# US 2013/0158650 A1 · Phase separation sprayed scaffold

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- Number: US 2013/0158650 A1
- Document ID: US20130158650A1
- Status: Published application
- Kind: A1
- Application number: 13/642,439
- Filed: 2010-10-29
- Published: 2013-06-20
- Earliest claimed: 2010-04-20
- Assignees: Universily of Utah Research Foundation
- Inventors: James P. Kennedy; Robert Hitchcock
- Web page: https://patentgrep.com/patent/US20130158650A1

## CPC

- A61F 2/06: Blood vessels
- C07D 401/04: directly linked by a ring-member-to-ring-member bond
- 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)
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## Abstract

Systems and methods for producing scaffolds are disclosed. The system includes a polymer solution and a non-solvent, which are sprayed into receiving portions of support elements. After scaffolds are formed on the support elements, the support elements permit elongation of the scaffolds. Composites formed from a plurality of scaffolds are also disclosed.

## Claims

### Claim 1

A method for producing at least one scaffold, comprising:
securing at least one frame thereon a backing member, wherein an inner portion of each frame of the at least one frame defines a central opening, wherein at least a portion of each frame of the at least one frame is configured to promote adherence of a scaffold;
simultaneously spraying a polymer solution and a non-solvent therein one or more central openings of the at least one frame such that a scaffold of the at least one scaffold is formed therein and adhered to each frame; and
elongating each scaffold of the at least one scaffold by a desired length such that each scaffold develops at least one desired property.

### Claim 2 (depends on 1)

The method of claim 1, wherein the at least one scaffold is biocompatible.

### Claim 3 (depends on 1)

The method of claim 1, wherein the at least one desired property comprises at least one of desired anisotropic properties, a desired cellular alignment, and a desired porosity.

### Claim 4 (depends on 1)

The method of claim 1, further comprising rinsing the at least one scaffold after the step of simultaneously spraying a polymer solution and a non-solvent.

### Claim 5 (depends on 1)

The method of claim 1, further comprising drying the at least one scaffold after the step of elongating each scaffold.

### Claim 6 (depends on 1)

The method of claim 1, wherein the polymer solution comprises polyether polyurethane.

### Claim 7 (depends on 6)

The method of claim 6, wherein the polymer solution further comprises dimethylacetamide, and wherein the polyether polyurethane is dissolved therein the dimethylacetamide.

### Claim 8 (depends on 7)

The method of claim 7, wherein the polymer solution comprises a desired amount of polyether polyurethane, wherein the desired amount of polyether polyurethane ranges from about 1% to about 10% by weight of the polymer solution.

### Claim 9 (depends on 1)

The method of claim 1, wherein the non-solvent comprises deionized water.

### Claim 10 (depends on 9)

The method of claim 9, wherein the non-solvent further comprises a desired amount of ethanol, and wherein the desired amount of ethanol ranges from about 0% to about 80% by weight of the non-solvent.

### Claim 11 (depends on 1)

The method of claim 1, wherein the central opening of each frame of the at least one frame has a length and a width, wherein the length of each central opening ranges from about 1.25 cm to about 4.50 cm, and wherein the width of each central opening ranges from about 1.00 cm to about 4.00 cm.

### Claim 12 (depends on 1)

The method of claim 1, wherein the step of elongating each scaffold comprises selectively moving at least one of a first and a second portion of each frame such that each scaffold is elongated by the desired length along a longitudinal axis of the frame.

### Claim 13 (depends on 12)

The method of claim 12, wherein the step of elongating each scaffold comprises selectively moving at least one of the first and the second portion of each frame along a first and a second elongation guide member of the frame.

### Claim 14 (depends on 13)

The method of claim 13, wherein the first and second portions of each frame each comprise a first side member and a second side member, and wherein the first and second portions of each frame are positioned in opposed relation to one another along the longitudinal axis of the frame so as to define at least a portion of the central opening.

