maintains the correct in use position of the spine rail assembly  122 . 
         [0098]      FIGS. 19B and 19C  show the ceiling boom frame assembly  290  mechanically connected the vertical wall rail  110  which is mechanically connected to the telescoping tube assembly  134  which supports the spine rail assembly  122 . The fully collapsed orientation of the telescoping tube assembly  134  maintains the storage position of the spine rail assembly  122 . 
         [0099]    As shown in  FIG. 20  the organization rack system  100  may be nested or stacked together with multiple organizational rack systems  100 . The telescoping tube assembly  134  is fully collapsed so that the organization rack system  100  is in the storage position in order to reduce the surface area footprint from the organizational rack system  100 . 
         [0100]    Many variations on the basic design are possible. Some (not all) possible variations will now be quickly mentioned to help evoke the full scope of various aspects of the present disclosure. There may more or fewer than four cross rails on the spine assembly, the angle at which they are mounted to the spine may be greater or less than thirty degrees. The length of cross rails may be longer or shorter than forty two inches. The frame assembly may have fewer or more than two vertical wall rails. The frame assembly may be mounted and oriented on the ceiling. A variety of geometry may also exist for the rack assembly.