Abstract
Purpose:
To assess the fluidics of 23-gauge (G) large-port (L) and tear drop-port (TD) hypersonic vitrectomy probes (HVPs) compared with guillotine vitrectomy probes (GVPs) of various calibers (23G, 25G, and 27G) and geometries (single and double blades). Also, to identify the working parameters that provide the best balance between acceleration and flow rate, and, for HVPs, to measure temperature variations in the fluid.
Methods:
We used particle image velocimetry to measure flow fields in balanced salt solution and viscoelastic artificial vitreous. We analyzed acceleration, kinetic energy, and volumetric flux. The parameters considered were vacuum pressure, ultrasound stroke, and cut rate. Temperature measurements were taken using an infrared thermal camera.
Results:
The flow rate was significantly higher for HVPs than GVPs. With both probes, flow rate and acceleration increased with vacuum pressure. Flow rate depended weakly on the ultrasound stroke or cut rate. In HVPs, the acceleration peaked at a stroke of 30 µm, whereas in GVPs it peaked at a cutting rate of 4000 to 5000 cuts per minute (cpm). The HPV/TD combination generated higher flow rates and lower accelerations than did HPV/L. The increase in temperature was small.
Conclusions:
Under the present experimental setup and medium, HVPs offered better fluidics compared with GVPs in terms of flow and acceleration; however, the flow structure for HVPs is more complicated and unsteady. The HPV/TD combination produced larger flows than did the HPV/L combination and slightly smaller accelerations. HPVs generated a small temperature increase.
Translational Relevance:
In the tested artificial vitreous, HVPs were found to be more efficient in terms of generating lower acceleration for a given flow rate. The slight increase in temperature observed with HVPs is unlikely to be clinically significant.
We used three different working fluids: BSS and two AV solutions, which we labeled S1 and S2, prepared as a solution of hyaluronic acid in deionized water based on the recipe proposed by Kummer et al.
19 However, because the transparency of the fluid is a strict requirement for the optical measurements of the flow, we did not add the agar powder as suggested by these authors.
The rheological properties of each AV solution were tested with the Physica MCR 301 rotational rheometer (Anton Paar, Graz, Austria). In order to evaluate the complex modulus of the fluid, we performed oscillatory tests over a range of frequencies from 1 to 30 Hz with a shear strain of 0.05%, within the linear viscoelastic regime determined with preliminary amplitude sweep tests. The real part of it, G′, is a measure of the elastic response of the fluid, whereas the imaginary part, G′′, is a measure of the viscous response. Moreover, we tested fluid samples at a continuous rotational velocity and determined the stress–shear rate curve \(( {{\rm{\tau }} - {\rm{\dot \gamma }}} )\), in the range 0 < \({\rm{\dot \gamma }}\) < 1000 s–1, from which we obtained the value of the apparent viscosity \({\rm{\mu }} = {\rm{\tau }}/{\rm{\dot \gamma }}\). All measurements were taken at 20°C.
The results of rheological tests on the two AV solutions are shown in
Figure 1. The rheological properties, in terms of complex nodulus (
Fig. 1A), were reasonably close to those reported for porcine vitreous, even if the fluid has a smaller elastic modulus and a higher viscosity than the real vitreous.
20–22 The solutions had shear thinning properties, with an apparent viscosity that decreased significantly as the shear rate increased (
Fig. 1B). This is in good agreement with the rheological measurements that Silva et al.
23 performed on the vitreous of rabbit eyes. Finally, solution S2 had a significantly higher complex modulus, in terms of both real and imaginary parts, at least at small frequencies.
The flow field generated by the vitrectomy probes was measured using particle image velocimetry (PIV), an optical, non-intrusive technique able to produce measurements of two-dimensional flow fields on planes illuminated by a laser sheet. We performed measurements on two vertical planes containing the probe: one parallel to the port aperture (front view) and one across it (lateral view). Moreover, in order to more accurately describe the flow structures for solution S2, two areas of interest were used for the acquisitions: (1) a large field the same size as the experimental box, with the aim of describing possible large-scale circulations; and (2) a small field, which was a zoomed area of about 11 × 13 mm around the cutter tip.
