System for producing a graft device with a three-dimensional covering

Abstract

A system for producing a graft device for a patient may comprise: an imaging device configured to produce image data of a tubular conduit; and a processing unit configured to receive the image data from the imaging device. The processing unit may comprise an algorithm configured to process the image data, and produce a construction signal based on the image data. A material delivery device may be configured to receive the construction signal from the processor, and deliver material to produce a 3D covering based on the construction signal. The graft device may comprise the 3D covering positioned about the tubular conduit. Graft devices and methods of producing graft devices may also be provided.

What is claimed is: 
     
         1 . System for producing a graft device for a patient comprising:
 an imaging device configured to produce image data of a tubular conduit; and   a processing unit configured to receive the image data from the imaging device and comprising an algorithm, wherein the algorithm is configured to process the image data and produce a construction signal based on the image data;   a material delivery device configured to receive the construction signal from the processing unit, and deliver material to produce a 3-dimensional (3D) covering based on the construction signal;   wherein the graft device comprises the 3D covering positioned about the tubular conduit.   
     
     
         2 . The system according to any claim herein, wherein the material delivery device is configured to deliver the 3D covering onto the tubular conduit. 
     
     
         3 . The system according to any claim herein, wherein the 3D covering is configured to be positioned about the tubular conduit after being produced by the material delivery device. 
     
     
         4 . The system according to any claim herein, wherein the graft device comprises a coronary artery bypass graft. 
     
     
         5 . The system according to any claim herein, wherein the graft device comprises a dialysis graft. 
     
     
         6 . The system according to any claim herein, wherein the graft device comprises an implant selected from the group consisting of: artery bypass graft; coronary artery bypass graft; dialysis graft; peripheral arterial bypass graft; great vessel replacement; great vessel bypass graft; esophageal graft; tracheal graft; bronchial graft; biliary duct graft; intestinal graft; organ transplant vascular connection graft; neuronal replacement implant; ligament graft; ligament replacement; tendon graft; tendon replacement; transplant organ coating; fallopian tube; urethra; ureter; cartilage; hip joint; shoulder joint; intervertebral disc; menisci; and any combination thereof. 
     
     
         7 . The system according to any claim herein, wherein the imaging device comprises a device selected from the group consisting of: computerized tomography (CT) imager; optical coherence tomography (OCT) imager; magnetic resonance imaging (MRI); 3D Scanner; Camera; Infrared Camera; Ultrasound imager; and any combination thereof. 
     
     
         8 . The system according to any claim herein, wherein the image data comprises information related to the tubular conduit. 
     
     
         9 . The system according to any claim herein, wherein the image data comprises information related to a portion of the patient's anatomy. 
     
     
         10 . The system according to any claim herein, wherein the image data comprises data collected when the tubular conduit is in-situ. 
     
     
         11 . The system according to  claim 10 , wherein the image data further comprises data collected after the tubular conduit is harvested from the patient. 
     
     
         12 . The system according to any claim herein, wherein the image data comprises data collected after the tubular conduit is harvested from the patient. 
     
     
         13 . The system according to any claim herein, wherein the image data comprises data selected from the group consisting of: surface topography data; surface geometry data; periphery data; length data; diameter data; thickness data such as wall thickness data; taper data; eccentricity data; relative position data; trajectory data; speed of motion data; relative angle data; radiopacity data; blood flow data; echographic data; spectroscopic data; and any combination thereof. 
     
     
         14 . The system according to any claim herein, wherein the image data comprises at least one discrete feature of the tubular conduit. 
     
     
         15 . The system according to  claim 14 , wherein the at least one discrete feature is identified by the algorithm. 
     
     
         16 . The system according to  claim 14 , wherein the at least one discrete feature comprises a feature selected from the group consisting of: sidebranch; recess; projection; end; end portion; bend portion; lobe; bifurcation; trifurcation; a dilated portion; a swollen portion; valve; a tapered portion; a location of a surgical staple; an angled portion; a calcified tissue portion; an atheromatous tissue portion; a partially occluded portion; a fully occluded portion; and any combination thereof. 
     
