[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/305,929, filed February 2, 2022, the disclosure of which is incorporated herein by reference.

TECHNICAL FIELD

[0002] This document relates generally to a device for quantifying, archiving, and reporting matter removed from a living body, and in particular to aspirate from a patient during a liposuction procedure.

BACKGROUND

[0003] Matter obtained from a patient is traditionally collected in a container or vessel having a graduated scale used for determining a total quantity of the matter. The containers are typically disposable along with the matter collected therein in order to prevent health care worker exposure to biohazardous content. The matter, including bodily fluids, is collected in a variety of different medical settings including, but not limited to, suction aspirates during surgery, drains placed in body cavities, paracentesis aspirates, pleurocentesis aspirates, and liposuction procedures.

[0004] Depending on the procedure, information relating to the collected matter beyond just overall quantity can be utilized. For example, monitoring an amount of fluid and/or blood loss in any procedure is important for patient safety as the amount of aspirate guides replacement needs to avoid hypovolemic shock. In a liposuction procedure, as another example, the product of the surgical process, or the matter removed, includes a fluid component and a fat cells component. A majority of the fluid component is a tumescent fluid which was injected prior to the start of the liposuction process and consists of saline and trace amounts of local anesthetic drugs. Additional contributors to the fluid component include, among other possibilities, oil from ruptured fat cells and certain, typically small, amounts of blood.

[0005] A typical liposuction procedure involves treatment of multiple discrete areas on the same patient. As it is desirable to maintain symmetry in complimentary discrete areas, accurate measurement and tracking of the of the amount of matter removed from each such area is important. However, the components which make up the matter will vary not only from patient to patient but even from area to area within the same patient. Hence, one area may yield a higher percentage of fat cells than another area in the same patient. Accordingly, accurate quantification of the liposuction aspirate volume, or the matter removed, from each area is important to ensure symmetric treatment of the complimentary discrete areas.

[0006] Liposuction devices typically use the same or similar collection vessels or containers as those used in the variety of different medical settings as noted above. Commonly used containers include graduated scales for determining aspirate quantity which are notoriously imprecise due in part to a reliance on graduations of up to 50 mL or more. Even within this accuracy limit, readings must be performed with a level line of sight to avoid additional error. If the container is not located on eye level, as is often the case, additional error is likely to be imposed. It necessarily follows that the current standard for determining a quantity of liposuction aspirate in a container is highly imprecise. Even more, the error(s) is magnified as the overall volume is tracked from one patient area to another.

[0007] In addition to overall quantitative issues, there are currently no available means for accurately determining components of the matter removed from the body (e.g., a relative percentage or quantity of fat cells contained in the liposuction aspirate). In other words, there is no way to determine what portion of the matter removed from the patient is a fat cells component compared to, for example, a fluid component. As noted above, accurately determining this additional information would be particularly helpful to allow the surgeon to generate a symmetric treatment of complimentary discrete treatment areas.

[0008] One known approach to component quantification relies on flow rate measurements of matter being removed from the patient. The discontinuous and highly variable flow of the matter or aspirate being removed in liposuction procedures makes measuring and/or determining components parts of the matter utilizing such measurements by optical and weight determinations generally unreliable. Air gaps and periods of free air flow are normal with liposuction procedures which contribute to the unreliability.

[0009] Another approach to component quantification relies on a color of the harvested fat cells. Differentiating fat cells from fluid relying on a detected yellow color is similarly unreliable since fat cell color can vary dramatically from one patient to another, and even from one anatomic area to another within the same patient. In addition, fat cell size, the degree of fat cell disruption during the aspiration process, and the amount of dilution by the tumescent fluid can each affect fat cell color.

[0010] As a result, a need exists for a device capable of quantifying the matter removed regardless of whether a flow of matter being removed is continuous or variable or the color of the removed matter. As the fat cells component of the removed matter or aspirate is of primary concern in liposuction procedures, the device should be capable of quantifying the collected matter and at least the fat cells component thereof. Such quantification should occur for each discrete treatment area to support the goal of symmetry between complimentary discrete areas. All such quantifications should be archived and reported (e.g., visually displayed for the surgeon’s realtime utilization) throughout a liposuction procedure.

