Patent Application
20190008602
This invention relates generally to surgical instruments and, more specifically, to a standardized procedural methodology utilizing trays for transporting sterile surgical instruments to an operating room and presenting the instruments in a standardized configuration and order, ready-to-use and appropriate for nearly all types of surgery.
Storage and sterilization systems for veterinary and human dental and medical instruments are known in the art. Many devices include features to stack and space. In the art of medical surgical instruments, storage trays for sterilization and storage of instruments are common. However, such systems have limitations. For example, one type of tray, although well adapted for use in a first surgical procedure, is ill suited for a second type of surgical procedure. A general instrument kit, commonly used in many operating room procedures, is not suitably versatile to adapt for use as operating room procedures change, are modified, or are replaced with new procedures.
The term “general instrument kit” refers to a set of devices commonly used in surgery and includes ringed instruments such as snaps, clamps, Kellys, Ailises, Babcocks, Kochers, needle holders, sponge sticks and scissors, among other rigid instruments. Prior to use, a general instrument kit is sterilized and packaged at a location remote from a particular surgery suite. Before a specific surgery or procedure, the requisite sterilized instrument kit(s) are sent to a particular operating room, which is being prepared for that specific procedure. In the operating room a back table is lined with sterile drapes. Then, sterile supplies are removed from their outer packaging and placed on this back table. One surgical nurse does a surgical scrub, puts on a sterile gown and gloves and rearranges the multiple sterile supplies needed for the given procedure—placing them in an arrangement and order—not governed by specific instructions, not standardized, but rather based on that person's experience and preference, which is determined in part on the nature of the surgical procedure and the anticipated sequence of use, probable outcomes, potential error-mitigation efforts, and other criteria.
During this preparation, the ringed instruments are removed from sterile buckets and unstrung from each of two long-armed “stringers.” The buckets include other instruments that are not strung on the stringers, but are, rather, left loose in the bottom of the bucket. These instruments, too, need to be arranged for later use and are placed on the back table. Once all the supplies and instruments are arranged a required complete count of all the instruments and supplies is made.
The lack of standardization causes delays in both the initial preparation of the instruments and, more critically, during surgery, especially when a scrub nurse is commonly relieved during a procedure. The replacement scrub nurse, who did not arrange the instruments, does not have implicit knowledge of the location of each instrument or supply. This is a known limitation to the aforementioned method.
Currently used instrument trays contain grooves or recesses, which are designed for specific, individual instruments. While many of these known trays include additional mechanisms or features configured to hold specific individual instruments in a preferred orientation, they are not optimized to hold a large quantity of varying instruments in an “operation ready” position. Other known trays increase adaptability by providing removable section dividers combined with fixed section dividers. However, this is disadvantageous as the removable dividers must be accounted for and can be dislodged during use. This adds risk by potentially becoming lost inside the patient during surgery, or simply dislodged causing one or more instruments to be disrupted while on the tray, thus delaying the surgical process, for example.
One known device in the art is a multipurpose surgical instrument tray disclosed by Smith in U.S. Pat. No. 6,426,041, and issued on 2002 Jul. 2. One significant limitation of the Smith device, as illustrated best in FIG. 3 of Smith, is that both a portion of the ring-end of a surgical instrument and the “sharp” end of the same instrument rests above, or stands proud, in relation to a first flat top surface of the tray. This enables users to be cut or punctured by the sharp end of the instrument, which is very undesirable. It also leaves the sensitive tips of the medical instruments exposed and subject to damage and degradation, thus requiring replacement often.
Other known devices and techniques include protective tip covers designed to protect the patient and staff from sharps injury with a certain degree of success. However, the success is limited as frequently these sharps protective tips must be carefully examined prior to use and the sharp instrument frequently cuts through the protective tip and wrapper or package. This methodology is limited in that it relies upon visual inspection by a trained, naked eye, and as such is highly variable and prone to human error. Furthermore, presuming all sharp tips are protected, well-inspected, and delivered to the sterile field, and then the protected instruments are properly placed on the Mayo stand and/or back table, the removed sharps protective tips are not tracked once they are removed from the instrument. Thus presents a major disadvantage, as it is known that these discarded protective tips may manage to find a way into the patient; this presents as a foreign object with ensuing poor patient outcomes and resultant adverse legal implications.
Other known art includes U.S. Pat. No. 7,565,972, issued on 2009 Jul. 28, titled “Medical Equipment Tray System” to Steppe. This medical equipment tray system includes three parts: a platform portion, a foldable liner, and a hand-piece cradle. Another known reference includes a “Grooved Angled Tray for Ring-Handled Surgical Instrument,” described in U.S. Pat. No. 7,066,328, issued on 2006 Jun. 72 to Pulsifer.
