Implant inventory control system and method

Abstract

The preset invention is an inventory-parts control system and supervisory arrangement suitable for tracking the actual use of and accounting for the ultimate disposition of at least some of the individual pieces constituting an implant (or a complete implant construct), which is then being surgically engrafted in-vivo. This inventory-parts control system and supervisory arrangement is accurate, reliable, and fully functional for inventory part control purposes during the surgery; and will account for the ultimate disposition of each required component item of that implant (or complete implant construct) individually and in a timely manner, as each part is individually surgically introduced and engrafted in-vivo at a preselected anatomic site upon or within the body of a living subject.

Claims

1. A parts inventory control system, for tracking the use of component parts, comprising: a tray housing comprising a plurality of component parts, each of which is associated with a corresponding unique part identification number; a plurality of discrete use-tracking badges, each of which corresponds to a distinct one of the plurality of component parts, wherein each of the plurality of discrete use-tracking badges: contains the unique part number identification number of the corresponding one of the plurality of component parts, and is adapted to release an RF signal representing the unique part identification number of the corresponding component part; and a plurality of transaction mode subassembly units, comprising: a first transponder unit adapted to release, in response to being scanned by a wand, a first unique modality RF signal representing a first transaction mode, wherein the first transaction mode comprises discarding the component part as surgical waste; and a second transponder unit adapted to release, in response to being scanned by the wand, a second unique modality RF signal representing a second transaction mode, wherein the second transaction mode comprises returning the component part to inventory; an RF signal recordation and data compilation unit adapted to: receive the first unique corresponding modality RF signal representing the first transaction mode from the first transponder unit; receive, from a particular one of the plurality of discrete use-tracking badges, the RF signal representing the unique part identification number of the component part corresponding to the particular one of the plurality of discrete use-tracking badges; correlate: (1) the RF signal representing the unique part identification number of the component part corresponding to the particular one of the plurality of discrete use-tracking badges with (2) the unique part identification number of the component part corresponding to the particular one of the plurality of discrete use-tracking badges; store: (1) the first unique modality RF signal; and (2) the unique part identification number of the component part corresponding to the particular one of the plurality of discrete use-tracking badges to indicate the disposition of the component part corresponding to the particular one of the plurality of discrete use-tracking badges.

2. The parts inventory control system of claim 1, wherein each of the plurality of discrete use-tracking badges is affixed to the corresponding one of the plurality of component parts.

3. The parts inventory control system of claim 1, wherein each of the plurality of discrete use-tracking badges is affixed at a corresponding pre-selected location on a face surface of the tray housing.

4. The parts inventory control system of claim 1, wherein each of the plurality of discrete use-tracking badges comprises a photovoltaic cell-chip transponder unit.

5. The parts inventory control system of claim 1, wherein each of the plurality of discrete use-tracking badges is micron-sized.

6. The parts inventory control system of claim 1: wherein a first one of the plurality of discrete use-tracking badges: corresponds to a first one of the plurality of component parts associated with a first unique part identification number; contains the first unique part identification number; and is adapted to release a first RF signal representing the first unique part identification number; wherein a second one of the plurality of discrete use-tracking badges: corresponds to a second one of the plurality of component parts associated with a second unique part identification number; contains the second unique part identification number; and is adapted to release a second RF signal representing the second unique part identification number.

7. The parts inventory control system of claim 6, wherein the first one of the plurality of component parts comprises a screw having a first length, and wherein the second one of the plurality of component parts comprises a screw having a second length.

8. The parts inventory control system of claim 1, wherein each of the plurality of discrete use-tracking badges is comprised of: (a) a discernible foundation layer having set dimensions, a fixed configuration, and an exposed face surface, said foundation layer being formed of at least one and not more than three different preformed sheets joined together in overlay series, each of said preformed sheet being selected from the group consisting of a flat backing sheet composed of a dense and visibly colored matter, a planar sheet composed of durable and visibly clear light transparent material, and a numbered label indicative of one specific component part of said complete implant; (b) an operative, micron-sized, photovoltaic cell-chip transponder unit disposed upon and contained within the surface area of said foundation layer, said photovoltaic cell-chip transponder unit becoming activated and energized by light energy to generate and electronically emit a singular RF response signal indicative of a specific component part number into the ambient environment, and (c) a preformed planar top sheet disposed upon and adhered fluid tight to said photovoltaic cell-chip transponder unit and the face surface of said foundation layer.

9. The parts inventory control system of claim 1, wherein the plurality of transaction mode subassembly units have visually distinguishable colors.

10. The parts inventory control system of claim 1: wherein the wand is adapted to emit light; wherein the first transponder unit is adapted to release the first unique modality RF signal in response to being energized by light from the wand; and wherein the second transponder unit is adapted to release the second unique modality RF signal in response to being energized by light from the wand.

Description

BRIEF DESCRIPTION OF THE DRAWING

(1) The present invention may be more easily understood and better appreciated when taken in conjunction with the accompanying Drawing, in which:

(2) Prior Art FIG. 1 presents Table A, which is an illustrative and representative listing of conventionally known and used implants and complete implant constructs;

(3) Prior Art FIGS. 2A and 2B respectively are photographs illustrating a typical format and representative example of a sterilized modular kit housing some of the component parts required for engrafting a complete implant construct in-vivo;

(4) Prior Art FIG. 3 is a photographic illustration of the surgeon(s) working with a surgical technologist, who is also dressed in sterile garb and stands in the aseptic operating field with the surgeon;

(5) Prior Art FIG. 4 is an illustrative example of a pre-printed form traditionally called an “Inventory Control Sheet”, which conventionally is used to organize the recorded random information that the surgical technologist has previously written down on a mayo stand;

(6) Prior Art FIG. 5 is a flow chart which summarizes the entire conventional practice and surgical procedure for implants and complete implant constructs as a whole;

(7) Prior Art FIG. 6 is a magnified illustration of FIG. 2A above which shows a plurality of original component part number labels;

(8) FIG. 7 is a representative and illustrative example of the present invention which shows the manner by which many use-tracking badges can be affixed at individual site locations on the exposed face surface of a modular kit;

(9) FIGS. 8A and 8B respectively are illustrations showing a preferred embodiment of the use-tracking badge in exploded and fully erected views, as well as in size relationship to a penny sized disc (“PSD”);

(10) FIGS. 9A and 9B respectively are illustrations of Format Variant A as a whole, wherein this variant of the use-tracking badge appears in complete and exploded views, and in size relationship to a penny sized disc (“PSD”);

(11) FIGS. 10A and 10B respectively are illustrations of Format Variant B as

(12) a whole, wherein this variant of the use-tracking badge appears in complete and exploded views, and in size relationship to a penny sized disc (“PSD”);

(13) FIG. 11 is an illustration of the intended manner of in-situ use-tracking badge generation and shows an exploded view of the Precursor Construct T kludge as an antecedent article of manufacture and a forerunner product formed by a preformed, planar top sheet and a single operative, micron-sized, photovoltaic cell-chip transponder unit;

(14) FIGS. 12A and 12B respectively are illustrations of a preferred modality disposition-accounting assembly, which presents an array of three discernible mode disposition subassemblies together with a penny-sized disc (or “PSD”) for making size comparisons visually;

(15) FIG. 13 is an illustration of a variant format of the modality disposition-accounting assembly which presents an array of three discernible mode disposition subassembly when the preformed planar base sheet is not present; and

(16) FIG. 14 is a photographic illustration of a preferred and commercially sold light-emitting wand embodiment, which is capable of energizing and then receiving the RF response signal released by individual micron-sized photovoltaic cell-chip transponders.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

(17) I. The Substantive Problems Solved by the Present Invention

(18) In order to appreciate properly what are the unique features and many advantages of the present invention as a whole, one must see the nature of the true problems from the perspective and frame of reference of the surgical operating team and the medical facility's administrative surgical staff.

(19) For the surgical team performing an in-vivo implant grafting procedure, there are a number of serious and substantive challenges which must be individually confronted and solved. All of these are manifest problems; and each of them must be effectively addressed and solved. In addition, the entire set of challenges must be successfully answered in decisive terms. Consequently, what might to the unacquainted seem to be merely superficial considerations or cursory questions—upon subsequent reflection and deliberation instead reveals itself to be truly substantive, significant, and of medical value.

(20) The true perspectives and proper reference context concerning these major problems therefore include all of the following:

(21) (a) A first medical challenge is to provide an operating room situated inventory-parts control system and arrangement that is both facile,

(22) dependable, and fully responsive to the surgeon's particular needs when engrafting an implant in-vivo. The necessary effort includes the capability to track and account for an enormous variety of different inventories, each of these inventories constituting the requisite type and number of individual component parts needed for one particular complete implant; and on each engraft occasion, the capability to identify accurately and record precisely the use and disposition of each individual component part actually used by the surgeon when joining the complete implant upon or into the body of the living patient.

(23) (b) A second medical problem is: How does one obtain an operating room situated inventory-parts control system and arrangement which will function indefinitely and can be used reliably and repeatedly for at least several calendar years' time.