     
         17 . The system according to  claim 14 , wherein the at least one discrete feature comprises a sidebranch. 
     
     
         18 . The system according to  claim 17 , wherein the image data comprises sidebranch information selected from the group consisting of: location; diameter; taper angle; ligation device position; ligation device geometry; ligation device type; and any combination thereof. 
     
     
         19 . The system according to any claim herein, wherein the image data comprises information related to a compliance of the tubular conduit. 
     
     
         20 . The system according to any claim herein, wherein the image data comprises information related to a shape of the tubular conduit changing over time. 
     
     
         21 . The system according to  claim 20 , wherein the information related to the shape of the tubular conduit changing over time comprises information related to the shape of the tubular conduit changing over time prior to harvesting. 
     
     
         22 . The system according to  claim 20 , wherein the tubular conduit changes shape due to a change in a parameter selected from the group consisting of: blood pressure; respiration; patient movement; and any combination thereof. 
     
     
         23 . The system according to any claim herein, wherein the tubular conduit comprises tissue selected from the group consisting of: cylindrical tissue; organ tissue; saphenous vein; vein; artery; urethra; intestine; esophagus; ureter; trachea; bronchi; duct; fallopian tube; and any combination thereof. 
     
     
         24 . The system according to any claim herein, wherein the tubular conduit comprises tissue selected from the group consisting of: bone; ligament; tendon; and any combination thereof. 
     
     
         25 . The system according to any claim herein, wherein the tubular conduit comprises artificial material. 
     
     
         26 . The system according to any claim herein, wherein the processing unit comprises memory circuitry. 
     
     
         27 . The system according to  claim 26 , wherein the memory circuitry is configured to store information selected from the group consisting of: tissue type; type of the material; information regarding the application of the graft device; information regarding use of one or more tools; compliance information; density information; strength information; modulus of elasticity information; elastic limit information; wall thickness information; shrinkage information of the material; cure time information of the material; spacing to a mandrel and/or other target; minimum bend radius of the covering; maximum ovality of the covering; and any combination thereof. 
     
     
         28 . The system according to  claim 26 , wherein the construction signal is based on information stored in the memory circuitry. 
     
     
         29 . The system according to any claim herein, wherein the processing unit comprises at least one of a microprocessor or a microcontroller. 
     
     
         30 . The system according to any claim herein, wherein the algorithm is configured to identify at least one discrete feature of the tubular conduit. 
     
     
         31 . The system according to  claim 30 , wherein the at least one discrete feature of the tubular conduit identified by the algorithm comprises a feature selected from the group consisting of: sidebranch; recess; projection; end; end portion; bend portion; lobe; bifurcation; trifurcation; a dilated portion; a swollen portion; valve; a tapered portion; a location of a surgical staple; an angled portion; a calcified tissue portion; an atheromatous tissue portion; a partially occluded portion; a fully occluded portion; and any combination thereof. 
     
     
         32 . The system according to  claim 30 , wherein the 3D covering comprises at least one customized portion positioned relative to the at least one discrete feature. 
     
     
         33 . The system according to  claim 32 , wherein the customized portion is positioned proximate the at least one discrete feature. 
     
     
         34 . The system according to  claim 32 , wherein the algorithm is configured to identify at least two discrete features of the tubular conduit, and wherein the 3D covering comprises at least two customized portions. 
     
     
         35 . The system according to  claim 32 , wherein the customized portion comprises a differentiating property selected from the group consisting of: different thickness; different material; different porosity; different pore size; different compliance in one or more directions; different level of conformality; different texture; different alignment and/or orientation of the deposited material; different stiffness; different fiber diameter; addition of a kink-resisting element; addition of an agent; and any combination thereof. 
     
     
         36 . The system according to  claim 31 , wherein the at least one discrete feature comprises a protrusion of the tubular conduit. 
     
     
         37 . The system according to  claim 36 , wherein the protrusion comprises a sidebranch. 
     