To date there is no known or proven methodology that adequately protects the patient and the users from sharps injury, while at the same time securing and protecting the surgical instruments themselves from damage and facilitating a faster more accurate accounting of instruments and materials at all relevant times of a surgical operation. And, despite attempts in the art at improving surgical trays, there remains a need for an improved surgical tray that retains all the general/major/trauma instruments, arranges these instruments in a ready-to-use orientation, allows these instruments to be sterilized ahead of use, delivered to the operating room sterile, and minimizes set up time. Further, there remains a need for a system and method that standardizes safe and efficient operating procedures. Use of the disclosed surgical instrument tray in conjunction with the surgical back table using an imprinted mapped back table drape that provides for specific designated areas for specific surgical instruments and materials commonly present and used addresses this need. Also, there is a need for a standardized tray that readily, easily, quickly, economically, and efficiently adapts for various uses.
The present invention contemplates a system and method that uses a one- or two-tiered surgical tray specific to the type of surgical procedure being performed, and a standardized back table drape having an imprinted mapped out orientation designating specific locations for a second-tier tray and other surgical materials. The primary tray, which is placed on a Mayo stand, also features a unique tray which is attached by mechanical armature to the primary tray. This allows the unique tray to be presented, retracted and manipulated in and out of the sterile field. The unique tray is equipped with recessed slotted areas specifically designed to hold, transfer, receive and secure all sharps instruments between the surgical scrub nurse and the surgeon during intraoperative surgical procedures.
The trays use unique features and elements that make safe and more efficiently organize instruments. The method improves the safety and efficiency of relaying the instruments during the surgical procedure. The surgical tray of the present invention can be conventionally sterilized and purposefully arranges surgical instruments in a perpendicular fashion in a space and manor similar to that used by surgical scrub nurses on their conventional Mayo stand and back tables, as well as to hold, and display with easy access, a predetermined number of surgical instruments in pre-designated locations. This serves to safe guard against commonly occurring sharps injuries to the patient and staff members of the preoperative setup, intraoperative procedure, and the post-operative re-sterilization process, in addition to safely securing surgical instruments from unnecessary damage and degradation requiring replacement. Additionally, the trays and back table drape, used in the method of set up contemplated, facilitates faster, more efficient and accurate accounting of surgical instruments and materials present in the operating room.
The tray may be sterile processed and delivered to the operating room in a sterile manner and quickly accessed for use. The design and construction of the tray, with recessed sections of defined shapes and sizes, designed to accommodate particular instruments and retractors, enables a user to extract a given instrument from the tray in a “ready position”, which may then be relayed to the surgeon with no further manipulation of the instrument.
The tray of the present invention, accordingly, is delivered to the operating room in a “ready-to-use” state, with the tray pre-populated with instruments. Each instrument is in a predetermined location on the tray, with the tray having features that retain each individual instrument in a predetermined orientation. This minimizes scrub nurse set up time, increases safety, improves efficiencies, and further helps to minimize procedural operating room count time between the scrub nurse and the circulating operating room nurse, while safely and simultaneously protecting the patient and operating room staff from commonly occurring sharps injuries during the preoperative, intraoperative and postoperative phases of the surgical procedure as well as protecting and safeguarding the surgical instruments.
The present invention further reduces preoperative set up time.
Without limitation, one aspect of the claimed invention includes a medical surgery tray for holding at least one medical instrument having a handle end and a working end. The tray is comprised of at least one substantially flat work surface disposed in a first reference plane, an edge feature surrounding the at least one substantially flat work surface that stands proud at a predetermined first positive offset distance from the first reference plane and comprises at least a work-surface-side wall intersecting the at least one substantially flat work surface at substantially 90-degrees at a top surface coupled to the work-surface-side wall, wherein the top surface disposes generally parallel to the first reference plane and further defines the first positive offset distance measured from the reference plane; and at least one recessed compartment comprising a bottom surface disposed substantially parallel to the first reference plane and offset therefrom at a first negative offset distance. The at least one recessed compartment further comprises a first support truss disposed intermediate to the reference plane and the bottom surface, the first truss comprising at least one tool-support notch and a cooperating and corresponding second support truss comprising at least one sharps-end support groove disposed at a negative offset from the reference plane and the groove further configured whereby the instrument inserted in the cooperating tool-support notch and sharps-end groove arranges the working end of the medical instrument to lie below the first reference plane.