SUMMARY OF THE INVENTION

[0011] In accordance with the purposes and benefits described herein, a device for quantifying, archiving, and reporting information relating to matter removed from a living body or patient is provided. The device may be broadly described as including a container for receiving the matter removed from the living body via an inlet tube, at least one load cell for weighing the container and the matter received therein, a base plate supports the at least one load cell, the container, and at least one display; and a processor programmed to determine at least a total matter volume and a total fat cells component volume of the matter in the container based in part on a weight of the matter, a density value stored in a memory, and at least one input selected from the group of procedure technique, treatment area, and body mass index of the living body.

[0012] In one possible embodiment, the stored density value is a baseline pre-programmed density value.

[0013] In another possible embodiment, the processor is programmed to adjust the baseline pre-programmed density value by averaging the pre-programmed density value with a current determined density value to create an adapted baseline density value which is stored in the memory.

[0014] In yet another possible embodiment, the processor is programmed to determine the current determined density value based on the weight of the matter in the container and user inputs including a total matter volume in the container and a total fat cells component volume in the container.

[0015] In one other possible embodiment, the processor is programmed to adjust the adapted baseline density value by averaging at least the adapted baseline density value with a subsequent determined density value to create a further adapted baseline density value which is stored in the memory.

[0016] In still another possible embodiment, the processor is programmed to determine the subsequent determined density value based on the weight of the matter in the container and user inputs including a total matter volume in the container and a total fat cells component volume in the container.

[0017] In another aspect of the invention, a method of quantifying, archiving, and reporting information relating to matter removed from a living body includes the steps of: (a) directing the matter removed from the living body into a container; (b) weighing the matter and the container; (c) obtaining information relating to at least one aspect of the matter in the container; and (d) determining at least a total matter volume and a total fat cells component volume of the matter in the container based in part on a weight of the matter, a density value stored in a memory, and at least one input selected from the group of procedure technique, treatment area, and body mass index of the living body.

[0018] In another possible embodiment, the stored density value is a baseline pre-programmed density value.

[0019] In yet another possible embodiment, the method may further include the steps of adjusting the baseline pre-programmed density value by averaging the pre-programmed density value with a current determined density value to create an adapted baseline density value, and storing the adapted baseline density value in the memory.

[0020] In one other possible embodiment, the method may further include the step of determining the current determined density value based on the weight of the matter in the container and user inputs including a total matter volume in the container and a total fat cells component volume in the container.

[0021] In the following description, there are shown and described several preferred embodiments of the device for quantifying, archiving, and reporting a quantity of a fat cells component of matter removed from a living body or patient and related methods. As it should be realized, the various devices and methods are capable of other, different embodiments and their several details are capable of modification in various, obvious aspects all without departing from the devices as set forth and described in the following claims. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0022] The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of a device for quantifying, archiving, and reporting information relating to matter removed from a living body or patient and related methods, and together with the description serve to explain certain principles thereof. In the drawing figures:

[0023] Figure 1 is a perspective view of a device for quantifying and reporting a quantity of matter removed from a living body including a container supported by a base;

[0024] Figure 2 is a schematic illustration of the device;

[0025] Figure 3 is a perspective view of a device for quantifying and reporting a quantity of matter removed from a living body including a sterile connector supporting the container;

[0026] Figure 4 is a detailed view of an exemplary display screen including soft keys for receiving user input; and

[0027] Figure 5 is an exemplary flowchart of the processing methods.

[0028] Reference will now be made in detail to the present embodiments of the device for quantifying, archiving, and reporting information relating to matter removed from a living body or patient and related methods, examples of which are illustrated in the accompanying drawing figures, wherein like numerals are used to represent like elements.

DETAILED DESCRIPTION

[0029] Reference is now made to Figure 1 which shows a device 10 for quantifying, archiving, and reporting information relating to matter removed from a living body (e.g., a patient). The device consists of a base 12 which supports a collection vessel or container 14. In the described embodiment, the container 14 is generally cylindrical in shape and centrally positioned on the base 12. The base 12 may include non-skid pads on a bottom surface thereof or wheels, casters, suction cups, etc. in alternate embodiments and may itself be attached to or otherwise supported by a liposuction machine.