     
         38 . The system according to  claim 36 , wherein the 3D covering comprises a customized portion including a void proximate the protrusion. 
     
     
         39 . The system according to  claim 38 , wherein the void comprises a hole. 
     
     
         40 . The system according to  claim 38 , wherein the void comprises a recess. 
     
     
         41 . The system according to  claim 36 , wherein the at least one customized portion comprises a portion selected from the group consisting of: a portion comprising a change in deposition of the material such as to mechanically reinforce and/or provide a strain relief at a sidebranch location; a portion configured to constrain a sidebranch such as to minimize hemodynamic disruption in a lumen of the tubular conduit; and any combination thereof. 
     
     
         42 . The system according to  claim 31 , wherein the 3D covering comprises a customized portion including a fillet positioned proximate the at least one discrete feature. 
     
     
         43 . The system according to  claim 31 , wherein the at least one discrete feature comprises an end of the tubular conduit. 
     
     
         44 . The system according to  claim 43 , wherein the 3D covering comprises a customized portion including a taper located proximate the end of the tubular conduit. 
     
     
         45 . The system according to  claim 44 , wherein the at least one discrete feature further comprises a second end of the tubular conduit, and wherein the 3D covering further comprises a second customized portion including a second tapered positioned proximate the second end of the tubular conduit. 
     
     
         46 . The system according to  claim 43 , wherein the 3D covering comprises a customized portion including a reinforced portion located proximate the end of the tubular conduit. 
     
     
         47 . The system according to  claim 43 , wherein the 3D covering comprises a customized portion including an optimized anastomosis portion located proximate the end of the tubular conduit. 
     
     
         48 . The system according to  claim 47 , wherein the optimized anastomosis portion comprises an optimized shape. 
     
     
         49 . The system according to  claim 47 , wherein the optimized anastomosis portion comprises an optimized structure. 
     
     
         50 . The system according to  claim 31 , wherein the at least one discrete feature comprises tissue whose softness is above a threshold. 
     
     
         51 . The system according to  claim 50 , wherein the customized portion comprises a differentiating property selected from the group consisting of: different material; different compliance; different thickness; different permeability; different porosity; different anisotropy; and any combination thereof. 
     
     
         52 . The system according to  claim 31 , wherein the at least one discrete feature comprises tissue whose flexibility is above a threshold. 
     
     
         53 . The system according to  claim 52 , wherein the customized portion comprises a differentiating property selected from the group consisting of: different material; different compliance; different thickness; different permeability; different porosity; different anisotropy; and any combination thereof. 
     
     
         54 . The system according to  claim 31 , wherein the at least one discrete feature comprises tissue whose shape changes over time. 
     
     
         55 . The system according to  claim 54 , wherein the customized portion comprises a differentiating property selected from the group consisting of: different material; different compliance; different thickness; different permeability; different porosity; different anisotropy; and any combination thereof. 
     
     
         56 . The system according to  claim 31 , wherein the 3D covering includes a customized portion including a reinforced portion. 
     
     
         57 . The system according to  claim 56 , wherein the at least one discrete feature comprises a thin-walled portion of the tubular conduit, and wherein the customized portion is located proximate the thin-walled portion. 
     
     
         58 . The system according to  claim 31 , wherein the 3D covering includes a customized portion including a strain relief. 
     
     
         59 . The system according to  claim 58 , wherein the at least one discrete feature comprises at least one of an end of the tubular conduit or a bend portion of the graft device, and wherein the customized portion is located proximate the at least one discrete feature. 
     
     
         60 . The system according to  claim 31 , wherein the 3D covering includes a customized portion including modified porosity. 
     
     
         61 . The system according to  claim 60 , wherein the at least one discrete feature comprises an anastomosis site and/or a segment of high curvature of the graft device, and wherein the customized portion is located proximate the at least one discrete feature. 
     
     
         62 . The system according to  claim 31 , wherein the 3D covering includes a customized portion including a modified compliance. 
     