In one embodiment, the tray further comprises a second recessed compartment separate from the first recessed compartment, the second recessed compartment comprising a circular opening in the work surface and having at least one curvilinear sidewall extender therefrom downward intersecting with a bottom-platform recessed in a negative offset from the reference plane whereby the second recess compartment configures to accept a fluids container.
Another aspect of the claimed invention encompasses a system for organizing a plurality of surgical instruments and a plurality of surgical supplies in a sterile operating room in preparation for a procedure, operation, or surgery. The system is comprised of a first tray and a second tray as described in the foregoing aspect, a linking support member adapted to couple to the first tray at a first proximal end of the linking support member and selectively attach to the second tray device at a second distal end of the linking support member whereby the linking support member is further configured to enable the second tray to rotate into and out of a field of sterilization and further configured to rotatably move from a first position over the first tray; and the linking support member further comprises an intermediate hinge disposed between the distal and proximal ends.
In one embodiment of the system the linking support member comprises a swing-arm bracket configured to couple to the work surface of the first tray, the swing-arm bracket further comprising a coupling member configured to engage a portion of the sidewall and work surface of the first tray, the coupling member further including a sleeve. A first arm member comprising a pin is disposed on a proximal end, the pin configured to slideably engage the sleeve and whereby the pin rotates in the sleeve, the first arm member further comprising a distal end having a first-hinge end. A second arm member is comprised of a cooperating second-hinge end configured to hingeably engage the first-hinge end and disposed on a proximal end of the second arm member, a distal end of the second arm member includes a post; and the second tray further comprises a post-receiving hole configured to rotatably receive the post of the second arm member, the second tray configured to be supported by the swing-arm in at least one position offset from the tray. At least one work surface defines a given reference plane, at least one recessed compartment offset at a negative distance from the given reference plane configured to selectively hold at least one surgical instrument in a position whereby the working end is below the given reference plane.
In another embodiment of the system at least one surgical drape has at least one predefined area printed thereon. The surgical drape is configured to cover a back table in the operating room, with the predefined area indicating the systematic placement of at least one surgical instrument or supply.
In yet another aspect of the disclosed invention, a method for organizing a plurality of surgical instruments and a plurality of surgical supplies in a sterile operating room in preparation for a procedure, operation, or surgery, is provided. The method comprises providing or selecting the system disclosed herein; placing at least one instrument into a specific location in a first tray, conducting a pre-operative accounting of instruments by visually inspecting the tray and observing that there is a corresponding instrument in each specific location, and recording the results of the pre-operative accounting.
An embodiment of the method of further comprises conducting a post-operative accounting and placing counted instruments in a contamination-container and transferring the container to the sterile processing department, sterilizing one or more instruments, and sterilizing at least one of the first or second tray.
In still another aspect of the disclosed invention, a method comprises providing a plurality of trays, a first tray according to claim 1, and a second tray also according to claim 1; placing the upper tray on a Mayo stand; coupling the first tray to a second tray by using a swing-arm bracket; placing the second tray outside a sterile field by rotating the bracket away from the first tray; placing the first tray and Mayo stand in the sterile field; and placing the second tray on a specifically designated location on a back table, the back table being covered by a drape having at least one specific location demarked thereon.
The present invention improves over the known art and includes many advantages, including, but not limited to:
The disclosed trays, systems and methods will become better understood through review of the following detailed description in conjunction with the figures. The detailed description and figures provide merely examples of the various inventions described herein. Those skilled in the art will understand that the disclosed examples may be varied, modified, and altered without departing from the scope of the inventions described herein. Many variations are contemplated for different applications and design considerations; however, for the sake of brevity, each and every contemplated variation is not individually described in the following detailed description.
Throughout the following detailed description, examples of various trays, systems and methods are provided. Related features in the examples may be identical, similar, or dissimilar in different examples. For the sake of brevity, related features will not be redundantly explained in each example. Instead, the use of related feature names will cue the reader that the feature with a related feature name may be similar to the related feature in an example explained previously. Features specific to a given example will be described in that particular example. The reader should understand that a given feature need not be the same or similar to the specific portrayal of a related feature in any given figure or example.
Overview
Each respective tray includes one or more features that, alone or in combination, present, display, or otherwise retain one or more surgical instruments such that the sharp or puncture or cutting end of the instrument(s) are held below the tray's work surface. In this way the user is unable to cut, prick, slice, or otherwise puncture him- or herself on the sharp end of the instrument when that instrument is stored in the tray at a “ready-to-use” perpendicular orientation.