[0030] The device 10 is utilized, in the described embodiment, for harvesting fat cells for grafting and the container 14 collects the matter (e.g., aspirate including a liquid component and a fat cells components) removed from the patient. In the described embodiment, a lid 16 seals the container 14 and has at least two ports 18, 20. An outlet port 18 connects to a vacuum line 22, or vacuum tube, which itself is connected to a pump (not shown) of a liposuction machine 24. An inlet port 20 is connected via an inlet line 26, or tube, to a liposuction cannula 28 for drawing the matter out of the patient. The liposuction machine 24 and cannula 28 can be any type generally known in the art. The ports 18, 20 may be covered by caps until ready for use, thereby maintaining sterility of an interior of the container 14. The container 14 is made of a translucent material in the described embodiment to accommodate visual inspection of the matter therein.

[0031] Both the vacuum line 22 extending between the container 14 and the liposuction machine 24 and the inlet line 26 extending between the container and the cannula 28 are immobilized by a stabilization device. In the described embodiment, the stabilization device includes clamps 30 positioned within distal portions of arms 32 which extend from a back 34 of container 14. The back 34 itself extends from the base 12, as shown in Figure 1, and the arms extend at least partially around the container 14. The stabilization device, including the clamps 30 in the described embodiment, is intended to isolate the container 14 from forces applied to one or both of the lines 22, 26. In other words, the clamps 30 ensure that neither movement nor the weight of the vacuum line 22 and/or the inlet line 26 influence a determination of a weight of the container 14. Of course, any type of stabilization device sufficient to prevent movement of the lines may be utilized whether independently supported or supported by the device 10.

[0032] Although not shown, at least one graduated scale is provided on the container 14 to allow the user to visually quantify the matter. Different scales may be provided to correspond with the various types of containers which may be used with the device 10. In other words, one graduated scale could apply to a container used for containment in a traditional liposuction procedure and another graduated scale could apply to a container used in a fat harvesting or grafting procedure, for example. In alternate embodiments, at least a portion of the container 14 may be transparent or translucent, or the entire container may be transparent or translucent.

[0033] A display 36 is supported by and extends from the back 34. The display 36 is located at a convenient viewing angle and working position for the surgeon or user and may be mounted for rotation in one or more axes. As will be described in more detail below, the display 36 is utilized to display information relating to the matter in the container via a screen 38 which may be a touch screen in certain embodiments. In the described embodiment, a second display 36a is located along a lower portion of the device 10 as shown in Figure 1. The second display 36a incorporates a touch screen 38a which serves as a user interface/display screen offering varying displays for reporting information to the user and soft key buttons for receiving user inputs. Even more, multiple displays may be used attached to the device at upper, lower, and/or middle positions with one or more having touch screen input capabilities.

[0034] As shown schematically in Figure 2, the display 36 is connected to and controlled by a microcontroller 40 (or similar microprocessor, processor, or controller as is known in the art). In the described embodiment, the user, whether surgeon and/or staff, utilizes soft key buttons to provide certain inputs while outputs (e.g., total/area volumes, area by area tracking information, and other desired output information) are reported or displayed for easy visual reading by the user. Preferably, the displayed information is in a large font and the display 36 is located, as shown in Figure 1, for easy visualization by the user during procedures for real-time monitoring and/or assessment. In alternate embodiments, an anatomical model of the patient shown on the display 36 may be utilized to accommodate discrete treatment area inputs, for example, and/or to display the outputs.

[0035] In further alternate embodiments, the device 10 may include a transmitter 41 for transmitting information provided by microprocessor 40, including information related to the matter in the container 14, to a receiver 43 positioned in the display 36 after processing. In such a setting, information is transferred using any type of wireless technology known in the art (e.g., near field or Bluetooth brand technology).

[0036] Such technology may be used, for example, to transmit all procedure related information to a patient’s medical record whether the record is locally or remotely stored. Additionally, procedure results may be uploaded to and tracked by software located on a desktop computer or other similar device in the operating room or elsewhere. In this way, procedure related information may be reviewed not only for each procedure individually, but also comparatively with other procedures to gain a better understanding of each surgeon’s patient population and surgical techniques. Likewise, the procedure related information (absent personally identifiable information) may be reported to a device manufacturer for monitoring of device calibration and accuracy over a lifespan of the device. Remote firmware updates may also be pushed to the device 10 based on pooled data or for other purposes.

[0037] In still other alternate embodiments, the display 36 may form part of a mobile device (not shown), such as, a smart phone, a personal digital assistant, or a laptop computer or tablet. In such a mobile setting, procedure related information may be transmitted from a transmitter supported by the base to the mobile device using commonly known wireless technology. Such additional information may be utilized by a processor or the like supported by the base and a result or an output based at least in part on the information may be transmitted to the mobile device, or combinations of information and results transmitted.

