IP Library Granted Patent US 12,635,682
Granted Patent B2
US 12,635,682 · App. 18/225,923 · Granted May 26, 2026

Packaging assembly for storing tissue and cellular material

Inventors: Silvia Chen (Virginia Beach, VA); Austin Johnson (Virginia Beach, VA); Roberto Bracone (Virginia Beach, VA)
Assignee: LifeNet Health
A01N1/122A01N1/146A01N1/147A61J1/10A61M5/002B65D39/0052B65D39/08
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Quick Facts
Patent No.
US 12,635,682
App. No.
18/225,923
Granted
May 26, 2026
Kind
B2
Abstract

An improved packaging assembly for storing, distributing, treating, mixing, and dispensing tissue and/or cellular material and/or implantable material. The packaging assembly may include pouches, tubes, and a bag made of a sealable, flexible polymeric material that is open at one end and a needle-free swabable connector attached to the pouch at the other end and acting as a port to allow for the introduction or discharge of biological solutions, rinsing solution, and/or preservation solutions into the packaging assembly. The designed thickness of the wall of the packaging assembly facilitates efficient heat/cold transfer, which is useful for successful controlled rate freezing, quick thawing, and resuscitation of viable cells or tissue. The packaging assembly is also useful for combining additional biological fluids with the cellular material or tissue, and for efficient mixing of the biological fluids with the tissue and/or cellular material in the assembly.

Claims (28)

1 . A packaging assembly for storing particulate tissue, comprising:

a pouch formed of a flexible polymeric material and defining a compartment, a first end of the pouch configured to be transitioned from an open configuration to a sealed configuration, the first end defining a first opening via which the pouch is configured to receive particulate tissue into the compartment in the open configuration, the pouch defining a second opening opposite the first opening,

the particulate tissue having viable cells and disposed within a preservation solution within the compartment; and

a port coupled to the pouch such that at least one of a biological solution, a rinsing solution or the preservation solution can be introduced into or withdrawn from the compartment through the second opening via the port without removal of the particulate tissue from the pouch through the port,

wherein the pouch is configured, when the first end is in the sealed configuration, to be cut to define a third opening for withdrawal of the particulate tissue from the compartment through the third opening.

2 . The packaging assembly of claim 1 , wherein the particulate tissue comprises at least one of dermal, fascia, tendon, cartilage, muscle, placenta material or mixtures thereof.

3 . The packaging assembly of claim 1 , wherein the particulate tissue comprises dermal material.

4 . The packaging assembly of claim 1 , wherein the particulate tissue comprises fascia material.

5 . The packaging assembly of claim 1 , wherein the particulate tissue comprises cartilage material.

6 . The packaging assembly of claim 1 , wherein the particulate tissue comprises muscle or tendon material.

7 . The packaging assembly of claim 1 , wherein the particulate tissue comprises placenta material.

8 . The packaging assembly of claim 1 , wherein the preservation solution includes a cryopreservation media.

9 . The packaging assembly of claim 1 , wherein a wall thickness of the pouch is between about 0.0005 inches and about 0.010 inches.

10 . A packaging assembly for storing implantable material, comprising:

a pouch formed of a flexible polymeric material and defining a compartment, a first end of the pouch configured to be transitioned from an open configuration to a sealed configuration, the first end defining a first opening via which the pouch is configured to receive implantable material into the compartment in the open configuration, the pouch defining a second opening opposite the first opening,

the implantable material including viable cells and disposed within a preservation solution within the compartment; and

a port coupled to the pouch such that at least one of a biological solution, a rinsing solution or the preservation solution can be introduced into or withdrawn from the compartment through the second opening via the port without removal of the implantable material from the pouch through the port,

wherein the pouch is configured, when the first end is in the sealed configuration, to be cut to define a third opening for withdrawal of the implantable material from the compartment through the third opening.

11 . The packaging assembly of claim 10 , wherein the implantable material comprises at least one of bone or cartilage.

12 . The packaging assembly of claim 10 , wherein the implantable material comprises bone and cartilage.

