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Brian Saltzman MD. Beth Israel-Deaconess Medical Center Harvard Medical School, and Staghorn Stones
Laser Boston, MA. and Josef Hochman, BSc. EE.Direx Systems Corporation, Natick, MA Treated With the Nova
American Urology Associaton Congress Ultima (Direx).80 Cases
Radiotherapy Evaluation of a Bifocal
Focal Cross-Section, the Truncated Focal Area and the Truncated Volume: Reflector on a Clinical
Orthopaedics Lithotripter
Abstract

The Peak Pressure at F2 and the Focal Area are the traditional parameters used to
compare the performance and effectiveness of the Shock Wave produced by different
lithotripters.

Lately, new electromagnetic lithotripters were introduced, some with higher Focal Peak
Pressure. This fact may lead to believe that they are more efficient than the traditional
spark gap systems.

At the same time all electromagnetic systems have very thin focal areas, much smaller
than the typical stone size, and therefore the available energy is not optimized for stone
fragmentation, usually requiring much more shocks compared to a traditional
Electrohydraulic lithotripter.

The Focal Cross Section at F2, the Truncated Focal Area and Volume are 3 new tools
which allow a more accurate evaluation of the Shock Wave characteristics and
efficiency of different lithotripters.

Eleven currently used lithotripters including the Dornier HM-3 were compared:
The results show two categories of Lithotripters:

a) Large Focus: Dornier HM-3, Medstone STS-T, Direx Tripter Compact and Medispec
Econolith.

b) Small Focus: All electromagnetic lithotripters, plus Edap Praktis and the
Healthronics Lithotron.

The Average Focal Cross Section for Large Focus lithotripters is 5 times bigger than
the small ones.

The Average Truncated Area is 2.35 times bigger and the Average Truncated Volume is
5 times bigger in Big Focus Lithotripters compared to Small Focus ones.

This may help to explain why usually the electromagnetic lithotripters require much
more shocks to break stones and have larger retreatment rates.

Introduction

Various lithotripters using different Shock Wave technologies are currently offered to
treat stones in the urinary tract.

In order to compare the various systems offered, Urologists analyze their technical
specifications to evaluate their performance. (Ref 1)

Traditionally the Peak Bar Pressure at F2 is the first parameter considered as an

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indicator of the available energy of a lithotripter and, therefore, has served as a first
indicator of the efficiency of the system.

Some confusion existed in the past regarding the numerical value of this Pressure at
F2.

Due to specific conditions of the Shock Waves, the measurements done with the older
Piezoelectric Crystal sensors lead to erroneous high values of pressure (above
thousand bars).

During the last years a new precise sensor made of a membrane of Poly Vinyl Duo
Fluoride (PVDF) was developed and adopted by FDA as the only one to be used in
Pressure measurements (Ref 2).

Using PVDF, the pressure values recorded are "smaller" compared to old Piezoelectric
Crystal sensors, but obviously this is are more accurate and "real" values.

Recently, new Electromagnetic lithotripters were introduced some of them with higher
Peak Bar Pressure. This fact leads one to believe that they are more efficient than the
traditional spark gap systems.

Looking carefully we can see that this may be misleading.

A correct analysis requires one to look not only at the Peak Bar pressure but also at the
focal area geometric dimensions.

All Electromagnetic systems have very thin focal areas - much smaller than the typical
stone size-and, therefore the available energy is not optimized for stone fragmentation.

The Total Focal Area which is also used sometimes to compare different lithotripters
may be misleading too, because it does not take into account the fact that the typical
stone size is much smaller than the long axis of the Focal ellipse and therefore a big
portion of the energy is not applied to the stone.

In order to clarify this issue three new tools were developed and are presented:

a) The Focal Cross Section

b) The Truncated Ellipse Focal Area

c) The Truncated Focal Volume.

They will allow a more precise geometrical comparison of the Focal Areas of different
lithotripters and hence their effectiveness.

Materials and Methods

Specifications of 11 currently used lithotripters were used from published references

(Ref 1).

The distribution of pressure of a lithotripter is centered at the focal point F2 and

includes all points whose pressure is between 100% ( f2) and 50% of the Peak Power(
6 dB).

The shape of this focal volume is approximately an ellipsoid (a "cigar" or "watermelon"

shape) (Ref 2).
This ellipsoid volume is obtained by rotating the focal ellipse around the long axis.

The geometric specifications of the focal area are the Long Dimension (LD) and Short
Dimension (SD) of the ellipse and ellipsoid. The (a) Long radius and (b) Short Radius
equal half of the previous values respectively.

1) Focal Area Cross Section (FACS)

The easiest way of visualizing how much of the stone is subjected to pressure is to
look at the Cross Section of the ellipsoid at F2 (Like "cutting" the ellipsoid/cigar at F2
and looking at the circle that originated).
We can calculate the Cross Section area using the formula of the circle area

b = Focal Short Radius =SD/2

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SD=Focal Short Dimension (diameter)

2) Ellipse shape geometric function

3) Ellipse Focal Area (EFA)

Using the ellipse Long Radius a , and the Short Radius b, we can calculate the full
Ellipse area using the formula

4) Truncated Ellipse Focal Area (TEFA)

Using the Long Radius a, and the Short Radius b, we can calculate the Truncated
Ellipse area using the formula5) Ellipsoid Focal Volume (EFV)

5) Ellipsoid Focal Volume (EFV)

6) Truncated Ellipsoid Focal Volume (TEFV)

