A definitive, quantitative investigation has been performed to determine whether orbital atherectomy gives rise to cavitation. The investigation encompassed a synergistic interaction between in vitro experimentation a...A definitive, quantitative investigation has been performed to determine whether orbital atherectomy gives rise to cavitation. The investigation encompassed a synergistic interaction between in vitro experimentation and numerical simulation. The experimentation was performed in two independent fluid environments: 1) a transparent tube having a diameter similar to that of the superficial femoral artery and 2) a large, fluid-filled, open-topped container. All of the experimental and simulation work was based on the geometric model of the Diamondback 360 atherectomy device (Cardiovascular Systems, Inc., St. Paul, MN). Rotational speeds ranged from 80,000 to 214,000 rpm. The presence or absence of cavitation in the experiments was assessed by means of high-speed photography. The photographic images clearly display the fact that there was no cavitation. Flow visualization revealed the presence of fluid flows driven by pressure gradients created by the geometry of the rotating crown. The numerical simulations encompassed the fluid environments and the operating conditions of the experiments. The key result of the numerical simulation is that the minimum fluid pressure due to the rotational motion was approximately 50 times greater than the saturation vapor pressure of the fluid. Since the onset of cavitation requires that the fluid pressure falls below the saturation vapor pressure, the computational outcome strongly supports the experimental findings.展开更多
The focus of this paper is to propose, model, and characterize a means of accelerating the rate of delivery of therapeutic drugs to human tissues. The investigated means is a pressurized, permeable-walled balloon fill...The focus of this paper is to propose, model, and characterize a means of accelerating the rate of delivery of therapeutic drugs to human tissues. The investigated means is a pressurized, permeable-walled balloon filled with a homogeneous mixture of the drug and the carrier fluid. The fluid mixture, driven by pressure, traverses the thickness of the balloon wall through laser-drilled pores. The number and deployment of the pores can be controlled to a high degree of precision. As a consequence, the wall of the balloon can be regarded as a homogeneous porous medium, and the traversing fluid flow can be analyzed by means of porous media models. When the balloon is in intimate contact with the surface of a tissue bed, the therapeutic fluid flows in series as it passes through the balloon wall and penetrates the tissue. The flow rate can be controlled by proper selection of the balloon permeability, the viscosity of the flowing medium, and the pressure internal to the balloon. The delivered concentration of the drug was predicted by coupling the present balloon-focused theory with a previously developed tissue-bed model that includes both diffusion and advection processes. The tribologic interaction of the pressurized balloon with an artery wall was investigated experimentally to assess the possible formation of aneurysms.展开更多
Acellular matrices derived from animal and human cadaveric donor vessels or other tubular matrices are appropriate candidates for the creation of tissue- en-gineered, small-diameter, muscular arteries. Engi-neering pr...Acellular matrices derived from animal and human cadaveric donor vessels or other tubular matrices are appropriate candidates for the creation of tissue- en-gineered, small-diameter, muscular arteries. Engi-neering principles have been used to design a bio-reactor and the necessary auxiliary systems for the reconstitution of a previously decellularized vascular matrix. The bioreactor enables the attachment of cells to the luminal and/or exterior surfaces of the matrix. For the recellularization procedure, the matrix is situated within a sealed compartment in order to maintain a sterile environment. The matrix is rotated continuously to assure a spatially uniform re-constitution. The auxiliary systems that serve the bioreactor are: (a) an oxygenator, (b) peristaltic pumps, one for conveying the internal cell medium and the other for conveying the external cell medium, (c) motor and gearing to create steady and controlled rotation, (d) reservoirs for the containment of the two media, and (e) tubing to convey the respective fluids and to interconnect the bioreactor culture chamber to the various auxiliary components. A recellularized matrix produced by the bioreactor demonstrated its capabilities to reconstitute a previously decellularized scaffold.展开更多
This project was intended to determine whether the preprogrammed time-varying recharge protocol for a battery incased in a neuromodulation implant can give rise to tissue temperatures that surpass a safe level or are ...This project was intended to determine whether the preprogrammed time-varying recharge protocol for a battery incased in a neuromodulation implant can give rise to tissue temperatures that surpass a safe level or are otherwise benign. The study included the development of a highly accurate model of all the thermal processes that are activated by the recharging of the battery contained within the neuromodulation implant. The model was implemented by numerical simulations performed for several realistic operating conditions. The computed spatial and temporal tissue temperature distributions were employed to estimate possible tissue damage by making use of two independent methodologies. Independent calorimeter-based experiments were performed to provide validation for the calculated rates of heat generation in the coils of the implant. Spatial and temporal tissue temperature distributions extracted from the numerical simulations revealed the thermal effects associated with several realistic operating protocols. None of the operating protocols gave rise to temperatures above 42℃. Numerical values of thermal tissue damage metrics were determined and compared with accepted values which correspond to the absence and the presence of tissue damage. The experimentally determined rate of heat generation in the implant coils validated that from electrical measurements to within 2%. Both the tissue temperature results and the thermal damage metrics found no evidence of tissue injury when time-varying preprogrammed protocols are used in the recharging of neuromodulation implant-encased batteries.展开更多