Each tray also holds and displays, for easy access, multiple forceps, knife-handles and retractors, while taking up minimal space on an operating room back table.
Each respective tray is made of rubber, plastic, or metal material that is capable of normal sterilization techniques and may either be reusable or disposable. Accordingly, each tray may include features to facilitate sterilization, such as being disposed with holes for flow during the sterilization process.
As mentioned above and visible in
The design of the two trays further enables users such as operating room personnel to quickly inventory, count, and account for all instruments and materials/supplies used preoperatively, intra-operatively, and post-operatively. This system of two trays and the method of use thus enables a more accurate and efficient final accounting of all surgical instruments and materials. Although most trays are generally universal in use, there are, in various contemplated alternative and preferred embodiments, some unique tray designs having common features that are optimized for a particular operation, sequence, procedure, and the like.
The precise ordering and location of individual instruments and supplies is defined in a standards or method and procedure manual. As will be well-understood by those having ordinary skill in the relevant art, after the final post-operative accounting, the counted instruments are placed in a contaminated container and transferred to the sterile processing department for re-sterilization according to normal hospital protocols. The sterile processing department, after separate sterilization of each of the two trays and all of the instruments, packages each tray with specific instruments and supplies in a prescribed manner—namely, each instrument has a specific, individual, location in a given tray.
The sterile processing room, in a controlled and sterile environment, pre-packages specific instruments in specific trays and seals the ensemble together for delivery, in a sterile fashion, to the end destination of use (i.e., the operating room). Because this assembly is done in the sterile processing department, should any instrument be dropped or damaged, a replacement can be obtained prior to packaging, thus avoiding waste in the surgery suite, and saving time as well.
All surgical instruments and materials are pre-selected from the surgeon's preference list according to surgical specialty, placed in a transfer cart and delivered from a sterile processing department and/or from the sub-sterile room to the operating room.
Once in the operating room, the system of the present invention—particularly, the two trays replete with surgical instruments and supplies, as applicable, already pre-loaded in specific, pre-designated locations in a given location on either the first or second tray, are then opened in a sterile fashion by the scrub nurse or surgical technician. This eliminates the need for the scrub nurse to organize and place each instrument on a given tray. Thus, system 10 offers significant benefits: in a hectic, busy, urgent or emergency situation, this invention saves time and ultimately lives. In the ordinary course of use, the invention not only saves time, but also provides a greater ability to track, record, inventory, and account for every item in the surgical suite.
System 10, especially when used in conjunction with method 100 as described herein is for use upon the operating room setting with no additional set up time and personnel requirements. System 10 (and corresponding method 100) provides a unique design intended for the purpose of protecting operating personnel and patients from all-to-common sharps injuries preoperatively, intra-operatively and post-operatively.
Such injuries are a major cause of patient and hospital staff injuries, adverse patient outcomes, staff safety and legal liability and damages. System 10 and method 100 purposefully promotes and maximizes patient and staff personnel safety with unique safety designs that greatly reduce or completely eliminate exposure from sharp objects used in surgeries.
System and Devices
With reference to
First tray 20 is configured for use as a medical surgery tray, holding at least one medical instrument 12 having a handle end 14 and a working end 16. First tray 20 includes at least one substantially flat work surface 41 that comprises a reference plane. An edge feature 43 surrounds the at least one substantially flat work surface 41 whereby edge feature 43 includes an edge feature top surface 45 standing proud at a predetermined positive offset distance from the reference plane. Edge feature 43 comprises at least a work-surface-side wall 47 intersecting the at least one substantially flat work surface 41 at approximately 90-degrees. Edge feature top surface 45 is coupled to the work-surface-side wall 47, wherein the top surface 45 disposes generally parallel to work surface 41 and is further defining the positive offset distance measured from the reference plane.
First tray 20 further includes at least one recessed compartment 21 comprising a bottom surface 23 disposed substantially parallel to work surface 41 and offset therefrom at a negative offset distance. The at least one recessed compartment 21 further comprises a first support truss 25 disposed intermediate to work surface 41 and bottom surface 23. First support truss 25 includes at least one tool-support notch 27 and a cooperating and corresponding second support truss 29 comprising at least one support groove 291 disposed at a negative offset from work surface 41. Groove 291 is further configured so the instrument inserted in the cooperating tool-support notch 27 and groove 291 arranges working end 16 of medical instrument 12 to lie below work surface 41.
