Tissue processing apparatus and method for processing adipose tissue

• US 10,336,980 B2
• Filed: 09/05/2014
• Issued: 07/02/2019
• Est. Priority Date: 09/05/2013
• Status: Active Grant

• Current Assignee: GID Bio Incorporated
• Original Assignee: The GID Group, Inc.
• Inventors: Cimino, William W., Llull, Ramon, Katz, Adam J.
• Primary Examiner(s): Prakash, Gautam
• Application Number:
  US14/915,867
• Publication Number:
  US 20160208211A1
• Time in Patent Office: 1,761 Days
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61L 27/00 Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• CPC Class Codes: A61M 1/88 Draining devices having means for processing the drained fluid, e.g. an absorber for liposuction A61M1/892
• CPC Class Codes: A61M 1/892 with treatment of the collected fat
• CPC Class Codes: A61M 2202/08 Lipoids
• CPC Class Codes: C12M 45/02 by mechanical forces; Stirring; Trituration; Comminuting crushing, pulverizing, disintegrating in general B02C
• CPC Class Codes: C12M 45/05 by centrifugation centrifuges in general B04B
• CPC Class Codes: C12M 47/04 Cell isolation or sorting purging biological preparations of unwanted cells C12N5/0081, determining the presence or kind of microorganism C12Q1/04
• CPC Class Codes: C12N 5/0653 Adipocytes; Adipose tissue

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.

Claims

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.

2. A portable apparatus according to claim 1, wherein the available processing volume is in a range of from 75 cubic centimeters to 300 cubic centimeters.

3. A portable apparatus according to claim 2, wherein the portion of the available processing volume in the tissue retention volume is in a range of from 25 cubic centimeters to 200 cubic centimeters.

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:

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.

5. A portable apparatus according to claim 4, wherein when the portable container apparatus is in the access orientation the internal containment volume comprises:

a first portion that is cylindrical or is frustoconical tapering toward the bottom of the internal containment volume with an angle of taper relative to horizontal of at least 70°

;

a second portion disposed below the first portion, the second portion being frustoconical tapering toward the bottom of the internal containment volume with an angle of taper relative to horizontal in a range of from 30°

to 60°

;

a third portion disposed below the second portion in the pellet well, the third portion being cylindrical or frustoconical tapering toward the bottom of the internal containment volume at an angle of taper relative to horizontal of at least 70°

.

6. A portable apparatus according to claim 4, wherein when the apparatus is in the access orientation, the pellet well has at least one portion with a vertical length of at least 1 centimeter and a maximum horizontal cross-dimension of no larger than 5millimeters.

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;

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.

8. A portable apparatus according to claim 7, wherein the internal containment volume is defined at least in part by a shell having a lip and a portion to be disposed in a centrifuge receptacle during centrifuge processing, the portion of the shell to be disposed in a centrifuge being below the lip when the apparatus is in the access orientation and having a height dimension when the apparatus is in the access orientation in a range of from 5 centimeters to 16 centimeters;

and

when the apparatus is in the access orientation, the portion of the shell below the lip to be disposed in a centrifuge has a maximum cross-section taken horizontally through the shell that is circular and fits entirely within a circle having a diameter of not larger than 16 centimeters.

9. A portable apparatus according to claim 7, wherein the volume of the pellet well is in a range of from 0.5 cubic centimeter to 2 cubic centimeters.

10. A portable apparatus according to claim 9, wherein the portion of the available processing volume in the tissue retention volume is in a range of from 40 percent to 60 percent of the available processing volume.

11. A portable apparatus according to claim 7, wherein the maximum horizontal cross-dimension is no larger than 8 millimeters.

12. A portable apparatus according to claim 11, wherein the vertical portion is disposed adjacent a bottom of the pellet well.

13. A portable apparatus according to claim 12, wherein when the portable container apparatus is in the access orientation the internal containment volume comprises:

a first portion that is cylindrical or is frustoconical tapering toward the bottom of the internal containment volume with an angle of taper relative to horizontal of at least 70°

;

a second portion disposed below the first portion and above the pellet will, the second portion being frustoconical tapering toward the bottom of the internal containment volume with an angle of taper relative to horizontal in a range of from 30°

to 60°

;

a third portion disposed below the second portion in the pellet well and including the vertical portion of the pellet well, the third portion being cylindrical or frustoconical tapering toward the bottom of the internal containment volume at an angle of taper relative to horizontal of at least 70°

.

14. A portable apparatus according to claim 13, wherein the vertical portion has a bottom portion with a vertical length of the bottom portion being at least 0.5 centimeter and with a maximum horizontal cross-dimension of the bottom portion being no larger than 5 millimeters.

15. A portable apparatus according to claim 14, wherein the portable apparatus in the access orientation has a total height in a range of from 6 centimeters to 26 centimeters.

16. A portable apparatus according to claim 15, wherein the pellet well has a vertical height dimension when the portable apparatus is in the access orientation in a range of from 1.5 centimeters to 4 centimeters.

17. A portable apparatus according to claim 16, wherein the portion of the available processing volume in the tissue retention volume is not larger than 55 percent of the available processing volume.

18. A portable apparatus according to claim 14, wherein the portable apparatus is in the access orientation and comprises a hypodermic needle extending downward through the internal containment volume into the pellet well from above and through the vertical portion of the pellet well, and wherein:

the minimum horizontal cross-dimension is larger than an outer diameter of the hypodermic needle disposed through the vertical portion and the outer diameter of the hypodermic needle is in a range of from 1 to 3 millimeters; and

the hypodermic needle is fluidly connected to a syringe disposed outside of the internal containment volume and the syringe contains a dispersion medium to mix with material of the pellet phase in the syringe when the pellet phase is directly aspirated from the pellet well.

19. A portable apparatus according to claim 18, comprising the pellet phase disposed in the pellet well and the lower-density material phases disposed above the pellet phase, and wherein the distal tip of the hypodermic needle is disposed in the pellet phase in the pellet well.