     
         63 . The system according to  claim 62 , wherein the modified compliance comprises a modified radial compliance. 
     
     
         64 . The system according to  claim 62 , wherein the modified compliance comprises a modified axial compliance. 
     
     
         65 . The system according to  claim 62 , wherein the at least one discrete feature comprises an anastomosis site, a ligament attachment site, a tendon attachment site and/or a site of segmented compliance, and wherein the customized portion is located proximate the at least one discrete feature. 
     
     
         66 . The system according to any claim herein, wherein the algorithm is configured to create a 3D model of the tubular conduit based on the image data. 
     
     
         67 . The system according to  claim 66 , wherein 3D model comprises a spatial model. 
     
     
         68 . The system according to  claim 66 , wherein the algorithm is further configured to modify the 3D model of the tubular conduit. 
     
     
         69 . The system according to  claim 66 , wherein the image data comprises multiple slices of a CT image. 
     
     
         70 . The system according to any claim herein, wherein the algorithm is configured to create a 3D model of a proposed 3D cover. 
     
     
         71 . The system according to any claim herein, wherein the algorithm is configured to create a proposed 3D model of the 3D covering, and to modify the proposed 3D model to create a final 3D model of the 3D covering. 
     
     
         72 . The system according to  claim 71 , wherein the algorithm is configured to modify the proposed 3D model based on at least one discrete feature of the tubular conduit. 
     
     
         73 . The system according to  claim 71 , wherein the algorithm is configured to modify the proposed 3D model based on user input. 
     
     
         74 . The system according to any claim herein, wherein the algorithm is configured to create a 3D model of at least one of the tubular conduit or the 3D covering based on boundary conditions. 
     
     
         75 . The system according to  claim 74 , wherein the algorithm is configured to optimize hemodynamics within the tubular conduit by performing a function selected from the group consisting of: reducing flow turbulence; controlling bending radius; controlling lumen geometry; controlling a transition; controlling a taper; controlling a bend portion; controlling tortuosity; controlling wall shear; preventing buckling; optimizing wall shear stress; modifying an end portion to optimize an anastomotic connection; reducing geometric mismatch near an anastomotic connection; and any combination thereof. 
     
     
         76 . The system according to any claim herein, wherein the algorithm is configured to convert information from an imaging coordinate system to a material deposition coordinate system 
     
     
         77 . The system according to  claim 76 , wherein the imaging coordinate system comprises Cartesian coordinates and wherein the material deposition coordinate system comprises a cylindrical, spherical and/or curvilinear coordinate system. 
     
     
         78 . The system according to any claim herein, wherein the material delivery device comprises at least one nozzle, and wherein the algorithm is configured to create a pathway of motion for the at least one nozzle. 
     
     
         79 . The system according to  claim 78 , wherein the algorithm creates the pathway of motion based on one or more off limits locations. 
     
     
         80 . The system according to  claim 78 , wherein the pathway of motion avoids portions of the 3D covering that have already been created. 
     
     
         81 . The system according to  claim 78 , wherein the pathway of motion avoids the tubular conduit. 
     
     
         82 . The system according to  claim 78 , wherein the material delivery device comprises a mandrel, and wherein the pathway of motion avoids the mandrel. 
     
     
         83 . The system according to  claim 78 , wherein the pathway of motion minimizes dissipation of heat to the tubular conduit. 
     
     
         84 . The system according to  claim 83 , wherein the pathway of motion reduces multiple passes of delivery of material in neighboring regions of the tubular conduit within a time period. 
     
     
         85 . The system according to any claim herein, wherein the algorithm is configured to perform a self-diagnostic. 
     
     
         86 . The system according to  claim 85 , further comprising at least one sensor configured to produce a signal, wherein the self-diagnostic is based on the signal from the at least one sensor. 
     
     
         87 . The system according to  claim 86 , wherein the sensor comprises one or more sensors selected from the group consisting of: an optical sensor; a laser; a magnetic sensor; an electrical sensor; an energy sensor; a pressure sensor; a force sensor; a strain gauge; a position sensor; a flow sensor; a sound sensor; an ultrasound sensor; a humidity sensor; and any combination thereof. 
     