13 . The packaging assembly of claim 10 , wherein the implantable material comprises one or more sheets of tissue.

14 . The packaging assembly of claim 10 , wherein the implantable material comprises a membrane.

15 . The packaging assembly of claim 10 , wherein the implantable material comprises a sponge.

16 . The packaging assembly of claim 10 , wherein the preservation solution comprises a cryopreservation media.

17 . The packaging assembly of claim 10 , further comprising a sealable secondary container within which the pouch is disposed.

18 . The packaging assembly of claim 10 , wherein a wall thickness of the pouch is between about 0.0005 inches and about 0.010 inches.

19 . The packaging assembly of claim 10 , wherein the flexible polymeric material includes at least one of polyethylene, polypropylene, or polyester.

20 . The packaging assembly of claim 10 , wherein the first opening is larger than the second opening.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 24, 2023
From: CHEN, SILVIA; BRACONE, ROBERTO; JOHNSON, AUSTIN
To: LIFENET HEALTH
Reel/Frame 065319/0952 →
Continuity (4)
Division 17142707 · Jan 6, 2021
Continuation 14769694
Provisional Application 61767858 · Feb 22, 2013
Related Publication 20230363374A1 · Nov 16, 2023
References Cited (79)
US 4630448A · Bilstad et al. · 1986 [cited by applicant]
US 4998671A · Leifheit · 1991 [cited by applicant]
US 5098636A · Balk · 1992 [cited by applicant]
US 5209745A · Irr et al. · 1993 [cited by applicant]
US 5253754A · Soodak · 1993 [cited by applicant]
US 5284655A · Bogdansky et al. · 1994 [cited by applicant]
US 5306305A · Lee · 1994 [cited by applicant]
US 5346061A · Newman et al. · 1994 [cited by applicant]
US 5366507A · Sottosanti · 1994 [cited by applicant]
US 5738671A · Niedospial et al. · 1998 [cited by applicant]
US 5948426A · Jefferies · 1999 [cited by applicant]
US 5972703A · Long et al. · 1999 [cited by applicant]
US 6089541A · Weinheimer et al. · 2000 [cited by applicant]
US 6648133B1 · Blaschke et al. · 2003 [cited by applicant]
US 6723131B2 · Muschler · 2004 [cited by applicant]
US 7001370B2 · Kubalak et al. · 2006 [cited by applicant]
US 7498040B2 · Masinaei et al. · 2009 [cited by applicant]
US 7740596B2 · Hibner · 2010 [cited by applicant]
US 8002813B2 · Scarborough et al. · 2011 [cited by applicant]
US 8278102B2 · Ennis et al. · 2012 [cited by applicant]
US 8551068B2 · Kyle et al. · 2013 [cited by applicant]
US 8790923B2 · Ennis et al. · 2014 [cited by applicant]
US 8883210B1 · Truncale et al. · 2014 [cited by applicant]
US 10905801B2 · Gaskins et al. · 2021 [cited by applicant]
US 10932464B2 · Chen et al. · 2021 [cited by applicant]
US 11365395B2 · Wolfinbarger, Jr. et al. · 2022 [cited by applicant]
US 11730163B2 · Chen et al. · 2023 [cited by applicant]
US 20010014831A1 · Scarborough · 2001 [cited by applicant]
US 20030180263A1 · Geistlich · 2003 [cited by applicant]
US 20050059952A1 · Giuliano et al. · 2005 [cited by applicant]
US 20060266431A1 · Thilly et al. · 2006 [cited by applicant]
US 20060270961A1 · Costa et al. · 2006 [cited by applicant]
US 20070162132A1 · Messerli · 2007 [cited by applicant]
US 20070191963A1 · Winterbottom et al. · 2007 [cited by applicant]
US 20080214998A1 · Kurek et al. · 2008 [cited by applicant]
US 20080234654A1 · McCarthy et al. · 2008 [cited by applicant]
US 20080254471A1 · Bordano · 2008 [cited by applicant]
US 20080262633A1 · Williams et al. · 2008 [cited by applicant]
US 20090030396A1 · Ferris · 2009 [cited by applicant]
US 20090191533A1 · Bussolati · 2009 [cited by applicant]
US 20100034783A1 · Son et al. · 2010 [cited by applicant]
US 20100303389A1 · Armau et al. · 2010 [cited by applicant]
