Tissue processing apparatus and method for processing adipose tissue
First Claim
1. A portable apparatus with a container for multi-step processing of human biological material containing stringy tissue including washing, enzymatic digestion and centrifuging to prepare a cell concentrate in the container in the form of a pellet phase formed during the centrifuging, the apparatus being orientable in an access orientation and the apparatus comprising:
- the container having an internal containment volume including a tissue retention volume and a filtrate volume;
a filter disposed within the internal containment volume with the tissue retention volume on one side of the filter and the filtrate volume on another side of the filter with the tissue retention volume and the filtrate volume being in fluid communication through the filter;
an inlet port in fluid communication with the tissue retention volume and configured to access the tissue retention volume for introducing human biological material into the tissue retention volume;
a suction port in fluid communication with the filtrate volume and configured to access the filtrate volume for suctioning material from the filtrate volume;
wherein;
the internal containment volume includes a pellet well disposed in a bottom portion of the filtrate volume below a bottom elevation of the filter and accessible only from above when the apparatus is in the access orientation;
the pellet well has a volume in a range of from 0.3 cubic centimeter to 3 cubic centimeters;
when the apparatus is in the access orientation, the pellet well has at least one portion with a vertical length of 0.5 centimeter, a maximum horizontal cross-dimension of no larger than 10 millimeters and a minimum horizontal cross-dimension of no smaller than 1.5 millimeters; and
the internal containment volume comprises an available processing volume with a portion of the available processing volume being in the tissue retention volume and the volume of the pellet well is in a range of from 0.2 percent to 2 percent of the portion of the available processingvolume in the tissue retention volume;
wherein the available processing volume is in a range of from 20 cubic centimeters to 400 cubic centimeters.
3 Assignments
0 Petitions
Accused Products
Abstract
A portable apparatus useful for collection and processing of human biological material, such as adipose or cancellous bone material, to prepare a concentrated product (e.g., stromal vascular fraction). The apparatus has a container with a containment volume with a tissue retention volume and a filtrate volume separated by a filter and with a pellet well for collecting concentrate product in the form of a pellet phase from centrifuge processing. The pellet well is accessible only from above when the apparatus is in an access orientation. Collected pellet phase material may be removed from the pellet well by direct aspiration, without suspending the material in a suspension liquid within the container. Access ports may be configured for access only from above the container. The apparatus may include a tissue collector disposed in the disuse retention volume to engage and collect collagen or other stringy tissue. A method of processing adipose tissue to concentrate leuko stromal vascular cells includes multi-step processing using a portable container.
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Citations
19 Claims
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1. A portable apparatus with a container for multi-step processing of human biological material containing stringy tissue including washing, enzymatic digestion and centrifuging to prepare a cell concentrate in the container in the form of a pellet phase formed during the centrifuging, the apparatus being orientable in an access orientation and the apparatus comprising:
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the container having an internal containment volume including a tissue retention volume and a filtrate volume; a filter disposed within the internal containment volume with the tissue retention volume on one side of the filter and the filtrate volume on another side of the filter with the tissue retention volume and the filtrate volume being in fluid communication through the filter; an inlet port in fluid communication with the tissue retention volume and configured to access the tissue retention volume for introducing human biological material into the tissue retention volume; a suction port in fluid communication with the filtrate volume and configured to access the filtrate volume for suctioning material from the filtrate volume; wherein; the internal containment volume includes a pellet well disposed in a bottom portion of the filtrate volume below a bottom elevation of the filter and accessible only from above when the apparatus is in the access orientation; the pellet well has a volume in a range of from 0.3 cubic centimeter to 3 cubic centimeters; when the apparatus is in the access orientation, the pellet well has at least one portion with a vertical length of 0.5 centimeter, a maximum horizontal cross-dimension of no larger than 10 millimeters and a minimum horizontal cross-dimension of no smaller than 1.5 millimeters; and the internal containment volume comprises an available processing volume with a portion of the available processing volume being in the tissue retention volume and the volume of the pellet well is in a range of from 0.2 percent to 2 percent of the portion of the available processingvolume in the tissue retention volume; wherein the available processing volume is in a range of from 20 cubic centimeters to 400 cubic centimeters. - View Dependent Claims (2, 3)
