Redesign of a Distal Protection Filter

for Carotid Artery Angioplasty

By:
Sandeep Devabhakthuni
Chenara Johnson
Daphne Kontos
Perry Tiberio

Professor Mark Garter

Bioeng 1160 Bioengineering Design
26 April 2004

1
Introduction
The first percutaneous carotid angioplasty was performed in 1980, and since then, there

has been a continuous influx of new interventional technologies1. The main safety issue arising

from this procedure is the risk of cerebral embolization. This occurs when the angioplasty

balloon is inflated to clear the stenosis, resulting in the release of debris into the blood stream.

This debris (emboli) travels to the brain, potentially causing a stroke. Hence a new technology

was developed to increase the safety of the procedure, the neuroprotection device.

Neuroprotection devices are designed to capture and remove emboli released during

carotid angioplasty. There are two main types: balloon occlusion devices and distal protection

filters (DPF). Since the balloon occlusion inhibits blood flow during the procedure and does not

allow for continuous angiographic feedback, the distal protection filter is favored. The filters

permit continuous blood flow during the procedure while still providing distal cerebral

protection. The main weaknesses of the filters, however, are their pore size. Since the blood is

composed of particles ranging from 2 to 120 m2, determining the most efficient pore size is

critical to the design of a distal protection filter. Currently, the smallest pore diameter in filter

devices is about 40 m, with the majority of filters having an 80 to 100 m pore diameter. The

largest pore diameter is about 190 m3. In addition to pore size, an inadequate fit to the artery

allows emboli to pass the filter.

The three filters that minimize these complications are the FilterWire EX (Boston

Scientific, Natick, MA, USA), the AccuNet (Guidant Corporation, Indianapolis, IN) and the

AngioGuard (Cordis Corporation, Miami Lakes, FL). These filters are considered to be the three

best distal protection filters.

The FilterWire EX (see Fig. 1) polyurethane filter has one of the largest filter volumes

(15 mm long), allowing it to capture more embolic particles. The 110m-pore filter bag is

2
aligned at an angle to the vessel wall. The main benefits of this simple design are its filter

volume and large proximal opening. Also, its nitinol ring support allows the filter to mold

against the vessels topography. Some complications with this design include incorrect

placement in the vessel due to the filters angled orientation in the vessel.

Figure 1: FilterWire EX (Boston Scientific, Natick, MA)5

The AccuNet (see Fig. 2) polyurethane filter has a tubular-shape consisting of 4 pre-

shaped nitinol wire struts with one opening at the proximal end to allow perfusion. Just like the

FilterWire EX, the AccuNet also has a large filter volume (20 mm in length) allowing for

maximum capture. The 115m-pore filter bag is deployed perpendicular to the vessel and its

nitinol struts expand a lie flush to the vessel wall.

Figure 2: The AccuNet with a centrally mounted filter3

The Angioguard (see Fig. 3) has a hemispherical polyurethane filter basket supported by

8 pre-shaped nitinol wire struts. The filter has one large proximal opening but has a small filter

3
volume, unlike FilterWire EX and AccuNet. The 100m-pore filter bag is deployed

perpendicular to the vessel. Because of the filters shallow basket, embolic particles overfill the

basket and may escape into the vessel lumen during retrieval.

Figure 2: The AngioGuard (Cordis Corporation, Miami Lakes, FL)3

Based on the research on these current filters, our goal is to redesign the distal embolic

protection filter device to be more efficient in capturing embolic particles by decreasing the pore

size and adding a skirt to prevent passage of emboli. Furthermore, we propose that a

nylon/nitinol filter material be used in our design to maintain the mechanical properties, while

retaining viability of these two materials. This will be tested through comparison of results of in-

vitro studies that mimic in vivo conditions under which the device will be operated. When the

experiment is performed and the analytical results are calculated, we hope to determine that the

redesign of the distal embolic protection filter is providing protection at a greater efficiency than

other filters, is no more difficult to use than other filters, will be used in future studies, and be

marketed as the top distal protection device.