(24) (c) A third major medical difficulty is the availability of an operating room situated inventory-parts control system and arrangement which allows for and is able to accommodate the huge variety of in-vivo engraftable implants and implant constructs—given that no two implant types are alike as to their structural parts, or its intended anatomic purpose, or the true number of requisite parts, or the nature of its particular component parts.

(25) (d) A fourth medical burden is: How does one provide for the broadcast and detection of individual RF signals in a system and arrangement where multiple CMOS-chip transponders exist as operative components. This particular challenge presents two notably different, but intimately related, problems, which are these:

(26) To be both operative and effective, there must exist an unobstructed and optically clear travel direction pathway for an activation signal to reach the embedded CMOS-chip. This unhampered travel direction pathway requirement exists and signifies that any pre-chosen type of activation signal and energy source (such as laser light energy) sent by a remote transceiver device must not only have unhampered access to and an open path for directly reaching the embedded CMOS-chip of the transponder unit; but also present sufficient signal strength and energy power at the moment of direct contact to activate the CMOS-chip and allow the then energized chip to respond and broadcast its unique recognition-return signal to a remotely placed reception device.

(27) The mode of attachment for the discrete CMOS-chip must avoid unintentional creation of obstructions and avert accidental blockage of an available clear optical pathway to the CMOS-chip. Thus, the affixation technique for the CMOS-chip cannot allow use of any dense adhesive label which might be wound over itself, thereby unintentionally covering the CMOS-chip, and consequently not allowing the CMOS-chip to receive sufficient activation signal and/or energy power to activate or to broadcast a response signal in sufficient strength and adequate distance for the remote receiving device to record it.

(28) II. Unexpected Advantages and Unforeseen Benefits

(29) A significant number of unexpected advantages and unforeseen benefits are provided by the inventory-parts control system and supervisory arrangement of the present invention. The capabilities stated below explicitly set forth some of the most valued characteristics and features of the invention as claimed.

(30) In this regard, one should now recall and reconsider what the conventional surgical practice and procedure has traditionally been to date—as summarily described above and as illustrated by the flow chart of Prior Art FIG. 5. In this context also, it is emphasized here that the information given below is not merely a pro forma listing of certain traits and attributes; but rather is a statement which provides a true explanation and an accurate understanding of the meaningful advantages and particular benefits that are in fact provided by the present invention, as seen from the viewpoint and perspective of the ordinarily skilled practitioner working today in the implant medical/surgical field. Accordingly, these qualities include all of the following:

(31) 1, The control system of the present invention carefully monitors and

(32) fully accounts for some or all the available component parts that may be—but are not necessarily always—actually used in-vivo to engraft a complete implant onto or within the body of the patient. Thus, regardless of the number of parts constituting the complete implant, the control system can and will identify each component part individually; and in detail accurately indicate what the ultimate disposition and present status of that single component part is.

(33) 2. The control system of the present invention tracks each component part of the complete implant via its correlated and corresponding part number identification; and will concurrently release one singular and unique RF signal into the environment as a broadcast RF identifying tag indicative of that specific component part.

(34) 3. Due to the nature of the relationship between the laser light energy which powers the micron-sized photovoltaic cell-chip transponder unit as well as because of the small size of the chip transponder unit itself, the control system of the present invention can identify and distinguish between different implant parts in the tray that are in very close proximity with great accuracy, and with little chance of “misreading” the wrong chip transponder unit.

(35) 4. The control system of the present invention can and will automatically receive, record, and store a large variety of different broadcast RF signals concurrently, in a manner which indicates what the actual use and ultimate disposition for each specific component part was during the performance of the surgery.

(36) 5. The control system of the present invention envisions and provides for the accumulation, compilation, and analysis of one, or some, or many, or even all of the individual component parts which were actually used by the surgeon during the engrafting procedure.

(37) 6. The control system of the present invention provides a comprehensive inventory of parts statement and a listing of each component part actually inserted into the body of the patient as a recorded set of individual component part numbers on-demand; and offers a recorded listing which, in turn, informs the surgical technician of what specific component parts then need to be replenished, when the tray is re-stocked post surgery.

(38) 7. The control system of the present invention substantively reduces the risks of human error when accounting for each of the component parts that were actually used in the surgery; and distinguishes those parts actually grafted into the patient from those other component parts which were either returned to the available inventory or were discarded as surgical waste.

(39) 8. The unique nature of the variants in the control system envisions and purposely allows for the retrofitting of existing modular kits and trays presently having one or more pre-existing original component part number identification labels affixed to the face surface of the kit or tray.

(40) 9. The control system of the present invention has the distinct advantage of using a micron-sized photovoltaic cell-chip transponder unit having extreme durability despite being repeatedly subjected to water and other aqueous fluids; and to cleaning agents and other noxious chemical compositions; and to harsh sterilization environments. In particular, the present control system works far better than small 2D barcodes, which fade with repeated washes and quickly lose contrast and readability.

(41) III. The Control System & Supervisory Arrangement as a Whole

(42) The present invention is an inventory-parts control system and

(43) supervisory arrangement for tracking the actual use of and for accounting the ultimate disposition of at least some of the individual parts constituting a complete implant. The system is fully operative and functional for inventory control purposes throughout the entire surgical procedure; and will track and account for a component item of that implant as it is individually introduced and engrafted in-vivo at a preselected anatomic site upon or within the body of a living subject.

(44) In order to achieve these goals, the inventory-parts control system and supervisory arrangement of the present invention employs not less than seven (7) essential elements, which are cumulatively and collectively as follows.

Arrangement Requirement 1: An Inventory-Parts Dual Correlation

(45) The present invention is based upon a double correlation system and employs a tandem reciprocal correspondence of information, which are: A 1.sup.st correlation made between each implant component part and a single and an unique corresponding part identification number; and a 2.sup.nd correlation made between a single component part identification number and an identifying and directly corresponding singular RF signal.

(46) For the 1.sup.st correlation, each requisite component part constituting the complete implant must be given, must be associated with, and must be uniquely recognizable by a single corresponding component part identification number—as an organized and systematized 1:1 reciprocal correlation. The existence of such a prepared in advance 1.sup.st correlation is an unequivocal and absolute requirement; and once made, should be a permanent arrangement and constant reciprocal correspondence.

(47) The underlying reason and rational for this correlation demand is this: Because each type and kind of implant is to be erected in-situ piece by piece upon or within the living body of the patient, each particular implant will invariably comprise at least one functional device, object or article; will require a range of different supports, plates, posts, girders, braces, rods, joices, or beams; and will use associated hardware—such as surgical nails, screws, bolts, pins, anchors, and K-wires—to tangibly attach and join the complete implant item in-vivo at a preselected anatomic site upon or within the body of a living subject.

(48) The present inventory-parts control system expects that many of the devices, objects and articles that are used in the erection and formation of the complete implant in-situ, as well as such hardware pieces which might at any time be employed by the surgeon to join and physically attach the implant to the body of the patient—will have its own unique and individual component part number identification. As merely a simple representative example: A 4 mm long Philips screw, and a 5 mm long Philips screw, and a 6 mm Philips screw, will each have its own singular and individual component part number; and each such identifying part number will effectively separate and meaningfully distinguish one sized screw from each of the two other screw length sizes.

(49) In addition, one should recognize that in limited stances, such individual component part identification numbers not only already exist, but also often visibly appear as original number labels which are then tangibly adhered to the exposed surface of the modular kit. These adhered original number labels typically are the manufacturer's or vendor's own prepared numbered listing for those items, supplies and associated hardware needed for erecting and engrafting the complete implant in-vivo. To illustrate this situation, particular attention is directed to FIG. 6 (an enlargement of FIG. 2B), which shows many different original number part labels visibly located on the exposed exterior surface of the modular kit adjacent to each of the support arms then housed within the shaped wells of the modular kit.

(50) Consequently, the present invention presents an explicit and absolute demand for a 1.sup.st reciprocal correlation: Each operative item, and every functional component, and all the tangible hardware support and attachment/juncture pieces—without regard to the individual size, shape, and dimensions—must be assigned and be directly correlatable with its own uniquely recognizable and identifying component part number.

(51) To meet and satisfy the requirement for a 2.sup.nd reciprocal correlation, a prepared-in-advance correspondence is made between each uniquely recognizable component part number identification and one singular directly associated RF signal.

(52) Again, as merely a simple representative example: A 4 mm long Philips screw, and a 5 mm long Philips screw, and a 6 mm Philips screw are similar except for its length dimension. Thus, each individual length Philips screw will have its own uniquely associated and corresponding singular RF signal; and each of the three different RF signals is a singular identifying electronic emission which will separate and distinguish one particular screw length size from both of the two other RF signals indicative of the other screw length sizes.

(53) This 2.sup.nd correlation and correspondence is also a direct 1:1 relationship. Each singular RF signal is one that can be detected, received, and recorded by a RF signal receiver; and is a RF signal which then can be stored indefinitely within the electronic memory of a RF signal data compilation unit. Consequently, the existence and use of such a prepared in advance 2.sup.nd correlation is an unequivocal and absolute requirement which will appear and be employed in combination with the 1.sup.st reciprocal correlation.