     
         88 . The system according to  claim 85 , wherein the self-diagnostic is configured to assess a parameter selected from the group consisting of: electrical connection status; rotational speed; translational speed; nozzle status; material delivery status; temperature; chamber environment condition; energy delivered; home position; a distance between two components of the system; and any combination thereof. 
     
     
         89 . The system according to any claim herein, wherein the algorithm is configured to create the construction signal based on a property of the tubular conduit. 
     
     
         90 . The system according to  claim 89 , wherein the construction signal produces a 3D covering that provides mechanical support to the tubular conduit. 
     
     
         91 . The system according to  claim 89 , wherein the construction signal produces a 3D covering with varied properties along a length of the tubular conduit. 
     
     
         92 . The system according to any claim herein, wherein the material delivery device comprises at least one nozzle. 
     
     
         93 . The system according to  claim 92 , wherein the material delivery device comprises at least two nozzles. 
     
     
         94 . The system according to any claim herein, wherein the material delivery device comprises a 3D printer. 
     
     
         95 . The system according to any claim herein, wherein the material delivery device is configured to deliver the material using an additive printing process. 
     
     
         96 . The system according to any claim herein, wherein the material delivery device is configured to deliver the material as a series of layers. 
     
     
         97 . The system according to any claim herein, wherein the material delivery device comprises a device selected from the group consisting of: a 3D printer; a layer printing device; an electrospinning device; a melt-spinning device; a melt-electrospinning device; a misting assembly; a sprayer; an electrosprayer; a fused deposition device; a selective laser sintering device; a fiber dispenser; a wire dispenser; a thread dispenser; a resin deposition device, such as a UV-curable resin deposition device; a stereolithography device; a phase separation device; a wet spinning device; a dip coating device; a lathe; a milling machine; a chemical etching device; a plasma etching device; a negative mold-over device; an injection molding device; and any combination thereof. 
     
     
         98 . The system according to  claim 97 , wherein the material delivery device comprises two or more devices selected from the group consisting of: a 3D printer; a layer printing device; an electrospinning device; a melt-spinning device; a melt-electrospinning device; a misting assembly; a sprayer; an electrosprayer; a fused deposition device; a selective laser sintering device; a fiber dispenser; a wire dispenser; a thread dispenser; a resin deposition device, such as a UV-curable resin deposition device; a stereolithography device; a phase separation device; a wet spinning device; a dip coating device; a lathe; a milling machine; a chemical etching device; a plasma etching device; a negative mold-over device; an injection molding device; and any combination thereof. 
     
     
         99 . The system according to any claim herein, wherein the material comprises one or more materials selected from the group consisting of: synthetic polymer; natural polymer; protein; metal; metal alloy; collagen; elastin; a glycosaminoglycan;a proteoglycan; an alginate; cellulose; gelatin; silk fibroin; fibrinogen; chitosan; an enzyme; fibronectin; glycerin; integrin; keratin; a vitamin; a carbohydrate; a monosaccharide; a disaccharide; a polysaccharide; a nucleoside; abductin; lignin; a glycolipid; a phospholipid; a sterol; shrilk; cobalt-chrome; nitinol; aluminum oxide; magnesium; iron; zinc; steel; titanium; vitalium; alacrite; platinum; gold; silver; copper; manganese; a polyester; a polyurethane; a polycarbonate; a polyether; a polysulfone; a polyamide; a polyetheramide; a polystyrene; a polybutadiene; a polyisoprene; a poly(methyl methacrylate); a polyanhydride; a polydimethylsiloxane; a polydioxanone; polyethylene; glycol; polyethylene terephthalate; a polyglycolide; a polyhydroxyalkanoate; polyimide; polytetrafluoroethylene; polyvinylidene fluoride; polyethylene; polypropylene; polyvinylfluoride; polyvinylchloride; polyacylonitrile; silicone; a ceramic; a bioceramic; a bioglass; a composite material; and any combination thereof. 
     