Methods

Through analyzing previous designs, we determined that the optimal pore size should be

between 70 and 80 m. As shown in Figure 3, the redesign of the distal protection filter included

a radio plaque nitinol elliptical ring with the 8.51mm being the short diameter. It had a

cylindrical filter bag (28mm long) mounted on the side. The nitinol ring was supported by one

4
nitinol strut in order to support the filter and position it at a 20 angle to the vessel. The filter

had a nylon skirt (roughly 0.1 mm) extending outward from the nitinol ring. The filter will be

delivered by pushing the strut to collapse the nitinol ring and deployed by releasing the strut.

The ring will default to the manufactured 20 angle.

Figure 3: Picture of Redesigned Distal Protection Filter

This preliminary design provided all the safety precautions necessary for embolic

protection during the procedure. The filter was redesigned using the SolidWorks program. The

SolidWorks files were then used as a guideline for the fabrication of a testable prototype. To

build the model above, the following materials were required: nylon for the basket (Sefar

Holding Inc, Freibach, Thailand), nitinol, polyimide tubing and stainless steel for the frame (New

England Precision Guiding Inc, Holliston, MA.).

Before testing the new filter model, the flow loop used in previous studies was

redesigned in order to obtain more efficient results7. The flow loop

previously used utilized continuous flow. The new flow pump induced

peristaltic movements, simulating vascular smooth muscle

contractions.

5
 Figure 4: Insertion points for catheter8

The flow loop length represented the path from the groin to the carotid artery (Figure 4).

Also, the flow rate, in addition to being peristaltic, was set to 150 mL/min which was the

approximate flow rate in the internal carotid artery. The material of the flow loop was changed

from silicon to vinyl, a more flexible and compliant material, that more accurately imitated the

arterial walls. Changing the in vitro set up to model in vivo conditions provided more accurate

results in testing. Using this modified flow loop design, the efficiency of the filter redesign was

examined and compared to the previously tested filters: AngioGuard, AccuNet and FilterWire.

Silica artificial embolic microspheres (Bangs Laboratory, Fischers, IN) were

premanufactured to simulate the emboli released during angioplasty. Collection of the particles

took place in an inline filter distal to the protection filter deployment point. The size of the

microspheres ranged from 150m to 300m, and an average weight of about 85mg was used in

each trial. Weight was measured using an analytical and toploading balance by Fisher Science

Education, Hanover Park, IL. The microspheres were used to establish capture efficiency by

quantifying the amount of emboli captured while the filter was in place. The fluid used to model

6
blood in the flow loop was a solution consisting of glycerol and water at a ratio of 9:16 resulting

in a viscosity of 3.5 cP in order to have a viscosity similar to blood.

After the prototype was manufactured and the in vitro flow loop was completed, training

was implemented for the use of the delivery of the filter and use of the flow loop. If improperly

used, the results would have been poor due to human error. In addition, the placement of the

filter was crucial in gaining precise results. Therefore, five trial runs with the filter in the flow

loop were performed before the actual experiment is conducted.

After proper training of filter use, the new filter design was tested and results were

compared to previously tested filters to determine if the new design was more efficient in

capturing the embolic particles and if it was a competitive new product. Ten subsequent runs,

with only 5 successful trial runs, were used for analysis. Collection of the embolic microspheres

occurred at one point within the filter during each trial. While the filter was deployed within the

vessel walls, the in-line filter collected the missed particles to determine efficiency while

deployed. The in-line filter had a pore size of less than 100m.

7
 Peristaltic Flow Pump

Glycerin/Water
solution (9:16)

Reservoir
Insertion Point of
Filter (one-way valve)

Inline filter

Point of Filter
Deployment Length = 20 cm

Figure 5. Redesigned flow loop schematic

The flow loop is detailed in Figure 5. Per trial, 28 liters of liquid (10 L of glycerol and 18

L of water) originated in the reservoir and was pumped through the circuit back to the same

reservoir. Before the flow pump was turned on, the filter was inserted through the one-way valve

and deployed. Then, the peristaltic flow pump (ISMATEC, Glattbrugg, Switzerland) was set to

150 mL/min. Once the flow was stabilized, microspheres that functioned as embolic particles

were injected through a one-way valve to allow for continuous flow for each trial. After the

microspheres were inserted, the trial ran for five minutes before the flow pump was shut off.

Once the filter was retrieved, the mass of the particles removed from the filter was weighed.