Arrangement Requirement 2: At Least One Preformed, Sterilizable On-Demand, Modular Kit Housing Individual Parts

(54) Accurately keeping track of the actual use and true ultimate disposition of the individual component parts needed in-situ to construct and attach the chosen implant in-vivo via the surgical procedure is both medically crucial and essential for both the surgeon and the patient. This criticality and urgency stems from several different but related causes:

(55) First, the surgeon must have intimate knowledge and precise awareness of what tangible implant parts have in fact been surgically inserted into and tangibly joined to living body at all times during and throughout the entire surgical procedure. It is medically vital and essential that no unattached hardware or structural parts be left accidently and unknowingly in the living body at any time during the surgical grafting process.

(56) Second, the patient's surgical record must accurately reflect and document precisely what items have actually been surgically put into and joined to the body of the patient; and to be able to separate and distinguish those component parts actually in the body from those individual pieces which have (for any reason) been removed and replaced back into the modular kit; or alternatively have been deemed unusable (for any reason) and thus were discarded as medical waste.

(57) Third, the operating room surgical technologist or circulating nurse, and the hospital's administrative and billing staff must have a true track of and verifiable accounting for all the individual component pieces actually used at any time during the surgical implant process. This requirement and need pertains to the replenishing of inventory parts for the modular kit; and to the reordering and restocking of depleted implant parts; as well as for the proper billing of the attendant true surgery costs to the medical insurance carrier or financially responsible person for performing the implant surgery itself.

(58) In order to meet and satisfy these surgical needs, a modular kit or tray housing is typically employed by the surgeon and surgical technologist to hold and contain at least some of the requisite component parts for a complete implant to be surgically engrafted in-vivo onto or within the body of a living subject. As shown by Prior Art FIGS. 2A and 2B respectively herein, at least one modular kit is typically prepared in advance which offers a modular kit box; presents a modular kit face surface; and has a plurality of shaped wells for housing and storing the various hardware component parts needed to engraft the complete implant in-vivo. Attention is also again directed to Prior Art FIG. 6 (an enlargement of Prior Art FIG. 2B) which shows many different part identification number labels located on the exposed exterior surface of the modular kit adjacent to the individual support arms then housed within the shaped wells of the modular kit.

Arrangement Requirement 3: A Plurality of Discrete Use-Tracking Badges

(59) The supervisory arrangement of the present invention utilizes a plurality of discrete u se-tracking badges, each such badge being suitable for affixation at an individually selected location on the exposed face surface of the sterilizable modular kit (then containing at least some of the requisite component parts of a complete surgical implant). Thus, the working rule and requirement of the present control system and supervisory arrangement is that one use-tracking badge is uniquely associated with and lies tangibly affixed adjacent to each individual component part that is housed within the modular kit.

(60) Accordingly, one discrete use-tracking badge is specifically assigned to, is intimately associated with, and reciprocally corresponds to a single component part (having its own unique part number identification). Moreover, the individually different use-tracking badges deployed and tangibly appearing upon the exposed face surface of the modular kit will each vary directly and be in 1:1 correspondence with the true number of different components parts then housed within the shaped wells of the entire modular kit.

(61) A representative and illustrative example of the manner by which many discrete use-tracking badges can be affixed at individual site locations on the exposed face surface of a sterilizable modular kit is shown by FIG. 7.

(62) In the particular instance illustrated by FIG. 7, it will be noted and appreciated that the number of use-tracking badges total 28 units in all; and that each badge is separately and individually affixed at approximately the following locations: Adjacent to each of the variously shaped large support plates housed at the top of the kit; at the kit center where a plurality of 3 mm, 4 mm, and 5 mm sized Philips screws are separately housed; and at the kit bottom where smaller-sized support plates of varying configurations are housed. Typically therefore, the total number of separate and individual use-tracking badges deployed over and affixed to the face surface of a single modular kit can routinely app roach 30, or 40, or even more discrete embodiments in all.

(63) In addition, as exists at many of the use-tracking badge affixation locations shown by FIG. 7, a numbered label is visibly present; and each of these numbered labels indicates and states exactly what the corresponding component part number identification is for that specific part. In this illustrated instance also, the use-tracking badges individually affixed to each of these locations are overlay variant constructions; and are purposely sized to incorporate and protect each of these pre-existing component part number labels within the measurable dimensions of each badge as a whole.

(64) A. The Elements in Each Use-Tracking Badge Construction

(65) As illustrated in detail by FIGS. 8A and 8B respectively, a preferred embodiment of a use-tracking badge 50 appears in exploded and fully erected views, as well as in size relationship to a penny sized disc (“PSD”). In general, a use-tracking badge can have a bout a 2-20 milli meter (mm) length dimension; and can have about a 3-6 mm width dimension; and can present a thickness dimension ranging from about 4-20 mils. However, as shown by FIG. 8B, the particular dimensions for the preferred use-tracking badge 50 are a length of 14 mm, a width of 5 mm, and a thickness of about 12 mils.

(66) Notably, each operative use-tracking badge—without regard to its specific construction format, existing design variant, and preferred style particulars—is comprised of not less than three requisite elements, which are as follows.

Element (a): A Discernible Foundation Layer

(67) The foundation layer is formed of at least one and not more than three different preformed sheets joined together in overlay stacked series; wherein each said sheet is one selected from the group consisting of a flat backing sheet composed of a dense and visibly colored matter, a planar sheet composed of durable and visibly clear light transparent material, and a visually-readable numbered label whose given number identifies one specific component part of a complete surgical implant or engraftable prosthetic device.

(68) The discernible foundation layer as a whole, which is formed of at least one and not more than three different preformed sheets of material joined together in overlay series, is a discrete stratum of matter which preferably: presents a pre-selected overall configuration and has limited millimeter-sized length, width and thickness dimensions; has an anterior face surface and a posterior face surface; is repellent to water and other aqueous fluids; is resistant to cleaning agents and other noxious chemical compositions; is enduring of harsh sterilization environments; and has a transparent adhesive coating disposed upon its posterior face surface.

(69) As shown in detail by the exploded view embodiment of FIG. 8A, the discernible foundation layer 10 is in this illustrated instance formed of three different and distinct preformed sheets—a flat backing sheet 12 composed of a dense and visibly colored matter; a planar sheet 14 composed of durable and visibly clear light transparent material; and a visually-readable numbered label 16. These three discrete sheets 12, 14, and 16 are joined together fluid-tight in overlay stacked series; and collectively present a unified stratum of matter having a substantially rectangular overall configuration.

(70) Furthermore, the foundation layer 10 as a whole (and without regard to the actual number of preformed sheets) will always cumulatively present an anterior face surface as its obverse side, and a posterior face surface as its reverse side. Both the obverse side and the reverse side of the discernible foundation layer 10 have particular functions and applications.

Element (ß): A Photovoltaic Cell-Chip Transponder Unit

(71) As shown by FIG. 8A, an operative, micron-sized, photovoltaic cell-chip transponder unit 30 lies disposed upon and contained within the anterior face surface area of the foundation layer 10. This photovoltaic cell-chip transponder unit 30 becomes activated and energized by light energy; and then will generate and electronically emit an unique RF response signal into the ambient environment, wherein each unique emitted RF signal correlates with and corresponds to a single component part number identification.

(72) The photovoltaic cell powered-integrated circuit transponder typically comprises a silica wafer semiconductor chip with internal circuitry sufficient to broadcast a unique identifying number or data; but is a miniature-sized transponder unit which does not employ either a battery or large-sized antennae.

(73) Accordingly and as seen in FIG. 8A, the operative micron-sized photovoltaic cell-integrated chip transponder unit 30 lies embedded within and is completely contained between the planar top sheet 40 and the foundation layer 10. In this protected position and location, the embedded photovoltaic cell-integrated chip transponder unit 30 can be activated and energized by light energy photons on-demand. Then, after receiving and converting such a light energy transmission, the embedded transponder unit will produce and electronically emit an encoded singular RF response signal—which travels through the material thickness of the transparent top planar sheet 40 and is broadcast into the immediately surrounding environment. Once broadcast into the ambient atmosphere of the operating room, the uniquely encoded singular RF response signal can be detected and accepted by a RF signal receiver located nearby; and the received RF signal can subsequently be electronically conveyed, recorded in memory, and stored indefinitely by a RF signal data compilation apparatus.)

(74) In this particular kind of CMOS technology, the embedded transponder's internal circuitry employs one or more tiny photocells which accept and absorb light energy rays (transmitted from a remotely located external light source) in order to activate and electrically power the chip's circuitry. The transponder also includes a very small signal-transmitting antenna by which a responsive RF signal broadcast is sent into the ambient environment for detection and acceptance by a remotely located reader/transceiver.

(75) Operationally, each embedded photovoltaic cell-integrated chip transponder unit 30 (as appearing in FIG. 8 as a whole) will contain encoded identity information which relates to and identifies a single implant component and an unique identification part number. The photovoltaic cell transponder unit can receive and accept light energy photons from a light-emitting source; and can convert the received light energy into internal electric current power for the chip circuitry, which then holds encoded data indicating the identity number of the component part. The chip circuitry, in turn, then can produce and emit a singular RF response signal(s) corresponding to the transponder's individual coded numbered part identity data; and this emitted response RF signal is broadcast over a short distance into the surrounding ambient environment of the operating room.