[0038] In other words, the utilization of procedure related information may occur in all embodiments. Processing of such information may occur before or after transmission to the displays 36 and/or 36a. For example, the surgeon and/or staff members may input additional information into the device 10. Such additional information may include a quantity of washing fluid, and/or quantities of fluid and/or oil added or drained from the container 14 and may be utilized by the microprocessor 40 in calculations to yield a total aspirate volume and a total fat cells component volume as described in more detail below.

[0039] With reference back to Figure 1, the base 12 supports a base plate 42 on which the container 14 rests and is secured in position during use. In the described embodiment, the container 14 is releasably locked to the base plate 42 in a manner known in the art. One or more load cells 44 (hereinafter “load cell 44”) are in communication with the base plate 42. As matter flows into the container 14, the arrangement allows the load cell 44 to register the weight of the container, stabilized lines 22, 26, and matter. The load cell 44 provides an analog signal indicative of the combined weight. The analog signal is received by processing circuitry including, for example, an amplifier 46 to amplify the analog signal and a converter 48 to convert the analog signal to a digital signal. Utilizing those processed input signals, the microprocessor 40 is configured to determine a weight of the matter in the container 14 and to calculate or determine a density of the matter.

[0040] Although not shown, the base 12 is used to support the electronic components of the device 10 in a manner known in the art, the display 36 via back 34, and the display 36a. More specifically, the base 12 supports at least one circuit board in the described embodiment. The amplifier 46, converter 48, and microprocessor 40 are mounted on the circuit board through which inputs and outputs, including information concerning the weight of the matter and the container 14 from the load cell 44, are received and sent, for example, to the displays 36 and 36a. Additional components such as transmitters and receivers, if used, may be mounted to the circuit board as well. A power supply 50 (shown only in Figure 2), connected to line power via a power cord (not shown), is also supported by the base 12 in the described embodiment. In alternate embodiments, the device 10 may utilize a battery power source and/or a battery back-up power source in the event of a power outage.

[0041] With reference to Fig 2, a general schematic of the device 10 is provided. A microprocessor 40, microcontroller, or like device, is provided and receives inputs from at least the load cell 44, touch screen 38, and memory 52 whether the memory is external or within the microprocessor. Broadly speaking, the microprocessor 40 is programmed to determine components of the matter in the container 14 based on certain inputs which may include: (1) the weight of the matter in the container 14 as measured by the load cell 44; (2) information about the user/surgeon; (3) information about the discrete treatment area of the patient; and/or (4) information about the patient themselves. This process is described in additional detail below.

[0042] As described above, the display 36a incorporates a touch screen 38a which is used to display information relating to the matter in the container 14. As noted, the touch screen 38a is effectively a user interface/display screen offering display screens including soft key or fixed buttons for receiving user inputs (e.g., the inputs described above and below in relation to flowchart box 62). In other words, the touch screen 38a accepts user inputs and displays information output from the device 10. An exemplary touch screen is shown in Figure 5 and discussed in detail below.

[0043] In operation and upon startup, the device 10 will automatically tare the weight of the container 14 and stabilized lines 22, 26. As shown in Figure 4, the touch screen 38a displays a soft key 74 labelled “New Canister” to indicate that a new container 14 has been secured to the base 12. When depressed, the “New Canister” soft key signals the microprocessor 40 to tare the weight as described above. Throughout operation, the display 36 via touch screen 38 provides real time measurements of a total aspirate volume, a total fat cells component volume, a discrete area aspirate volume, and a discrete area fat cells component volume. For example, the “Fat” cells component volume in “Area 1” may be displayed as 65 ml and the “Fluid” volume as 10 ml. In the described embodiment, the volumes are displayed in milliliters although other units of measure may be utilized.

[0044] When the user has completed suctioning in a first discrete treatment area, a “New Area” soft key 76 may be depressed indicating that further suctioning will occur in a different, second discrete treatment area of the patient. Once the soft key 76 is depressed, the user is directed to a secondary menu screen to input parameters relating to the new area. For example, the user may select a side of the patient (e.g., left or right) and a location (e.g., flank, hip, or thigh) from a listing of such items or a patient diagram, or the user may key in such information using a soft key keyboard on the display screen 38a. The data from each completed treatment area is retained by the device 10 in the memory 52, as noted above, and displayed in a scroll menu below a larger “Current Area” and “Cumulative Total” headings above the actual readings as shown in Figure 5. In accordance with the described invention, however, the information may be displayed in any usable format.