文摘A definitive, quantitative investigation has been performed to determine whether orbital atherectomy gives rise to cavitation. The investigation encompassed a synergistic interaction between in vitro experimentation and numerical simulation. The experimentation was performed in two independent fluid environments: 1) a transparent tube having a diameter similar to that of the superficial femoral artery and 2) a large, fluid-filled, open-topped container. All of the experimental and simulation work was based on the geometric model of the Diamondback 360 atherectomy device (Cardiovascular Systems, Inc., St. Paul, MN). Rotational speeds ranged from 80,000 to 214,000 rpm. The presence or absence of cavitation in the experiments was assessed by means of high-speed photography. The photographic images clearly display the fact that there was no cavitation. Flow visualization revealed the presence of fluid flows driven by pressure gradients created by the geometry of the rotating crown. The numerical simulations encompassed the fluid environments and the operating conditions of the experiments. The key result of the numerical simulation is that the minimum fluid pressure due to the rotational motion was approximately 50 times greater than the saturation vapor pressure of the fluid. Since the onset of cavitation requires that the fluid pressure falls below the saturation vapor pressure, the computational outcome strongly supports the experimental findings.
文摘The focus of this paper is to propose, model, and characterize a means of accelerating the rate of delivery of therapeutic drugs to human tissues. The investigated means is a pressurized, permeable-walled balloon filled with a homogeneous mixture of the drug and the carrier fluid. The fluid mixture, driven by pressure, traverses the thickness of the balloon wall through laser-drilled pores. The number and deployment of the pores can be controlled to a high degree of precision. As a consequence, the wall of the balloon can be regarded as a homogeneous porous medium, and the traversing fluid flow can be analyzed by means of porous media models. When the balloon is in intimate contact with the surface of a tissue bed, the therapeutic fluid flows in series as it passes through the balloon wall and penetrates the tissue. The flow rate can be controlled by proper selection of the balloon permeability, the viscosity of the flowing medium, and the pressure internal to the balloon. The delivered concentration of the drug was predicted by coupling the present balloon-focused theory with a previously developed tissue-bed model that includes both diffusion and advection processes. The tribologic interaction of the pressurized balloon with an artery wall was investigated experimentally to assess the possible formation of aneurysms.
文摘Acellular matrices derived from animal and human cadaveric donor vessels or other tubular matrices are appropriate candidates for the creation of tissue- en-gineered, small-diameter, muscular arteries. Engi-neering principles have been used to design a bio-reactor and the necessary auxiliary systems for the reconstitution of a previously decellularized vascular matrix. The bioreactor enables the attachment of cells to the luminal and/or exterior surfaces of the matrix. For the recellularization procedure, the matrix is situated within a sealed compartment in order to maintain a sterile environment. The matrix is rotated continuously to assure a spatially uniform re-constitution. The auxiliary systems that serve the bioreactor are: (a) an oxygenator, (b) peristaltic pumps, one for conveying the internal cell medium and the other for conveying the external cell medium, (c) motor and gearing to create steady and controlled rotation, (d) reservoirs for the containment of the two media, and (e) tubing to convey the respective fluids and to interconnect the bioreactor culture chamber to the various auxiliary components. A recellularized matrix produced by the bioreactor demonstrated its capabilities to reconstitute a previously decellularized scaffold.
文摘This project was intended to determine whether the preprogrammed time-varying recharge protocol for a battery incased in a neuromodulation implant can give rise to tissue temperatures that surpass a safe level or are otherwise benign. The study included the development of a highly accurate model of all the thermal processes that are activated by the recharging of the battery contained within the neuromodulation implant. The model was implemented by numerical simulations performed for several realistic operating conditions. The computed spatial and temporal tissue temperature distributions were employed to estimate possible tissue damage by making use of two independent methodologies. Independent calorimeter-based experiments were performed to provide validation for the calculated rates of heat generation in the coils of the implant. Spatial and temporal tissue temperature distributions extracted from the numerical simulations revealed the thermal effects associated with several realistic operating protocols. None of the operating protocols gave rise to temperatures above 42℃. Numerical values of thermal tissue damage metrics were determined and compared with accepted values which correspond to the absence and the presence of tissue damage. The experimentally determined rate of heat generation in the implant coils validated that from electrical measurements to within 2%. Both the tissue temperature results and the thermal damage metrics found no evidence of tissue injury when time-varying preprogrammed protocols are used in the recharging of neuromodulation implant-encased batteries.
