# US 8,932,805 B1 · Birth tissue material and method of preparation

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- Number: US 8,932,805 B1
- Document ID: US8932805B1
- Status: Granted
- Kind: B1
- Application number: 13/664,857
- Filed: 2012-10-31
- Granted: 2015-01-13
- Earliest claimed: 2011-10-31
- Assignees: BioDlogics, LLC
- Applicants: BioDlogics, LLC
- Inventors: Timothy R. Brahm
- Web page: https://patentgrep.com/patent/US8932805B1

## CPC

- A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel}
- A01N 1/125: Freeze protecting agents, e.g. cryoprotectants or osmolarity regulators
- A61B 17/4208: {Instruments for rupturing the amniotic membrane}
- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/58: Materials at least partially resorbable by the body
- A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)}
- A61M 25/1011: {Multiple balloon catheters}
- C12N 5/0605: {Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly}
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2300/43: Hormones, e.g. dexamethasone
- A61L 2300/438: Antigens
- A61L 2430/34: for soft tissue reconstruction
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Methods of preparing a human birth tissue material are provided. A placental construct for treatment of a disease or condition is also provided. A kit including at least one placental construct and at least one structural carrier is provided. A catheter for recovering amniotic fluid is also provided.

## Claims

### Claim 1

A method of preparing a human birth tissue material, comprising the steps of:
(a) recovering placental tissue components and amniotic fluid from a seronegative, healthy human via cesarean section or vaginal delivery;
(b) subjecting the placental tissue components to cryopreservation;
(c) morselizing the cryopreserved placental tissue components;
(d) homogenizing the morselized placental tissue components in a tissue suspension solution to form a tissue suspension;
(e) homogenizing the tissue suspension with an amniotic fluid composition to form a bulk tissue product; and
(f) cryofreezing the bulk tissue product to form the human birth tissue material.

### Claim 2 (depends on 1)

The method of claim 1, further comprising the step of placing the placental tissue components in a sterile transport solution after the step of obtaining the placental tissue components and amniotic fluid.

### Claim 3 (depends on 2)

The method of claim 2, wherein the sterile transport solution supports the natural function of the placental tissue components.

### Claim 4 (depends on 2)

The method of claim 2, wherein the sterile transport solution comprises one or more components selected from the group consisting of Minimum Essential Medium, Dulbecco's Modified Eagle's Medium (DMEM), Plasma Lyte-A, human albumin 25% solution, calcium-rich water, alkaline ionized water, and acidic ionized water.

### Claim 5 (depends on 1)

The method of claim 1, wherein the placental tissue components include one or more components selected from the group consisting of amniotic membrane, chorionic membrane, Wharton's jelly, umbilical cord tissue, placental globe, other gelatins, other cells and extracellular matrix from placental tissue components.

### Claim 6 (depends on 1)

The method of claim 1, wherein the step of subjecting the placental tissue components to cryopreservation begins no more than four hours after recovering placental tissue components and amniotic fluid.

### Claim 7 (depends on 1)

The method of claim 1, wherein the tissue suspension solution comprises Plasma Lyte-A, human albumin 25% solution, and dimethyl sulfoxide.

### Claim 8 (depends on 1)

The method of claim 1, wherein the amniotic fluid composition is prepared according to a process comprising the steps of:
centrifuging amniotic fluid at ambient temperature for a period of up to 30 minutes at 200 rpm to 15,000 rpm;
aspiring off a first supernatant and re-suspending a first pellet in an isotonic solution;
centrifuging the first pellet/isotonic solution combination at ambient temperature for a period of up to 30 minutes at 200 rpm to 15,000 rpm; and
aspiring off a second supernatant and re-suspending a second pellet in a pre-determined volume of cell suspension solution to form the amniotic fluid composition.

### Claim 9 (depends on 8)

The method of claim 8, wherein the amniotic fluid composition is prepared no more than four hours after recovery of the amniotic fluid.

### Claim 10 (depends on 8)

The method of claim 8, wherein the isotonic solution comprises Plasma Lyte-A.

### Claim 11 (depends on 8)

The method of claim 8, wherein the cell suspension solution comprises Plasma Lyte-A and human albumin 25% solution.

### Claim 12 (depends on 8)

The method of claim 8, further comprising the steps of precipitating the first and second supernatant and homogenizing any remaining material with the amniotic fluid composition.