     
         100 . The system according to any claim herein, wherein the 3D covering comprises varied properties along its length. 
     
     
         101 . The system according to  claim 100 , wherein the 3D covering comprises at least one customized portion. 
     
     
         102 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a thickness from about 10 micrometer (μm) to about 1 centimeter (cm). 
     
     
         103 . The system according to  claim 102 , wherein the 3D covering comprises at least a portion with a thickness from about 50 μm to about 500 μm. 
     
     
         104 . The system according to  claim 102 , wherein the 3D covering comprises at least a portion with a thickness from about 200 μm to about 300 μm. 
     
     
         105 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a bulk porosity less than about 99%. 
     
     
         106 . The system according to  claim 105 , wherein the 3D covering comprises at least a portion with a bulk porosity from about 30% to about 80%. 
     
     
         107 . The system according to  claim 105 , wherein the 3D covering comprises at least a portion with a bulk porosity from about 50% to about 70%. 
     
     
         108 . The system according to any claim herein, wherein the 3D covering comprises a length from about 1 millimeter (mm) to about 1 meter (m). 
     
     
         109 . The system according to  claim 108 , wherein the 3D covering comprises a length from about 3 centimeter (cm) to about 50 cm. 
     
     
         110 . The system according to  claim 108 , wherein the 3D covering comprises a length from about 20 cm to about 30 cm. 
     
     
         111 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a compliance under a physiologic load that is less than about 99%. 
     
     
         112 . The system according to  claim 111 , wherein the 3D covering comprises at least a portion with a compliance under a physiologic load that is from about 1% to about 50%. 
     
     
         113 . The system according to  claim 111 , wherein the 3D covering comprises at least a portion with a compliance under a physiologic load that is from about 10% to about 25%. 
     
     
         114 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with an ultimate strength from about 0.1 Megapascal (MPa) to about 500 MPa. 
     
     
         115 . The system according to  claim 114 , wherein the 3D covering comprises at least a portion with an ultimate strength from about 0.5 MPa to about 100 MPa. 
     
     
         116 . The system according to  claim 114 , wherein the 3D covering comprises at least a portion with an ultimate strength from about 1 MPa to about 10 MPa. 
     
     
         117 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a biodurability from about 1 hour to about 10 years. 
     
     
         118 . The system according to  claim 117 , wherein the 3D covering comprises at least a portion with a biodurability from about 48 hours to about 2 years. 
     
     
         119 . The system according to  claim 117 , wherein the 3D covering comprises at least a portion with a biodurability from about 3 months to about 6 months. 
     
     
         120 . The system according to any claim herein, wherein the 3D covering comprises a drug, and wherein the 3D covering is configured to release the drug for a duration from about 1 hour to about 10 years. 
     
     
         121 . The system according to  claim 120 , wherein the 3D covering is configured to release the drug for a duration from about 48 hours to about 2 years. 
     
     
         122 . The system according to  claim 120 , wherein the 3D covering is configured to release the drug for a duration from about 3 months to about 6 months. 
     
     
         123 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a macropore size from about 10 μm to about 1000 μm. 
     
     
         124 . The system according to  claim 123 , wherein the 3D covering comprises at least a portion with a macropore size from about 20 μm to about 200 μm. 
     
     
         125 . The system according to  claim 123 , wherein the 3D covering comprises at least a portion with a macropore size from about 50 μm to about 100 μm. 
     
     
         126 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a macropore spacing from about 10 μm to about 1000 μm. 
     
     
         127 . The system according to  claim 126 , wherein the 3D covering comprises at least a portion with a macropore spacing from about 100 μm to about 500 μm. 
     
     
         128 . The system according to  claim 126 , wherein the 3D covering comprises at least a portion with a macropore spacing from about 200 μm to about 400 μm. 
     
     
         129 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a water permeability of less than about 300 milliliter per centimeter squared per minute (ml/cm 2 /min). 
     
