# US 10,368,542 B2 · Methods for collecting and processing autografts, processed autografts, kits for collecting and transporting autografts, and tools for preparing autografts

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- Number: US 10,368,542 B2
- Document ID: US10368542B2
- Status: Granted
- Kind: B2
- Application number: 14/031,033
- Filed: 2013-09-18
- Published: 2014-01-16
- Granted: 2019-08-06
- Earliest claimed: 2009-06-26
- Assignees: LifeNet Health
- Applicants: LifeNet Health
- Inventors: Roberto Bracone; Jingsong Chen; Silvia Chen; James A. Clagett; Marilyn Gatin; Daniel Osborne
- Web page: https://patentgrep.com/patent/US10368542B2

## CPC

- A01N 1/124: Disinfecting agents, e.g. antimicrobials
- A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)}
- A61F 2/4644: {Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material (bone material A61F2/28; disintegrating or milling devices B02C)}
- A61F 2/28: Bones
- A61F 2310/00359: Bone or bony tissue
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

The present invention is directed to methods for collecting and processing autografts, processed autografts, kits for collecting and transporting autografts, and tools for preparing autografts. It is also directed to autologous bone grafts, and methods of preparing them.

## Claims

### Claim 1

A method of preparing a clean, disinfected autologous tissue implant for implantation, the method comprising
a) pre-treating an autologous tissue surgically removed and collected from a patient,
b) shipping the pre-treated autologous tissue to a tissue processing facility,
c) receiving at the tissue processing facility the pre-treated autologous tissue that has been removed from the patient,
d) processing the pre-treated autologous tissue to clean and disinfect the tissue, wherein the processing comprises treating the tissue with a detergent and a plasticizer,
e) storing the processed autologous tissue at an external storage facility, and
f) providing the clean, disinfected autologous tissue to a surgical facility for re-implantation into the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the autologous tissue comprises bone, tendon or ligament.

### Claim 3 (depends on 2)

The method of claim 2, wherein the autologous tissue is a cranial bone flap.

### Claim 4 (depends on 2)

The method of claim 2, wherein the processing comprises debridement.

### Claim 5 (depends on 2)

The method of claim 2, wherein the processing comprises creating an instrument insertion site in the autologous tissue.

### Claim 6 (depends on 1)

The method of claim 1, wherein the pre-treating comprises treating the collected autologous tissue with an antibiotic solution, a bactericidal solution, a virucidal, a glycerol-containing solution, water, saline or a combination thereof.

### Claim 7 (depends on 1)

The method of claim 1, wherein the processing comprises exposing the autologous tissue to at least one bioactive factor.

### Claim 8 (depends on 1)

The method of claim 1, wherein the autologous tissue is sterilized using irradiation after processing.

### Claim 9 (depends on 1)

The method of claim 1, further comprising storing the processed autologous tissue in a storage solution.

### Claim 10 (depends on 9)

The method claim 9, wherein the autologous tissue is irradiated while in the storage solution.

### Claim 11 (depends on 1)

The method of claim 1, further comprising seeding cells onto the autologous tissue.

### Claim 12 (depends on 1)

The method of claim 1, wherein the autologous tissue is a bone flap.

### Claim 13

A method of preparing a clean, disinfected autologous tissue implant for implantation, the method comprising
a) pre-treating autologous tissue surgically removed and collected from a patient,
b) shipping the pre-treated autologous tissue to a tissue processing facility,
c) receiving at the autologous tissue processing facility the pre-treated tissue that has been removed from the patient,
d) processing the pre-treated tissue to clean and disinfect the autologous tissue, wherein the processing comprises treating the autologous tissue with a detergent,
e) seeding cells onto the autologous tissue,
f) storing the processed autologous tissue at an external storage facility, and
g) providing the clean, disinfected autologous tissue to a surgical facility for re-implantation into the patient.

### Claim 14 (depends on 13)

The method of claim 13, wherein the autologous tissue comprises bone, tendon or ligament.

### Claim 15 (depends on 14)

The method of claim 14, wherein the autologous tissue is a cranial bone flap.

### Claim 16 (depends on 14)

The method of claim 14, wherein the processing comprises debridement.

### Claim 17 (depends on 14)

The method of claim 14, wherein the processing comprises creating an instrument insertion site in the autologous tissue.

### Claim 18 (depends on 13)

The method of claim 13, wherein the pre-treating comprises treating the collected autologous tissue with an antibiotic solution, a bactericidal solution, a virucidal, a glycerol-containing solution, water, saline or a combination thereof.

### Claim 19 (depends on 13)

The method of claim 13, wherein the processing comprises treating the autologous tissue with a plasticizer.

### Claim 20 (depends on 13)

The method of claim 13, wherein the processing comprises exposing the autologous tissue to at least one bioactive factor.

### Claim 21 (depends on 13)

The method of claim 13, wherein the autologous tissue is sterilized using irradiation after processing.

### Claim 22 (depends on 13)

The method of claim 13, further comprising storing the processed autologous tissue in a storage solution.

### Claim 23 (depends on 22)

The method claim 22, wherein the autologous tissue is irradiated while in the storage solution.

### Claim 24 (depends on 13)

The method of claim 13, wherein the autologous tissue is a bone flap.

### Claim 25

A method of preparing a clean, disinfected autologous tissue implant for implantation, the method comprising
a) pre-treating autologous tissue surgically removed and collected from a patient,
b) shipping the pre-treated autologous tissue to a tissue processing facility,
c) receiving at the tissue processing facility the pre-treated autologous tissue that has been removed from the patient,
d) processing the pre-treated autologous tissue to clean and disinfect the autologous tissue, wherein the processing comprises treating the autologous tissue with a detergent,
e) storing the processed autologous tissue at an external storage facility, and
f) providing the clean, disinfected autologous tissue to a surgical facility for re-implantation into the patient,
wherein the autologous tissue is a bone flap.

### Claim 26 (depends on 25)

The method of claim 25, wherein the autologous tissue is a cranial bone flap.

### Claim 27 (depends on 25)

The method of claim 25, wherein the pre-treating comprises treating the collected autologous tissue with an antibiotic solution, a bactericidal solution, a virucidal, a glycerol-containing solution, water, saline or a combination thereof.

### Claim 28 (depends on 25)

The method of claim 25, wherein the processing comprises debridement.

### Claim 29 (depends on 25)

The method of claim 25, wherein the processing comprises treating the autologous tissue with a plasticizer.

### Claim 30 (depends on 25)

The method of claim 25, wherein the processing comprises creating an instrument insertion site in the autologous tissue.

### Claim 31 (depends on 25)

The method of claim 25, wherein the processing comprises exposing the autologous tissue to at least one bioactive factor.

### Claim 32 (depends on 25)

The method of claim 25, wherein the autologous tissue is sterilized using irradiation after processing.

### Claim 33 (depends on 25)

The method of claim 25, further comprising storing the processed autologous tissue in a storage solution.

### Claim 34 (depends on 33)

The method claim 33, wherein the autologous tissue is irradiated while in the storage solution.

### Claim 35 (depends on 25)

The method of claim 25, further comprising seeding cells onto the autologous tissue.