### Claim 15 (depends on 14)

The method of claim 14, wherein the first elongation guide member is attached thereto the first side members of the first and second portions of each frame, and wherein the second elongation guide member is attached thereto the second side members of the first and second portions of each frame.

### Claim 16 (depends on 15)

The method of claim 15, wherein the first and second elongation guide members of each frame are substantially parallel to the longitudinal axis of each frame.

### Claim 17 (depends on 14)

The method of claim 14, wherein the first and second portions of each frame further comprise a base member, wherein the first side member, the base member, and the second side member of the first portion of each frame cooperate to form a U-shape and thereby define at least a portion of the central opening of the frame, and wherein the first side member, the base member, and the second side member of the second portion of each frame cooperate to form a U-shape and thereby define at least a portion of the central opening of the frame.

### Claim 18 (depends on 17)

The method of claim 17, wherein each frame of the at least one frame further comprises first and second screens, wherein the first screen is secured thereto the base member of the first portion of the frame such that at least a portion of the first screen extends into the central opening of the frame, and wherein the second screen is secured thereto the base member of the second portion of the frame such that at least a portion of the second screen extends into the central opening of the frame.

### Claim 19 (depends on 18)

The method of claim 18, wherein the first and second screens of each frame comprise porous, stainless steel screens, and wherein the first and second screens are configured to promote adherence of a scaffold.

### Claim 20 (depends on 1)

The method of claim 1, wherein the step of simultaneously spraying the polymer solution and the non-solvent comprises simultaneously spraying the polymer solution and the non-solvent at respective, desired spray rates.

### Claim 21 (depends on 20)

The method of claim 20, wherein the desired spray rate of the polymer solution ranges from about 6.50 grams per minute to about 8.50 grams per minute, and wherein the desired spray rate of the non-solvent ranges from about 35.0 grams per minute to about 55.0 grams per minute.

### Claim 22

A system for producing at least one scaffold, comprising:
a polymer solution;
a non-solvent;
a backing member;
at least one frame secured thereon the backing member, wherein an inner portion of each frame of the at least one frame defines a central opening, wherein at least a portion of each frame of the at least one frame is configured to promote adherence of a scaffold, and wherein the at least one frame is configured to permit elongation of each scaffold of the at least one scaffold by a desired length such that each scaffold develops at least one desired property; and
means for simultaneously spraying the polymer solution and the non-solvent therein one or more central openings of the at least one frame such that a scaffold of the at least one scaffold is formed therein and adhered to each frame.

### Claim 23 (depends on 22)

The system of claim 22, further comprising means for rinsing the at least one scaffold after each scaffold is formed therein and adhered to a frame.

### Claim 24 (depends on 22)

The system of claim 22, further comprising means for drying the at least one scaffold after elongation of each scaffold by the desired length.

### Claim 25 (depends on 22)

The system of claim 22, wherein the means for simultaneously spraying the polymer solution and the non-solvent comprises a spraying machine, the spraying machine comprising:
a processor;
a motor in electrical communication with the processor;
a spindle head coupled to the motor and in electrical communication with the processor, wherein the spindle head is configured for selective three-dimensional movement;
at least two fluid reservoirs, wherein a first fluid reservoir of the at least two fluid reservoirs contains the polymer solution, and wherein a second fluid reservoir of the at least two fluid reservoirs contains the non-solvent;
at least two spray nozzles coupled to the spindle head, wherein a first spray nozzle of the at least two spray nozzles is in fluid communication with the first fluid reservoir, wherein a second spray nozzle of the at least two spray nozzles is in fluid communication with the second fluid reservoir, and wherein each spray nozzle of the at least two spray nozzles is configured to selectively spray fluid,
wherein the processor is configured to perform the steps of:
activating the first and second spray nozzles to spray the polymer solution and the non-solvent at respective, desired spray rates; and
selectively controlling the three-dimensional movement of the spindle head such that the polymer solution and the non-solvent are sprayed in a desired pattern.