     
         130 . The system according to  claim 129 , wherein the 3D covering comprises at least a portion with a water permeability from about 50 ml/cm 2 /min to about 200 ml/cm 2 /min. 
     
     
         131 . The system according to  claim 129 , wherein the 3D covering comprises at least a portion with a water permeability from about 100 ml/cm 2 /min to about 150 ml/cm 2 /min. 
     
     
         132 . The system according to any claim herein, wherein the 3D covering comprises a texture with from about 0.25 nanometer (nm) to about 50 μm roughness value Ra. 
     
     
         133 . The system according to  claim 132 , wherein the 3D covering comprises a texture with from about 0.2 μm to about 12.5 μm roughness value Ra. 
     
     
         134 . The system according to  claim 132 , wherein the 3D covering comprises a texture with from about 1.6 μm to about 6.3 μm roughness value Ra. 
     
     
         135 . The system according to any claim herein, wherein the 3D covering comprises a suture retention strength up to about 1 kilogram-force (Kgf). 
     
     
         136 . The system according to  claim 135 , wherein the 3D covering comprises a suture retention strength of from about 50 gram-force (gf) to about 500 gf. 
     
     
         137 . The system according to  claim 135 , wherein the 3D covering comprises a suture retention strength of from about 100 gf to about 200 gf. 
     
     
         138 . The system according to any claim herein, wherein the 3D covering comprises at least a portion with a kink radius of up to about 1 meter (m). 
     
     
         139 . The system according to  claim 138 , wherein the 3D covering comprises at least a portion with a kink radius of from about 5 millimeter (mm) to about 100 mm. 
     
     
         140 . The system according to  claim 138 , wherein the 3D covering comprises at least a portion with a kink radius of from about 10 mm to about 20 mm. 
     
     
         141 . The system according to any claim herein, wherein the 3D covering comprises fibers with a width and/or diameter from about 10 μm to about 1 mm. 
     
     
         142 . The system according to  claim 141 , wherein the 3D covering comprises fibers with a width and/or diameter from about 20 μm to about 500 μm. 
     
     
         143 . The system according to  claim 141 , wherein the 3D covering comprises fibers with a width and/or diameter from about 50 μm to about 100 μm. 
     
     
         144 . The system according to any claim herein, wherein at least a portion of the 3D covering comprises a greater axial compliance than radial compliance. 
     
     
         145 . The system according to  claim 144 , wherein the at least a portion of the 3D covering comprises a majority of fibers that are circumferentially oriented. 
     
     
         146 . The system according to any claim herein, wherein at least a portion of the 3D covering comprises relatively equal axial compliance and radial compliance. 
     
     
         147 . The system according to  claim 146 , wherein the at least a portion of the 3D covering comprises a majority of fibers that are anisotropically oriented. 
     
     
         148 . The system according to any claim herein, wherein the 3D covering comprises a material selected from the group consisting of: fiber reinforced material; particle reinforced material; flake reinforced material; a multi-layered material; a segmented material; and any combination thereof. 
     
     
         149 . The system according to any claim herein, further comprising a user interface. 
     
     
         150 . The system according to  claim 149 , wherein the system is configured to display an image of the tubular conduit on the user interface. 
     
     
         151 . The system according to  claim 150 , wherein the displayed image is a 3D image. 
     
     
         152 . The system according to  claim 150 , wherein the system is configured to allow a user to modify the displayed image. 
     
     
         153 . The system according to  claim 149 , wherein the system is configured to display an image of a proposed 3D covering. 
     
     
         154 . The system according to  claim 153 , wherein the displayed image is a 3D image. 
     
     
         155 . The system according to  claim 153 , wherein the system is configured to allow a user to modify the displayed image. 
     
     
         156 . The system according to  claim 149 , wherein the user interface comprises a user control comprising an electronic model modifying tool. 
     
     
         157 . The system according to  claim 156 , wherein the tool is configured to modify a model of the tubular conduit. 
     
