SYSTEM FOR DETERMINING COMPONENTS OF MATTER REMOVED FROM A LIVING BODY AND RELATED METHODS
20170239402 · 2017-08-24
Inventors
- David S. KIRN (Lexington, KY, US)
- Richard D. HISEL (Nicholasville, KY, US)
- William WHITMAN (Somerville, MA, US)
Cpc classification
A61M1/60
HUMAN NECESSITIES
A61M1/88
HUMAN NECESSITIES
G01N33/4833
PHYSICS
A61M2205/505
HUMAN NECESSITIES
A61M1/73
HUMAN NECESSITIES
A61M2205/3379
HUMAN NECESSITIES
A61M2205/52
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
A system for determining components of matter removed from a body includes a container for receiving the matter, a device for weighing the container and the matter therein, an instrument for obtaining information relating to determine the components of the matter based in part on a weight of the matter determined by said device and the information relating to the at least one aspect of the matter obtained by said instrument. A display includes a screen for displaying information relating to the matter provided by said processer. The information may include a height and/or a color of the matter among other aspects. An insert containing an absorbent material may be utilized to separate fat cells from a fluid when liposuction is used to remove the matter. The insert may be porous allowing fluid to enter the absorption.
Claims
1-93. (canceled)
94. A system for determining components of matter removed from a living body, comprising: a container for receiving the matter removed from the living body via an inlet tube; a device for weighing said container and the matter received therein; an instrument for obtaining information relating to at least one aspect of the matter in said container; and a processor programmed to determine the components of the matter in said container based in part on a weight of the matter determined by said device and the information relating to the at least one aspect of the matter obtained by said instrument.
95. The system for determining components of matter removed from a living body of claim 94, further comprising a base supporting said container, said device, and said instrument.
96. The system for determining components of matter removed from a living body of claim 94, wherein said instrument obtains information relating to a height of the matter in said container.
97. The system for determining components of matter removed from a living body of claim 96, wherein said instrument includes at least one camera positioned adjacent said container for obtaining at least one image of the matter in said container.
98. The system for determining components of matter removed from a living body of claim 97, wherein said processor is programmed to analyze the at least one image to determine a height of the matter in said container.
99. The system for determining components of matter removed from a living body of claim 94, wherein said instrument obtains information relating to a color of the matter in said container.
100. The system for determining components of matter removed from a living body of claim 99, wherein said processor is programmed to determine an amount of a blood component of the matter based in part on the weight of the matter determined by said device and the color of the matter in said container.
101. The system for determining components of matter removed from a living body of claim 99, wherein said instrument includes at least one optical sensor positioned adjacent said container and at least one corresponding receiver for obtaining the color of the matter in said container.
102. The system for determining components of matter removed from a living body of claim 94, further comprising a memory associated with said processor for storing information relating to an area of the living body from which the matter was removed.
103. The system for determining components of matter removed from a living body of claim 102, further comprising a switch for indicating to said processor a transition from one area of the living body from which the matter was removed to another area of the living body from which additional matter is to be removed.
104. The system for determining components of matter removed from a living body of claim 94, further comprising a cannula connected to said container via said inlet tube, said cannula partially inserted into the living body for suctioning the matter from the living body.
105. The system for determining components of matter removed from a living body of claim 94, further comprising an insert positioned within said container and containing an absorbent material, wherein the matter includes a fat cells component and a fluid component, and said insert is porous allowing the fluid component to enter said insert for absorption by said absorbent material.
106. The system for determining components of matter removed from a living body of claim 105, further comprising an inner container positioned within said container for receiving the matter from the patient, said inner container supporting said insert.
107. The system for determining components of matter removed from a living body of claim 106, wherein said processor is programmed to determine whether said container includes said inner container.
108. A method of determining components of matter removed from a living body, comprising the steps of: directing the matter removed from the living body into a container; weighing the matter and the container; obtaining information relating to at least one aspect of the matter in said container; and determining the components of the matter in said container based in part on the weight of the matter and the information relating to at least one aspect of the matter.