The depiction of recessed compartment 21 in
As can be seen in
Second tray 30 is constructed of identical or similar materials to first tray 20 and varies from first tray 20 primarily in size and configuration of the various recessed compartments. Second tray 30 includes a corresponding at least one work surface 31 defining a reference plane, at least one recessed compartment 34 offset at a negative distance from this reference plane and is configured to selectively hold at least one medical instrument 12 in a position whereby working end 16 is below this reference plane.
First tray 20, second tray 30, and other similarly implemented trays useful with system 10 consist, comprise, or otherwise include, are manufactured, molded, stamped, or machined of, or from, sturdy plastic, metal, composite, or any other material or combination of materials now known or later developed that are coated, painted, rubberized, finished, sealed, or left in a state as a natural result of the process used to create the tray, so long as such materials are useful for use in a surgical environment and are sufficiently durable to withstand the stresses imposed by repeated sterilization processes.
Linking member 50 attaches or otherwise couples to first tray 20 at a first proximal end 51 of the linking support member and selectively attaches or otherwise couples to any additional tray, such as second tray 30, at a second, distal end 53 of the linking support member. Linking member 50 is configured to enable second tray 30 to rotate into and out of a field of sterilization and is further configured to rotatably move from a first position over first tray 20. In the present embodiment, linking member 50 further includes an intermediate hinge 55 disposed between the distal and proximal ends.
Linking member 50 further is preferably configured to position first tray 20 on an upper plane, or upper tier, relative to second tray 30, which is positioned as a lower tier. Accordingly, second tray 30 is positioned and configured to move relative to first tray 20 such that first tray 20 is above second tray 30 as second tray 30 is brought proximate to first tray 20. Second tray 30 thereby can essentially dock beside and below, or beneath, first tray 20.
Linking member 50 preferably attaches or couples to first tray 20 and second tray 30 in a removable fashion, so as to facilitate break down and ease the process of sterilization of the trays and linking member 50 between surgical procedures. As depicted in the figures, such removable coupling is accomplished by use of various clamps or connectors. However, some embodiments may have linking member 50 permanently or semi-permanently attach to first tray 20 and second tray 30. Such permanent or semi-permanent attachment can be affected by any known or later devised method of attachment, such as adhesives, mechanical fasteners, or molding/embedding during the manufacture of the trays and/or linking member 50.
Turning to
Linking member 50 further includes a second arm member 510 comprising a cooperating second-hinge end 512 configured to hingeably engage first-hinge end 509 and disposed on a proximal end 511 of second arm member 510. Second arm member 510 further includes a distal end 513 having a post 515.
While linking member 50 and its constituent components are depicted in the example embodiment as an articulated arm with one center pivot point, this is in no way intended to be limiting. Linking member 50 can be implemented using any design that facilitates second tray 30 to move with respect to first tray 20, thereby allowing second tray 30 to be moved into or away from the surgical field. For example, some such implementations may have a single member which pivotably attaches on a proximal end to first tray 20 and a distal end to second tray 30, with no intermediate pivot point. Other examples may include a linking member 50 with multiple pivot points, or likewise configured with an accordion-style folding mechanism, thereby allowing second tray 30 to telescope away from first tray 20, in addition to or in the alternative to pivoting.
Linking member 50 and its various components are preferably constructed from a durable material such as metal or plastic that can be readily and easily sterilized, and which is robust enough to withstand multiple sterilization process cycles. Alternatively, linking member 50 can be constructed from any other similarly suitable material or combination of materials now known or later developed.
In this way, system 10, having second tray 30, uses linking member 50 to position first tray 20 and second tray 30 relative to each other. Second tray 30 is configured to receive distal end 513 of linking member 50. Accordingly, second tray 30 includes a post-receiving hole 32 configured to rotatably receive post 515 of second arm member 510. This allows second tray 30 to be moved from a first position to a second position, relative to the location of first tray 20.
Optionally, any additional plurality of trays can be provided, and each includes any combination of features, alone, or combined as described with respect to first tray 20 and second tray 30, above. Or, additional trays can include features not discussed herein wherein those features would be well understood by those skilled in the art at the time of this invention. Linking member 50 may be reconfigured to accommodate one or more additional trays, in addition to second tray 30. Alternatively, or additionally, one or more additional trays could be mounted separately to first tray 20, either directly or via additional linking members 50.