### Claim 26 (depends on 25)

The system of claim 25, wherein the spraying machine further comprises a pressure regulator in fluid communication with the at least two spray nozzles and in electrical communication with the processor, wherein the pressure regulator is configured to selectively control the pressure at which fluid is sprayed from the at least two spray nozzles, and wherein the processor is configured to selectively control the pressures at which the polymer solution and the non-solvent are sprayed from the first and second spray nozzles.

### Claim 27 (depends on 25)

The system of claim 25, wherein the spindle head comprises at least one spindle, and wherein each spray nozzle of the at least two spray nozzles is coupled to a spindle of the at least one spindle.

### Claim 28

A method for producing a composite comprising a plurality of scaffolds, the method comprising:
securing at least one support element thereon a backing member, wherein a receiving portion of each support element of the at least one support element is configured to promote adherence of a scaffold of the plurality of scaffolds;
simultaneously spraying a polymer solution and a non-solvent therein one or more receiving portions of the at least one support element such that a scaffold of the plurality of scaffolds is formed therein and adhered to each respective support element;
positioning the plurality of scaffolds in a stacked relationship such that at least one scaffold is superposed relative to another scaffold; and
curing the plurality of scaffolds such that the scaffolds are connected together to form the composite.

### Claim 29 (depends on 28)

The method of claim 28, wherein the step of positioning the plurality of scaffolds in a stacked relationship further comprises positioning a plurality of spaced tubular members having a selected diameter therebetween contiguous scaffolds.

### Claim 30 (depends on 29)

The method of claim 29, further comprising removing the plurality of spaced tubular members from the composite to thereby form a plurality of channels therein the composite.

### Claim 31 (depends on 28)

The method of claim 28, further comprising elongating at least one scaffold of the plurality of scaffolds by a desired length such that each elongated scaffold develops at least one desired property prior to the step of positioning the plurality of scaffolds in a stacked relationship.

### Claim 32 (depends on 31)

The method of claim 31, wherein the at least one desired property comprises at least one of desired anisotropic properties, a desired cellular alignment, and a desired porosity.

### Claim 33 (depends on 29)

The method of claim 29, wherein the selected diameter of the plurality of spaced tubular members ranges from about 200 micrometers to about 600 micrometers.

### Claim 34 (depends on 28)

The method of claim 28, wherein the plurality of scaffolds comprises three or more scaffolds.

### Claim 35 (depends on 29)

The method of claim 29, wherein the plurality of spaced tubular members comprise polytetrafluoroethylene.

### Claim 36 (depends on 28)

The method of claim 28, wherein the at least one support member comprises at least one frame, wherein the receiving portion of each frame comprises a central opening.

### Claim 37 (depends on 28)

The method of claim 28, wherein the at least one support member comprises at least one mold, wherein the receiving portion of each mold comprises a corrugated outer surface, wherein the corrugated outer surface of each respective mold is configured to define a plurality of channels therein a scaffold of the plurality of scaffolds, and wherein the plurality of channels defined therein each scaffold have at least one desired property.

### Claim 38 (depends on 37)

The method of claim 37, wherein the at least one desired property of the plurality of channels defined therein each scaffold comprise at least one of a desired width, a desired depth, and a desired spacing of channels.

### Claim 39 (depends on 37)

The method of claim 37, wherein the plurality of channels defined therein each scaffold cooperate with the plurality of channels defined therein contiguous scaffolds to form perfusion channels extending therethrough the composite.

### Claim 40

A composite having a longitudinal axis, the composite comprising:
a plurality of scaffolds connected to one another in a stacked relationship such that at least one scaffold is superposed relative to another scaffold, wherein each scaffold of the plurality of scaffolds possesses at least one desired property; and
a plurality of spaced perfusion channels positioned therebetween contiguous scaffolds therein the composite, wherein the plurality of spaced perfusion channels extend substantially parallel to the longitudinal axis of the composite.

### Claim 41 (depends on 40)

The composite of claim 40, wherein the at least one desired property of each scaffold of the plurality of scaffolds comprises at least one of desired anisotropic properties, a desired cellular alignment, a desired porosity, and desired perfusion properties.