109. The method of determining components of matter removed from a living body of claim 108, wherein the step of obtaining information relating to at least one aspect of the matter in said container includes obtaining information relating to a color of the matter in said container.
110. The method of determining components of matter removed from a living body of claim 109, wherein the step of determining the components of the matter in said container includes determining an amount of a blood component of the matter based in part on the weight of the matter and the color of the matter in said container.
111. The method of determining components of matter removed from a living body of claim 108, wherein the step of obtaining information relating to at least one aspect of the matter in said container includes obtaining information relating to a height of the matter in said container.
112. The method of determining components of matter removed from a living body of claim 111, obtaining information relating to the height of the matter in said container includes the step of analyzing at least one image of the matter in said container.
113. The method of determining components of matter removed from a living body of claim 112, wherein the step of determining the components of the matter in said container is based in part on the weight of the matter and the height of the matter in said container.
114. The method of determining components of matter removed from a living body of claim 108, further comprising the step of separating a fluid component from a fat cells component of the matter.
115. The method of determining components of matter removed from a living body of claim 114, wherein the step of separating the fluid component from the fat cells component of the matter includes the step of drawing the fluid component through a filter using an absorbent material.
Description
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0060] The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the system for determining components of 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:
[0061]
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[0070] Reference will now be made in detail to the present embodiments of the system for determining components of 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
[0071] Reference is now made to
[0072] The system 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. Alternate embodiments of the system may be utilized for component determination and/or fluid tracking in other settings including general, orthopedic, gynecologic, otolaryngology, and other surgical procedures involving blood loss. In these alternate embodiments, the system may provide an accurate volume of a blood component, for example, of the matter collected in the container for at least monitoring and possible replenishing purposes. The system may further be utilized to provide an accurate volume of a blood component of matter collected from a chest tube, wall suction containers in patient rooms, and/or urinary catheters.
[0073] In the described embodiment, a lid 20 seals the container 14 and has two ports 22, 24. An outlet port 22 for a vacuum line 26, or vacuum tube, is connected to a pump of a liposuction machine 27 and an inlet port 24 is connected by an inlet line 28, or tube, to a liposuction cannula 29 for drawing the matter out of the patient. The liposuction machine 27 and cannula 29 can be any type known in the art. The ports 22, 24 may be covered by caps until ready for use, thereby maintaining sterility of an interior of the container 14, and the container 14 is made of a translucent material in the described embodiment. Each are described in further detail below.
[0074] Both the vacuum line 26 extending between the container 14 and the liposuction machine 27 and the inlet line 28 extending between the container and the liposuction cannula 29 are immobilized by a clamp 30 extending from the base 14. The clamp 30 in the described embodiment is intended to isolate the container 14 from forces applied to one or both of the lines 26, 28. In other words, the clamp 30 ensures that neither movement nor the weight of the vacuum line 26 and/or the inlet line 28 influence a determination of a weight of the container 14. Of course, any type of device sufficient to prevent movement of the lines may be utilized whether independently supported or supported by the system.
[0075] A viewing window 32 is provided in the cover 16 for the user to visually confirm displayed output parameters and also to make observations about the matter collected in the container 14. Although not shown, a graduated scale may be provided on the container 14 to allow the user to visually quantify the matter. In an alternate embodiment, the graduated scale may be provided on the viewing window 32 itself. Different scales are provided to correspond with the various types of containers which may be used with the system. In other words, one graduated scale could apply to a container used for containment and another graduated scale could apply to a container used in the fat harvesting 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.
[0076] A display 36, incorporating a touch screen 34 in the described embodiment, is attached to a support 38 extending from the cover 16. The display 36 is located at a convenient viewing angle and working position for the 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 14 via the touch screen 34 which is effectively a user interface/display screen offering display screens including soft key buttons for receiving user inputs.