     
         158 . The system according to  claim 156 , wherein the tool is configured to modify a model of a proposed 3D covering. 
     
     
         159 . The system according to  claim 156 , wherein the tool comprises a property modifying function selected from the group consisting of: smooth; erase; spline; fillet, fill; insert a building block; and any combination thereof. 
     
     
         160 . The system according to  claim 159 , wherein the tool comprises a property modifying function including inserting a building block, the building block comprising an electronic model selected from the group consisting of: anastomosis; dimple; reinforcing spline; and any combination thereof. 
     
     
         161 . The system according to  claim 149 , wherein the tool is configured to measure distance. 
     
     
         162 . The system according to  claim 149 , wherein the construction signal is based on information provided by a user of the system via the user interface. 
     
     
         163 . The system according to any claim herein, wherein the material delivery device further comprises a modification assembly configured to modify at least one of the 3D covering or the tubular conduit. 
     
     
         164 . The system according to  claim 163 , wherein the modification assembly is configured to deliver energy to at least one of the 3D covering or the tubular conduit. 
     
     
         165 . The system according to  claim 164 , wherein the energy comprises heat and/or cooling. 
     
     
         166 . The system according to  claim 163 , wherein the modification assembly is configured to deliver a second material to at least one of the 3D covering or the tubular conduit. 
     
     
         167 . The system according to  claim 166 , wherein the second material comprises a material selected from the group consisting of: solvent; drug; agent; and any combination thereof. 
     
     
         168 . The system according to  claim 163 , wherein the modification assembly is configured to deliver moisture to at least one of the 3D covering or the tubular conduit. 
     
     
         169 . The system according to any claim herein, further comprising a target onto which the material is delivered. 
     
     
         170 . The system according to  claim 169 , wherein the target comprises a mandrel configured to rotate. 
     
     
         171 . The system according to  claim 169 , wherein the material delivery device is constructed and arranged to produce the target. 
     
     
         172 . The system according to  claim 169 , wherein the target comprises a disposable component. 
     
     
         173 . The system according to any claim herein, further comprising a sterile barrier constructed and arranged to maintain sterility between the material delivery device and one or more other portions of the system. 
     
     
         174 . A graft device produced by a system of any claim herein, wherein the graft device comprises:
 a tubular conduit;   a 3D covering surrounding the tubular conduit, wherein the 3D covering is produced by a material delivery device based on image data of the tubular conduit.   
     
     
         175 . The graft device according to any claim herein, wherein the tubular conduit comprises a discrete feature and the 3D covering comprises at least one customized portion positioned relative to the discrete feature. 
     
     
         176 . A method of producing a graft device using the system of any claim herein. 
     
     
         177 . The method according to any claim herein, comprising:
 (1) producing image data of a tubular conduit;   (2) receiving the image data of the tubular conduit and creating an electronic model of the tubular conduit;   (3) creating an electronic model of a 3D covering;   (4) delivering material to produce a 3D covering.   
     
     
         178 . The method according to  claim 177 , further comprising modifying the electronic model of the tubular conduit produced in (2). 
     
     
         179 . The method according to  claim 177 , further comprising modifying the electronic model of the 3D covering produced in (3). 
     
     
         180 . The method according to  claim 177 , wherein the 3D covering is produced in (4) by delivering the material onto the tubular conduit. 
     
     
         181 . The method according to  claim 177 , further comprising: (5) placing the 3D covering about the tubular conduit. 
     
     
         182 . The system according to  claim 99 , wherein the material comprises the glycosaminoglycan, and wherein the glycosaminoglycan comprises heparin, heparan sulfate, chondroitin sulfate, dermatan sulfate, keratan sulfate, and/or hyaluronic acid, or any combination thereof. 
     
     
         183 . The system according to  claim 99 , wherein the material comprises the proteoglycan, and wherein the proteoglycan comprises decorin, biglycan, testican, bikunin, fibromodulin, lumican, versican, perlecan, neurocan, aggrecan and/or brevican.