# US 11,077,241 B2 · Standardizations and medical devices for the preparation of platelet rich plasma (PRP) or bone marrow concentrate (BMC) alone or in combination with hyaluronic acid

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- Number: US 11,077,241 B2
- Document ID: US11077241B2
- Status: Granted
- Kind: B2
- Application number: 15/529,415
- Filed: 2015-11-26
- Published: 2018-04-26
- Granted: 2021-08-03
- Earliest claimed: 2014-11-26
- Assignees: Regen Lab USA LLC
- Applicants: Regenlab USA LLC
- Inventors: Antoine Turzi
- Web page: https://patentgrep.com/patent/US11077241B2

## CPC

- A61M 1/38: Removing constituents from donor blood and {storing or} returning remainder to body {, e.g. for transfusion}
- A61J 1/2089: {Containers or vials which are to be joined to each other in order to mix their contents (combinations of vial and syringe for mixing their contents A61J1/2096)}
- A61K 35/16: Blood plasma; Blood serum (umbilical cord blood A61K35/51)
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61M 1/029: {Separating blood components present in distinct layers in a container, not otherwise provided for (containers for storing blood or blood components A61J1/05; sampling or analysing blood by separating blood components G01N33/491)}
- A61M 1/3672: {Means preventing coagulation}
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/02: for peripheral neuropathies
- A61P 27/02: Ophthalmic agents
- A61B 17/34: Trocars; Puncturing needles
- A61J 1/2013: {having two piercing ends}
- A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39)
- A61M 2202/0415: Plasma
- A61M 2202/08: Lipoids
- A61M 2202/10: Bone-marrow
- 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)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The present invention is related to the field of tissue regeneration. It concerns more particularly new standardizations and medical devices for the preparation of A-PRP, PRP, BMC, fat tissue, alone or in combination with a biomaterial or cell extract.

## Claims

### Claim 1

A system for the preparation of a cell composition, comprising:
a tube having:
an opening;
an anticoagulant;
a thixotropic gel adapted to separate blood by forming a barrier between a platelet rich plasma and red blood cells when the tube is centrifuged for a length of time;
a stopper sealing the opening of the tube and keeping the anticoagulant and the thixotropic gel sterile in the tube;
a container having:
an opening;
a biomaterial comprising hyaluronic acid and a coagulation activator prefilled therein;
a stopper sealing the opening of the container and keeping the biomaterial sterile in the container;
at transfer device having:
a first connector adapted to connect to the tube;
a second connector adapted to connect to the container;
wherein said system is able to form a cell composition by mixing the platelet rich plasma and the biomaterial when the tube and container are both connected to the transfer device, and the platelet rich plasma transfers from the tube to the container in a closed circuit to maintain sterility.

### Claim 2 (depends on 1)

The system of claim 1, wherein the container is under vacuum pressure, the vacuum pressure facilitating transfer of the platelet rich plasma from the tube to the container.

### Claim 3 (depends on 2)

The system of claim 2, wherein the container comprises a syringe or tube.

### Claim 4 (depends on 1)

The system of claim 1, wherein the biomaterial comprises at least one of a chitosan, a silk protein, and a fibroin.

### Claim 5 (depends on 1)

The system of claim 1, further comprising a collection device for collecting the blood from a patient;
wherein the tube is under vacuum pressure and the collection device is adapted to pierce the stopper of the tube so that the vacuum pressure facilitates aspiration of the blood from the patient.

### Claim 6

A system for the preparation of a cell composition, comprising:
a tube having:
an opening;
an anticoagulant;
a biomaterial;
a stopper sealing the opening of the tube and keeping the anticoagulant and the biomaterial sterile in the tube;
the tube being adapted to centrifuge blood to form a platelet concentrate;
a container having:
an opening;
wherein the container comprises a composition including a hyaluronic acid and a coagulation activator prefilled therein, the composition mixing with the platelet concentrate when the platelet concentrate transfers from the tube to the container;
a stopper sealing the opening of the container and keeping an inside of the container sterile;
a transfer device having:
a first connector adapted to connect to the tube;
a second connector adapted to connect to the container; and
wherein when the tube and container are both connected to the transfer device, the platelet concentrate is able to transfer from the tube to the container in a closed circuit to maintain sterility.

### Claim 7 (depends on 6)

The system of claim 6, further comprising a cell selector gel in the tube, the cell selector gel adapted to separate the blood by forming a barrier between the platelet concentrate and red blood cells when the tube is centrifuged for a length of time.

### Claim 8 (depends on 6)

The system of claim 6, wherein the container is sealed with the stopper of the container under vacuum pressure, the vacuum pressure facilitating transfer of the platelet concentrate from the tube to the container.

### Claim 9 (depends on 6)

The system of claim 6, wherein the container comprises a syringe, the syringe adapted to disconnect from the transfer device and connect to a needle for administering the platelet concentrate to a patient.

### Claim 10 (depends on 6)

The system of claim 6, wherein the container comprises another tube.

### Claim 11 (depends on 6)

The system of claim 6, wherein the first connector of the transfer device comprises a luer connector and the second connector of the transfer device comprises a luer connector.

### Claim 12 (depends on 6)

The system of claim 6, further comprising another container;
the transfer device has a third connector adapted to connect to another container;
when the tube, the container, and the another container are all connected to the transfer device they are in fluid communication with each other in a closed circuit to maintain sterility.

### Claim 13 (depends on 6)

The system of claim 6, further comprising a harvesting cannula for collecting adipose tissue from a patient and transferring the adipose tissue to the container, the adipose tissue mixing with the platelet concentrate when the platelet concentrate transfers from the tube to the container.

### Claim 14 (depends on 6)

The system of claim 6, further comprising a preservation solution.

### Claim 15 (depends on 14)

The system of claim 14, wherein the container comprises the preservation solution, the preservation solution mixing with the platelet concentrate when the platelet concentrate transfers from the tube to the container.

### Claim 16 (depends on 14)

The system of claim 14, wherein the preservation solution comprises a plasmalyte-A.

### Claim 17

A system for the preparation of a cell composition, comprising:
a tube having:
an opening;
an anticoagulant:
a biomaterial comprising hyaluronic acid and a coagulation activator prefilled therein;
a stopper sealing the opening of the tube and keeping the anticoagulant and the biomaterial sterile in the tube;
the tube adapted to centrifuge blood to form a platelet concentrate;
a container having:
an opening;
a preservation solution;
a stopper sealing the opening of the container and keeping an inside of the container sterile;
a transfer device having:
a first connector adapted to connect to the tube;
a second connector adapted to connect to the container; and
wherein a cell composition is able to be formed by mixing the platelet concentrate, the biomaterial and the preservation solution when the tube and container are both connected to the transfer device and the platelet concentrate and the biomaterial transfer from the tube to the container in a closed circuit to maintain sterility.