[0077] In alternate embodiments, the system 10 may include a transmitter for transmitting information including at least a weight of the matter in the container 14 and information relating to at least one aspect of the matter in the container. As will be described in more detail below, the information relating to at least one aspect of the matter in the container 14 may include a color of the matter and/or a height of the matter in the container, or other aspects. The display includes a receiver for receiving the transmitted information which is subsequently processed by a processor. In another embodiment, the system may include a transmitter for transmitting information provided by a processor, including information related to the matter in the container (e.g., a percentage of components in the matter), to a receiver positioned in the display after processing. In such a setting, information is transferred using any type of wireless technology known in the art.
[0078] In other alternate embodiments, the display may form part of a mobile device, such as, a smart phone, a personal digital assistant, or a laptop computer or tablet. In such a mobile setting, information relating to the matter in the container 14 may be transmitted from a transmitter supported by the base to the mobile device using wireless technology as is known in the art. In an alternate embodiment, 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. In other words, processing of the information may occur before or after transmission to the mobile device.
[0079] With reference to
[0080] As shown in
[0081] In the described embodiment shown in
[0082] As further shown in
[0083] Information concerning both the color and height of the matter in the container 14 is obtained in the described embodiment using a camera 50 as the instrument. As shown, the cameras are generally positioned adjacent the container 14. More specifically, each camera 50 is removeably supported by a support member 52 that is in turn attached to the arm 48. In the described embodiment, a camera 50 is supported by each of the arms 48 and enjoys an unobstructed view of a side of the container 14. In alternate embodiments, fewer or more cameras and/or one or more minors may be utilized as part of the instrument.
[0084] The use of multiple cameras allows for image averaging which increases accuracy and also allows the system 10 to obtain an average height of the matter in the event the system 10 is not level. It is worth noting here that the cover 16 prevents ambient light from interfering with the view of the container 14 as seen by the cameras 50. In alternate embodiments, supplemental lighting may be provided inside of the cover 16 to improve the images captured by the cameras for use in obtaining information relating to the matter in the container 14.
[0085] In an alternate embodiment, the instrument may be positioned adjacent a top of the container 14 (e.g., above the container). For instance, a lid 62 of the container may be transparent or clear allowing for a non-invasive sensing of the height of the matter therein. In other words, the level of the matter may be sensed using a non-invasive level sensing device as is known in the art. For example, a level sensing device may transmit a signal into the matter and determine a height based on a signal reflected from a matter-air interface.
[0086] In another possible embodiment, the instrument may include at least one optical sensor positioned adjacent the container 14. Preferably, at least one corresponding receiver would be utilized. The at least one optical sensor and receiver pairs may be utilized to obtain information relating to an aspect of the matter in the container 14. In one other embodiment, the at least one optical sensor utilizes a red beam and an infrared beam and the at least one optical receiver includes a red receiver and an infrared receiver to obtain the information.
[0087] As best shown in
[0088] With reference to
[0089] In the described embodiment, signals from the cameras 58 include information used in determining both the color and height of the matter in the container 14. Similarly, the load cell 42 provides an analog signal indicative of the weight of the matter in the container 14. The analog signal is amplified by amplifier 68 and converted from an analog signal to a digital signal in converter 70. From those signal inputs, the processor 66 determines a density of the matter in the container 14. Understanding that the density of fat cells is known to be approximately 0.9 g/cm.sup.3, water is 1.0 g/cm.sup.3, and blood is 1.1 g/cm.sup.3, the processor 66 can determine a quantity of the matter which is a fat cells component and a quantity which is a fluid component.
[0090] Even more, the processor 66 can determine an amount of a blood component within the fluid component based in part on information relating to the color of the matter. This information is used in the aforementioned alternate embodiments of the system utilized for fluid tracking and component determination in other settings involving blood loss. In these alternate embodiments, the system 10 would provide an accurate volume of a blood component of the matter collected in the container 14 for at least monitoring and possible replenishing purposes. The system may further be utilized to provide an accurate volume of a blood component of matter collected from a chest tube, wall suction containers in patient rooms, and/or urinary catheters.