System 10 further may include in some embodiments at least one specialized surgical drape 400. Surgical drape 400 has at least one predefined area 410 printed or otherwise demarked thereon. Surgical drape 400 is configured to cover a back table in the operating room. The at least one predefined area 410 cooperates with a method of arranging supplies or instruments thereon. Thus, drape 400 enables and indicates the systematic placement of at least one surgical instrument or supply, and also facilitates pre- and post-operative audit counts.
Referring now to
While surgical drape 400 is depicted in
The instruments used intra-operatively, also called “sharps” in the relevant art, are each individually placed in second tray 30 by the surgical technician or scrub nurse into a unique designated position. Second tray 30, when needed for use, is moved from the first, retracted position, to a second, extended position. The second, extended position is within the sterile field. Second tray 30 swings or otherwise is angled to and presented to the sterile field and is used to deliver or receive sharps. When this specific action is completed, second tray 30 is returned to the first, retracted position below the surgical stand. This process may be repeated several times during a single procedure. At the end of a surgical procedure, the sharps instruments contained in second tray 30 are counted and removed and placed in approved sharps containers and disposed of per hospital protocol.
Second tray 30 of system 10 is placed on back-table drape 400 in a pre-designated standardized location as set forth on the mapped back-table drape 400. Instruments delivered to the operating room are then counted and accounted for per protocol.
In another preferred embodiment, system 10 can be adapted for organizing a plurality of medical instruments 12 and a plurality of surgical supplies in a sterile operating room in preparation for a procedure, operation, or surgery. In this embodiment system 10 includes a first tray 20, a second tray 30, an optional third tray 60 (seen in
The present invention contemplates a system of specialized trays adapted for specific, predetermined surgical procedures. These trays share common traits, characteristics, and elements as just described above, but are further customized to hold specific instruments based on the intended use during a given procedure. Some examples of these specialized trays are now described, below.
General Surgery Services:
Adapted for use with general surgery services, the present invention includes a system comprising a plurality of devices. Example trays are depicted in
A universal major tray, similar to first tray 20 depicted in
System 10 may further include a minor tray, presented in detail in
In a similar manner, specialized trays having features to orient the surgical instruments in a “ready” position, and further configured to hold only the specific supplies, retractors, and instruments associated with the respective specialized surgical procedure are contemplated. Some contemplated tray systems include, but are not limited to, a Common Bile Duct Tray, a Laparoscopy tray, a Laparoscopic Cholecystectomy Tray, a General Surgery Closing Tray, an Orthopedic Services System including a Major Ortho Tray and a Minor Ortho Tray, an Open Shoulder Tray, an Arthroscopy Tray, a Podiatry Services system including a Podiatry Tray, an Ob/Gyn Services System including the Laparoscopy Tray, an Abdominal hysterectomy Tray, a Vaginal Hysterectomy Tray, a Laparoscopic Hysterectomy Tray, a Dilation and Curettage Tray, and a Caesarean Section Tray.
Other specialized tray systems include a Vascular Services system including a Major Vascular Tray, a Minor Vascular Tray, and a Vein Ablation Tray. Yet others include a Urology system including an Open Prostatectomy Tray, An Ear Nose and Throat system including a Myringotomy Tray, a Nasal Septoplasty Tray, a Tracheostomy Tray, a Stapedectomy Tray, a Major Plastics Tray, and a Minor Plastics Tray.
Each of these aforementioned trays share similar characteristics including materials, construction, the ability to be re-sterilized, having sharp-safe features, and including individual slots for pre-determined instruments. Thus, each of the aforementioned trays is useable as a first tray 20 and/or second tray 30 with system 10, and method 100.
The trays work with system 10 and method 100 disclosed herein, including embodiments of method 100 for inventorying instruments both pre-, intra- and post-operatively, for example. The associated
These specific examples, however, should not be viewed as limiting. Further, features on one specific tray should be understood to be included on other trays, even if those specific features are not shown in the drawing. Further still, features, elements, and components can be combined in any combination.
Method
The present invention further contemplates a method 100 using the system and devices described above. The method enables efficient, reliable, repeatable, and accurate set-up, use, and cleanup of a surgery replete with all necessary instruments and supplies. Method 100 as depicted in
With reference to
In step 102, the component instruments of assembled system 10 are counted, the count is recorded on a count sheet, and verified against the count sheet as well as the various mapped slots for the component instruments. A first tray 20 and second tray 30 as part of system 10 may be designated as upper tier tray and lower tier tray, respectively.