This completed the use of the flow loop and the process was repeated for the next trial

Once this experiment was completed, data analysis was performed. To analyze the data,

the percentage device efficiency was calculated and compared with the other previously tested

filters. The overall device efficiency will be determined using Equation 1.

8
 (mass _ particles _ filter )
%Efficiency 100 [1]
(total _ mass _ particles _ injected )

In addition to overall device efficiency, statistical analysis including ANOVA and paired

t-tests (assuming normality) determined the significance of the data obtained from the

experiments using a p-value of 0.05. ANOVA was used for between-group comparison (i.e. how

the new design compares with the AngioGuard, AccuNet, and Filterwire), and the paired t-test

was used to determine in-group differences, (e.g. the amount of emboli captured vs. total amount

of emboli). ezANOVA, a computerized analysis program, was used.

Results

After each trial was completed, the mass of the particles captured by the filter was

weighed. Using Equation 1, the efficiency was determined for each of the trials. This efficiency

represented the number of embolic particles that the filter was able to capture relative to the

number of embolic particles injected. The results of these calculations were are tabulated in

Table A.1 (Appendix A). Next, the device efficiencies of all ten trials were plotted with error

bars, depicting the variation between trials. Shown in Figure 6, the graphical representation of

the efficiencies indicated a significant amount of variation.

9
 Figure 6. Graphical representation of the capture efficiency for all trials

As Figure 6 shows, there were data points that were significantly low. These data points

were determined to be a result of device or human error and were excluded. Out of then ten

trials that were performed, five trials resulted in significantly low efficiencies due to device

failure. Because the results obtained for these trials were not accurate, these results were

excluded in order to determine the overall efficiency of the device more accurately. As shown in

Figure 7, the modified data was plotted for the five successful trials. The plot indicates that the

capture efficiency decreased as the filter use increased.

10
 Figure 7. Graphical representation using the modified data for capture efficiency

Once the overall device efficiency was calculated for each of these trials, the efficiency of

our filter was then compared to the efficiency of predicate devices: AngioGuard, AccuNet, and

FilterWire. Data for each of these three filters collected using an old flow loop tested in previous

studies was used for the comparison7. The overall device efficiency for each of these filters was

calculated and the results of these calculations are shown in Table A.2 (Appendix A). The

average and standard deviation was calculated for all of the filters in order to make the

comparison. Table 3 showed the comparison of the device efficiency of our filter with the

average device efficiency of the other filters. As the table indicates, our filter was slightly lower

in the overall device efficiency with a higher standard deviation as compared to the other filters.

Table 3. Comparison of Overall Device Efficiency for the Four Filters

11
 Our
AngioGuard AccuNet FilterWire
Filter
Capture
96.81+4.78 97.73+3.94 90.86+12.57 82.8+14.5
Efficiency

However, when ezANOVA was used to analyze the variations between the four filters,

the analysis revealed that there was no significant difference between our filter and each of the

predicate filters (p > 0.05 for all the comparisons between our filter and each of the predicate

filters). In addition, a paired t-test using Microsoft Excel was performed for our filter in order

to compare the initial weight of particles and the final weight of the particles that were captured

in the filter. This test indicated that there was no significant difference between these two

measurements (p < 0.0784).

Discussion

Although the overall device efficiency of our filter was comparable to the efficiencies of

the filters on the market, the insignificant difference between all four filters indicated that our

filter did not have a significant advantage over the other filters. However, this conclusion may

be inaccurate because of the variance associated with our filters performance and because of

several problems that occurred during the testing of the filter. First, the filter was designed to be

used only once. This accounts for the highest efficiency that occurred during the first trial. After

the first trial, there was a significant decrease in the efficiency as the filter use increased.

Second, there were unexpected failures that arose as the testing proceeded. For example, the

nitinol ring/polyimide tubing cracked in one of the later trials, which made it difficult for the

filter to capture emboli effectively. In addition, the back end of the filter tore, causing a gap

12
between the vessel lumen and the filter. This gap allowed the emboli particles to escape the

filter, resulting in lower capture efficiency.

The reason for these unforeseen failures was due to the human error involved in the

testing and device failure. As Figure 6 indicated, there was a significant amount of variation

when comparing the efficiencies for all ten trials. This significant amount was considered to be

caused by excessive user error during some of the trials. Because the error was preventable, the

data for these trails were not relevant in determining the overall device efficiency of the filter.