(76) After the response RF signal broadcast by the transponder unit 30 is

(77) detected and received by a RF signal receiver unit, an adjacently located computer controlled reader/transceiver unit decodes the response RF signal(s), stores the signal data in its memory, and typically displays the decoded specific component part identification number to the surgical technologist or technician.)

(78) The photovoltaic cell-integrated circuit transponder unit 30 embedded in the preferred use-tracking badge 50 is miniscule in scale and size; and is at most a bout 500 microns square in area, and typically is no more than about 100 microns in thickness or depth. Such micron-sized transponders with photovoltaic cell activated integrated circuitry are presently commercially manufactured and sold as the P-Chip® transponder [Pharmaseq Inc., Princeton N.J.].

(79) The heart of the micron-sized photovoltaic cell-integrated chip transponder is an ultra-small light-powered electronic chip circuitry electrically joined to an antenna. The chip is a monolithic integrated electrical circuit made using standard/conventional manufacturing technology. An essential part of the P-Chip® transponder unit is its internal photovoltaic cell, which when illuminated by light energy, is activated and provides adequate electric power for operating the electronic circuits of the chip. The remaining electronic circuitry of the P-Chip® silicon wafer are typically a read-only memory unit for the unique 50-bit ID decoders and counters; and a small simple radio antenna for transmission of a return RF signal.

(80) Moreover, there are commercially available at least two different micron-sized constructed versions of a completely functional and operative

(81) P-Chip® transponder: A 500×500×100 micron sized unit and a 250×250×50 micron sized unit respectively.

Element (y): A Preformed Planar Top Sheet

(82) As shown by the preferred embodiment of FIG. 8A, a single preformed, planar top sheet 40 lies disposed upon and adhered fluid-tight to the photovoltaic cell-chip transponder unit 30 and the anterior face surface of the foundation layer 10. This planar top sheet 40 has certain properties and characteristics, which most desirably include: being composed of durable and visibly clear light transparent material; presenting an anterior face sheet surface and a posterior face sheet surface; having an elongated configuration and millimeter-sized dimensions which are not less than the size dimensions of the foundation layer; being repellent to water and other aqueous fluids; being resistant to cleaning agents and other noxious chemical compositions; being enduring of and resistant to harsh sterilization environments; and having a visibly clear adhesive coating disposed upon its posterior

(83) face sheet surface.

(84) It will be noted that the planar top sheet 40 must be composed of a clear material or visibly transparent substance which is repellent to water and other aqueous fluids; is resistant to cleaning agents and other noxious chemical compositions; and is repeatedly enduring of harsh sterilization environments. The planar top sheet 40 presents a discrete anterior face surface 42 as its obverse side and an adhering posterior face surface 44 as its reverse side; and is aligned with, is disposed upon, and is permanently adhered in a fluid-tight manner both to the operative, micron-sized, photovoltaic cell-chip transponder unit 30 and the discernible foundation layer 10.

(85) Accordingly, the planar top sheet illustrated by FIG. 8A will have a fixed configuration and millimeter-sized length and width dimensions which are never less than the actual length and width dimensions of the discernible foundation layer—and often are slightly greater in length and width dimensions; and will present a thickness or depth dimension of about 4-6 mills (101.6-152.4 microns) in size—but which optionally can vary from about 3-15 mills in thickness in alternative embodiments, if and when so desired. Accordingly, this discernible foundation layer is longer and extends laterally; but can be cut, however, to any desired size and shape.

(86) The planar top sheet must always provide clear matter or visibly transparent material which allows for both unhindered light energy transmissions and unobstructed responsive RF signal passage on-demand. Thus, the top sheet always will present and include a discernible light energy transmitting zone whose transparent surface area and perimeter edges are aligned with and overlie the photovoltaic cell-chip transponder unit. In each and every embodiment, it is through this definitive light transmitting zone and transparent surface area that light energy signals will travel unhampered and responsive RF signals from the photovoltaic cell-chip transponder unit will freely pass.

(87) In addition, the planar top sheet must always provide clear matter or visibly transparent material through which a person can see the component part number label which might be present at the particular use-tracking badge location. It will be recalled that each of these numbered labels will indicate and state exactly what the corresponding component part number identification is for that specific part. Therefore, the use-tracking badges individually affixed to each of these locations are purposeful overlay variant constructions wherein the planar top sheet of the construct is adequately sized in its length and width dimensions to incorporate and protect the pre-existing part number labels within the overall dimensions of the individual badge as a whole.

(88) B. Properties & Characteristics of the Use-Tracking Badge

(89) (i) It is required that each required element in the constructed use-tracking badge as a whole—i.e., the preformed foundation layer, and the photovoltaic cell-chip transponder unit, and the planar top sheet—be firmly attached and permanently joined together in a fluid-tight manner. Such fluid-tight juncture and permanent bonding of essential constituents is necessary to yield a single unified badge composite which: Is protective and safeguarding against external impact forces and collision effects; is repeatedly able to repel water and other aqueous fluids; is highly resistant to cleaning agents and noxious chemical compositions; will repetitiously endure and withstand the extremely harsh treatment conditions of repeated sterilization (via any conventionally known method); and will last for a long-term and indefinite period of usage (extending several calendar years in duration).

(90) The fluid-tight juncture and bonding of these tangible items together preferably employs high-strength, temperature resistant, and long lasting adhesive substances for this purpose. There are today many different conventionally known and commercially available adhesive compounds and bonding compositions that are heat and moisture resistant, that are high temperature durable, and which can effect permanent bonding of multiple discrete layers. All such adhesives and bonding agents are typically applied as a distinct coating to each posterior face surface of each discrete sheet before joining the sheets together in the making of the construct.

(91) (ii). The structural integrity of the constructed three element use-tracking badge will remain resilient, materially uniform and dimensionally unaltered over its entire lifetime of intended and expected usage.

(92) (iii). The construction of the use-tracking badge will adequately protect and long safeguard the embedded photovoltaic cell-activated transponder unit from major impact forces and the damaging effects of inadvertent collisions with other surrounding tangible objects.

(93) (iv). The construction of the use-tracking badge will adequately protect and long safeguard the embedded photovoltaic cell-activated transponder unit from the effects of any stray electrical current(s) which then might be present within the surgical operating room environment.

(94) (iv). The multi-tier use-tracking badge consistently allows light energy photons—i.e., any form, frequency or intensity of light radiation existing either as particles or waves—to pass freely and unhampered through its transparent top planar sheet, and then to enter the embedded photovoltaic cell-activated transponder unit.

(95) (v). The unitary use-tracking badge will on any and all occasions allow radiofrequency (RF) waves and signals generated by the embedded photovoltaic cell-activated transponder unit to travel outwardly; to pass freely through the visibly transparent top planar sheet; and be released into the surrounding air environment.

(96) (vi). The unitary use-tracking badge will typically also include on-demand affixation means—i.e., present a transparent and visibly clear adhesive substance as a discrete coating which lies disposed over the posterior face surface of the foundation layer in the construction; and also provide a peel-away liner joined to the adhesive coating and which is subsequently removed to expose the adhesive for affixation to a pre-chosen location. Thus, given an adhesive substance disposed as a discrete coating upon the posterior face surface (rearward side) of the foundation layer—the operative use-tracking badge as a whole can become subsequently affixed at will to any chosen surface.

Illustrative Format Variants of & Representative Structural

Alternatives for the Use-Tracking Badge

(97) Format Variant A: A Two-Sheet Foundation Layer Construction

(98) The Format Variant A embodiment is illustrated by FIGS. 9A and 9B as a whole, wherein this construction of the use-tracking badge appears in complete and exploded views, in size relationship to a penny sized disc (“PSD”). In this variant instance, the use-tracking badge 50a has particular dimensions which are: A length of about 14 mm, a width of about 5 mm, and a thickness of about 12 mils.

(99) As shown in detail by the exploded view embodiment of FIG. 9A, the discernible foundation layer 10a is formed of two different preformed sheets a flat backing sheet 12a composed of a dense and visibly colored matter, and a visually-readable numbered label 16a (which presents the component part identification number). The two preformed sheets 12a and 160a are joined together fluid-tight in overlay stacked series; and collectively present a substantially rectangular overall configuration. Also, the two-sheet foundation layer 10a as a whole cumulatively presents an anterior face surface as its obverse side and a posterior face surface as its reverse side. Both the obverse side and the reverse side of the discernible foundation layer 10a have particular functions and applications.

(100) Also as seen in FIG. 9A, an operative, micron-sized, photovoltaic cell-chip transponder unit 30a lies disposed upon and is contained within the anterior face surface area of the two-sheet foundation layer 10a. This photovoltaic cell-chip transponder unit 30a will become activated and energized by light energy; and then will generate and electronically emit an unique RF response signal into the ambient environment, wherein each unique emitted RF signal correlates with and corresponds to a single component part identification number part.