[0045] In alternate embodiments, any soft key which acts as a switch within the touch screen 38 (for example, “New Area” soft key 76) may take the form of a physical switch (e.g., a momentary switch or a foot switch). Such a physical switch could be mounted on the cannula 28 or positioned on the operating room floor in order to provide convenient access without interrupting an ongoing procedure.

[0046] If the container 14 reaches maximum capacity, i.e., the container has reached a predetermined level or is completely full, then pressing the “New Canister” soft key 74 will indicate a desire to remove and replace the original container with a new container. After placement of the new container, pressing the “New Canister” soft key 74 will indicate that the new container is secured to the base 12 and the device 10 will again tare while providing a continuation of data acquisition in the current area. A “Menu” soft key 80 allows the user to reset the device 10 for a new procedure or patient, or to change display parameters, units, etc.

[0047] Through testing and analysis, it has been determined that a ratio of a liquid component to a fat cells component in matter removed from a body is relatively consistent. Variations in the ratio may occur based on the particular surgeon performing the liposuction procedure including the type of procedure utilized, the specific discrete treatment area from which the matter is removed, and/or the body mass index of the patient. Of course, other variables may likewise affect the ratio including some that are not inconsequential, but the described process relies primarily on those outlined above.

[0048] In the described embodiment, the device 10 is initially provided with a set of preprogrammed values and functions as a baseline which utilizes load cell outputs and user inputs to generate real time density calculations and certain desired output values based thereon. As generally described above, these output values may include at least one of a total aspirate volume, a total fat cells component volume, a discrete area aspirate volume, and a discrete area fat cells component volume. The noted baseline pre-programmed values are determined from data generated through prior testing and analysis acquired through a plurality of liposuction procedures and initially stored in the device memory 52.

[0049] More specifically, the pre-programmed values include at least a density (e.g., 0.96 g/mL) and a density range (e.g., between 0.76 and 1.16). In addition, the pre-programmed functions are utilized to determine the total aspirate volume, the total fat cells component volume, the discrete area aspirate volume, and the discrete area fat cells component volume. In determining these values, device relies on the following functions and relationships. Total Aspirate = Volume. Total Fat Cells Component Volume = (Volume - Weight) * [l/(D _a - Df )] (where D _a = Density Aqueous = ~ 1.0 g/cc and Df = Density of Fat = ~ 0.92 g/cc). Accordingly, Total Fat Cells Component Volume = (Volume - Weight) * (12.5). Thus, Total Fluid Component = Volume - [(Volume - Weight) * [l/(D _a - Df)]].

[0050] Prior to relying on the device 10 in the operating field as broadly described above, each user utilizes the device 10 for a plurality of procedures (e.g., 5-10 or more liposuction procedures) in a pre-use or calibration stage. Prior to each procedure, information including the particular user performing the liposuction procedure, the type of procedure utilized, the specific discrete treatment area from which the matter is to be removed, and/or the body mass index of the patient may be manually input into the device 10 via the display touchscreen 38a. This is the case whether the procedure is a calibration procedure or an actual use procedure as represented by flowchart box 62. After each procedure, additional information is manually input into the device 10 via the display touchscreen 38a. This additional information includes at least a total aspirate volume of the aspirate in the container 14 and, optimally, a total fat cells component volume. As is described further below, all of this information may be used in the initial calibration stage and in a continuing calibration stage of the device 10.

[0051] In practice, the user can acquire information concerning the total aspirate volume by reading graduations on the container 14, using a dipstick (or electronic dipstick), or other optical readers as is known in the art. In addition, the user may allow the fat cells component to separate from the fluid component over a period of time and then acquire the fat cells and fluid components by reading graduations or otherwise. Other means of acquiring information concerning the aspirate in the container 14 are known in the art, for example, a centrifuge may be used to separate and quantify the fat cells and fluid components.

[0052] Following an initial calibration stage procedure and manual input of information both pre- and post-procedure, the baseline pre-programmed density value is compared with a density value determined based on information from the current procedure. If the determined density value is within a useable or expected range, then adjustments to the pre-programmed baseline density value may be made. More specifically, the manually determined density value is determined in flowchart box 64 and is averaged with the pre-programmed baseline density value in flowchart box 66. This average density value becomes an adapted baseline density value for use in subsequent procedures. In a second calibration stage procedure, for example, the adapted baseline density value is compared to a subsequent density value determined based on information from the second procedure. Again, if the subsequent determined density value is within an expected range, it is averaged with the adapted baseline density value. The result is a new adapted baseline density value that can be used in subsequent procedures.