[0091] As noted above, the processor 66 is programmed to analyze the signals from the cameras 50, including the at least one image, to determine the height of the matter in the container 14. The information obtained may further include information relating to a height of the fat cells component in the container. In an alternate embodiment, the system 10 may include a digital pattern recognition analysis system to analyze the at least one image from the cameras 50 to determine the height of the matter in the container 14.
[0092] As described above, the display 36 incorporates a touch screen 34 which displays information relating to the matter in the container 14. As noted, the touch screen 34 is effectively a user interface/display screen offering display screens including soft key or fixed buttons for receiving user inputs. In other words, the touch screen 34 accepts user inputs and displays information output from the system 10.
[0093] Upon startup, the system 10 will automatically tare the weight of the container 14 and stabilized lines 26, 28. The touch screen 34 displays a soft key 74 labelled “New Container” to indicate that a new container has been secured to the platform. When depressed, the “New Container” soft key 74 signals the processor 66 to tare the weight as described above. Throughout operation, the display 36 via touch screen 34 provides real time measurements of fat volume, fluid volume, and total volume. For example, the “Fat” volume in “Area 1” is shown as 65 ml and the “Fluid” volume as 10 ml. As shown, the volumes are displayed in milliliters although other units of measure may be utilized.
[0094] When the user/surgeon has completed suctioning in a first area, a “New Area” soft key 76 may be depressed indicating that further suctioning will occur in a different, second area of the living body or 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 and a location from a listing of such items or may key in such information using a soft key keyboard for example. The data from each completed area is retained by the system 10 in a memory 78 and displayed in a scroll menu below a larger “Current Area” and “Cumulative Total” headings above the actual readings. As shown, an “Area” “1” may be a “Flank” on the right side (“R”) of the patient or an “Area” “2” may be a “Flank” on a left side (“L”) of the patient.
[0095] In alternate embodiments, the soft key 76 which acts as a switch within the touch screen 34 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 or positioned on the operating room floor in order to provide convenient access without interrupting an ongoing procedure.
[0096] If the container 14 reaches maximum capacity, i.e., the container has reached a predetermined level or is completely full, then pressing the “New Container” soft key 74 will indicate a desire to remove and replace the original container with a new container. Accordingly, the processor 66 will activate the solenoids 46 to move the latches 44 thereby releasing the flange 47 and the container 14. After placement of the new container, pressing the “New Container” soft key 74 will cause the latches 44 to secure the new container 14′ and the system 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 system 10 for a new procedure or patient, or to change display parameters, units, etc.
[0097] As described above, the system 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 system 10 would efficiently separate fat cells from the fluid, or slurry, within the matter removed from the patient, i.e., the liposuction aspirate, while minimizing mechanical trauma to the fat cells. Even more, the system 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 container 100, in the described embodiment, includes two nested containers, i.e., inner and outer containers 102, 104 as shown in
[0098] For the alternate embodiments of the system utilized for fluid tracking and component determination in other settings including general, orthopedic, gynecologic, otolaryngology, and other surgical procedures involving blood loss, the use of nested containers is not required and the container 14 described above would be sufficient. For the described embodiment, however, the container 100 includes inner and outer containers 102, 104 in order to separate fat cells from the fluid within the matter removed from the patient. The elements of the container 14 described above which remain unchanged in the container 100 (e.g., lid 20) will maintain the same reference numerals.
[0099] A lid 20, shown separated from outer container 104 in
[0100] As best shown in
[0101] Even more, the insert 112 is designed, as depicted in
[0102] As shown in
[0103] In one alternate embodiment, the insert 112 could be integrally molded with the inner container 102 rather than exist as a separate component. Alternatively, the insert 112 could include a handle or like mechanism to facilitate removal of the insert from the inner container 102. A further alternate embodiment could have the superabsorbent material 114 reside within the outer container 104 and be brought into direct or indirect contact with the inner container 102 (e.g., via a central column having a large surface area). With these configurations, when the user removes the inner container 102, the saturated superabsorbent would already have been removed or would remain with the outer container and only the fat cells to be used for grafting would remain in the inner container. A handle (not shown) could be provided on the inner container 102 to assist with its removal from the outer container 104.
