APPARATUS AND METHOD FOR PRODUCING A BIOCOMPATIBLE THREE-DIMENSIONAL OBJECT

• US 20160001469A1
• Filed: 09/11/2015
• Published: 01/07/2016
• Est. Priority Date: 03/07/2013
• Status: Active Grant

• Current Assignee: S.M. Scienzia Machinale Srl
• Original Assignee: S.M. Scienzia Machinale Srl
• Inventors: Bacchereti, Marco, Bosio, Luca, Soldani, Giorgio
• Granted Patent: US 10,654,200 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: B29C 41/08 Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder spray-up of reinforcing fibres B29C70/305
• CPC Class Codes: B29C 41/34 Component parts, details or accessories; Auxiliary operations
• CPC Class Codes: B29C 41/365 Construction of spray-up equipment, e.g. spray-up guns spraying apparatus in general B05B
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: B33Y 10/00 Processes of additive manufacturing
• CPC Class Codes: B33Y 30/00 Apparatus for additive manufacturing; Details thereof or accessories therefor
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: G05B 19/4099 Surface or curve machining, making 3D objects, e.g. desktop manufacturing

Abstract

An apparatus for making a biocompatible three-dimensional object including at least one delivery unit arranged to deliver at least one biocompatible fluid substance towards a 3D mold having a matrix surface to obtain a coating layer of a predetermined thickness configured for coating the matrix surface. The three-dimensional object may be a heart valve. Furthermore, a handling unit is provided arranged to provide a relative movement according to at least 3 degrees of freedom between the 3D mold and each delivery unit. The 3D mold is arranged to be coated by the delivered biocompatible fluid substance, in order to obtain a three-dimensional object having an object surface copying the matrix surface of the support body.

Claims

1. A method for making a biocompatible three-dimensional heart valve, the method comprising the steps of:

delivering at least one biocompatible fluid substance towards a mold having a mold surface to obtain a coating layer of predetermined thickness configured for coating the mold surface, using at least one delivery unit, the biocompatible fluid substance including a plurality of particles;

handling with a handling unit the mold and the delivery unit in order to provide a relative movement with at least three degrees of freedom between the mold and the delivery unit, the mold coated with the at least one biocompatible fluid substance that is delivered to obtain a three-dimensional heart valve having a surface corresponding to the mold surface;

removing from the mold any surplus particles of the at least one biocompatible fluid substance dispensed using a suction and blowing device in order to make uniform the predetermined thickness of the coating layer; and

pressing a counter mold on the coating layer deposited on the mold after delivering the biocompatible fluid substance.

2. The method of claim 1, further comprising determining a size and geometry of the heart valve.

3. The method of claim 2, wherein determining the size of the heart valve is achieved by scanning.

4. The method of claim 3, wherein the scanning is selected from the group consisting of CT, FL, DR and MRI.

5. The method of claim 2, wherein the geometry of the heart valve is selected from the group consisting of narrow orifice, symmetrical leaflets and asymmetrical leaflets.

6. The method of claim 2, further comprising producing, using a computer processor, a virtual three-dimensional model of the heart valve.

7. The method of claim 6, further comprising creating the mold and the counter mold based on the virtual three-dimensional model of the heart valve.

8. The method of claim 1, wherein the at least one biocompatible fluid substance is selected from the group consisting of biocompatible polymeric resin, elastomer biomaterial, polyurethane, and silicone.

9. The method of claim 1, further comprising curing and drying the mold coated with the at least one biocompatible fluid substance in situ.

10. The method of claim 9, further comprising sterilizing the dry mold coated with the at least one biocompatible fluid substance.

11. The method of claim 10, further comprising extracting the dry mold coated with the at least one biocompatible fluid substance from the counter mold.

12. The method of claim 11, further comprising removing a dry layer of the biocompatible fluid substance from the mold.

13. The method of claim 1, wherein a plurality of biocompatible fluid substances are delivered towards mold using a plurality of delivery units.

14. The method of claim 1, wherein the heart valve is chosen from a group consisting of a bicuspid valve, single leaflet valve, bileaflet valve, cage and ball valve, and titling disc valve.

15. A system for making a biocompatible three-dimensional heart valve, the system comprising:

at least one delivery unit configured to deliver at least one biocompatible fluid substance towards a mold having a mold surface to obtain a coating layer of predetermined thickness configured for coating the mold surface, the biocompatible fluid substance having a plurality of particles;

a handling unit configured to provide a relative movement with at least three degrees of freedom between the mold and the delivery unit, wherein the mold is coated with the at least one biocompatible fluid substance that is delivered to obtain a three-dimensional heart valve having a surface corresponding to the mold surface; and

a suction and blowing device configured to generate a suction and blowing current, wherein the suction and blowing current removes from the mold any surplus particles of the biocompatible fluid substance supplied by the delivery unit.

16. The system of claim 15, wherein the handling unit includes an anthropomorphic robot having a chain of pivot joints, the chain of pivot joints having a first end connected to a fixed base and a second end connected to a support base to which the mold is mounted in a removable way, the chain of pivot joints arranged to move the mold, according to at least 6 degrees of freedom.

17. The system of claim 15, wherein the handling unit includes a plurality of linear actuators, each actuator of the plurality having a first end engaged with a fixed base and a second end engaged with a support base to which the mold is mounted in a removable way.

18. The system of claim 15, wherein the suction and blowing device is fixed.

19. The system of claim 15, wherein the suction and blowing device is movable and associated with a motor arranged to move the suction and blowing device, the motor being configured to allow the suction and blowing device to follow spatially the position of the mold during its handling by the handling unit.

20. The system of claim 15, wherein the suction and blowing device includes a suction hood integral to the support base and configured to surround laterally the mold to maximize the suction of the surplus particles of the biocompatible fluid substance, and a suction tube arranged to connect pneumatically the suction hood with a suction system to generate a suction flow.

21. The system of claim 15, wherein the at least one delivery unit includes a first delivery unit arranged to deliver a first jet of a first biocompatible fluid substance towards the mold, the first biocompatible fluid substance being a biomaterial of synthetic origin, and a second delivery unit arranged to deliver a second jet of a second biocompatible fluid substance towards the mold, the second biocompatible fluid substance being a non-solvent, the second delivery unit arranged to direct the second delivery jet towards the mold in such a way that the second delivery jet is overlapped to the first delivery jet, inducing a quick deposit of the synthetic biomaterial supplied onto the mold from the first delivery unit obtaining a filamentous three-dimensional structure.

22. The system of claim 21, wherein the second biocompatible fluid substance is water.

23. The system of claim 15, further comprising a counter-mold that is adapted to press the coating layer deposited on the mold.

24. The system of claim 21, wherein the at least one delivery unit further includes a plurality of delivery units arranged to deliver a plurality of biocompatible fluid substances.

25. The system of claim 24, wherein the plurality of biocompatible fluid substance includes a biopolymeric material of synthetic origin.

26. The system of claim 15, where the mold is three-dimensional.

27. The system of claim 16, further comprising at least one air compressor and at least one chemical container in communication with the delivery unit.

28. The system of claim 27, further comprising one or more continuous pumps attached to the fixed base, wherein the one or more continuous pumps deliver fluids from the chemical container to the delivery unit.

29. The system of claim 28, further comprising an electronic control unit in communication with the anthropomorphic robot, the electronic control unit supplies power and operating instructions to the anthropomorphic robot, continuous pumps, air compressor and the delivery unit.