(101) Finally, as shown by FIG. 9A, a preformed, planar top sheet 40a lies disposed upon and is adhered fluid-tight to the photovoltaic cell-chip transponder unit 30a and the anterior face surface of the foundation layer 10a.

(102) The completely erected variant embodiment of the use-tracking badge 50a is illustrated by FIG. 9B. As seen therein, the operative micron-sized photovoltaic cell-integrated chip transponder unit 30a lies embedded within and is completely contained between the planar top sheet 40a and the foundation layer 10a. In this protected position and location, the embedded photovoltaic cell-integrated chip transponder unit 30a can be activated and energized by light energy photons on-demand. Then, after receiving and converting such a light energy transmission, the embedded transponder unit will produce and electronically emit an uniquely encoded RF response signal—which travels through the material thickness of the transparent top planar sheet 40a into the and immediately surrounding environment; and once in the atmosphere of the operating room, can be detected by an adjacently located RF signal receiver, and subsequently then be recorded and stored indefinitely by a RF signal data compilation apparatus.

(103) Format Variant B: A Single-Sheet Foundation Layer Construction

(104) The Format Variant B embodiment is illustrated by FIGS. 10A and 10B as a whole; and this use-tracking badge variant 50ß appears in complete and exploded views, in size comparison relationship to a penny sized disc (“PSD”). In this variant embodiment, the use-tracking badge 50ß has particular dimensions which are: A length of about 14 mm, a width of about 5 mm, and a thickness of about 12 mils.

(105) As shown in detail by the exploded view embodiment of FIG. 10A, the discernible foundation layer 10ß is formed using a single material sheet—in this instance, a visually-readable, numbered label 16ß which shows the specific component part identification number for the component part. The single numbered label 16ß is prepared-in-advance as a material sheet; presents a substantially rectangular overall configuration; has an anterior face surface as its obverse side; and presents a posterior face surface as its reverse side.

(106) Also as seen in FIG. 10A, an operative, micron-sized, photovoltaic cell-chip transponder unit 30ß lies disposed upon and contained within the anterior face surface area of the single-sheet foundation layer 10ß. This photovoltaic cell-chip transponder unit 30ß becomes activated and energized by light energy; and will generate and electronically emit an unique RF response signal into the ambient environment, wherein each unique emitted RF signal correlates with and corresponds to a single component part identification number part.

(107) Lastly, as shown by FIG. 10A, a p reformed, planar top sheet 40 lies disposed upon and adhered fluid-tight to the photovoltaic cell-chip transponder unit 30 and the anterior face surface of the foundation layer 10ß.

(108) The completely formed variant embodiment of the use-tracking badge 50ß is illustrated by FIG. 10B. As seen therein, the operative micron-sized photovoltaic cell-integrated chip transponder unit 30ß lies embedded within and is completely contained between the planar top sheet 40ß and the foundation layer 10ß. In this protected position and location, the embedded photovoltaic cell-integrated chip transponder unit 30ß can be activated and energized by light energy photons on-demand. Then, after receiving and converting such a light energy transmission, the embedded transponder unit will produce and electronically emit an uniquely encoded RF response signal which travels through the material thickness of the transparent top planar sheet 40ß into the and immediately surrounding environment; and once in the atmosphere of the operating room, can be detected by an adjacently located RF signal receiver, and subsequently then be recorded and stored indefinitely by a RF signal data compilation apparatus.

(109) Format Variant T: An In-Situ Generated Foundation Layer Construction

(110) The present invention recognizes and expects that in many surgical implant instances, the modular kit(s) will have a plurality of different pre-existing original numbered labels attached to the exposed face surface of the modular kit, each such original numbered label then lying adjacent to the shaped well(s) where one individual component part is housed. Attention is again directed to Prior Art FIG. 6 hereof, as one representative example where many such original numbered labels appear together in one modular kit.

(111) Accordingly, this alternative Format Variant T embodiment knowingly and intentionally employs any one, or merely a few, or many (if not all) of the pre-existing original part number labels (having visible numbers on their face surfaces) as the requisite foundation layer in the badge construction. In point of fact, these pre-existing original labels having visible part numbers on their face surfaces can properly serve as the necessary material sheet and foundation layer of the embodiment; and in this manner, serve as the tangible stratum by which to generate in-situ a complete and operative use-tracking badge 50y directly upon the face surface of the modular kit.

(112) It is important to understand and appreciate that this in-situ generated alternative Format Variant T embodiment of the use-tracking badge meaningfully and substantively differs from the Format Variant B embodiment (described above and illustrated by FIGS. 10A and 10B herein) in one critical aspect: The maker of this alternative Format Variant T embodiment of the use-tracking badge does NOT himself prepare or create in advance any numbered label as a material sheet. Instead, the maker merely employs a Precursor Construct T kludge, which is formed of two elements only: a micron-sized photovoltaic cell-integrated chip transponder unit and a planar top sheet. This Precursor Construct T kludge and the intended manner of in-situ badge generation is illustrated by FIG. 11.

(113) As shown by the exploded view of FIG. 11, the Precursor Construct T kludge 60y is an antecedent article of manufacture and a forerunner product formed by a preformed, planar top sheet 40y and a single operative, micron-sized, photovoltaic cell-chip transponder unit 30y. The micron-sized, photovoltaic cell-chip transponder unit 30y lies disposed upon and is adhered fluid-tight to the posterior face surface of the visibly transparent planar top sheet 40y; and it is noted that no other material sheet or tangible stratum is present with the confines of the constructed Precursor Construct T kludge 60y. In particular, please recognize that there is no foundation layer other material sheet as such within the construction of the Precursor Construct T kludge 60y.

(114) The alternative Format Variant T embodiment of the use-tracking badge 50y is then subsequently generated in-situ directly upon the exposed face surface of the modular kit. This in-situ generated event occurs when the Precursor Construct T kludge 60y is oriented, aligned, and deposited directly over the pre-existing original part number label 70y (having visible part numbers on its exposed face surface); and the Precursor Construct T kludge 60y becomes permanently affixed to the pre-existing original part number label 70y.

(115) Via this act of in-situ affixation and in this manner, the pre-existing original part number label 70y (with visible numbers on its face surface) thus becomes the necessary material sheet and the requisite foundation layer of the embodiment. Clearly, the Precursor Construct T kludge acts as a discrete intermediate article and product by which to generate in-situ a complete and operative use-tracking badge 50y at will—directly, at the exact location on the face surface of the modular kit where the original numbered label appears. Then, and only then, is the true and complete alternative Format Variant T embodiment actually generated in-situ in substantive and operative form.

(116) After the alternative Format Variant T embodiment of the use-tracking badge 50y has in fact been generated in-situ using the pre-existing original numbered label 70y, then the embedded photovoltaic cell-chip transponder unit 30y of this embodiment can become activated and energized by light energy; and will generate and electronically emit an unique RF response signal into the ambient environment, wherein each unique emitted RF signal correlates with and corresponds to a single component part identification number part.

Arrangement Requirement 4: At Least One Discernible Modality Disposition-Accounting Assembly

(117) The system and arrangement of the present invention requires the presence and use of at least one discrete modality disposition-accounting assembly; a unitary ensemble which is structurally different and functionally distinct from the use-tracking badges described above.

(118) Typically, it is envisioned and expected that only one operative modality disposition-accounting assembly will appear in the system arrangement of the present invention under most surgical circumstances. However, it will be expressly understood that two, or three, or even more discrete modality assemblies can optionally be usefully employed together in the supervisory arrangement in those surgical situations where the complete implant to be engrafted in-vivo is an especially sophisticated and complex apparatus. Thus, the minimal requirement is that there be at least one modality disposition-accounting assembly within the system arrangement.

(119) In addition, although the requisite modality disposition-accounting assembly can and will be operationally located and tangibly positioned anywhere within the existing spatial confines of the operating room or surgical theatre as such—it is preferred and typical that the modality disposition-accounting assembly be affixed (for the ST's convenience) at one preselected site on the exposed face surface of a sterilizable modular kit (which then contains at least some of the requisite component parts for a complete surgical implant).

(120) The Essential Constituents of the Modality Disposition-Accounting Assembly

(121) As the preferred embodiment illustrated by FIGS. 12A and 12B respectively, the modality disposition-accounting assembly 100 appears as a 10 mm width×28 mm length×12 mils thickness construct which safeguards its internal photovoltaic chip transponder contents from attack and degradation by repeated exposures to a harsh sterilizing environment. Solely for illustration purposes, a penny-sized disc (or “PSD”) appears in FIG. 12B for making size comparisons visually.

(122) As shown by FIGS. 12A and 12B, the preferred assembly 100 is a unitary construction which presents an array of three discernible mode disposition subassemblies 110, 120, and 130 respectively. Each of these subassemblies 110, 120, and 130 is spaced apart [about 5 mm distance] in sequential series from the others; and each subassembly 110, 120, and 130 is structured as a modality choice entity formed of the following.

