3D BIOPRINTING A MEDICAL DEVICE THROUGH FREEFORM REVERSIBLE EMBEDDING

20240367382

18/659047

May 09, 2024

Various systems and process for fabricating customized medical devices via the freeform reversible embedding of suspended hydrogels process are disclosed. The mechanical properties of the fabricated objects can be controlled according to the manner or orientation in which the structure material is deposited into the support material and the three-dimensional movement of the extruder assembly. Further, the dimensions of the fabricated objects can be validated by adding a contrast agent to the structure material, obtaining a three-dimensional reconstruction of the fabricated object, and then comparing the three-dimensional reconstruction to the computer model upon which the fabricated object is based. These and other techniques are described herein.

1-36. (canceled)

37. A method for fabricating a medical device, the method comprising the steps of: receiving, with a computer system, a computer model of the medical device; modifying the computer model with the computer system to conform to an anatomy of a patient thereby forming a patient specific computer model; converting the patient specific computer model with the computer system into instructions for controlling an extruder assembly, wherein the converting step comprises slicing the patient specific computer model into a plurality of layers; transmitting the instructions from the computer system to an extruder assembly; and depositing a structure material into a support material to fabricate the medical device in accordance with the instructions, wherein the structure material is deposited in a non-planar path to produce three-dimensional filaments.

38. The method of claim 37, further comprising the steps of: obtaining image data of a biological structure of the patient; and generating the computer model of the medical device from the image data of the biological structure.

39. The method of claim 37, wherein the support material is stationary at an applied stress level below a threshold shear stress level and flows at an applied shear stress level at or above the threshold shear stress level.

40. The method of claim 37, wherein the support material is configured to physically support the structure material during deposition of the structure material.

41. The method of claim 37, wherein at least one of the extruder assembly and an extruder nozzle coupled with the extruder assembly is rotatable.

42. The method of claim 41, wherein the instructions include directions to move at least one of the extruder assembly and an extruder nozzle coupled with the extruder assembly according to both Cartesian and rotational coordinates.

43. The method of claim 37, wherein the instructions include parameters to control at least one of infill density and pattern of fabricated structures.

44. The method of claim 43, wherein the infill density is represented as a percentage between 0-100%.

45. The method of claim 43, wherein the infill density is 50%.

46. The method of claim 37, further comprising the steps of: receiving, with the computer system, imaging data corresponding to a biological muscle of the patient; determining, with the computer system, three-dimensional orientation of two or more muscle fibers in the biological muscle based on the imaging data; converting, with the computer system, the three-dimensional orientation of the two or more muscle fibers from the computer model into the instructions for controlling an extruder assembly; and depositing the structure material in the three-dimensional orientation with the extruder assembly.

47. A method for fabricating a medical device, the method comprising the steps of: receiving, with a computer system, a computer model of the medical device; modifying the computer model with the computer system to conform to an anatomy of a patient thereby forming a patient specific computer model; converting the patient specific computer model with the computer system into instructions for controlling an extruder assembly, wherein the converting step comprises slicing the patient specific computer model into a plurality of layers; and transmitting the instructions from the computer system to an extruder assembly; depositing a structure material into a support material to fabricate the medical device in accordance with the instructions, wherein the support material is stationary at an applied stress level below a threshold shear stress level and flows at an applied shear stress level at or above the threshold shear stress level wherein the support material is configured to physically support the structure material during deposition of the structure material.

48. The method of claim 47, further comprising the steps of: obtaining image data of a biological structure of the patient; and generating the computer model of the medical device from the image data of the biological structure.

49. The method of claim 47, wherein the structure material is deposited in a non-planar path to produce three-dimensional filaments, wherein the medical device mimics a mechanical property of a corresponding biological structure.

50. The method of claim 47, wherein at least one of the extruder assembly and an extruder nozzle coupled with the extruder assembly is rotatable.

51. The method of claim 50, wherein the instructions include directions to move at least one of the extruder assembly and an extruder nozzle coupled with the extruder assembly according to both Cartesian and rotational coordinates.

52. The method of claim 47, wherein the instructions include parameters to control at least one of infill density and pattern of fabricated structures.

53. The method of claim 52, wherein the infill density is represented as a percentage between 0-100%.

54. The method of claim 52, wherein the infill density is 50%.

55. The method of claim 47, further comprising the steps of: receiving, with the computer system, imaging data corresponding to a biological muscle of the patient; determining, with the computer system, three-dimensional orientation of two or more muscle fibers in the biological muscle based on the imaging data; converting, with the computer system, the three-dimensional orientation of the two or more muscle fibers from the computer model into the instructions for controlling an extruder assembly; and depositing the structure material in the three-dimensional orientation with the extruder assembly.

56. The method of claim 47, wherein the structure material comprises a hydrogel comprising a material selected from the group consisting of collagen, alginate, decellularized extracellular matrix material, fibrinogen, Matrigel, and hyaluronic acid.

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