[0053] In this manner, the pre-programmed or initial baseline density value may be adapted to more accurately align with the particular user’s output results which depend in part on their selected liposuction techniques and other information noted above. Subsequent processing of new load cell outputs would utilize the evolving adapted baseline density value for improved results. After several calibration stage procedures, the initial baseline density value is evolved into the adapted baseline density volume which is unique to the particular user and stored in memory for use in later procedures performed by the same user. In a shared use environment, each user should utilizes the device 10 for a plurality of procedures (e.g., 5-10 or more liposuction procedures) in a pre-use or calibration stage. As described above, the result is a new adapted baseline density value that can be used in subsequent procedures by the specific user.

[0054] The above-described calibration stage techniques may be further utilized to determine separate baseline sets of adapted density values for discrete treatment areas providing additional refinement. For instance, fat cells removed from a first treatment area may have different qualities when compared to fat cells removed from a second treatment area. By manually collecting data points for each discrete treatment area over several procedures in each discrete treatment area, the initial baseline density value may be adapted to be more in line not only with a particular user’s output results but also with discrete treatment areas. Again, such refinement should be made for each individual user.

[0055] Although pre-calibration of the device 10 is required in the present described embodiment of the invention and provides more accurate overall results, the device may be utilized without performing the calibration stage. In such a scenario, the pre-programmed baseline set of pre-programmed values and functions would be utilized to determine the desired outputs without the refinement provided through the calibration stage. Although not recommended, the first several uses of the device 10 could also serve a similar role as a calibration stage with the understanding that the first 5-10 procedures may provide less accurate outputs until the device acquires certain knowledge of the user and adapts the pre-programmed baseline density value.

[0056] Once calibrated, the device 10 is ready for use. After taring the weight of the container 14 and stabilized lines 22, 26 and providing certain inputs as generally described above, the user may begin a liposuction procedure. Once commenced, the microprocessor 40 receives outputs from the load cell 44 via processing circuity 60 in accordance with the flowchart shown in Figure 5 and as described above. Using outputs from the load cell 44, the microprocessor 40 determines a density of the matter in the container 14. [0057] Initially, the microprocessor 40 performs statistical filtering in flowchart box 72 to ensure the determined density based in part on the raw data provided by the load cell 44 is not corrupted. In the described embodiment, statistical filtering includes comparing the preprogrammed density value (e.g., 0.96 g/mL) or adapted baseline density value to the current determined density value. If the current determined density value falls within a pre-determined density range (e.g., between 0.76 and 1.16), then the load cell reading is determined to be a “good” reading. Other known filtering techniques, for example, band-pass or other digital filtering may be utilized, and the density range may be adjusted manually based on separate testing and analysis or based on the current averaged density plus or minus a certain amount (e.g., 0.2 g/mL). In other words, the microprocessor 40 determines whether the load cell reading is a “good” reading or a “bad” reading based on generally expected results stored in memory for comparison purposes. Bad readings typically result from human error (e.g., inputting erroneous information), bumped equipment causing the load cells to improperly read the weight of the container and aspirate, the weight of the input and output tubing attached to the container being added, and/or similar issues.

[0058] As the load cell 44 continually provides outputs to the microprocessor 40 (about every two seconds in the described embodiment), readings determined to be “bad” are simply discarded in flowchart box 74 and a subsequent load cell output is obtained from the load cell 44, processed by processing circuitry in flowchart box 60, and provided to microprocessor 40 for determining a density value. Once a “good” reading is obtained in flowchart box 76, the determined density value is stored in long term memory in flowchart box 68 and in short term memory 78 for use in subsequent statistical filtering in flowchart box 72. In addition, the determined density value is provided for further processing in flowchart box 70 to accommodate continual evolution of the device 10.