As a result, the data for the five unsuccessful trials were excluded, and the device efficiency of

the filter was determined by the modified data shown in Figure 7.

In addition to these unexpected occurrences, there were other possible limitations that

accounted for poor results. For instance, the placement of the filter was not consistent for all the

trials. After each trial was performed, the flow loop had to be disassembled and the filter had to

be removed in order to retrieve the captured particles for weighing. Once the filter was inserted

again and the flow loop was reassembled, the filter placement was changed. Therefore, this

inconsistent filter placement may have affected results. Moreover, when the filter was being

retrieved, the filter was not fully collapsible. This made it easier for the particles to escape the

filter. Since this retrieval mechanism was not efficient, this resulted in lower capture efficiency.

With that stated, our filter also suffered from mechanical failures associated with manufacturing

techniques. Consequently, these limitations generated poor results that did not accurately assess

the device efficiency of our filter.

Due to these limitations and user error during testing, several modifications to the design

were recommended for higher capture efficiency. First, a more manageable retrieval mechanism

is needed in order to minimize the loss of emboli particles when the filter is in movement. A

13
possible improvement would be to collapse the filter completely, which would minimize the loss

of particles. Second, instead of using nylon as the material for the filter basket, using

polyurethane would be more efficient because polyurethane is more elastic leading to greater

flexibility. This material property would be beneficial because it can aid in the capture of the

particles and prevent loss of particles as the filter is being retrieved. Finally, using nitinol tubing

for the ring would allow more flexibility for the filter, which would allow the filter to collapse

easily. While the current materials used are all biocompatible as demonstrated by their use in

other medical devices that contact blood, using materials that are seen in the predicate devices

would give our filter the necessary mechanical properties. These modifications to the design

would allow the filter to be more efficient in both capturing the particles and retrieving the

particles.

14
References

1. Liistro, Di Mario. Carotid Artery Stenting. Heart 2003; 89:944-948

2. Freitas RA. Nanomedicine, Volume I: Basic Capabilities. Landes Bioscience, Georgetown,
TX, 1999.
3. Kasirajan K, Schneider P, and Kent K. Filter devices for cerebral protection during
carotid angioplasty and stenting. Journal of Endovascular Therapy. 2003;10:1039-
1045.
4. Ohki, Takao. The Dark Side of Embolic Protection Devices. Endovascular Today
September 2003.
5. Fasseas P, Orford J, Denkta A, Berger P. Distal protection devices during percutaneous
coronary carotid interventions. Current Controlled Trials in Cardiovascular Medicine.
2001;2:286-291.
6. Reimers B, Corvaja N, Moshiri S, Sacca S, Albiero R, Di Mario C, Pascotto P, Colombo A.
Cerebral Protection With Filter Devices During Carotid Artery Stenting. Circulation.
2001;104:12.
7. Azemi E, Gray H, Miner E. Comparison and Redesign of Distal Protection Filters for
Angioplasty Stenting Procedures. University of Pittsburgh. 2003.
8. FreePatentsOnline. 14 Dec 04. <http://www.freepatentsonline.com/4700705.html>
9. VascularWeb. 14 Dec 04. <http://vascularweb.org/_CONTRIBUTION_PAGES/
Patient_Information/NorthPoint/Carotid_Stenting.html>

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Appendix A: Data Collection

Table 1. Measurements of the Weight of the Particles Before and After Trials

Initial Weight Filter Particle Weight

(mg) (mg)
Trial 1 79.6 78.1
Trial 2 84.7 37.4
Trial 3 92.7 42.6
Trial 4 85.4 82.2
Trial 5 87.3 28.1
Trial 6 84.7 22.7
Trial 7 88.0 70.4
Trial 8 108.4 83.0
Trial 9 80.7 15.6
Trial 10 82.0 51.9

Table 2. Overall Device Efficiencies for Three Filters Currently on the Market

AngioGuard AccuNet FilterWire

Trial 1 100 100 100
Trial 2 100 100 75.47
Trial 3 89.29 97.73 100
Trial 4 94.74 100 78.85
Trial 5 100 90.91 100

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