We determined whether the raw output of the PIV analysis—the velocity field u(x, y, t)—was affected by systematic errors (bias and/or pixel locking effects) by computing the probability density function of the velocity magnitude. Moreover, we verified that the percentage of the outliers for each velocity fields never exceeded 3% of the total number of velocity vectors, which is an indication of the reliability of the measurements.
The measured velocity fields, u(x, y, t), have been used to calculate fluid acceleration, a = ∂u/∂t + (u · ∇)u, and kinetic energy per unit mass, Ec = 1/2u · u.
In order to compare the behavior of vitrectomy probes employed in various conditions, we referred to synthetic quantities obtained by performing averages of the experimental measurements over time and space. For spatial averages, we adopted a circular averaging area, with a diameter of 6 mm, centered in correspondence with the port of the probe. Spatial averaging leads to time signals, which we analyzed by constructing power density spectra (PDS) of the kinetic energy per unit mass in order to identify the dominant frequencies of the flow. Time averaging, on the other hand, produces spatial maps that provide information about the mean flow characteristics. Finally, the result of averaging over time and space is a single quantity that is a synthetic measure of flow properties.
Flow rate measurements were taken tracking the free surface of the liquid in the measuring chamber over time. Automatic tracking was performed, and the digital images were analyzed with Motion Studio software (Integrated Design Tools, Pasadena, CA, USA). From time measurements of the free surface level, we extracted the surface speed by performing a linear regression of each signal. In particular, we adopted a linear regression based on the ordinary least-squares method. The error of the flow rate measurements was estimated computing the standard deviation of the coefficient representing the slope of the linear fitting multiplied by the chamber area, which turned out to be within the range of ±10−2 to 10−3 ml/min. Thus, the error was two or three orders of magnitude smaller than the measured flux. From knowledge of the vertical speed of the surface and of the cross-sectional area of the chamber we computed the flow rate.
We also performed temperature measurements for the HVPs. A Perspex floating panel was placed on the free surface of the experimental chamber in order to decrease thermal dispersion. We used a FLIR i7 infrared thermal camera (FLIR Systems, Inc., Wilsonville, OR, USA), which reconstructs a temperature map on the measuring plane based on measurement of the infrared radiation emitted by the fluid. Temperature measurements were taken only in BSS (as its thermal properties are very similar to those of AV) at zero vacuum pressure so that the amount of fluid in the domain remained constant over time. The temperature measurements obtained by the FLIR camera have been preliminarily validated against air and BSS temperature measurements performed with a standard thermometer with a resolution of 0.1°C. At the beginning of the test, the fluid was at room temperature (around 21.5°C), and the HVP was then operated continuously at a fixed stroke (the amplitude of the probe elongation) for 5 minutes, during which temperature was measured once every minute.
Ultrasound-based vitrectomy systems have been recently introduced as promising alternatives to the traditional guillotine-based cutters (GVPs).
7,28 HVPs possibly have several advantages over GVPs,
7 such as the design of the probe that includes a single needle and a port that is always open, as well as the fact that vitreous liquefaction is likely to be induced, thus facilitating vitreous aspiration. These effects are thought to have a favorable influence in terms of steadiness of the flow, which is widely recognized as a crucial point for safe and effective surgery. So far, however, our knowledge about the effect of HVPs on vitreous properties and characteristics of the flow generated in the vitreous chamber is very limited.
7
In the present study, we investigated experimentally the fluidics of two HPVs (VIT-L and VIT-TD) and compared them with four GVPs (23SB, 25SB, 25BB, and 27BB). We performed the experiments in a cubical measuring chamber, using both BSS and AV as working fluids, in order to simulate both liquefied and healthy vitreous conditions.
The choice of an open cubical domain implies that pressure values generated in the fluid will differ from those in the eye, which is a pressurized organ. However, the intraocular pressure is small compared to the aspiration pressure imposed on the vitrectomy device, which means that the flow rate would not significantly change if a pressurized chamber was adopted. Moreover, pressure variations associated with fluid flow are correctly reproduced in our model, as fluid motion is produced by pressure gradients so there is gauge freedom in the pressure.