(123) Constituent (a): An optionally present, preformed planar base sheet 140 which is composed of a durable and visibly clear light transparent matter. This optionally present clear base sheet in its preferred embodiments: has a set elongated configuration and predetermined millimeter-sized

(124) length, width, and thickness dimensions; presents a discrete anterior face surface and a discrete posterior face surface; is repellent to water and other aqueous fluids; is resistant to cleaning agents and other noxious chemical compositions; is enduring of and resistant to harsh sterilization environments; and has a visibly clear adhesive coating disposed upon its posterior face surface.

(125) Constituent (ß): A plurality of preformed and differently colored flat backing sheets 150—shown as flat backing sheets 150a,150b, 150c—which are each spaced apart from one another; are collectively linearly oriented and aligned in as a linear row and are individually permanently positioned in separated sequential series. Each of these flat backing sheets 150 presents a recognizably different and disparate colored material which can be easily visually distinguished by the human eye as alternatively colored materials. Cumulatively and collectively, each of the three differently colored flat backing sheets 150a, 150b, 150c in its preferred embodiments: has a pre-selected configuration and thickness dimension; presents limited length and width millimeter-sized dimensions; has an anterior face surface and a posterior face surface of predetermined surface area; is repellent to water and other aqueous fluids; is resistant to cleaning agents and other noxious chemical compositions; is enduring of harsh sterilization environments; and has an adhesive coating disposed upon its posterior face surface.

(126) Constituent (y): Three individual and discrete micron-sized photovoltaic cell-chip transponder units 160—shown as individual transponder units 160a, 160b, and 160c respectively—are cumulatively and collectively disposed in series upon and contained entirely within the anterior face surface area for each of said three colored intermediate backing sheets 150. In addition, each of said three photovoltaic cell-chip transponder units 140a, 140b, and 140c can be separately activated and individually energized by light energy to generate and electronically emit one corresponding singular and unique identifying RF response signal into the ambient environment.

(127) And

(128) Constituent (δ): A single, preformed planar top sheet 170 which lies disposed upon and joined fluid-tight to each of the three operative micron-sized photovoltaic cell-chip transponder units 160a, 160b, and 160c, as well as to the anterior face surface areas for each of the three colored flat backing sheets 150a, 150b, and 150c.

(129) Accordingly, the planar top sheet 170 in its preferred embodiments: is composed entirely of a durable, visibly clear, transparent material; presents a discrete anterior face sheet surface and a discrete posterior face sheet surface; has an elongated configuration and millimeter-sized length and width dimensions which are not less than the dimension of said colored backing sheets; is repellent to water and other aqueous fluids; is resistant to cleaning agents and other noxious chemical compositions; is enduring of and resistant to harsh sterilization environments; and has a visibly clear, light transparent adhesive coating disposed upon its posterior face surface.

(130) Functionally Independent and Distinct Modality Disposition Subassemblies

(131) The preferred embodiment illustrated by FIGS. 12A and 12B respectively is an unitary modality disposition-accounting assembly 100 which has three discernible subassemblies 110, 120, 130, each of which acts independently from the others as one discrete operative subunit. The three subassemblies 110, 120, 130 are individually activated and separately operative on-demand; and each subassembly visually appears as a differently colored subunit to the human eye; and each subassembly is spaced apart a short distance (typically 3-6 mm) from the others. Together, the three subassemblies are oriented and aligned along a single axis as an organized array; and are collectively and cumulatively positioned in sequential sequence series as a linear row of subunits.

(132) Equally important, each modality subassembly 110, 120, 130 independently identifies and individually accounts for one, and only one, particular transaction pattern and performance activity sequence involving a single number identified component part of the complete implant.

(133) Accordingly, the first modality subassembly 110—when activated and energized by light energy photons—will independently release and broadcast a first unique modality RF signal which, in turn, will serve to indicate a first mode of transaction and performance history for that specific component number identified part.

(134) Similarly, if and when the second modality subassembly 120 becomes activated and energized by light energy photons, the subunit 120 will independently release a second modality RF signal which uniquely serves to indicate a different second mode of specific transaction and performance history for that component number identified part.

(135) Lastly, if and when the third modality subassembly 106 is activated and energized by light energy photons, the subunit 130 will then independently release and broadcast a third modality RF signal which provides a third and alternative transaction pattern and performance history for a component number identified part.

(136) Examples of the Different Modes of Surgical Transaction & Performance

(137) In the preferred embodiment shown by FIGS. 12A and 12B respectively, the constructed operational assembly 100 offers and provides a range of not less than three different surgical use patterns as distinct transactions and alternative performance outcomes. It is critical that the substantive differences separating these three surgical transaction patterns and performance histories be properly understood and fully appreciated.

(138) By commonly accepted dictionary definition, the term ‘modality’ is understood to mean the way or mode in which something exists or is done. Also by common dictionary definition, the term ‘disposition’ is understood to mean the manner in which something is placed or arranged, especially in relation to other things then also appearing in the same locale.

(139) Therefore as employed herein, the term ‘modality disposition’ will define the exact nature of one surgical act, activity, and engrafting performance history occurring for a specific number-identified component part which is then being used for a complete implant construct; and this term will identify the true factual outcome and ultimate surgical fate for that single component number-identified part.

(140) Also within the surgical context of the present invention, the term ‘accounting’ will be understood to be limited to a manner of summarizing individual transactions and performance histories via a unique RF signal which is released and broadcast into the surrounding operating room environment. Accordingly, the accounting function and capability of the ‘modality assembly’ identifies and summarizes the true transaction history and ultimate outcome of a one transaction or performance activity by the surgeon.

(141) The preferred embodiment of the modality disposition-accounting assembly 100 illustrated by FIGS. 12A and 12B respectively will identify and summarize which of three possible and most-likely transaction patterns and performance outcomes did in fact occur concerning one individual number identified component part as actually used by the surgeon during the in-vivo engrafting procedure. Within the confines of a traditional surgical operating room, the three most likely kinds of surgical transactions and alternative ultimate disposition outcomes are deemed to be these presented below.

(142) Mode of Transaction & Performance History 1:

(143) In this 1st transaction pattern, the particular component number identified part (such as a 4 mm length, 1 mm diameter, Philips screw) was requested by the surgeon; and was aseptically handed to the surgeon by the ST; and then was successfully surgically placed and inserted into the patient's body at a prechosen anatomic site. In this 1st pattern, the

(144) transaction (an insertion of the 4 mm screw into the patient) was surgically successful; and thus the ultimate disposition in this 1st pattern instance is that this particular number identified component part (the 4 mm Philips screw) now actually resides and can be found in-vivo at one precisely known location within the body of the living patient.

(145) Accordingly, when the screw was aseptically handed to the surgeon by the ST, the first modality subassembly 110 of the assembly 100 was concurrently activated and energized by light energy photons; and this act in turn released a first unique modality RF signal into the ambient environment. The broadcast of this first unique modality RF signal overtly serves to indicate that a first mode of transaction and performance history for that single component number identified part, the 4 mm Philips screw; and acts to account for a successful insertion of that 4 mm screw as the ultimate disposition and final result as the direct consequence of this transaction.

(146) It will be noted and appreciated also that the operational capabilities of the modality subassembly 110 are limited and restricted to indicating only this first type of transactional and performance history—where the ultimate disposition and result is that the particular component part now actually resides in the living body of the patient.

(147) Mode of Transaction & Performance History 2:

(148) In this 2.sup.nd transaction pattern, the particular component number identified part (such as a 4 mm length, 1 mm diameter, Philips screw) was requested by the surgeon; was aseptically handed to the surgeon by the ST; and was initially placed into the patient's body at a prechosen anatomic site—but was subsequently removed [for any reason] from the subject's body in a re-usable condition. Then, because that part was re-usable, that 4 mm Philips screw was replaced back into its individual shaped well within the modular kit. The outcome and ultimate disposition of this second circumstance is that this particular component part—although initially used by the surgeon—nevertheless was removed and now presently resides again within the modular kit.

(149) To indicate this second fact pattern, the second modality subassembly 120 of the assembly 100 has been activated and energized by light energy photons; and in turn, has independently released a second unique modality RF signal—which serves to identify that this particular 4 mm screw is not actually in the patient. Instead, the broadcast of the second modality RF signal will act to account for the actual return of the 4 mm screw to the modular kit as the ultimate disposition and performance outcome for that screw as the direct consequence of this transaction.

(150) It will be noted and appreciated, again, that the operational capabilities of the modality subassembly 120 are limited and restricted to indicating only this second type of transactional and performance history—where the ultimate disposition and result is that the particular component part (the 4 mm screw) now resides once again within the modular kit.

(151) Mode of Transaction & Performance History 3:

(152) In this 3.sup.rd transaction pattern, the particular component number identified part (such as a 4 mm length, 1 mm diameter, Philips screw) was requested by the surgeon; was aseptically handed to the surgeon by the ST; was initially inserted into the patient's body—but was subsequently removed from the patient (for any given reason) in a non-usable condition.

(153) Furthermore, because this component number identified part (the 4 mm Philips screw) was bent or modified by the surgeon, or was defective in its performance, or was deficient in its requisite screw thread properties—that particular Philips 4 mm screw was then discarded by the surgeon as waste matter, and was removed from the surgical field, and eliminated forever from any further possible surgical use. Accordingly, the outcome and ultimate disposition of this third surgical transaction pattern is that this particular component part (the 4 mm Philips screw) lies neither within the patient's body, nor has it been returned to the modular kit inventory; but instead has been removed from use entirely, and has been knowingly discarded as surgical trash.

