# US 10,118,005 B2 · Delivery system

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- Number: US 10,118,005 B2
- Document ID: US10118005B2
- Status: Granted
- Kind: B2
- Application number: 14/019,714
- Filed: 2013-09-06
- Published: 2014-01-09
- Granted: 2018-11-06
- Earliest claimed: 2011-03-07
- Assignees: Wake Forest University Health Sciences
- Applicants: Wake Forest University Health Sciences
- Inventors: James J. Yoo; Anthony Atala; Kyle W. Binder; Mohammad Z. Albanna; Weixin Zhao; Dennis Dice; Tao Xu
- Web page: https://patentgrep.com/patent/US10118005B2

## CPC

- A61M 11/00: Sprayers or atomisers specially adapted for therapeutic purposes (in general B05B; {aerosol containers B65D83/14})
- A61B 5/0064: {Body surface scanning}
- A61B 5/1077: {Measuring of profiles}
- A61B 5/1079: {using optical or photographic means}
- A61B 5/445: {Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore}
- A61B 5/6835: {Supports or holders, e.g., articulated arms}
- A61L 27/225: {Fibrin; Fibrinogen}
- A61L 27/24: Collagen
- A61L 27/3813: {Epithelial cells, e.g. keratinocytes, urothelial cells}
- A61L 27/60: Materials for use in artificial skin
- A61M 35/20: {Non-portable devices, e.g. spraying booths}
- C12N 5/0656: {Adult fibroblasts}
- A61B 34/30: Surgical robots
- A61B 90/50: Supports for surgical instruments, e.g. articulated arms
- A61B 2017/00969: {used for transplantation}
- A61B 2017/3225: {with processing of harvested tissue}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- B41J 3/4073: {Printing on three-dimensional objects not being in sheet or web form, e.g. spherical or cubic objects (B41J3/283, B41J3/286 take precedence; building up a 3D object using individual droplets from jetting heads B29C64/112)}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- B41J: TYPEWRITERS; SELECTIVE PRINTING MECHANISMS, i.e. MECHANISMS PRINTING OTHERWISE THAN FROM A FORME; CORRECTION OF TYPOGRAPHICAL ERRORS

## Abstract

Provided herein is a delivery system, including: (a) an optical sensor configured to detect data to create a map of a patient bodily surface; and (b) a dispenser operatively associated with the optical sensor and configured to deliver compositions (optionally including cells) to the patient bodily surface based upon the data or map. Methods of forming a tissue on a patient bodily surface of a patient in need thereof are also provided, as are methods, systems and computer program products useful for processing patient bodily surface data.

## Claims

### Claim 1

A method of dispensing a composition onto a bodily surface of a patient in need thereof, comprising:
(a) detecting said bodily surface with an optical detector to obtain three-dimensional coordinates thereof, wherein said optical detector further comprises a depth detector to account for movement of the patient;
(b) processing the three-dimensional coordinates by:
(i) interpreting the coordinates to form a model of the bodily surface;
(ii) transforming the model into a negative mold of the bodily surface, which mold is split into a plurality of Z-axis layers; and
(iii) overlaying each of said Z-axis layers in the negative mold with a series of lines which represent coverage of the bodily surface, wherein said lines provide a path for a dispenser; and
(c) dispensing the composition onto said bodily surface of said patient with said dispenser based upon said coordinates, wherein the dispensing step is carried out by:
(i) mixing fibroblast cells with a hydrogel to form a composition comprising fibroblast cells;
(ii) dispensing the composition comprising fibroblast cells onto the bodily surface;
(iii) crosslinking the composition comprising fibroblast cells to form a gel layer;
and
(iv) dispensing a composition comprising keratinocytes over the gel layer.

### Claim 2 (depends on 1)

The method of claim 1, wherein the dispensing step (ii) is carried out not more than five minutes after said mixing step (i).

### Claim 3 (depends on 1)

The method of claim 1, wherein said hydrogel comprises fibrinogen.

### Claim 4 (depends on 1)

The method of claim 1, wherein said hydrogel comprises collagen.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition comprising keratinocytes comprises a hydrogel.

### Claim 6 (depends on 5)

The method of claim 5, wherein the keratinocytes is mixed in the hydrogel not more than five minutes prior to the dispensing step (iv).

### Claim 7 (depends on 1)

The method of claim 1, wherein said fibroblast cells are delivered at a concentration of about 50,000 to 500,000 cells per cm2.

### Claim 8 (depends on 1)

The method of claim 1, wherein said keratinocytes are delivered at a concentration of about 50,000 to 500,000 cells per cm2.

### Claim 9 (depends on 1)

The method of claim 1, wherein said fibroblast cells and said keratinocytes are autologous with respect to said patient.

### Claim 10 (depends on 9)

The method of claim 9, wherein said fibroblast cells are produced by obtaining cells from said patient and culturing said cells to form a cell culture.

### Claim 11 (depends on 9)

The method of claim 9, wherein said keratinocytes are produced by obtaining cells from said patient and culturing said cells to form a cell culture.

### Claim 12 (depends on 1)

The method of claim 1, wherein said optical detector is a hand-held scanner.

### Claim 13 (depends on 1)

The method of claim 1, wherein the dispensing step (ii) or the dispensing step (iv) is carried out in a time of from 5 to 30 minutes.

### Claim 14 (depends on 1)

The method of claim 1, wherein the dispensing step (ii) or the dispensing step (iv) is carried out by depositing drops of said composition along said path, wherein said drops have a volume of from 1 to 500 microliters.

### Claim 15 (depends on 14)

The method of claim 14, wherein said drops have a volume of from 50 to 250 microliters.

### Claim 16 (depends on 1)

The method of claim 1, wherein said composition comprises viable cells and wherein said dispensing step comprises forming a tissue.

### Claim 17 (depends on 16)

The method of claim 16, wherein said tissue is skin tissue.

### Claim 18 (depends on 1)

The method of claim 1, wherein said optical detector is a scanner.

### Claim 19 (depends on 1)

The method of claim 1, wherein the Z-axis layers correspond to one or more tissue layers.

### Claim 20 (depends on 1)

The method of claim 1, wherein said depth detector comprises a range camera that collects three-dimensional scene information from a continuously-projected light.

### Claim 21 (depends on 20)

The method of claim 20, wherein said continuously-projected light is an infrared structured light.

### Claim 22 (depends on 1)

The method of claim 1, wherein the three-dimensional coordinates are updated in real time during said dispensing.