[0104] In the described embodiment, the inner and outer containers 102, 104, the lid 20 and the insert 112 with its superabsorbent material 114, are supplied to the user sterilely. Outer surfaces of the outer container 104 and the lid 20 will become contaminated as they are handled non-sterilely and may be attached to the non-sterile liposuction machine. However, interior surfaces of the outer container 104 and lid 20 remain sterile along with the inner container 102. The interior of tubing 28 connecting the cannula 29 to the inlet port 24 is also sterile. To maintain a sterile path for matter or aspirate flow, the inlet port 24 is covered by a sterile cap 108 (shown in
[0105] In accordance with a method of determining components of matter removed from a living body, a patient, matter removed from the living body is directed into a container 14. In the described embodiment, a vacuum is applied to the cannula 29 of the system 10 by a liposuction machine 27 and the matter, or fat aspirate in this instance, is directed into the container 14. The matter and the container 14 are weighed and a weight of the matter is determined by a processor 66 which monitors an output of a load cell 42 in the described embodiment. As described above, a tare weight of the container 14 is determined using the load cell 42 before the matter is directed into the container and utilized by the processor 66. The load cell 42 is then utilized to ascertain a combined weight.
[0106] Information relating to at least one aspect of the matter in the container 14 is also obtained. In the described embodiment, the information is obtained using a plurality of cameras 50. As described above, the cameras 50 are mounted on arms 48 and positioned adjacent the container 14 for capturing images of the matter in the container. Based in part on the weight of the matter and the information relating to at least one aspect of the matter, the processor 66 is programmed to determine the components of the matter in the container 14. In the described embodiment, the components include a fat cells component and a fluid component.
[0107] In alternate embodiments, the system 10 may be utilized for component determination and/or fluid tracking in other settings involving blood loss. These may include general, orthopedic, gynecologic, otolaryngology, and other surgical procedures for example. In conjunction with the needs associated with these alternate procedures, the system 10 may provide an accurate volume of a blood component, for example, of the matter collected in the container 14 rather than a fat cells component. This may be done for at least monitoring and possibly replenishing purposes. In such alternate embodiments, the information relating to at least one aspect of the matter in the container 14 includes information relating to a color of the matter. More specifically, the cameras 50 or other instruments are used to determine the color of the matter which is subsequently used in determining the amount of the blood component of the matter. This is determined in part on the weight and the color of the matter in the container 14.
[0108] The information obtained using the plurality of cameras 50, or other instruments, may also relate to a height of the matter in the container 14. In the described embodiment, the height of the matter in the container 14 is obtained by analyzing the image(s) of the matter. Information relating to the height of the matter in the container 14 is used to determine the components of the matter.
[0109] In an alternate embodiment described above, the fluid component is separated from the fat cells component of the matter in the container 100. The fluid component is drawn away from the fat cells component through a filter using an absorbent material. The filter may include a plurality of holes 120 in an insert 112 of the container 100 or filter paper or the like as described above. In this embodiment, the plurality of cameras 50, or other instruments, obtain information relating to a height of the fat cells component of the matter in the container 14. Similarly, the height of the fat cells component is obtained by analyzing the image(s) of the matter. In this instance, however, the components are determined based in part on the weight of the matter and the height of the fat cells component.
[0110] In summary, numerous benefits result from providing a system for determining components of matter removed from a living body. 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 system allows the fat cells to be rapidly separated from fluid in a liposuction aspirate mixture and the absorbent materials utilized within the separating process allows for an atraumatic separation. In this manner, the separated fat cells should be ready for re-injection with minimal delay. Even more, the fat cells may be separated and re-injected without leaving the sterile operating environment.
[0111] 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. For example, alternate embodiments may utilize the superabsorbent materials within the container in non-fat cell harvesting procedures in order to increase the accuracy of the component determining system. 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.