(154) In this alternative third performance pattern, the third modality subassembly 130 of the badge assembly 100 has been activated and energized by light energy photons; and has independently released a third unique modality RF signal which will serve to identify that the component number identified part (the 4 mm screw) is not in the patient, and has not been returned to the modular kit inventory—but instead has been discarded as surgical waste mater.

(155) Once again, it is understood that the operational capabilities of the modality subassembly 130 are limited and restricted to indicating only this third pattern type of transactional and performance history—where the ultimate disposition and result is that the 4 mm screw is now mere medical trash.

The Scope of the Envisioned Variants

(156) (a). There are always a plurality of discernible modality disposition sub-assembly units in the erected assembly, each discrete section and subunit being spaced apart from the others in sequential series. These multiple subunits cumulatively and collectively appear as an array of aligned individually operative subassemblies, which are oriented and positioned in a linear row across the length dimension of the erected assembly as a whole, as seen in FIG. 12B. Accordingly, in each and every embodiment of the modality disposition-accounting assembly, there will be not less than two (2) and not more than six (6) discrete subassembly sections spaced apart a few millimeters distance from one another.

(157) (b). A preformed planar base sheet 140 (seen in FIG. 12A) is desirably, but optionally, present in any given embodiment of the modality disposition-accounting assembly. When present, this base sheet is composed of a durable and visibly clear light transparent matter; and all the other required constituents of the assembly as a whole are then located and held in desired positioned upon the anterior face surface of the clear base sheet.

(158) (c). If and when the preformed planar base sheet is not present as such in the particular embodiment, then this variant format appears and is constructed as illustrated by FIG. 13. A plurality of preformed and differently colored flat backing sheets 150—shown as flat backing sheets 150i, 15ii, 150iii—which are each spaced apart from one another; are collectively linearly oriented and aligned in as a linear row and are individually permanently positioned in separated sequential series. Each of these flat backing sheets 150 presents a recognizably different and disparate colored material which can be easily visually distinguished by the human eye as alternatively colored materials. Also, three individual and discrete micron-sized photovoltaic cell-chip transponder units 160i, 160ii, and 160iii respectively are cumulatively and collectively disposed in series upon and contained entirely within the anterior face surface area for each of said three colored intermediate backing sheets 150. Finally, a single, preformed planar top sheet 170i lies disposed upon and joined fluid-tight to each of the three operative micron-sized photovoltaic cell-chip transponder units 160i, 160ii, and 160iii, as well as to the anterior face surface areas for each of the three colored flat backing sheets 150i, 150ii, and 150iii.

(159) (d). The true number of preformed and differently colored backing sheets and the number of micron-sized photovoltaic cell-chip transponder units in each constructed embodiment of the modality disposition-accounting assembly will vary directly and correspond exactly with the desired number of individual subassembly units. Thus, if the minimal two modality subassemblies are to be arrayed in the embodiment, then only two differently colored flat backing sheets and only two micron-sized photovoltaic cell-chip transponder units will be concomitantly present in this particular embodiment. Similarly, if the maximum six modality subassemblies are to appear in the given embodiment, then six differently colored flat backing sheets and six discrete micron-sized photovoltaic cell-chip transponder units will be present in this alternative embodiment.

(160) (e). For each modality disposition subassembly present in the assembly as a whole, each such subassembly will display a recognizably different and disparate colored material which can be easily visually distinguished by the human eye as alternatively colored materials. It is recommended and preferred that the different colors chosen for use will be vivid shades and bold hues such that there will be little or no difficulty in distinguishing among the range and variety of colors as separated operational subassembly segments.

(161) (f). Because the disposition-accounting function and capability of each modality disposition subassembly appearing within the assembly as a whole must identify and summarize one, and only one, surgical transaction pattern and ultimate outcome for a single component number identified part as actually used by the surgeon—it is vital that the particular embodiment be prepared and erected to provide a sufficient number of possible surgical transaction patterns and ultimate performance outcomes that are realistically consistent with the kind and type of complete implant construct which is being engrafted in-vivo. Accordingly, it will be understood that a first type of complete implant construct, such as an “implantable defibrillator”, will present the need for a greater number of possible alternative transaction patterns—and for more modality subassembly units than will an “internal fixator” such as a single bone plate.

Arrangement Requirement 5: A Light-Energy Emitting Wand

(162) For purposes of the present invention, a light-emitting wand is defined as any small, hand-holdable baton, stick, staff, bar, or dowel-like apparatus which can generate a stream of photons on-demand; has a fixed beam diameter size; and will emit light energy photons at a prechosen light wavelength and at a pre-determined light intensity.

(163) Such light-emitting devices have been known conventionally for many years; and one generally useful prior art example is described by U.S. Pat. No. 6,293,684 [of E. L. Riblett issued on Sep. 25, 2001]. As disclosed therein, the wand light has a base tube with a light-tube end in which a base end of a light tube is pivotal concentrically with pivotal-light-switch attachment of the light tube to the base tube. The base tube contains a stored-energy unit, in addition to being a handle and a daytime signaler. The light tube contains a light emitter which can include a flashlight bulb or a plurality of light-emitting diode units on a circuit board. The light tube is twisted in the base tube for selective switching of current for the light emitter.

(164) Quite often, a wand light will comprise a laser diode, a programmable current driver, and an optical collimation/focusing module. Many styles of light-emitting wands are known and conventionally available today for a variety of purposes; and a wide range of operative models are sold commercially. Thus, for the present invention in many of its preferred embodiments, the wand will comprise an operative laser apparatus—which, for example, can emit an average of 60 mW of optical power at a frequency of 658 nm; and be pulsed at 1 MHz.

(165) The preferred, tightly focused, narrow light beam emitted by the laser diode of the wand also offers some unique benefits: It allows for precise positional specificity that can be applied to small and closely spaced items. This desirable capability allows the human user the capability of physically to address and to illuminate one micron-sized photovoltaic cell− chip transponder unit at a time-despite that these a plurality of such transponder unit lie together in close proximity to each as a dense array of micron-sized photovoltaic cell-chip transponder units. In this manner, only one specific photovoltaic cell-chip transponder unit is energized at a time; and only one response RF signal at a time is subsequently released by the energized transponder unit into the ambient environment.

(166) It will be noted and appreciated that this particular feature and capability is not feasible with conventional RFID tags and methods because an array of RFID tags disposed in close proximity will attempt to communicate simultaneously, and will mutually interfere with one another; and thus preclude and prevent individual activation of the tags—a phenomenon known as “RFID tag collision”.

A Preferred Wand Embodiment

(167) A preferred embodiment of the light-emitting wand is commercially sold by PharmaSeq Wand; and is a small, hand-held device capable of energizing and then receiving the RF response signal released by individual micron-sized photovoltaic cell-chip transponders, one at a time. Such a preferred wand 200 is about 17.5 cm in length; is about 2.8 cm in diameter; and appears as FIG. 14.

(168) As seen therein, the wand 200 is electronically connected to a conventional personal computer or laptop via a USB cable that provides both electrical power and direct electronic communication. Typically, the wand 200 can be either hand-held or be mounted on a fixed stand.

(169) The wand 200 generally comprises: a laser diode with programmable laser driver, an optical focusing module, an air coil pickup connected to an RF receiver, a USB 2.0 microcontroller and power regulators. The laser Typically emits 5 to 60 mW of optical power at 660 nm; and is registered with the FDA as a Class 3R device, similar to a laser pointer.

(170) Operationally when placed over a micron-sized photovoltaic cell-chip transponder, the light photons emitted by the wand causes the transponder unit to become activated and energized; and to generate and broadcast a uniquely encoded RF response signal into the surrounding ambient environment.

Arrangement Requirement 6: A Discernible Telemetric RF Signal Receiver

(171) By definition, an RF signal receiver is any telemetric electronic device able to receive a range of different and diverse RF response signals as they individually are released and broadcast into the ambient environment. In turn, telemetry is defined as the sensing and measuring of information at some remote location and then transmitting that in formation to a different central or host location; and once there, the transferred signal in formation can be recorded, compiled, analyzed, and used to control a process.

(172) Telemetry RF signal receivers are well known and conventionally used articles of manufacture [see for example, Telemetry Standard RCC Document 106-07, Chapter 2, September 2007]; and are thus discrete acquisition unit of individual RF signals which have been broadcast into the environment. As such, RF signal receivers are electronic units operative to receive RF signal transmissions from remote locations via wireless communication; and then are able subsequently to transfer them electronically to another apparatus for recording, compilation, analysis, and visualization of information.

(173) The RF signal receiver units suitable for use in the present invention will each exhibit and collectively share several operating parameters and performance characteristics, which include the following: An operating frequency, which is the full range of specific RF signals that can be received; A measurement resolution, which is the minimum digital resolution possible for that unit; A maximum transmission distance, which is the greatest measurable distance that the receiver unit can be physically separated from the transponder source of the RF signal and still be able to receive that transmitted RF signal; A fixed data rate, which is the amount of RF signal data in bits per second that can be transferred subsequently by the receiver unit; and A rated output power, which is the maximum signal communication power that the receiver unit can transmit and transfer its received signal data to another electronic device.