[0059] As described above, the microprocessor 40 also receives user defined inputs as shown in flowchart box 62 for use in further processing of the determined density value in flowchart box 70. These inputs may include the user performing the procedure and/or a technique to be utilized by the user and are manually input. As described above, such inputs are provided via the touch screen 38a but other means of identifying the user may be utilized including logins, fobs or magnetic cards, and/or biometric utilities. In the described embodiment, the user defined inputs indicate a technique to be utilized by the user which defines an anticipated ratio of tumescent fluid infiltration volume versus aspirate volume. For example, surgeons employing a technique referred to as superwet anticipate a roughly 1 : 1 volume of tumescent infiltrate versus aspirate. Conversely, surgeons employing a tumescent technique anticipate a 2: 1 infiltrate to aspirate ratio. Based on preprogrammed values for each technique, and others as applicable, the microprocessor 40 adjusts the values and functions used to determine the aspirate density value based on the load cell outputs.

[0060] Within flowchart box 70, several processes are utilized to ensure the accuracy of the determined values prior to outputting whether for archival, display, and/or for further refinement of the device utilizing the calibration procedure in flowchart boxes 64 and 66. These processes may include one or more ranking filters, one or more running calibrations, and/or one or more short and/or long-term pattern analyses. Each of these processes are generally known in the art.

[0061] Outputs generated by the processor 40 in flowchart box 70 are further processed in flowchart boxes 64 and 80. As described in detail above for the pre-use calibration procedure, the adapted baseline density value, or average value, is compared with a current density value, i.e., a processor generated output, determined based on information from the current procedure following each procedure and manual input of information both pre- and post-procedure. If the current determined density value is useable, adjustments to the adapted baseline density value may be made. More specifically, the current density value is determined in flowchart box 64 and is averaged with the adapted baseline density value based on prior procedures run during the calibration stage, or otherwise, in flowchart box 66 and stored in memory in flowchart box 68 for use in ongoing current procedure calculations and/or later procedures performed by the user. In this manner, the adapted baseline density value may be further adapted to ensure accurate alignment with the particular user’s output results. For instance, subsequent processing of new load cell outputs would utilize the further adapted baseline density value for improved results. Given different user’s surgical preferences, as well as variances in patient populations and everchanging surgical techniques, it is important that the device 10 is adaptable to perceived and/or learned patterns in order to improve the accuracy of the data provided.

[0062] In flowchart box 80 (labelled Post Processing Signal Confirmation), the determined outputs are compared against expected results prior to display to ensure the outputs are within a range of reasonable outcomes. For example, a total aspirate volume of 2000 cc cannot be held in a 1000 cc container and such an erroneous result would not be displayed. If the generated outputs or values are confirmed, they are stored on a case-by-case basis as shown in flowchart box 82. The generated values for total aspirate volume, total fat cells component volume, total discrete area volume, and discrete area fat cells component volume are also transmitted to display 36 for realtime visual display to the user as shown in flowchart box 84 and described in greater detail above.

[0063] In the described embodiment, the generated values are further output or transmitted via wireless technology (described above) to a remote receiver for storage outside the operating room as shown in flowchart box 86. Such wireless technology may also be used, for example, to transmit all procedure related information to a patient’s medical record, to ascertain whether the device 10 is functioning correctly from an off-site or central location, and/or to determine device maintenance needs, and provide firmware updates. Additionally, procedure results may be uploaded to and tracked by software located on a desktop computer or other similar device in the operating room or elsewhere.

[0064] As described above, the device 10 is utilized, in the described embodiment, for harvesting fat cells for grafting and the container 14 collects the matter (e.g., aspirate) removed from the patient. Ideally in such a procedure, the device 10 would retain the separated fat cells in a sterile container that may be transferred onto a surgical field for grafting. To provide these capabilities, a sterile container 54, shown in Figure 3, may be attached to or supported by the base plate 42 and itself support a sterile container 56. Fat intended for grafting may be removed from the container 56 utilizing a syringe or a pump (not shown) while the container remains on the base plate 42. For this particular embodiment, the device 10 can measure both incoming fat from the liposuction procedure as well as outgoing fat for the grafting procedure.

[0065] In summary, numerous benefits result from providing a device for quantifying, archiving, and reporting information relating to matter removed from a living body are provided. For instance, blood loss during procedures may be monitored and possibly replenished. Even more, fat cells harvested from a patient may be quantitatively monitored for purposes of ensuring equivalent removal from paired body areas or to ensure a sufficient amount of fat cells for grafting purposes. In the fat grafting embodiment, the device also allows the fat cells to be quantified prior to re-injection. [0066] The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. All such modifications and variations are within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.