The designated trays with their slotted instruments, the count sheet, and other components of system 10 are placed into one or more containers for sterilization in step 103. In the preferred embodiment, a single container containing all components of system 10 is sterilized. However, in some embodiments, medical instruments 12 as well as the tray could each be sterilized separately, following which medical instruments 12 are placed into the tray while still in a sterilized area, and sealed for storage and subsequent delivery to the operating theater prior to a procedure. As discussed above, each tray may be implemented with a variety of different layouts of recesses to accommodate the varied types medical instruments 12 that would be useable with various procedures. Thus, a variety of trays and associated instruments 12 may be provided and kept ready for corresponding medical procedures.
Following insertion into the container(s), the container(s) are sterilized in step 104 with the enclosed system 10 per the policies and requirements of the sterilizing facility. Any appropriate method of sterilization may be utilized. Once sterilized, system 10 can be stored until needed. Once needed for its intended procedure, the sterile container(s) with system 10 are delivered to the operating room in step 105.
Medical instruments 12 in place in their various trays are delivered as complete and sterilized units to operating rooms. Where a surgical procedure may not use all instruments in a given tray, all slots should nevertheless be filled; during the surgical procedure, those tools that are unused are simply left in their given tray.
At the start of a given medical procedure, in step 106, the operating room staff verifies that the integrity and sterility of the container(s) and contained system 10 complies with facility policy, and proceeds with setting up the operating room with system 10. The components of system 10 are opened on the clean surface in a sterile fashion and setup using approved sterile technique. The various trays, including first tray 20 and second tray 30, are opened and dispersed upon suitable stands within the designated sterile area using national operating room standards of sterile technique. Preferably, all positions for medical instruments 12 in first tray 20 are filled, which makes visual inspection during pre- and post-operative counts for verification of the presence of all medical instruments 12 easy. A pre-marked surgical drape 400 can be placed on a designated back table, and trays 20, 30 may be initially placed upon drape 400 in the appropriate pre-marked areas (e.g. areas 410 to 440). The mayo stand(s) to be used is/are draped using sterile technique. All operating room materials pertinent to the surgical procedure are placed on a clean surface.
Once system 10 is deployed from its container(s), in step 107 tray 20 and tray 30 are prepared to the mayo stand 15 and back table. The designated upper tier tray is placed upon the mayo stand 15. First tray 20 is thus removed from surgical drape 400 and placed upon mayo stand 15. One or more medical instruments 12 are already situated and secured in a ready position within the upper tier tray to be relayed to the person performing the operation with no further manipulation of the instruments. Once so positioned, the upper tier tray is coupled to a lower tier tray, by using a swing-arm bracket, an embodiment of linking member 50. Instruments immediately needed for the procedures are placed into the designated lower tier tray, to be used for passing instruments and materials into the sterile operating field.
Any remaining countable items, such as sponges, needles, sutures, etc., are prepared in step 108, typically to the mapped back-table drape 400. The sharps container system for system 10 is also placed onto the back-table drape 400, and those countable items that are sharps are placed into the container system in pre-designated locations. Also, in step 108 other necessities such as one or more basins such as disposable basins and/or large basins for temporary use are placed into either mapped areas on drape 400 or appropriate stands, as determined by procedure protocols.
For purposes of implementing and using system 10, first tray 20 may be designated the upper tier tray to be used linking member 50, to a second tray 30. It should be appreciated by the reader that the designation of a particular tray as first tray 20, and correspondingly as the upper tier tray, where there are a plurality of trays in the operating theater is essentially determined by the nature of any particular surgical procedure. In the course of a sufficiently complex operation, it is possible that multiple trays may in turn, in an iterative fashion, be designated first trays.
In the final pre-operative step, the initial count is performed, recorded and verified in step 109. Per national operating room procedural standards, prior to commencement of a surgical procedure and prior to the “time out”, all countable surgical instruments and materials to be used during a surgical procedure are to be counted verbally and visually by the scrub nurse and circulating nurse. By seeing that all positions for medical instruments 12 are filled in any given tray, the nurse or tech charged with the count has an immediate visual signal whether any particular tool is missing. Medical instruments 12 are thus situated in a ready position to be relayed in a standardized method from their respective, predetermined locations.
Following completion of step 109, system 10 is ready for procedure commencement.
In step 110, any needed sharps such as needles, syringes, knife blades, etc., are placed onto appropriate positions on the lower tier tray, along with all surgical instruments to be relayed to the surgeon intra-operatively from the respective first tray 20 or second tray 30 upon the surgeon's request, with positions between first tray 20 and second tray 30 shifting with respect to each other as materials/instruments 12 are needed. Materials/instruments 12 are passed to/from the sterile field by extending/retracting the lower tier tray in step 111. The lower tier tray can be placed outside a sterile field by moving the lower tier away from the upper tier tray by use of linking member 50.