We also note that, during vitrectomy, fluid is pumped out of the vitreous chamber by the vitrectomy probe and is replaced with fluid entering from an infusion line; therefore, the overall circulation in the vitreous chamber is likely to differ from what we measured, as we do not account for infusion. However, we are mostly interested in fluid motion in the vicinity of the vitrectomy probe tip, which is not likely to be significantly affected by the overall circulation in the domain.
The use of an artificial rather than a real vitreous can obviously be seen as a limitation of the present approach, as measurements on a real vitreous would more closely mimic actual surgical conditions. However, the use of AV also offers significant benefits, in that the experiments are reproducible and the rheological properties of the fluid can be accurately measured and controlled. This is not the case with real vitreous, as it is well known that the properties of the vitreous body can vary significantly among individuals, with both age and location in the vitreous cavity. Moreover, measuring fluid flow in the vitreous cavity is very challenging, and the approaches proposed so far do not allow one to obtain temporal or spatial resolutions even nearly comparable to those for in vitro experiments.
26 We, therefore, believe that our approach complements similar studies performed on real vitreous humor, which better reproduce surgical conditions but cannot provide a deep description of the fluid mechanics events occurring close to the tip of the vitrectomy probe and the results of which are difficult to generalize.
For tests in BSS, the flow field was invariably found to be axisymmetric. The situation was significantly more complicated in the case of AV. In particular, for all tested GVPs the flow in the AV developed a confinement region in front of the tip port (
Fig. 2). This result is consistent with previous observations in both AV
1 and egg albumen.
2,10 The possible generation of confinement regions in viscoelastic and anisotropic viscous fluids is a known phenomenon in fluid mechanics and has been investigated in various contexts, such as the flow through an abrupt narrowing
30–32 and into an orifice,
33 which, similarly to the flow produced by a vitrectomy probe, is accelerated. From the surgical point of view, the generation of a confinement region characterized by large velocities and its extension and orientation are relevant whenever the cutter is used in the proximity of the retina, because, in that case, the orientation of the cutter port has a significant influence on the stresses on the retina. The flow generated by GVPs was also characterized by time fluctuations related to cutting frequency. In addition, in viscoelastic fluids, we also found one additional frequency with a high energy content that is likely to be related to a natural frequency of oscillation of the fluid in the domain.
1,4,24
For HVPs, the flow was highly unsteady and irregular in space. Unsteadiness in flows generated by steady mechanisms (such as a steady pumping pressure) is very common in fluid mechanics and is due to the onset of instabilities. This typically happens when the Reynolds number (
Re =
U ·
L/
v, where
U is a typical velocity,
L is a characteristic length scale, and
v is the kinematic viscosity of the fluid), a measure of the relative importance of inertial over viscous forces, is large enough. In the case of flows induced by vitreous cutters,
Re is at most of order 10 (
Re computed with
L equal to the probe diameter and with the viscosity estimated at large shear rates), which is not likely to result in the onset of hydrodynamic instabilities. However, in viscoelastic fluids, elastic instabilities are also known to possibly arise, even in the limit
Re → 0
34 and this might explain the phenomena observed in our tests. A deeper understanding of the mechanisms underlying our observations is complicated by a lack of knowledge regarding the effects that HVPs have locally on fluid properties.
We observed the generation of a steady flow (steady streaming), in the absence of an applied vacuum, that can be attributed to the periodic vibrations of the probe.
24
Finally, we never detected the occurrence of cavitation, even at high ultrasound power.
17 This is an important finding, as cavitation is highly undesirable in vitrectomy because it could disrupt the retinal tissue.
In order to characterize the efficiency of HVPs compared with GVPs, we focused on two synthetic quantities: flow rate and average fluid acceleration.
1,2,4 With regard to GVPs, our results are consistent with previous studies.
1,4,7,10,16 On the other hand, only two studies considered the flow rate generated by ultrasound-based vitrectomy systems, and none of them measured fluid acceleration or any other physical quantity related to the fluidics of HVPs.