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4. A portable apparatus with a container for multi-step processing of human biological material containing stringy tissue including washing, enzymatic digestion and centrifuging to prepare a cell concentrate in the container in the form of a pellet phase formed during the centrifuging, the apparatus being orientable in an access orientation and the apparatus comprising:
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the container having an internal containment volume including a tissue retention volume and a filtrate volume; a filter disposed within the internal containment volume with the tissue retention volume on one side of the filter and the filtrate volume on another side of the filter with the tissue retention volume and the filtrate volume being in fluid communication through the filter; an inlet port in fluid communication with the tissue retention volume and configured to access the tissue retention volume for introducing human biological material into the tissue retention volume; a suction port in fluid communication with the filtrate volume and configured to access the filtrate volume for suctioning material from the filtrate volume; wherein; the internal containment volume includes a pellet well disposed in a bottom portion of thefiltrate volume below a bottom elevation of the filter and accessible only from above when the apparatus is in the access orientation; the pellet well has a volume in a range of from 0.3 cubic centimeter to 3 cubic centimeters; when the apparatus is in the access orientation, the pellet well has at least one portion with a vertical length of 0.5 centimeter, a maximum horizontal cross-dimension of no larger than 10 millimeters and a minimum horizontal cross-dimension of no smaller than 1.5 millimeters; and the internal containment volume comprises an available processing volume in a range of from 20 cubic centimeters to 1300 cubic centimeters with a portion of the available processing volume being in the tissue retention volume and wherein the volume of the pellet well is in a range of from 0.3 percent to 1.5 percent of the portion of the available processing volume in the tissue retention volume. - View Dependent Claims (5, 6)
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7. A portable apparatus with a container for multi-step processing of adipose tissue in human biological material containing stringy tissue including washing, enzymatic digestion and centrifuging to prepare a cell concentrate in the container in the form of a pellet phase with stromal vascular fraction formed during the centrifuging, the apparatus being orientable in an access orientation and the apparatus comprising;
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the container having an internal containment volume including a tissue retention volume and a filtrate volume; a filter disposed within the internal containment volume with the tissue retention volume on one side of the filter and the filtrate volume on another side of the filter with the tissue retention volume and the filtrate volume being in fluid communication through the filter; an inlet port in fluid communication with the tissue retention volume and configured to access the tissue retention volume for introducing human biological material into the tissue retention volume; a suction port in fluid communication with the filtrate volume and configured to access the filtrate volume for suctioning material from the filtrate volume; wherein; the internal containment volume includes a pellet well disposed in a bottom portion of the filtrate volume below a bottom elevation of the filter and accessible only from above when the apparatus is in the access orientation; the container is configured to collect during the centrifuging of the multi-step processing density-separated phases including the pellet phase as a higher-density material phase in the pellet well and lower-density material phases adjacent to the pellet phase and extending in the internal containment volume outside of the pellet well and with the lower-density material phases being above the pellet phase when the apparatus is in the access orientation following the centrifuging; the pellet well has a volume in a range of from 0.3 cubic centimeter to 2 cubic centimeters; the apparatus in the access orientation is configured with access into the internal containment volume from above for selective insertion of an aspiration tube from outside of to inside of the internal containment volume and advancement of an advancing tip of the aspiration tube downward through the internal containment volume and into the pellet well; the pellet well is configured for direct aspiration of the pellet phase from the pellet well through the aspiration tube when the apparatus is in the access orientation without first removing the overlying less-dense material phases and without dispersing material of the pellet phase in a suspension liquid, wherein the pellet well has at least one vertical portion to receive therethrough the advancing tip of the aspiration tube for direct aspiration of the pellet phase from the vertical portion through the aspiration tube, the vertical portion having a vertical length of at least 1 centimeter, a maximum horizontal cross-dimension of no larger than 10 millimeters and a minimum horizontal cross-dimension of no smaller than 2 millimeters; and the internal containment volume comprises an available processing volume in a range of from 20 cubic centimeters to 400 cubic centimeters with a portion of the available processing volume being in the tissue retention volume and the volume of the pellet well is in a range of from 0.2 percent to 2 percent of the portion of the available processing volume in the tissue retention volume. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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Specification