US 20110160857A1 · Bracone et al. · 2011 [cited by applicant]
US 20120213754A1 · Chapman · 2012 [cited by applicant]
CN 101180088A · 2008 [cited by applicant]
CN 101479377A · 2009 [cited by applicant]
CN 101528157A · 2009 [cited by applicant]
CN 102170851A · 2011 [cited by applicant]
KR 20080081053A · 2008 [cited by applicant]
WO 9507665A1 · 1995 [cited by applicant]
WO 2010050935A1 · 2010 [cited by applicant]
WO 2011146046A1 · 2011 [cited by applicant]
Australian Examination Report for Australian Application No. 2014218619, dated Jan. 23, 2018, 4 pages. [cited by applicant]
Canadian Examination Report for Canadian Application No. 2,902,155, dated Mar. 6, 2020, 4 pages. [cited by applicant]
Canadian Examination Report for Canadian Application No. 2,902,155, dated Feb. 4, 2021, 4 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201480022933.9, dated Mar. 28, 2017, with English translation, 45 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201480022933.9, dated Dec. 26, 2017, with translation, 27 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201480022933.9, dated Jul. 26, 2018, with translation, 30 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201910587405.2, dated Aug. 28, 2020, with translation, 33 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201910587405.2, dated Apr. 29, 2021, with translation, 15 pages. [cited by applicant]
European Communication for European Application No. 14754747.5, dated Jun. 9, 2017, 1 page. [cited by applicant]
European Communication for European Application No. 14754747.5, dated Oct. 7, 2020, 4 pages. [cited by applicant]
Extended European Office Action for European Application No. 14754747.5, dated May 22, 2017, 13 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 15/494,001, mailed Apr. 22, 2020, 22 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 16/059,430, mailed Jun. 11, 2021, 12 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 16/179,173, mailed Jun. 14, 2021, 13 pages. [cited by applicant]
Indian Examination Report for Indian Application No. 3084/KOLNP/2015, dated May 6, 2019, with translation, 7 pages. [cited by applicant]
Korean Office Action for Korean Application No. 10-2015-7026210, mailed Mar. 4, 2020, with translation, 10 pages. [cited by applicant]
Non Final Office Action for U.S. Appl. No. 15/494,001, mailed Oct. 10, 2019, 16 pages. [cited by applicant]
Non Final Office Action for U.S. Appl. No. 16/179,173, mailed Oct. 2, 2019, 32 pages. [cited by applicant]
Non Final Office Action for U.S. Appl. No. 16/179,173, mailed Apr. 28, 2021, 14 pages. [cited by applicant]
Entire patent prosecution history of U.S. Appl. No. 14/769,694, filed Aug. 21, 2015, entitled, “Packaging Assembly for Storing Tissue and Cellular Material.” [cited by applicant]
Entire patent prosecution history of U.S. Appl. No. 17/142,707, filed Jan. 6, 2021, entitled, “Packaging Assembly for Storing Tissue and Cellular Material.” [cited by applicant]
Annex to Communication Re Intention to Grant for European Application No. 14754747, dated Jan. 21, 2025, 12 pages. [cited by applicant]
European Communication for European Application No. 14754747, dated Dec. 2, 2024, 7 pages. [cited by applicant]
European Communication for European Application No. 14754747, dated May 6, 2024, 4 pages. [cited by applicant]
European Communication for European Application No. 14754747, dated Nov. 4, 2022, 5 pages. [cited by applicant]
European Search Report and Search Opinion for European Application No. 25177989, dated Oct. 10, 2025, 13 pages. [cited by applicant]
Indian Hearing Notice for Indian Application No. 3084/KOLNP/2015, dated May 12, 2023, with translation, 3 pages. [cited by applicant]