(174) Consequently, the RF signal receiver unit is telemetric device that is typically connected to and is in electronic communication with a remotely located standard PC unit; and often appears today as a USB-powered unit containing a USB 2.0 transceiver microcontroller, a field programmable gate array code (FPGA), some power converters and regulators, and a tuned air coil pickup with a high gain. Most desirably, it is a low noise differential RF signal receiver with hysteretic comparator data slicer; and the FPGA code can be periodically upgraded to support incorporation of new features and performance enhancements.

A Preferred Format

(175) It is most desirable that the RF signal reader 300 be located at the distal end of the wand 200, as has been described above and as shown by FIG. 14. In this distal location setting, the RF signal reader 300 is capable of receiving the RF response signal and reading the encoded component part identification number broadcast by the individual photovoltaic transponders.

(176) A portable wand combined with a RF signal ID reader is commercially available from the manufacturer [Pharmaseq Inc., Princeton N.J.]; and such an remotely located response-signal ID reader/detector can and will communicate with any personal computer (PC) system via a standard USB port. Thus, the Series 8000 PharmaSeq Wand is both suitable and operative for detecting and reading responsive RF signals sent from embedded P-Chip® transponders. This response-signal ID reader/detector is calibrated for object identification applications; and includes CD-ROM with p-Chip Reader Software (compatible with Microsoft Excel, Access, and similar software programs).

(177) Accordingly as seen in FIG. 14, the RF signal reader 300 is located at the distal end of the wand 200; and is a USB-powered device typically connected to a standard PC. It often includes a USB 2.0 microcontroller, field programmable gate array, power regulators, and a radiofrequency receiver-coil assembly. It instantly receives and decodes the broadcast RF response signal; determines the identity information from the received RF signal using internal onboard firmware; and then reports the decoded identity information to a nearby data compilation unit via programmed software. The RF signal identity information is decoded and transmitted in a matter of milliseconds; and thus a minimum of time is required for the data to be recorded and visualized.

(178) Internal software processes the received RF response signals using an error checking decode algorithm; and transmits them, along with a log of activities, in an MS SQL database or other type of file specified by the user. The available software includes DLL and LabView application programming interfaces. Exporting data directly to MS Excel programming is also an option.

Arrangement Requirement 7: At Least One RF Signal Recordation and Data Compilation Unit

(179) In the present system, a RF signal recordation and data compilation unit is in operative electronic communication with the RF signal receiver described above. This RF signal recordation and data compilation unit provides a range of desired functions and capabilities: It accumulates, records and stores all received RF response signals as informational data; compiles and analyzes the stored RF informational data; and can display the complied and analyzed RF informational data in at least one visual display format.

(180) Many suitable RF signal compilation units are known in the relevant prior art and have been conventionally employed over several decades.

(181) Accordingly, for these reasons, for achieving the goals and purposes of the present invention—any kind, type, format, or style of conventional RF signal recordation and compilation unit is suitable and acceptable, so long as the necessary functions and essential actions of recording and storing all received RF response signals as informational data is performed.

(182) Thus, once all the broadcasted RF signal responses have been entered and recorded as stored data, the surgical technologist can then employ a wide range of different software programs to perform a host of additional functions—such as compiling and analyzing the stored RF in formational data, as well as displaying the complied and analyzed RF informational data in a desired visual presentation format.

(183) IV. The Methodology of the Control System & Supervisory Arrangement

(184) It is most desirable that no doubt or question remain or exist as to how to use the present invention in its intended surgical setting. For this reason, a summary description of the manner in which the present control system and supervisory arrangement would be operative and be used within the limited spatial confines of an Operating Room is given below.

(185) “Build a Patient Case History”

(186) Initially, the true numbered identities and individual component part contents of one or more modular kits, trays, or surgical sets which are needed and used for the engrafting of a complete implant are scanned into a software management program—as a group of items specific to the particular patient case. This is typically done before the surgery actually begins; and will routinely occur when the requisite tangible supplies and disposables to be used in the patient's surgery are put on a cart specific to that surgery (i.e., a patient's “case cart”).

(187) When these items are scanned and associated as a group, the user will assign a surgeon's name, a patient case time, and a surgical implant procedure title from a prepared menu offered by the software. The modular kits, trays, or sets are then set up for the operation, usually on the patient's case cart for that particular surgery.

(188) This preliminary action and activity is performed outside the Operating Room itself, usually in Central Supply or in the Sterile Processing Department. The prepared-in-advance cart is then moved and staged outside the OR until it is needed for the particular surgery.

(189) “Scan the Implant Parts”

(190) Three people will typically interact with the control system in the operating room itself. These are: The surgeon(s), the surgical technician (“ST”), and the circulating nurse.

(191) The circulating nurse is the person responsible for all surgeon support activities outside the sterile field during the surgery. In comparison, the surgical technician (or ST) is the person responsible for surgeon assistance and support within the sterile field (outside of anesthesia). The ST organizes and hands off the various tools and instruments, requisite implant component parts, and necessary medical supplies to the surgeon during the course and performance of the surgery—when and as requested by the surgeon.

(192) Once the surgery is underway, the surgeon will call for each of the implant parts he is to engraft into the patient. The previously-prepared patient's case cart will be drawn close by the circulating nurse to the sterile operating field and anatomic site; and the circulating nurse then typically stands across from the ST at the other side of the patient. The patient's case cart will remain a short distance [typically a distance of about 1 foot] from the patient so as to not contaminate the sterile operating field.

(193) Typically at this point, the surgical technician will then open the sterile packaging containing the preferred wand embodiment—a combination laser light and telemetric RF reader (described in particular detail above)—within the confines of the sterile field; the packaged wand having been previously sterilized via a chemical sterilization process (such as Sterad). The surgical technician then typically “hands off” the USB end of the connecting cord of the wand to the circulating nurse (who is not in sterile garb and thus stands outside of the sterile operating field).

(194) The circulating nurse will then plug the USB end of the wand cord into a separately prepared data-cart which contains and provides at least one RF data compilation unit; and preferably is a wireless and battery powered article suitable for electronic communication. Once the connections are complete, the circulating nurse then engages the software programs of the RF data compilation unit into the “scan implants” mode via the data-cart touch screen.

(195) At this stage, the ST can then begin to select and to hand the individual component parts called for by the surgeon as requested. The software of the RF data compilation unit automatically defaults when started into the “implanted into patient” mode of transaction and performance; and each time the ST selects and hands the surgeon an engraftable part, the ST will scan the corresponding use-tracking badge correlating to that specifically numbered component part then disposed upon the exposed face surface of the modular kit or tray; and via this act, the particular information will become automatically entered into and retained by the electronic memory of the RF data compilation unit on the data-cart.

(196) If at any time, should the ST be given a specific component part back by the surgeon which is deemed to be intact, can be used again, and thus can be returned back into the modular kit or tray—the ST will then light energy scan the particular subassembly unit of the modular assembly which designates this activity as a “removal and return of the part back into the modular kit inventory”; and then also light scan the corresponding use-tracking badge on the modular kit or tray which corresponds to and correlates with that one particular component part. By these actions, the control system records the details of the event whereby that component part is return to its previous place within the modular kit.

(197) In the alternative instance, if and when the component part is handed back to the ST by the surgeon because it then is insufficient in quality, or is somehow defective, or is deemed to be unsuitable for any reason; then, the ST would light energy scan the alternative performance modular subassembly unit. This particular act by the ST indicates that the specific component part is truly unfit and unsuitable for any use. The ST will then also light scan the proper corresponding use-tracking badge disposed on the exposed face surface of the modular kit or tray which corresponds to and correlates with that particular component part—which is now identified as being mere surgical waste.

(198) “After the Surgery is Completed”

(199) At the end of the engrafting surgery as a whole, the circulating nurse pushes the “save” and “print” buttons appearing on the screen of the RF data compilation unit then resting on the data-cart. The operative supervisory arrangement and control system will then save all the data previously entered which is pertinent to the patient's surgery and case history; and pass that recorded information to other software systems—in particular, to the inventory management and patient billing/patient record software, as well as to the software drivers to create a written printout of all the tangible items and supplies actually used for that particular surgery.

(200) It should be noted here also that—both for convenience and accommodation—one part of the RF data compilation unit on the data-cart desirably includes and provides a standard barcode scanner; i.e., a scanner which can be used to scan and track by conventional barcodes all pre-sterile supplies (e.g., gloves, suture, saline, biomaterials, biologics, etc.) that are put into the sterile operating field for use during the surgery. These commonplace items all are presently available in closed packaging which after sterilization keeps them sterile indefinitely; and such items typically have pre-printed barcode identification labels on their exterior package surfaces. In this manner, all currently used surgical items which are today traditionally identified by barcode labels can be used conveniently with the control system and supervisory arrangement of the present invention.

(201) The present invention is neither limited in form nor restricted in scope except by the claims appended hereto.