In sterile fashion (that is to say that an item has been sterilized by a sterile processing department or rendered sterile by the manufacturer and presented or delivered to the operating room as sterilized and ready for sterile operations and/or procedures), second tray 30 (and subsequent trays, if present) can be removed from back drape 400 and exchanged for first tray 20 on the mayo stand.
Once the surgeon completes use of a sharps instrument, the instrument may be placed on the lower tier tray in a pre-designated slot. The entire lower tier tray with the used instrument is then returned to the scrub nurse, facilitated by linking member 50. At any time, intra-operatively the lower tier tray, which is attached to the upper tier tray on the Mayo stand 15, may be easily retracted back below the Mayo stand 15 to its pre-designated position, away from the sterile operating field, thus preventing sharps exposure and injuries.
Any non-sharp instruments relayed to the surgeon are placed in the sterile field where the scrub nurse will pick up the instrument and return the instrument to the pre-designated instrument slot on its corresponding tray.
In step 112, inter-operative and post-operative counts are conducted and verified. Accountable items may be counted at any time during the surgical procedure at the request of any person involved in the surgical procedure. Closing counts are performed per protocol of all accountable instruments, sharps, sponges and other disposable items not included in this system. Thus, the medical provider involved with the surgery can be notified immediately of any discrepancies and take corrective action per hospital protocol. At the close of procedure, all items are counted by the scrub nurse and the circulating nurse to make certain all items are accounted for and placed in their pre-designated position. This is the Closing Count Procedure. The number of counts of surgical items and materials varies per surgical procedure (i.e. Uterine Count, Major Abdominal Vascular Count, Open Heart Count), as would be well understood in the art.
Upon announcement of closure of the surgical procedure, in step 113 all instruments are returned to their mapped positions on first tray 20, second tray 30, and any additional tray as appropriate. Sharps and surgical materials, and any additional items brought to the field during the operation, are placed on the drape 400 and sharps container as appropriate. This step may be conducted prior to the closing count procedure, to facilitate a quick visual inspection and verification of the count of all instruments and materials.
Following the final count, system 10 is disassembled, used non-useable materials are disposed of in an appropriate fashion, and all instruments, trays, and associated reusable equipment is sent for cleaning and resterilization in step 114. The upper tier tray, swing-arm and lower tier tray are removed from the mayo stand and placed into the previous sterile container to be sent to the sterile processing department for reprocessing per hospital policy, along with medical instruments 12, any additional trays, and any other reusable equipment. The sharps container is closed to contain the used sharps and disposed of in a hospital designated biohazard sharps container. Back-table drape 400 and other disposable items are discarded into designated biohazard receptacles per hospital policy.
It will be understood that method 100, while being performed in substance as described above, may have minor variations that are dependent upon the specific procedure being conducted.
An example of one possible container system 1200 is depicted in
The disclosure above encompasses multiple distinct inventions with independent utility. While each of these inventions has been disclosed in a particular form, the specific embodiments disclosed and illustrated above are not to be considered in a limiting sense as numerous variations are possible. The subject matter of the inventions includes all novel and non-obvious combinations and subcombinations of the various elements, features, functions and/or properties disclosed above and inherent to those skilled in the art pertaining to such inventions. Where the disclosure or subsequently filed claims recite “a” element, “a first” element, or any such equivalent term, the disclosure or claims should be understood to incorporate one or more such elements, neither requiring nor excluding two or more such elements.
Applicant(s) reserves the right to submit claims directed to combinations and subcombinations of the disclosed inventions that are believed to be novel and non-obvious. Inventions embodied in other combinations and subcombinations of features, functions, elements and/or properties may be claimed through amendment of those claims or presentation of new claims in the present application or in a related application. Such amended or new claims, whether they are directed to the same invention or a different invention and whether they are different, broader, narrower or equal in scope to the original claims, are to be considered within the subject matter of the inventions described herein.
The present application is a continuation of U.S. patent application Ser. No. 15/367,468, filed Dec. 2, 2016, which claims the benefit under 35 USC Section 119(e) of U.S. Provisional Patent Application Ser. No. 62/263,022 filed on Dec. 4, 2015 titled “System, Method, and Device for a Medical Surgery Tray” by a common inventor.
| Number | Date | Country | |
|---|---|---|---|
| 62263022 | Dec 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15367468 | Dec 2016 | US |
| Child | 16119533 | US |