Results

Calculations and graphs were made using the Excel (Microsoft) Program 1)

1) Focal Area Cross Section

Focal Cross Sections at F2

Circle Cross
Manufacturer Model Diameter
# Section
Short
Area
Dimension

SD(mm) (mm 2)

1 1 Dornier Doli S 5 20

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2 Siemens Lithostar 5 20
3 Edap Praktis 5 20
4 Storz Modulith 6 28
5 Siemens Modularis 6 28
Compact
6 Dornier 7.7 47
Delta
7 Healthronics Lithotron 8 50
8 Medispec Econolith 13 133
Tripter
9 Direx 13.5 143
Compact
10 Medstone STS-T 15 177
11 Dornier HM-3 15 177

Average Large Focal Areas 157

Standard Deviation Average
23
Small Focal Areas Standard
Deviation 30

13

Small Focal Areas Large Focal Areas

Table and Graph # 1

2) The Truncated Ellipse Focal Area

The Graph below represents all focal ellipses and their truncation.

Truncation of Focal Ellipses

Table and Graph # 2

3) Truncated Ellipse Focal Area

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Table and Graph # 3

4) Truncated Ellipsoid Focal Volume

Table and Graph #4

Discussion

Analyzing the results shown in Tables #1 through #4, we may distinguish two
categories of Lithotripters:

1. Large Focus: 4 lithotripters are in this category:

Dornier HM-3, Medstone STS-T, Direx Tripter Compact, and Medispec Econolith.

2. Small Focus: 7 Lithotripters are in this category:Storz Modulith, Dornier Doli S,

Dornier Compact Delta, Siemens Lithostar, Siemens Modularis (All
electromagnetic lithotripters), Edap Praktis, and the Healthronics Lithotron

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(Spark Gap)

Cross Cross Truncated Truncated Truncated Truncated

Section Section Area Area Volume Volume
Average Standard Average Standard Average Standard
Deviation Deviation Deviation

a)Large 157 23 (15%) 209 16 (8%) 2306 343

Focus (15%)

b) 30 13 (43%) 89 19 (21%) 435 191

Small (44%)
Focus

Ratio 5.23 5.3

2.35
a/b

The 2 categories of Lithotripters are clearly differentiated, the ration of their

Cross Sections, Areas and Volumes are between 2.35 and 5.3.

The Large Focus group is more homogeneous (Standard Deviation 8 to 15 %) ,

whereas the Small Focus is less (Standard Deviation 21% to 44 %). This is due
to the fact that the Dornier Delta and Healthronics Lithotron have relatively
bigger dimensions than the rest of the group, but still far form the Large Focus
group.

ALL Large Focus Lithotripters use the Spark Gap technology.

ALL Electromagnetic units fall into the Small Focus category.

Two Spark Gap units are also in the Small Focus category: Edap Praktis and
Healthronics Lithotron.

The Edap Praktis, although basically a Spark Device, uses a variation of what is called
the Electroconductive Technology.

The purpose of this technology is to reduce the pressure fluctuation between shocks.
In order to achieve this, the system uses a special electrode in a highly conductive
liquid, with a very small gap and as a result, the focal volume is much smaller than
conventional Spark Gap devices.

It can be seen on Graph # 1, that the Large Focus Lithotripters will " cover" most of the
stone areas at F2 ( diameter 13 to 15 mm) whereas the Small Focus ones will cover
only a fraction of the typical stone.

This may explain why the electromagnetic devices typically require significantly more
shocks to adequately fragment kidney stones and also may result in higher retreatment
rates.

Recently, concerns have been raised ( Ref 5) regarding the fact that some new
Electromagnetic Lithotripters that have very small focal areas and extremely high peak
positive pressures are reporting higher clinically significant hematoma rates of 3 to
12% (Ref 6,7 and 8). A trend that is worrisome.

It is becoming clear that the electromagnetic devices with very long and thin focal
area/volumes are not suited to fragment stones.

The Truncated Areas and Volumes are intended to advance the discussion relative to
the effectiveness of various lithotripters.

References

1. J. Stuart Wolf, Jr. M.D. Issues in choosing a Lithotriptor: Concepts in Design and use.
AUA, 2001.

2. Lewin P.A. and Schafer M.E. "Shock Wave sensors: Requirements and Design. J.
Lithotripsy and Stone Disease vol. 3 pp 3-17, 1991.

3. IEC International Standard pressure Pulse Lithotripters-Characteristics of Fields.

1998 -04 Annex C, page 21.

4. FDA Guidance for the Content of Premarket Notifications (510 k) for Extracorporeal
Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral
Calculi. August 9, 2000. Page 6.

5. 1st International Consultation on Stone Disease Committee 8: Bioeffects and

Physical Mechanisms of SW Effects in SWL. Chairman: James E. Lingeman, M.D. et al.

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6. Kohrmann KU, Rassweiler JJ, Manning M, et al. The clinical introduction of a third
generation lithotriptor Modulith SL 20. Journal of Urology, 1995; 153:1379-1383.

7. Stefan T, Thorsten B, Chaussy C. Reduced retreatment rate by anatomy related

shockwave (SW) energy. Journal of Urology, 1998; 159:S34 (abstract).

8. Piper NY, Dalrymple N, Bishoff JT. Incidence of renal hematoma formation after
ESWL using the new Dornier Doli-S lithotriptor. Journal of Urology, 2001; 165:S377
(abstract).

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