7,17 Thus, this is, to our knowledge, the first study to provide a comprehensive assessment of the fluidics of hypersonic vitrectomy systems.
We found that flow rate and acceleration had an approximately linear dependence on the pumping pressure and that flow rate was almost independent of the stroke for both BSS and AV. This last result is in agreement with the work by Stanga et al.
7 and Rizzo et al.
17 for BSS. On the other hand, on porcine vitreous, the authors found that the flow rate increased with increasing ultrasound power, although Rizzo et al.
17 observed that this increase was small and not invariably present. This difference with respect to our findings is possibly related to the use of a different medium. Acceleration, on the other hand, changed significantly with stroke and peaked for stroke values ranging from 20 to 40 µm.
In a seminal paper in the field, Rossi et al.
29 proposed estimating the safety and efficiency of vitrectomy probes using a scatterplot in the plane (
Q, |
a|) (i.e., flow rate and acceleration) for a given set of controlling parameters. The rationale behind this approach is that a vitrectomy system is efficient if it allows the surgeon to perform surgery in a short time (which implies large flow rates), and it is safe if it does not generate large stresses on the retina (which implies small fluid accelerations). Accordingly, we plotted the results of our experiments in the (
Q, |
a|) diagram shown in
Figure 9. Overall, the results suggest that HVPs offered better performance than the GVPs; for a given flux, accelerations were (on average) smaller for HVPs than for GVPs. Among the GVPs, the 25BB was found to perform better than the 25SB, as it produced higher flow rates with similar accelerations. This is consistent with previous studies comparing the fluidics of single-blade and double-blade cutters of the same size.
1,4 Comparing the two HVPs we found that the VIT-TD offered better performance, as it produced larger flows regardless of the stroke. The superiority of the VIT-TD over the VIT-L has also been documented by Stanga et al.
28
With regard to the 27BB GVP, under our experimental setup and medium we observed that no flow rate was produced at all when the fluid was very viscous and elastic (the corresponding points are not reported in
Fig. 9). This could be related to the extremely reduced internal lumen of the needle and obviously depends on the properties of the AV considered.
Finally, we measured temperature variations in the fluid during HVP operation, which is an important factor because high temperatures can damage ocular tissues.
18 In our experiments, we found a maximum temperature increase of 2.5°C after 5 minutes of continuous use of the HVP at a stroke of 60 µm. During the experiment, the temperature of the head of the HVP also increased, to a maximum of approximately 40°C. We note that, in terms of temperature variations in the fluid, our experimental setup did not accurately reproduce what happens during surgery, as we did not have an infusion line and the vacuum pressure was set to zero for temperature measurements, implying that there was no fluid exchange in the measuring chamber. During vitrectomy surgery, on the other hand, vitreous is pumped out of the eye and is replaced by a fluid that typically has a significantly lower temperature. This would drastically mitigate the tendency of the HVP to increase fluid temperature, which is already very small. For these reasons, we think that high temperatures in the vitreous chamber during vitrectomy with HVPs are not an issue.
We assessed the fluid dynamic performance of vitrectomy probes in BSS and AV using a cubical measuring chamber. This study confirmed that flow rate and acceleration grow with aspiration pressure for all vitrectomy probes. Flow rate exhibited a weak dependence on cutting frequency and stroke for GVPs and HVPs, respectively, whereas acceleration peaked at 4000 to 5000 cpm for GVPs and between 20 and 40 µm for HVPs. Overall, the HVPs performed better than the GVPs, producing lower acceleration for a given flow rate. However, the HVPs produced an irregular and time-dependent flow, probably due to the onset of flow instabilities. Temperature elevation during surgery is very unlikely to be an issue.
Supported by Bausch + Lomb through a research grant to the Department of Civil, Chemical and Environmental Engineering, University of Genoa. Bausch + Lomb also provided the surgical system for the experimental measurements.
Disclosure: A. Stocchino, None; I. Nepita, None; R. Repetto, None; A. Dodero, None; M. Castellano, None; M. Ferrara, None; M.R. Romano, None